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MCL: Ibrutinib could become the ‘new standard’
First-line patients fared well on ibrutinib, a Bruton’s tyrosine kinase inhibitor, according to the findings.
“Based on the results so far ... at least for the majority of patients, ibrutinib early will become the new standard,” said study lead author Martin Dreyling, MD, associate professor of medicine at Ludwig Maximilian University (LMU) Munich. Dr. Dreyling spoke in a news briefing and at a separate presentation at the annual meeting of the American Society of Hematology. “It might well be that specific subsets of patients may benefit from autologous transplant.”
MCL is a rare form of non-Hodgkin’s lymphoma that strikes cells in the mantle zone of lymph nodes. It is usually diagnosed in older men and often presents at an advanced stage. Multiple available treatments include rituximab/bendamustine, CAR-T cell therapy, stem cell transplants, and Bruton’s tyrosine kinase inhibitors. Ibrutinib is approved by the Food and Drug Administration only for refractory/relapsed cases, however.
Dr. Dreyling was a pioneer in confirming benefit from stem-cell transplants for MCL. “However,” he said, “no one likes autologous transplant because it also has side effects.”
For the new open-label study, Dr. Dreyling and colleagues in the European MCL Network in 2016 began recruiting patients with newly diagnosed, advanced stage II-IV MCL. The patients were younger than 65.
The subjects were randomly assigned to three trial arms: Standard treatment (high-dose cytarabine followed by autologous stem cell transplant and rituximab maintenance, n = 288), the standard treatment plus ibrutinib (n = 292), and ibrutinib without stem cell transplant (n = 290). The median age was 57, and 76% of patients were male.
The primary endpoint was failure-free survival at 31 months. Standard therapy was not superior to the ibrutinib without transplant group (72% vs. 86%, respectively, P = .9979). However, standard therapy with ibrutinib was superior to the standard therapy group (88% vs. 72%, respectively, P = .0008). The researchers haven’t finished their analysis of standard therapy with ibrutinib vs. ibrutinib without transplant.
Subjects in the standard therapy plus ibrutinib arm had more grade 3-5 adverse events than did the standard therapy and ibrutinib without transplant groups: Neutropenia, 44%, 17%, and 23%, respectively; leukopenia, 4%, 2%, and 2%; febrile neutropenia, 6%, 3%, and 3%; infections and infestations, 25%, 13%, and 19%; and cardiac disorders, 3%, 1%, 4%. P values were not provided.
In an interview, Ohio State University hematologist Narendranath Epperla, MD, MS, who was not involved in the study, said that this research reflects efforts to understand how novel agents such as ibrutinib and cellular therapies fit into MCL treatment. “We are trying to incorporate them in the frontline setting with either chemo backbone or with other targeted agents to improve outcomes and minimize toxicity. We are also trying to understand in whom auto-HCT can be precluded.”
The results of the new study appear promising, Dr. Epperla said, but he questioned the primary endpoint (failure-free survival instead of progress-free survival) and the short duration of the trial.
“I would like to see how the patients with high-risk features such as TP53 mutation, complex cytogenetics, and blastoid/pleomorphic variants did on the three arms,” Dr. Epperla said. “And I would like to see longer follow-up data before adapting this – [addition] of ibrutinib to the chemotherapy backbone without auto-HCT – into clinical practice.”
What’s next? Dr. Dreyling said that upcoming data will provide further insight into ibrutinib vs. stem-cell transplantation. And “within the next half year or so,” he said, “there will be a next generation of studies challenging chemotherapy overall in mantle cell lymphoma and substituting targeted treatment, hopefully achieving much better tolerability.”
Funding information was not provided. Dr. Dreyling disclosed ties with Lilly/Loxo, AstraZeneca, Novartis, Amgen, Roche, Janssen, Gilead/Kite, BMS/Celgene, Bayer, Abbvie, and Beigene. The other study authors reported various disclosures. Dr. Epperla disclosed a relationship with Pharmacyclics.
First-line patients fared well on ibrutinib, a Bruton’s tyrosine kinase inhibitor, according to the findings.
“Based on the results so far ... at least for the majority of patients, ibrutinib early will become the new standard,” said study lead author Martin Dreyling, MD, associate professor of medicine at Ludwig Maximilian University (LMU) Munich. Dr. Dreyling spoke in a news briefing and at a separate presentation at the annual meeting of the American Society of Hematology. “It might well be that specific subsets of patients may benefit from autologous transplant.”
MCL is a rare form of non-Hodgkin’s lymphoma that strikes cells in the mantle zone of lymph nodes. It is usually diagnosed in older men and often presents at an advanced stage. Multiple available treatments include rituximab/bendamustine, CAR-T cell therapy, stem cell transplants, and Bruton’s tyrosine kinase inhibitors. Ibrutinib is approved by the Food and Drug Administration only for refractory/relapsed cases, however.
Dr. Dreyling was a pioneer in confirming benefit from stem-cell transplants for MCL. “However,” he said, “no one likes autologous transplant because it also has side effects.”
For the new open-label study, Dr. Dreyling and colleagues in the European MCL Network in 2016 began recruiting patients with newly diagnosed, advanced stage II-IV MCL. The patients were younger than 65.
The subjects were randomly assigned to three trial arms: Standard treatment (high-dose cytarabine followed by autologous stem cell transplant and rituximab maintenance, n = 288), the standard treatment plus ibrutinib (n = 292), and ibrutinib without stem cell transplant (n = 290). The median age was 57, and 76% of patients were male.
The primary endpoint was failure-free survival at 31 months. Standard therapy was not superior to the ibrutinib without transplant group (72% vs. 86%, respectively, P = .9979). However, standard therapy with ibrutinib was superior to the standard therapy group (88% vs. 72%, respectively, P = .0008). The researchers haven’t finished their analysis of standard therapy with ibrutinib vs. ibrutinib without transplant.
Subjects in the standard therapy plus ibrutinib arm had more grade 3-5 adverse events than did the standard therapy and ibrutinib without transplant groups: Neutropenia, 44%, 17%, and 23%, respectively; leukopenia, 4%, 2%, and 2%; febrile neutropenia, 6%, 3%, and 3%; infections and infestations, 25%, 13%, and 19%; and cardiac disorders, 3%, 1%, 4%. P values were not provided.
In an interview, Ohio State University hematologist Narendranath Epperla, MD, MS, who was not involved in the study, said that this research reflects efforts to understand how novel agents such as ibrutinib and cellular therapies fit into MCL treatment. “We are trying to incorporate them in the frontline setting with either chemo backbone or with other targeted agents to improve outcomes and minimize toxicity. We are also trying to understand in whom auto-HCT can be precluded.”
The results of the new study appear promising, Dr. Epperla said, but he questioned the primary endpoint (failure-free survival instead of progress-free survival) and the short duration of the trial.
“I would like to see how the patients with high-risk features such as TP53 mutation, complex cytogenetics, and blastoid/pleomorphic variants did on the three arms,” Dr. Epperla said. “And I would like to see longer follow-up data before adapting this – [addition] of ibrutinib to the chemotherapy backbone without auto-HCT – into clinical practice.”
What’s next? Dr. Dreyling said that upcoming data will provide further insight into ibrutinib vs. stem-cell transplantation. And “within the next half year or so,” he said, “there will be a next generation of studies challenging chemotherapy overall in mantle cell lymphoma and substituting targeted treatment, hopefully achieving much better tolerability.”
Funding information was not provided. Dr. Dreyling disclosed ties with Lilly/Loxo, AstraZeneca, Novartis, Amgen, Roche, Janssen, Gilead/Kite, BMS/Celgene, Bayer, Abbvie, and Beigene. The other study authors reported various disclosures. Dr. Epperla disclosed a relationship with Pharmacyclics.
First-line patients fared well on ibrutinib, a Bruton’s tyrosine kinase inhibitor, according to the findings.
“Based on the results so far ... at least for the majority of patients, ibrutinib early will become the new standard,” said study lead author Martin Dreyling, MD, associate professor of medicine at Ludwig Maximilian University (LMU) Munich. Dr. Dreyling spoke in a news briefing and at a separate presentation at the annual meeting of the American Society of Hematology. “It might well be that specific subsets of patients may benefit from autologous transplant.”
MCL is a rare form of non-Hodgkin’s lymphoma that strikes cells in the mantle zone of lymph nodes. It is usually diagnosed in older men and often presents at an advanced stage. Multiple available treatments include rituximab/bendamustine, CAR-T cell therapy, stem cell transplants, and Bruton’s tyrosine kinase inhibitors. Ibrutinib is approved by the Food and Drug Administration only for refractory/relapsed cases, however.
