Research

Background and objective A cumulative review of hepatobiliary abnormalities in the lapatinib clinical program resulted in inclusion of detailed instructions for liver function test (LFT) monitoring in the US prescribing information (label). We sought to determine whether or not physicians adhere to these recommended guidelines.

Methods A retrospective observational cohort study comprising 396 women with HER2  metastatic breast cancer who initiated lapatinib between March 1, 2007 and June 30, 2010. Data were captured from electronic medical records (EMR) of communitybased oncology practices. Patients were categorized by whether they initiated lapatinib before or after the label change; LFT monitoring was evaluated using a pre- versus post-label study design. We measured the proportion of patients who had LFTs within 30 days before lapatinib initiation, LFTs during each 6-week period of treatment, and lapatinib permanently withdrawn after experiencing an extreme LFT elevation.

Results Among 396 patients, 128 (32%) initiated lapatinib pre-label change, and 268 (68%) initiated post-label change. LFTs were conducted 30 days prior to lapatinib start in 82% post-label versus 63% pre-label change patients (P greater than .001). Testing during each 6-week treatment interval was higher in post-label change patients: 81% versus 68% pre-label change patients during the first 6 weeks of therapy (P equals .004), and 83% versus 62%, respectively, during weeks 18-24 (P equals .0103). Four patients experienced a severe LFT elevation: 2 pre-label patients who resumed treatment, and 2 post-label change patients with complete discontinuation.

Conclusions We demonstrated that LFT monitoring increased after the addition of detailed LFT guidance to the lapatinib label.

*Click on the link to the left for a PDF of the full article.  

Background and objective A cumulative review of hepatobiliary abnormalities in the lapatinib clinical program resulted in