Dr. Dreyling was a pioneer in confirming benefit from stem-cell transplants for MCL. “However,” he said, “no one likes autologous transplant because it also has side effects.”
For the new open-label study, Dr. Dreyling and colleagues in the European MCL Network in 2016 began recruiting patients with newly diagnosed, advanced stage II-IV MCL. The patients were younger than 65.
The subjects were randomly assigned to three trial arms: Standard treatment (high-dose cytarabine followed by autologous stem cell transplant and rituximab maintenance, n = 288), the standard treatment plus ibrutinib (n = 292), and ibrutinib without stem cell transplant (n = 290). The median age was 57, and 76% of patients were male.
The primary endpoint was failure-free survival at 31 months. Standard therapy was not superior to the ibrutinib without transplant group (72% vs. 86%, respectively, P = .9979). However, standard therapy with ibrutinib was superior to the standard therapy group (88% vs. 72%, respectively, P = .0008). The researchers haven’t finished their analysis of standard therapy with ibrutinib vs. ibrutinib without transplant.
Subjects in the standard therapy plus ibrutinib arm had more grade 3-5 adverse events than did the standard therapy and ibrutinib without transplant groups: Neutropenia, 44%, 17%, and 23%, respectively; leukopenia, 4%, 2%, and 2%; febrile neutropenia, 6%, 3%, and 3%; infections and infestations, 25%, 13%, and 19%; and cardiac disorders, 3%, 1%, 4%. P values were not provided.
In an interview, Ohio State University hematologist Narendranath Epperla, MD, MS, who was not involved in the study, said that this research reflects efforts to understand how novel agents such as ibrutinib and cellular therapies fit into MCL treatment. “We are trying to incorporate them in the frontline setting with either chemo backbone or with other targeted agents to improve outcomes and minimize toxicity. We are also trying to understand in whom auto-HCT can be precluded.”
The results of the new study appear promising, Dr. Epperla said, but he questioned the primary endpoint (failure-free survival instead of progress-free survival) and the short duration of the trial.
“I would like to see how the patients with high-risk features such as TP53 mutation, complex cytogenetics, and blastoid/pleomorphic variants did on the three arms,” Dr. Epperla said. “And I would like to see longer follow-up data before adapting this – [addition] of ibrutinib to the chemotherapy backbone without auto-HCT – into clinical practice.”
What’s next? Dr. Dreyling said that upcoming data will provide further insight into ibrutinib vs. stem-cell transplantation. And “within the next half year or so,” he said, “there will be a next generation of studies challenging chemotherapy overall in mantle cell lymphoma and substituting targeted treatment, hopefully achieving much better tolerability.”
Funding information was not provided. Dr. Dreyling disclosed ties with Lilly/Loxo, AstraZeneca, Novartis, Amgen, Roche, Janssen, Gilead/Kite, BMS/Celgene, Bayer, Abbvie, and Beigene. The other study authors reported various disclosures. Dr. Epperla disclosed a relationship with Pharmacyclics.
AT ASH 2022
‘Clear answer’: ALL study defies conventional wisdom
The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.
“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.
Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.
There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.
He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.
Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”
“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.
“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
Complex design
The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.
One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.
Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.
Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.
Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.
High-dose methotrexate was given at a dose of 5 g/m2 for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
Equivocal conclusions
As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).
There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).
An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.
In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.
The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.
UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.
“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.
Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.
There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.
He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.
Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”
“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.
“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
Complex design
The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.
One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.
Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.
Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.
Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.
High-dose methotrexate was given at a dose of 5 g/m2 for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
Equivocal conclusions
As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).
There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).
An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.
In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.
The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.
UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The same study also addressed two other issues related to standard care for these patients: 1) the dosage of dexamethasone used during the first treatment phase (results of which had already been reported some years ago) and 2) the impact of omitting monthly pulses of dexamethasone and vincristine after initial treatment.
“The trial did not give us the answers we were looking for, but that’s why we do randomized trials, and at least we have one clear answer, which is that high-dose methotrexate does not seem to have benefit in reducing the risk of CNS relapse,” reported study investigator Ajay Vora, MSc, from Great Ormond Street Hospital, London.
Among 1,570 patients randomly assigned in one group of the UKALL2011 trial, 5-year rates of CNS relapse were identical at 5.6% for patients treated with either high-dose methotrexate or standard interim maintenance with oral mercaptopurine and oral and intrathecal methotrexate.
There was a hint, however, that high-dose methotrexate could have a beneficial effect by reducing relapses in bone marrow for some subgroups of patients with B-lineage disease after dexamethasone induction, Dr. Vora commented.
He was speaking at a press briefing at the annual meeting of the American Society of Hematology, prior to the presentation of the data by Amy A. Kirkwood, MSc, from the University College London Cancer Institute.
Reacting to the results, Cynthia E. Dunbar, MD, chief of the Translational Stem Cell Biology Branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., emphasized that “in patients treated with the UKALL regimen, high doses of methotrexate did not reduce the rate of CNS relapse, contrary to our long-standing beliefs.”
“Going forward, patients can be spared the risk of high-dose methotrexate without increasing their risk of recurrence in the central nervous system,” she said.
“As researchers in hematology, we look at it as our duty to question the standard approaches that we use to treat patients, even those that we thought of as tried-and-true,” said briefing moderator Mikkael Sekeres, MD, of the Sylvester Comprehensive Cancer Center at the University of Miami. This is one of the abstracts that “challenge some of those standards and in fact reveal that in many cases, giving less therapy and being less restrictive is actually better for patients or at least no worse.”
Complex design
The UKALL2011 trial had a byzantine design, with the overarching goal of finding out which treatment and maintenance strategy best finds the sweet spot between efficacy and toxicity in children and young adults (up to age 25) with ALL and lymphoblastic lymphoma.
One question that was already answered, as investigators reported at the 2017 ASH annual meeting, came from the first randomization in the study, designed to see whether a shorter course of dexamethasone – 14 days versus the standard 28 days – could reduce induction toxicity. It did not.
Now, at ASH 2022, the investigators reported outcomes from the second phase of the trial, which included two randomizations: one comparing high-dose methotrexate with standard interim maintenance to reduce CNS relapse risk, and one to see whether forgoing pulses of vincristine/dexamethasone could reduce maintenance morbidity.
Patients were stratified by National Cancer Institute minimal residual disease (MRD) risk categories, cytogenetics, and end-of-induction MRD to receive one of three treatment regimens. Patients with MRD high risk, defined as MRD greater than 0.5% at the end of consolidation, were not eligible for second-phase randomization and instead received off-protocol therapies.The second randomization was factorial, stratified by NCI and MRD risk groups, resulting in four arms: high-dose methotrexate with or without pulses and standard interim maintenance with our without pulses.
Standard interim maintenance in this trial was 2 months of oral mercaptopurine/methotrexate monthly pulses and single intrathecal methotrexate in two of the regimens, as well as five doses of escalating intravenous methotrexate plus vincristine and two doses of pegylated asparaginase in the third.
High-dose methotrexate was given at a dose of 5 g/m2 for four doses 2 weeks apart, low dose 6-mercaptopurine, plus two doses of pegylated asparaginase in one regimen only.
Equivocal conclusions
As noted above, CNS relapse, the primary endpoint for the interim maintenance randomization, did not differ between the groups, with identical 5-year relapse rates. Similarly, 5-year event-free survival (EFS) rates were 90.3% in the high-dose group and 89.5% in the standard group, a difference that was not statistically significant (P = .68).
There was, however, an interaction between the first (short- vs. standard-course dexamethasone) and the interim maintenance randomizations, indicating significantly inferior EFS outcomes for patients who had received the short dose of dexamethasone followed by high-dose methotrexate, especially among patients who did not receive pulses (P = .006).
An analysis of patients treated with standard dexamethasone showed that those who received high-dose methotrexate had a lower risk for bone marrow relapse, with a hazard ratio of 0.62 (P = .029), and trends, albeit nonsignificant, toward better EFS and overall survival.
In addition, the overall results suggested that steroid pulses could be safely omitted without leading to an increase in bone marrow relapses: the 5-year rates of bone marrow relapse were 10.2% with pulses and 12.2% without, although omitting pulses was associated with a slight but significant decrease in EFS overall (P = .01). The effect was attenuated among patients who had received standard-course dexamethasone and high-dose methotrexate. Leaving out the pulses also reduced rates of grade 3 or 4 adverse events, including febrile neutropenia, Ms. Kirkwood noted in her presentation.
The investigators plan to analyze quality-of-life outcomes related to dexamethasone-vincristine pulses to see whether doing so could tip the balance in favor of leaving them out of therapy, and they will continue to follow patients to see whether their findings hold.
UKALL2011 was funded by Children with Cancer UK, Blood Cancer UK, and Cancer Research UK. Ms. Kirkwood disclosed consulting for and receiving honoraria from Kite. Dr. Vora reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ASH 2022
‘Astonishing’ results: Skip salvage chemo, proceed to HSCT
NEW ORLEANS –
The results come from the phase 3 ASAP Trial and were presented at the annual meeting of the American Society of Hematology.
“We selected this to be in the plenary because it completely changes how we’ve traditionally thought about acute myeloid leukemia,” commented press briefing moderator Mikkael A. Sekeres, MD, from the University of Miami, who also serves as chair of the ASH Committee on Communications.
“When we have a patient who has relapsed or refractory AML, that person is in a very, very difficult situation, and the mortality among those sort of patients is incredibly high,” Dr. Sekeres commented. “So traditionally we’ve given them very high doses of chemotherapy to try to reduce the tumor burden – at least that’s been the theory – to then get them successfully to a transplant.”
This new finding “completely upends that, if these results hold,” he said. The clinical implication is that “we no longer have to hospitalize these patients and give them very aggressive chemotherapy ... [and] we don’t introduce all the morbidity from giving them very high dose chemotherapy, which can actually prevent a transplant from happening if they get sick enough, and we can get them to a transplant quicker.”
The ASAP trial was conducted in patients with an unfavorable risk AML who either had a poor response to first induction therapy or a relapse after first induction therapy.
They were randomly assigned to either a remission-induction strategy aiming for a better response prior to an allogeneic hematopoietic stem cell transplant (alloHCT), or a disease-control strategy consisting primarily of watchful waiting with low-dose cytarabine and single doses of mitoxantrone as needed, followed by sequential conditioning and alloHCT.
The results after 4 years of follow-up showed no differences in either leukemia-free survival or overall survival between patients who underwent additional chemotherapy with the remission-induction strategy and those who went straight to transplant, reported Johannes Schetelig, MD, MSc, from the Clinical Trials Unit at DKMS, Dresden, Germany.
“We expected non-inferiority – this was what we tested, and of course this was based on an assumption that we could get close or even somewhat better with respect to the primary endpoint, disease-free survival, after transplantation,” he said.
“What we did not expect is that the early success, [complete response] on day 56 after transplantation, also translates into equal long-term benefit, so this is what I was really astonished about,” Dr. Schetelig said at a press briefing prior to his presentation.
Less intensive approach
Dr. Schetelig explained that the rationale for the study was previous work by his group and others showing that alloHCT in patients with residual aplasia after first induction is feasible, with favorable outcomes, compared with standard of care. Additionally, the impetus for the research was evidence that sequential conditioning based on high-dose cytarabine or melphalan plus reduced-intensity conditioning and alloHCT resulted in long-term control for relapsed or refractory AML.
Dr. Schetelig also gave details of the two treatment arms of the ASAP trial. The remission-inducing arm consisted of cytarabine (3 g/m2 for younger patients or 1 g/m2 for patients over age 60) twice daily on days 1-3 plus 10 mitoxantrone mg/m2 on days 3-5 and subsequent alloHCT. In the other group – disease control prior to sequential conditioning and alloHCT – watchful waiting was recommended, but low-dose cytarabine (LDAC) and single doses of mitoxantrone were permitted for disease control.
Although, as Dr. Schetelig noted, the statistical goal of the study was to show non-inferiority of the disease control arm, this less intensive strategy exceeded expectations for meeting the primary endpoint of disease-free survival (DFS; a maintained complete response) by day 56 after alloHCT.
In an intention-to-treat and per-protocol analysis, the respective rates of DFS at 56 days in the disease control group were 83.5% and 84.1%. In comparison, the respective rates in the remission-induction group were 81% and 81.3%.
Further, after a median follow-up from randomization of 37 months, there were no differences in either leukemia-free survival or overall survival out to 4 years after DFS at day 56.
The disease-control strategy was also associated with significantly fewer adverse events grade 3 or greater (23% vs. 64%, P < .001), and fewer days in hospital prior to transplant (mean 19 vs. 42, P < .001). There were no significant differences between the trial arms in either deaths within 28 days of randomization or time to discharge from hospital (28 days in each arm).
“These data support sequential conditioning and alloHCT without prior remission-induction chemotherapy whenever a stem cell donor is readily available,” the researchers concluded.
“These results underline the importance of facilitating alloHCT as [the] most effective anti-leukemic therapy in patients with [relapsed or refractory] AML and stress the need for starting donor search at diagnosis,” they added.
The study was sponsored by DKMS gemeinnützige GmbH. Dr. Schetelig disclosed honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Sekkeres reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW ORLEANS –
The results come from the phase 3 ASAP Trial and were presented at the annual meeting of the American Society of Hematology.
“We selected this to be in the plenary because it completely changes how we’ve traditionally thought about acute myeloid leukemia,” commented press briefing moderator Mikkael A. Sekeres, MD, from the University of Miami, who also serves as chair of the ASH Committee on Communications.
“When we have a patient who has relapsed or refractory AML, that person is in a very, very difficult situation, and the mortality among those sort of patients is incredibly high,” Dr. Sekeres commented. “So traditionally we’ve given them very high doses of chemotherapy to try to reduce the tumor burden – at least that’s been the theory – to then get them successfully to a transplant.”
This new finding “completely upends that, if these results hold,” he said. The clinical implication is that “we no longer have to hospitalize these patients and give them very aggressive chemotherapy ... [and] we don’t introduce all the morbidity from giving them very high dose chemotherapy, which can actually prevent a transplant from happening if they get sick enough, and we can get them to a transplant quicker.”
The ASAP trial was conducted in patients with an unfavorable risk AML who either had a poor response to first induction therapy or a relapse after first induction therapy.
They were randomly assigned to either a remission-induction strategy aiming for a better response prior to an allogeneic hematopoietic stem cell transplant (alloHCT), or a disease-control strategy consisting primarily of watchful waiting with low-dose cytarabine and single doses of mitoxantrone as needed, followed by sequential conditioning and alloHCT.
The results after 4 years of follow-up showed no differences in either leukemia-free survival or overall survival between patients who underwent additional chemotherapy with the remission-induction strategy and those who went straight to transplant, reported Johannes Schetelig, MD, MSc, from the Clinical Trials Unit at DKMS, Dresden, Germany.
“We expected non-inferiority – this was what we tested, and of course this was based on an assumption that we could get close or even somewhat better with respect to the primary endpoint, disease-free survival, after transplantation,” he said.
“What we did not expect is that the early success, [complete response] on day 56 after transplantation, also translates into equal long-term benefit, so this is what I was really astonished about,” Dr. Schetelig said at a press briefing prior to his presentation.
Less intensive approach
Dr. Schetelig explained that the rationale for the study was previous work by his group and others showing that alloHCT in patients with residual aplasia after first induction is feasible, with favorable outcomes, compared with standard of care. Additionally, the impetus for the research was evidence that sequential conditioning based on high-dose cytarabine or melphalan plus reduced-intensity conditioning and alloHCT resulted in long-term control for relapsed or refractory AML.
Dr. Schetelig also gave details of the two treatment arms of the ASAP trial. The remission-inducing arm consisted of cytarabine (3 g/m2 for younger patients or 1 g/m2 for patients over age 60) twice daily on days 1-3 plus 10 mitoxantrone mg/m2 on days 3-5 and subsequent alloHCT. In the other group – disease control prior to sequential conditioning and alloHCT – watchful waiting was recommended, but low-dose cytarabine (LDAC) and single doses of mitoxantrone were permitted for disease control.
Although, as Dr. Schetelig noted, the statistical goal of the study was to show non-inferiority of the disease control arm, this less intensive strategy exceeded expectations for meeting the primary endpoint of disease-free survival (DFS; a maintained complete response) by day 56 after alloHCT.
In an intention-to-treat and per-protocol analysis, the respective rates of DFS at 56 days in the disease control group were 83.5% and 84.1%. In comparison, the respective rates in the remission-induction group were 81% and 81.3%.
Further, after a median follow-up from randomization of 37 months, there were no differences in either leukemia-free survival or overall survival out to 4 years after DFS at day 56.
The disease-control strategy was also associated with significantly fewer adverse events grade 3 or greater (23% vs. 64%, P < .001), and fewer days in hospital prior to transplant (mean 19 vs. 42, P < .001). There were no significant differences between the trial arms in either deaths within 28 days of randomization or time to discharge from hospital (28 days in each arm).
“These data support sequential conditioning and alloHCT without prior remission-induction chemotherapy whenever a stem cell donor is readily available,” the researchers concluded.
“These results underline the importance of facilitating alloHCT as [the] most effective anti-leukemic therapy in patients with [relapsed or refractory] AML and stress the need for starting donor search at diagnosis,” they added.
The study was sponsored by DKMS gemeinnützige GmbH. Dr. Schetelig disclosed honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Sekkeres reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
NEW ORLEANS –
The results come from the phase 3 ASAP Trial and were presented at the annual meeting of the American Society of Hematology.
“We selected this to be in the plenary because it completely changes how we’ve traditionally thought about acute myeloid leukemia,” commented press briefing moderator Mikkael A. Sekeres, MD, from the University of Miami, who also serves as chair of the ASH Committee on Communications.
“When we have a patient who has relapsed or refractory AML, that person is in a very, very difficult situation, and the mortality among those sort of patients is incredibly high,” Dr. Sekeres commented. “So traditionally we’ve given them very high doses of chemotherapy to try to reduce the tumor burden – at least that’s been the theory – to then get them successfully to a transplant.”
This new finding “completely upends that, if these results hold,” he said. The clinical implication is that “we no longer have to hospitalize these patients and give them very aggressive chemotherapy ... [and] we don’t introduce all the morbidity from giving them very high dose chemotherapy, which can actually prevent a transplant from happening if they get sick enough, and we can get them to a transplant quicker.”
The ASAP trial was conducted in patients with an unfavorable risk AML who either had a poor response to first induction therapy or a relapse after first induction therapy.
They were randomly assigned to either a remission-induction strategy aiming for a better response prior to an allogeneic hematopoietic stem cell transplant (alloHCT), or a disease-control strategy consisting primarily of watchful waiting with low-dose cytarabine and single doses of mitoxantrone as needed, followed by sequential conditioning and alloHCT.
The results after 4 years of follow-up showed no differences in either leukemia-free survival or overall survival between patients who underwent additional chemotherapy with the remission-induction strategy and those who went straight to transplant, reported Johannes Schetelig, MD, MSc, from the Clinical Trials Unit at DKMS, Dresden, Germany.
“We expected non-inferiority – this was what we tested, and of course this was based on an assumption that we could get close or even somewhat better with respect to the primary endpoint, disease-free survival, after transplantation,” he said.
“What we did not expect is that the early success, [complete response] on day 56 after transplantation, also translates into equal long-term benefit, so this is what I was really astonished about,” Dr. Schetelig said at a press briefing prior to his presentation.
Less intensive approach
Dr. Schetelig explained that the rationale for the study was previous work by his group and others showing that alloHCT in patients with residual aplasia after first induction is feasible, with favorable outcomes, compared with standard of care. Additionally, the impetus for the research was evidence that sequential conditioning based on high-dose cytarabine or melphalan plus reduced-intensity conditioning and alloHCT resulted in long-term control for relapsed or refractory AML.
Dr. Schetelig also gave details of the two treatment arms of the ASAP trial. The remission-inducing arm consisted of cytarabine (3 g/m2 for younger patients or 1 g/m2 for patients over age 60) twice daily on days 1-3 plus 10 mitoxantrone mg/m2 on days 3-5 and subsequent alloHCT. In the other group – disease control prior to sequential conditioning and alloHCT – watchful waiting was recommended, but low-dose cytarabine (LDAC) and single doses of mitoxantrone were permitted for disease control.
Although, as Dr. Schetelig noted, the statistical goal of the study was to show non-inferiority of the disease control arm, this less intensive strategy exceeded expectations for meeting the primary endpoint of disease-free survival (DFS; a maintained complete response) by day 56 after alloHCT.
In an intention-to-treat and per-protocol analysis, the respective rates of DFS at 56 days in the disease control group were 83.5% and 84.1%. In comparison, the respective rates in the remission-induction group were 81% and 81.3%.
Further, after a median follow-up from randomization of 37 months, there were no differences in either leukemia-free survival or overall survival out to 4 years after DFS at day 56.
The disease-control strategy was also associated with significantly fewer adverse events grade 3 or greater (23% vs. 64%, P < .001), and fewer days in hospital prior to transplant (mean 19 vs. 42, P < .001). There were no significant differences between the trial arms in either deaths within 28 days of randomization or time to discharge from hospital (28 days in each arm).
“These data support sequential conditioning and alloHCT without prior remission-induction chemotherapy whenever a stem cell donor is readily available,” the researchers concluded.
“These results underline the importance of facilitating alloHCT as [the] most effective anti-leukemic therapy in patients with [relapsed or refractory] AML and stress the need for starting donor search at diagnosis,” they added.
The study was sponsored by DKMS gemeinnützige GmbH. Dr. Schetelig disclosed honoraria from BeiGene, BMS, Janssen, AstraZeneca, AbbVie, and DKMS. Dr. Sekkeres reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
AT ASH 2022
Post-transplant diet: Gruel no longer rules
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
NEW ORLEANS – A new Italian study yields more evidence that stem-cell transplant patients need not lose their appetites along with their immune systems. Low-bacterial, gruel-like diets, once the mainstay of immunity-lowering surgeries, don’t actually provide any protection against infections, researchers reported.
University of Miami hematologist Mikkael A. Sekeres, MD, MS, expressed delight to hear these findings.
“Around the world, we should eliminate these silly neutropenic diets, let people eat what they want, and give them a much better quality of life while they’re in the hospital,” said Dr. Sekeres, moderator of the news briefing where these research results were discussed at the annual meeting of the American Society of Hematology.
In recent decades, physicians and nutritionists have questioned the value of low-bacterial/neutropenic menus, designed to protect people with compromised immune systems from germs in food. These diets can be quite strict, outlawing food such as deli, processed, and cured meats; yogurt; hummus; strawberries and raspberries; lettuce; raw nuts; certain kinds of seafood; and herbs and spices such as pepper, unless they were cooked. Patients may be urged to avoid salad bars, buffets, and potlucks.
MD Anderson Cancer Center pediatrician Karen Moody, MD, MS, who has studied the diet, said in an interview that the diet has been around since the 1970s, despite a lack of evidence supporting it. “Cancer patients often suffer from treatment-related side effects that affect taste, appetite, and tolerance of food,” she said. “Further restricting food options in this population can be burdensome and reduce diet-related satisfaction.”
For the new multi-center, phase 3 study, researchers led by hematology resident Federico Stella, MD, of the University of Milan, randomly assigned consecutive adult patients undergoing hematopoietic stem cells transplantation or high-dose induction chemotherapy to either a low-bacterial diet (n = 224) or a non-restrictive diet (n = 224).
The low-bacterial diet emphasized food cooked to at least 176 degrees Fahrenheit and thick-skinned fruit. Raw fruits/vegetables, yogurt, honey, cold cuts and sausages, and raw fish and meat were forbidden.
The two groups were similar in age (median = 56 years), gender (about 57% male), and reason for admission (97% stem-cell transplants and 3% high-dose chemotherapy). The plan was to follow the patients for 100 days (stem-cell transplant recipients) or 30 days (high-dose chemotherapy patients).
No statistically significant differences between the group were found in the rates of infections of higher than Grade 2 (per CTCAE 4.0): These infections occurred in 38 (34%) of those on the low-bacterial diet and 44 (39%) of those on the non-restrictive diet (P = 0.5).
There were also no statistically significant differences in rates of fever of unknown origin (P = 0.2), sepsis (P = 0.5), and gastrointestinal infection (P = 0.7).
The findings show that the “use of a restrictive diet is an unnecessary burden for our patients’ quality of life,” said study lead author Dr. Stella at the news briefing.
Dr. Sekeres, the news briefing moderator, noted that the findings reflect his own suspicions about the worthlessness of the low-bacterial diet. “I’ve never seen a patient die of an infection that was foodborne. So years ago, when I was still in Cleveland, I eliminated the neutropenic diet on the leukemia floor. That did face a lot of resistance, as you can imagine. There were decades of people saying we should do this.”
Now, Dr. Sekeres said, he feels validated. “I love this study because it formalizes what I thought was true,” he said.
Dr. Moody said it’s difficult to evaluate the study since it’s in abstract form, and details are limited. “However,” she said, “the sample size, study design, and outcomes appear very appropriate, and I think most likely the full-length study will provide additional evidence to support abandonment of the low-microbial diet in transplant patients.”
Also, Dr. Moody said, the study “replicates the same findings of other prospective randomized trials of this diet that say it confers no protection from infection and has no identified health benefit whatsoever. Bottom line? This diet has burden without benefit.”
Moving forward, she said, “we need a lot more research on diet in general for cancer patients. Recently, there is a lot more interest in this topic. I think we are going to learn a lot in the next few decades about the relationship between diet, epigenetics, the microbiome, and various cancer-related health issues.”
No study funding was reported. Dr. Stella reports no disclosures, and other authors report various relationships with industry. Dr. Moody reports no disclosures, and disclosures for Dr. Sekeres were not available.
AT ASH 2022
Global effort needed to widen access to HSCT
The use of HSCT, the main curative option for AML, “remains unacceptably low,” commented Molly Tokaz, MD, a hematology/oncology fellow at the Fred Hutchinson Cancer Center, Seattle.
She was presenting the findings from a study of worldwide HSCT utilization at the annual meeting of the American Society of Hematology.
Globally, the incidence of AML has increased 16.2% – from 101,867 cases in 2009 to 118,404 in 2016, she noted. This in turn has led to a 54.9% increase in the worldwide use of HSCT for AML, from 9,659 to 14,965 transplants per year over the same period.
North America and Europe have the highest utilization rates of allogeneic HSCT for AML, but even so, fewer than 40% of patients have the procedure, raising a “question of how [well] we are prioritizing the use of HSCT, even in these resource-abundant health systems,” Dr. Tokaz said.
Meanwhile, in Africa, South America, and the Eastern Mediterranean, fewer than 5% of AML patients undergo transplant. Although “resource-constrained regions have the largest growth in HSCT use” in recent years, utilization rates remain abysmally low, “which has profound effects on the expected outcomes for patients in these regions,” she said.
Overall, “patients from lower- and middle-income countries face substantial barriers to accessing stem cell transplantation for AML,” commented Chancellor Donald, MD, a hematologist/oncologist at Tulane University, New Orleans, who moderated the session.
The “stark regional differences” illustrate “inequities in the delivery of stem cell transplants” but also opportunities “to improve access to this potentially curative treatment,” he said.
The goal of the study was to establish a global baseline of HSCT utilization to help focus future expansion efforts aimed at closing regional access gaps. It shows there is much work to be done, Dr. Tokaz said.
An international effort is needed to address the issue, including better data collection, implementation of regional HSCT programs, increased representation of ethnic and racial minorities in international donor registries, and other measures. In many cases, telemedicine can help with sharing cross-border expertise.
In short, what’s needed is a “comprehensive global effort to improve outcomes for patients with AML” worldwide, Dr. Tokaz said.
Timing of transplant is similar across regions, generally coming during the first complete remission, and there’s also been a global shift toward collecting stem cells from peripheral blood.
There has also been a marked shift away from autologous procedures and toward allogeneic transplants, she said.
A key difference between regions, however, is that while more than half of transplants are from unrelated donors in Europe and North America, almost all are from related donors in Africa and the Eastern Mediterranean, with an increasing proportion of haploidentical donors. In addition, the majority of transplants in Asia, the western Pacific, and South America are from related donors.
The use of related donors has implications for HSCT treatment algorithms and outcomes, Dr. Tokaz said.
The estimates of AML incidence were obtained from the 2019 Global Burden of Disease study. Data on HSCT utilization came from the Worldwide Network for Blood and Marrow Transplantation. No funding source was reported. Dr. Tokaz reports no relevant financial relationships, but some co-authors had numerous industry ties. Dr. Donald reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The use of HSCT, the main curative option for AML, “remains unacceptably low,” commented Molly Tokaz, MD, a hematology/oncology fellow at the Fred Hutchinson Cancer Center, Seattle.
She was presenting the findings from a study of worldwide HSCT utilization at the annual meeting of the American Society of Hematology.
Globally, the incidence of AML has increased 16.2% – from 101,867 cases in 2009 to 118,404 in 2016, she noted. This in turn has led to a 54.9% increase in the worldwide use of HSCT for AML, from 9,659 to 14,965 transplants per year over the same period.
North America and Europe have the highest utilization rates of allogeneic HSCT for AML, but even so, fewer than 40% of patients have the procedure, raising a “question of how [well] we are prioritizing the use of HSCT, even in these resource-abundant health systems,” Dr. Tokaz said.
Meanwhile, in Africa, South America, and the Eastern Mediterranean, fewer than 5% of AML patients undergo transplant. Although “resource-constrained regions have the largest growth in HSCT use” in recent years, utilization rates remain abysmally low, “which has profound effects on the expected outcomes for patients in these regions,” she said.
Overall, “patients from lower- and middle-income countries face substantial barriers to accessing stem cell transplantation for AML,” commented Chancellor Donald, MD, a hematologist/oncologist at Tulane University, New Orleans, who moderated the session.
The “stark regional differences” illustrate “inequities in the delivery of stem cell transplants” but also opportunities “to improve access to this potentially curative treatment,” he said.
The goal of the study was to establish a global baseline of HSCT utilization to help focus future expansion efforts aimed at closing regional access gaps. It shows there is much work to be done, Dr. Tokaz said.
An international effort is needed to address the issue, including better data collection, implementation of regional HSCT programs, increased representation of ethnic and racial minorities in international donor registries, and other measures. In many cases, telemedicine can help with sharing cross-border expertise.
In short, what’s needed is a “comprehensive global effort to improve outcomes for patients with AML” worldwide, Dr. Tokaz said.
Timing of transplant is similar across regions, generally coming during the first complete remission, and there’s also been a global shift toward collecting stem cells from peripheral blood.
There has also been a marked shift away from autologous procedures and toward allogeneic transplants, she said.
A key difference between regions, however, is that while more than half of transplants are from unrelated donors in Europe and North America, almost all are from related donors in Africa and the Eastern Mediterranean, with an increasing proportion of haploidentical donors. In addition, the majority of transplants in Asia, the western Pacific, and South America are from related donors.
The use of related donors has implications for HSCT treatment algorithms and outcomes, Dr. Tokaz said.
The estimates of AML incidence were obtained from the 2019 Global Burden of Disease study. Data on HSCT utilization came from the Worldwide Network for Blood and Marrow Transplantation. No funding source was reported. Dr. Tokaz reports no relevant financial relationships, but some co-authors had numerous industry ties. Dr. Donald reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
The use of HSCT, the main curative option for AML, “remains unacceptably low,” commented Molly Tokaz, MD, a hematology/oncology fellow at the Fred Hutchinson Cancer Center, Seattle.
She was presenting the findings from a study of worldwide HSCT utilization at the annual meeting of the American Society of Hematology.
Globally, the incidence of AML has increased 16.2% – from 101,867 cases in 2009 to 118,404 in 2016, she noted. This in turn has led to a 54.9% increase in the worldwide use of HSCT for AML, from 9,659 to 14,965 transplants per year over the same period.
North America and Europe have the highest utilization rates of allogeneic HSCT for AML, but even so, fewer than 40% of patients have the procedure, raising a “question of how [well] we are prioritizing the use of HSCT, even in these resource-abundant health systems,” Dr. Tokaz said.
Meanwhile, in Africa, South America, and the Eastern Mediterranean, fewer than 5% of AML patients undergo transplant. Although “resource-constrained regions have the largest growth in HSCT use” in recent years, utilization rates remain abysmally low, “which has profound effects on the expected outcomes for patients in these regions,” she said.
Overall, “patients from lower- and middle-income countries face substantial barriers to accessing stem cell transplantation for AML,” commented Chancellor Donald, MD, a hematologist/oncologist at Tulane University, New Orleans, who moderated the session.
The “stark regional differences” illustrate “inequities in the delivery of stem cell transplants” but also opportunities “to improve access to this potentially curative treatment,” he said.
The goal of the study was to establish a global baseline of HSCT utilization to help focus future expansion efforts aimed at closing regional access gaps. It shows there is much work to be done, Dr. Tokaz said.
An international effort is needed to address the issue, including better data collection, implementation of regional HSCT programs, increased representation of ethnic and racial minorities in international donor registries, and other measures. In many cases, telemedicine can help with sharing cross-border expertise.
In short, what’s needed is a “comprehensive global effort to improve outcomes for patients with AML” worldwide, Dr. Tokaz said.
Timing of transplant is similar across regions, generally coming during the first complete remission, and there’s also been a global shift toward collecting stem cells from peripheral blood.
There has also been a marked shift away from autologous procedures and toward allogeneic transplants, she said.
A key difference between regions, however, is that while more than half of transplants are from unrelated donors in Europe and North America, almost all are from related donors in Africa and the Eastern Mediterranean, with an increasing proportion of haploidentical donors. In addition, the majority of transplants in Asia, the western Pacific, and South America are from related donors.
The use of related donors has implications for HSCT treatment algorithms and outcomes, Dr. Tokaz said.
The estimates of AML incidence were obtained from the 2019 Global Burden of Disease study. Data on HSCT utilization came from the Worldwide Network for Blood and Marrow Transplantation. No funding source was reported. Dr. Tokaz reports no relevant financial relationships, but some co-authors had numerous industry ties. Dr. Donald reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASH 2022
Poorly matched stem cell transplants linked to ancestry
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
There is “an intersectionality between ancestry and socioeconomic status and an association with donor type, with the most vulnerable patients” – those of non-European ancestry with low socioeconomic status (SES), especially people of African ancestry – “receiving the most complex [i.e., human leukocyte antigen (HLA)–disparate] transplants,” said lead investigator Warren Fingrut, MD, a research fellow in the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center, New York.
“Successful extension of transplant access to minority patients will be contingent on addressing [their] financial hardship,” said Dr. Fingrut, who presented the findings at the meeting.
To better channel support services and ensure that resources are available, he also noted that centers will have to do a better job of identifying patients with financial struggles.
“Household income data is not collected at our center, and neither is it collected at most centers,” hence assessments of SES are based on imperfect surrogates, such as neighborhood poverty by zip code. “Interventions to advance equity will require better SES classifications or detailed recording of household income,” Dr. Fingrut said.
Overall, the study highlights “inequities in the delivery of stem cell transplants,” pointing to opportunities “to improve access to this potentially curative treatment,” said hematologist/oncologist Chancellor Donald, MD, of Tulane University, New Orleans, who moderated the study presentation.
Dr. Donald said that the new research shows “how interactions between racial backgrounds and socioeconomic status relate to the type of allogenic stem cell transplant patients receive.” The team “identified that [people] of non-European ancestry and especially those of low SES, are more likely to receive the most specialized type of allogeneic stem cell transplantation, which notably require the highest level of care,” Dr. Donald said.
The investigators reviewed 372 consecutive adults transplanted at MSKCC from March 2020 to February 2022, mostly for myeloid malignancies.
Thirty-one percent of patients had non-European ancestry, including 11% of African, 9% of Asian, and 8% of White Hispanic descent.
With no information about household income, the team used neighborhood poverty (which affected 5% of patients); Medicaid as the primary insurance (6% of patients), and financial support for living and medical expenses (19%) as surrogates of lower SES. Classification depended largely on what criteria were used, with only 20 patients meeting two criteria and only one patient meeting all three.
Overall, more than half (58%) of non-European ancestry patients received HLA-disparate grafts, compared with 24% of people with European ancestry, including 48% of White Hispanic patients, 58% of Asian patients, and 78% of patients of African decent.
Markers of lower SES were more common among non-European patients. For instance, among people of European ancestry, 4% were on Medicaid and 15% were on financial aid, versus 10% on Medicaid and 29% on financial support among people of other ancestries. Medicaid use (12.5%) and financial aid (42.5%) were highest among patients of African descent.
Among patients who received HLA-disparate grafts, patients of non-European descent were three times more likely to be on Medicaid (12% versus 4%) and more than twice as likely to be on financial support (33% versus 15%).
People of African ancestry who received HLA-disparate grafts had the highest proportions of Medicaid reliance (16%) and financial support (45%).
FROM ASH 2022
For minorities with PE: Less advanced treatment, more mortality
NEW ORLEANS –
According to the research, released at the annual meeting of the American Society of Hematology, the biggest disparities affected Asian/Pacific Islander patients with PE. While they were the least likely among ethnic groups to be hospitalized for PE, the odds were 53% higher that they’d die in the hospital (adjusted odds ratio, 1.53; 95% confidence interval, 1.32-1.78), and 24% lower that they would get advanced therapies (aOR, 0.76; 95% CI, 0.59-0.98, P values not provided in this study).
“The findings really raise the importance of this research area and call for vigorous future research to try to better identify why we see these patterns and then come up with solutions to solve them,” said hematologist and study coauthor Mary Cushman, MD, of the University of Vermont, Burlington, at an ASH news briefing.
As Dr. Cushman noted, details about disparities in PE care are limited. It’s known that “Black people have a twofold greater mortality from pulmonary embolism compared to other groups, and this is a persistently observed disparity over many years,” she said. However, “little is known about the relationships of social determinants with treatment and course of pulmonary embolism,” she added.
The researchers used data from the Nationwide Inpatient Sample to track 1.1 million U.S. hospitalized patients with PE from 2016 to 2018. PE was the primary diagnosis in 615,570 patients (54.8%), and 66,570 (5.9%) had high-risk PE.
Among ethnic groups, hospitalization rates “differed pretty dramatically,” Dr. Cushman said. The researchers found that Blacks had the highest rate of PE hospitalization (20.1 per 10,000 person-years; 95% CI, 20.0-20.2), followed by Whites (13.1 per 10,000 person-years; 95% CI, 13.1-13.2), Hispanics (6.0 per 10,000 person-years; 95% CI, 5.9-6.1), Native Americans (5.6 per 10,000 person-years, 95% CI, 5.4-5.7) and Asians/Pacific Islanders (3.0 per 10,000 person-years; 95% CI, 2.9-3.1). Overall, the rate was 14.9/10,000 person-years.
With regard to treatment, therapies defined by the researchers as advanced – systemic thrombolysis, catheter-directed therapy, surgical embolectomy, and venoarterial extracorporeal membrane oxygenation – were also less commonly used in treating ethnic minorities.
These treatments were used in 5.5% of all patients, and 19% of those with high-risk PE. After adjusting for nearly 20 factors such as age, sex, and place of residence, researchers found that the odds that a patient would receive advanced treatment were lower in Blacks (aOR, 0.87; 95% CI, 0.81-0.92) and Asians/Pacific Islanders (aOR, 0.76; 95% CI, 0.59-0.98) compared with Whites. The differences in Hispanics and Native Americans were not statistically significant.
As for insurance, those with Medicare and Medicaid were less likely to get advanced treatment vs. those with private insurance (aOR, 0.73; 95% CI, 0.69-0.77 and aOR, 0.68; 95% CI, 0.63-0.74, respectively). Differences among income levels were not statistically significant.
In the hospital, 6.4% of patients with PE died, as did 50% of those with high-risk PE. There was no statistically significant difference in death rates overall between Whites and Blacks or Native Americans. However, Asians/Pacific Islanders had a much higher death rate (aOR, 1.53; 95% CI, 1.32-1.78), as did Hispanics (aOR, 1.10; 95% CI, 1.00-1.22).
Why are Asians/Pacific Islanders at such high risk of death? Dr. Cushman noted that, while their hospitalization rate is low, they are especially likely to present with high-risk PE.
The difference in death rates between patients with Medicare/Medicaid insurance and those with private insurance was not statistically significant. Neither was the difference in death rates among income groups vs. the highest quartile with one exception: The lowest quartile (aOR, 1.09; 95% CI, 1.02-1.17).
As for the reasons for the higher risks among various groups, Dr. Cushman said there are several possible theories. “It could be due to differences in awareness of PE symptoms: They don’t know how ill they are, so they present later in the course. Or they might have less trust in the system, which might lead to delayed care. Or it could be that they have misdiagnosis of PE symptoms when they present initially.”
Alternatively, she noted, the differences “could be rooted in structural racism and other social determinants of health that weren’t measured, such as education level and quality of education.”
In an interview, Dr. Cushman expressed the hope that “clinicians will think about these findings in terms of how they take care of patients and try their best to recognize any unconscious biases that might creep into their approach. In addition, as a society we need more education of the general public about PE. Some of our findings might be caused by delayed care due to lack of recognition of a need to seek care.”
In an interview, University of Pittsburgh vascular surgeon Rabih Chaer, MD, MSc, who didn’t take part in the study, said it relies on a "large dataset which offers valuable information but with limited granularity and follow-up. This limits the accurate categorization of PE severity, as well as comorbidities, all of which impact outcomes and survival.”
For example, Dr. Chaer said, PE treatments can be limited in some patients due to their comorbidities that cause bleeding risk. Still, Dr. Chaer said the findings mesh with his own research that has shown racial disparities in PE treatment and outcomes, including a 2021 study. "While we did not see a difference by race in in-hospital mortality, Black patients hospitalized with PE are younger with a higher severity of disease compared with White patients,” he said. "Although Black patients are less likely to receive an intervention overall, this differed depending on PE severity with higher risk of intervention only for life-threatening PE." And a 2022 study found that “patients with PE from deprived neighborhoods have worse survival beyond the index [first] admission and were more likely to suffer from cardiovascular or PE-related causes of death in the first year after the index pulmonary embolism,” he said.
Dr. Chaer noted that his research team “is actively working on the next steps beyond identifying the fact that there are racial disparities in PE treatment and outcomes. We are fortunate to have access to a large granular database with long-term follow up and are currently reviewing the medical record details to identify causes for disparities and potential solutions.”
Dr. Cushman received funding from the National Institutes of Health. Other study authors report various disclosures. Dr. Chaer has no disclosures.
NEW ORLEANS –
According to the research, released at the annual meeting of the American Society of Hematology, the biggest disparities affected Asian/Pacific Islander patients with PE. While they were the least likely among ethnic groups to be hospitalized for PE, the odds were 53% higher that they’d die in the hospital (adjusted odds ratio, 1.53; 95% confidence interval, 1.32-1.78), and 24% lower that they would get advanced therapies (aOR, 0.76; 95% CI, 0.59-0.98, P values not provided in this study).
“The findings really raise the importance of this research area and call for vigorous future research to try to better identify why we see these patterns and then come up with solutions to solve them,” said hematologist and study coauthor Mary Cushman, MD, of the University of Vermont, Burlington, at an ASH news briefing.
As Dr. Cushman noted, details about disparities in PE care are limited. It’s known that “Black people have a twofold greater mortality from pulmonary embolism compared to other groups, and this is a persistently observed disparity over many years,” she said. However, “little is known about the relationships of social determinants with treatment and course of pulmonary embolism,” she added.
The researchers used data from the Nationwide Inpatient Sample to track 1.1 million U.S. hospitalized patients with PE from 2016 to 2018. PE was the primary diagnosis in 615,570 patients (54.8%), and 66,570 (5.9%) had high-risk PE.
Among ethnic groups, hospitalization rates “differed pretty dramatically,” Dr. Cushman said. The researchers found that Blacks had the highest rate of PE hospitalization (20.1 per 10,000 person-years; 95% CI, 20.0-20.2), followed by Whites (13.1 per 10,000 person-years; 95% CI, 13.1-13.2), Hispanics (6.0 per 10,000 person-years; 95% CI, 5.9-6.1), Native Americans (5.6 per 10,000 person-years, 95% CI, 5.4-5.7) and Asians/Pacific Islanders (3.0 per 10,000 person-years; 95% CI, 2.9-3.1). Overall, the rate was 14.9/10,000 person-years.
With regard to treatment, therapies defined by the researchers as advanced – systemic thrombolysis, catheter-directed therapy, surgical embolectomy, and venoarterial extracorporeal membrane oxygenation – were also less commonly used in treating ethnic minorities.
These treatments were used in 5.5% of all patients, and 19% of those with high-risk PE. After adjusting for nearly 20 factors such as age, sex, and place of residence, researchers found that the odds that a patient would receive advanced treatment were lower in Blacks (aOR, 0.87; 95% CI, 0.81-0.92) and Asians/Pacific Islanders (aOR, 0.76; 95% CI, 0.59-0.98) compared with Whites. The differences in Hispanics and Native Americans were not statistically significant.
As for insurance, those with Medicare and Medicaid were less likely to get advanced treatment vs. those with private insurance (aOR, 0.73; 95% CI, 0.69-0.77 and aOR, 0.68; 95% CI, 0.63-0.74, respectively). Differences among income levels were not statistically significant.
In the hospital, 6.4% of patients with PE died, as did 50% of those with high-risk PE. There was no statistically significant difference in death rates overall between Whites and Blacks or Native Americans. However, Asians/Pacific Islanders had a much higher death rate (aOR, 1.53; 95% CI, 1.32-1.78), as did Hispanics (aOR, 1.10; 95% CI, 1.00-1.22).
Why are Asians/Pacific Islanders at such high risk of death? Dr. Cushman noted that, while their hospitalization rate is low, they are especially likely to present with high-risk PE.
The difference in death rates between patients with Medicare/Medicaid insurance and those with private insurance was not statistically significant. Neither was the difference in death rates among income groups vs. the highest quartile with one exception: The lowest quartile (aOR, 1.09; 95% CI, 1.02-1.17).
As for the reasons for the higher risks among various groups, Dr. Cushman said there are several possible theories. “It could be due to differences in awareness of PE symptoms: They don’t know how ill they are, so they present later in the course. Or they might have less trust in the system, which might lead to delayed care. Or it could be that they have misdiagnosis of PE symptoms when they present initially.”
Alternatively, she noted, the differences “could be rooted in structural racism and other social determinants of health that weren’t measured, such as education level and quality of education.”
In an interview, Dr. Cushman expressed the hope that “clinicians will think about these findings in terms of how they take care of patients and try their best to recognize any unconscious biases that might creep into their approach. In addition, as a society we need more education of the general public about PE. Some of our findings might be caused by delayed care due to lack of recognition of a need to seek care.”
In an interview, University of Pittsburgh vascular surgeon Rabih Chaer, MD, MSc, who didn’t take part in the study, said it relies on a "large dataset which offers valuable information but with limited granularity and follow-up. This limits the accurate categorization of PE severity, as well as comorbidities, all of which impact outcomes and survival.”
For example, Dr. Chaer said, PE treatments can be limited in some patients due to their comorbidities that cause bleeding risk. Still, Dr. Chaer said the findings mesh with his own research that has shown racial disparities in PE treatment and outcomes, including a 2021 study. "While we did not see a difference by race in in-hospital mortality, Black patients hospitalized with PE are younger with a higher severity of disease compared with White patients,” he said. "Although Black patients are less likely to receive an intervention overall, this differed depending on PE severity with higher risk of intervention only for life-threatening PE." And a 2022 study found that “patients with PE from deprived neighborhoods have worse survival beyond the index [first] admission and were more likely to suffer from cardiovascular or PE-related causes of death in the first year after the index pulmonary embolism,” he said.
Dr. Chaer noted that his research team “is actively working on the next steps beyond identifying the fact that there are racial disparities in PE treatment and outcomes. We are fortunate to have access to a large granular database with long-term follow up and are currently reviewing the medical record details to identify causes for disparities and potential solutions.”
Dr. Cushman received funding from the National Institutes of Health. Other study authors report various disclosures. Dr. Chaer has no disclosures.
NEW ORLEANS –
According to the research, released at the annual meeting of the American Society of Hematology, the biggest disparities affected Asian/Pacific Islander patients with PE. While they were the least likely among ethnic groups to be hospitalized for PE, the odds were 53% higher that they’d die in the hospital (adjusted odds ratio, 1.53; 95% confidence interval, 1.32-1.78), and 24% lower that they would get advanced therapies (aOR, 0.76; 95% CI, 0.59-0.98, P values not provided in this study).
“The findings really raise the importance of this research area and call for vigorous future research to try to better identify why we see these patterns and then come up with solutions to solve them,” said hematologist and study coauthor Mary Cushman, MD, of the University of Vermont, Burlington, at an ASH news briefing.
As Dr. Cushman noted, details about disparities in PE care are limited. It’s known that “Black people have a twofold greater mortality from pulmonary embolism compared to other groups, and this is a persistently observed disparity over many years,” she said. However, “little is known about the relationships of social determinants with treatment and course of pulmonary embolism,” she added.
The researchers used data from the Nationwide Inpatient Sample to track 1.1 million U.S. hospitalized patients with PE from 2016 to 2018. PE was the primary diagnosis in 615,570 patients (54.8%), and 66,570 (5.9%) had high-risk PE.
Among ethnic groups, hospitalization rates “differed pretty dramatically,” Dr. Cushman said. The researchers found that Blacks had the highest rate of PE hospitalization (20.1 per 10,000 person-years; 95% CI, 20.0-20.2), followed by Whites (13.1 per 10,000 person-years; 95% CI, 13.1-13.2), Hispanics (6.0 per 10,000 person-years; 95% CI, 5.9-6.1), Native Americans (5.6 per 10,000 person-years, 95% CI, 5.4-5.7) and Asians/Pacific Islanders (3.0 per 10,000 person-years; 95% CI, 2.9-3.1). Overall, the rate was 14.9/10,000 person-years.
With regard to treatment, therapies defined by the researchers as advanced – systemic thrombolysis, catheter-directed therapy, surgical embolectomy, and venoarterial extracorporeal membrane oxygenation – were also less commonly used in treating ethnic minorities.
These treatments were used in 5.5% of all patients, and 19% of those with high-risk PE. After adjusting for nearly 20 factors such as age, sex, and place of residence, researchers found that the odds that a patient would receive advanced treatment were lower in Blacks (aOR, 0.87; 95% CI, 0.81-0.92) and Asians/Pacific Islanders (aOR, 0.76; 95% CI, 0.59-0.98) compared with Whites. The differences in Hispanics and Native Americans were not statistically significant.
As for insurance, those with Medicare and Medicaid were less likely to get advanced treatment vs. those with private insurance (aOR, 0.73; 95% CI, 0.69-0.77 and aOR, 0.68; 95% CI, 0.63-0.74, respectively). Differences among income levels were not statistically significant.
In the hospital, 6.4% of patients with PE died, as did 50% of those with high-risk PE. There was no statistically significant difference in death rates overall between Whites and Blacks or Native Americans. However, Asians/Pacific Islanders had a much higher death rate (aOR, 1.53; 95% CI, 1.32-1.78), as did Hispanics (aOR, 1.10; 95% CI, 1.00-1.22).
Why are Asians/Pacific Islanders at such high risk of death? Dr. Cushman noted that, while their hospitalization rate is low, they are especially likely to present with high-risk PE.
The difference in death rates between patients with Medicare/Medicaid insurance and those with private insurance was not statistically significant. Neither was the difference in death rates among income groups vs. the highest quartile with one exception: The lowest quartile (aOR, 1.09; 95% CI, 1.02-1.17).
As for the reasons for the higher risks among various groups, Dr. Cushman said there are several possible theories. “It could be due to differences in awareness of PE symptoms: They don’t know how ill they are, so they present later in the course. Or they might have less trust in the system, which might lead to delayed care. Or it could be that they have misdiagnosis of PE symptoms when they present initially.”
Alternatively, she noted, the differences “could be rooted in structural racism and other social determinants of health that weren’t measured, such as education level and quality of education.”
In an interview, Dr. Cushman expressed the hope that “clinicians will think about these findings in terms of how they take care of patients and try their best to recognize any unconscious biases that might creep into their approach. In addition, as a society we need more education of the general public about PE. Some of our findings might be caused by delayed care due to lack of recognition of a need to seek care.”
In an interview, University of Pittsburgh vascular surgeon Rabih Chaer, MD, MSc, who didn’t take part in the study, said it relies on a "large dataset which offers valuable information but with limited granularity and follow-up. This limits the accurate categorization of PE severity, as well as comorbidities, all of which impact outcomes and survival.”
For example, Dr. Chaer said, PE treatments can be limited in some patients due to their comorbidities that cause bleeding risk. Still, Dr. Chaer said the findings mesh with his own research that has shown racial disparities in PE treatment and outcomes, including a 2021 study. "While we did not see a difference by race in in-hospital mortality, Black patients hospitalized with PE are younger with a higher severity of disease compared with White patients,” he said. "Although Black patients are less likely to receive an intervention overall, this differed depending on PE severity with higher risk of intervention only for life-threatening PE." And a 2022 study found that “patients with PE from deprived neighborhoods have worse survival beyond the index [first] admission and were more likely to suffer from cardiovascular or PE-related causes of death in the first year after the index pulmonary embolism,” he said.
Dr. Chaer noted that his research team “is actively working on the next steps beyond identifying the fact that there are racial disparities in PE treatment and outcomes. We are fortunate to have access to a large granular database with long-term follow up and are currently reviewing the medical record details to identify causes for disparities and potential solutions.”
Dr. Cushman received funding from the National Institutes of Health. Other study authors report various disclosures. Dr. Chaer has no disclosures.
AT ASH 2022
ASH 2022: New clinical data challenge long-held assumptions
The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
“Feeding Our Patients Gruel”
Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).
“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”
He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”
Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
Practice-changing data
ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).
Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
Premature aging in HL survivors
ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).
“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”
Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
Inherited thrombophilia and miscarriage
Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).
“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.
Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.
Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).
“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”
A version of this article first appeared on Medscape.com.
The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
“Feeding Our Patients Gruel”
Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).
“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”
He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”
Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
Practice-changing data
ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).
Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
Premature aging in HL survivors
ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).
“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”
Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
Inherited thrombophilia and miscarriage
Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).
“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.
Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.
Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).
“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”
A version of this article first appeared on Medscape.com.
The conference starts in New Orleans on Saturday, Dec. 10, , but a sample of what is to come was given last week in a preview media briefing, moderated by Mikkael A. Sekeres, MD, from the University of Miami. Dr. Sekeres, who recently authored a book on the FDA and how it regulates drug approvals, also serves as chair of the ASH Committee on Communications.
“Feeding Our Patients Gruel”
Dr. Sekeres expressed particular excitement about a multicenter randomized trial done in Italy. It showed that patients who have neutropenia after a stem cell transplant need not be required to eat a bland diet (Abstract 169).
“We for years have been essentially feeding our patients gruel in the hospital, and these are folks who have to be hospitalized for a stem cell transplant or in my case – I’m a leukemia specialist – for acute leukemia, for 4-6 weeks. The neutropenic diet consists of the blandest food you can imagine, with nothing to really spice it up.”
He noted that a neutropenic diet is so unpalatable that family members often sneak food into patient rooms, and “for years we’ve never seen adverse outcomes in any of those folks who instead of having mashed potatoes and oatmeal ate a corned beef sandwich for dinner.”
Now, the results from this trial “actually give us license to finally allow patients to eat whatever they want,” Dr. Sekeres said.
Practice-changing data
ASH experts pointed to two more presentations that are expected to change clinical practice. These include the finding that high-dose methotrexate does not reduce the risk for central nervous system relapse in children with acute lymphoblastic leukemia and lymphoblastic lymphoma (Abstract 214).
Another new study that seems to defy conventional wisdom showed that in adults with relapsed or refractory acute myeloid leukemia, intensive chemotherapy in an effort to achieve remission before a stem cell transplant did not result in better outcomes, compared with sequential conditioning and immediate transplant (Abstract 4).
Premature aging in HL survivors
ASH President Jane N. Winter, MD, from Northwestern University, Chicago, who also spoke at the briefing, highlighted a study that followed adult survivors of pediatric Hodgkin lymphoma. This study, from St. Jude Children’s Research Hospital in Memphis and the Wilmot Cancer Institute at the University of Rochester (N.Y), found that these adult survivors are at significantly elevated risk for epigenetic age acceleration accompanied by neurocognitive deficits when compared with controls (Abstract 902).
“This is an area that is very near and dear to my heart,” she said. “Much of my career has focused on reducing the therapy to reduce the long-term consequences of treatments. Pediatricians have been very much wedded to very intensive therapies and tend to incorporate radiation more commonly in their treatment strategies for children than we do in adults.”
Dr. Winter noted that, although clinicians focus primarily on the link between mediastinal radiation and long-term adverse events such as breast cancer, “now we’re shedding a light on the neurocognitive deficits, which I think are underappreciated. Being able to screen for this impact of our treatment, and perhaps then develop strategies to deal with it or prevent it, will have very wide-ranging impact.”
Inherited thrombophilia and miscarriage
Cynthia E. Dunbar, MD, chief of the translational stem cell biology branch at the National Heart, Lung, and Blood Institute in Bethesda, Md., who also spoke at the briefing, said that one of the abstracts most important to her practice is a study concerning pregnancy. It showed that low-molecular-weight heparin did not prevent miscarriage in pregnant women with confirmed inherited thrombophilia who had two or more prior pregnancy losses, compared with standard surveillance (Abstract LBA-5).
“This is not my field at all; on the other hand, as a hematologist and a woman, that’s what my emails in the middle of the night and my panicked phone calls are often about. Once somebody has one miscarriage, especially if they feel like they’re already over 30 and the clock is ticking, there’s a huge emphasis and a huge amount of pressure on obstetricians to basically work up for everything, kind of a shotgun [approach],” she said.
Those workups may reveal genetic mutations that are associated with mild elevations in risk for clotting. As a result, some pregnant women are put on anticoagulation therapy, which can cause complications for both pregnancy and delivery. These study findings don’t solve the problem of spontaneous pregnancy loss, but they at least rule out inherited thrombophilia as a preventable cause of miscarriages, Dr. Dunbar said.
Another potentially practice-changing abstract is a study showing that, in younger adults with mantle cell lymphoma, the addition of the Bruton’s tyrosine kinase inhibitor ibrutinib (Imbruvica) to induction therapy and as maintenance with or without autologous stem cell transplant had strong efficacy and acceptable toxicity (Abstract 1).
“The results show that the ibrutinib-containing regimen without transplant is at least as good as the current standard of care with transplant.” Dr. Winter said. “Additional follow-up will be required to show definitively that an autotransplant is unnecessary if ibrutinib is included in this treatment regimen.”
A version of this article first appeared on Medscape.com.
FROM ASH 2022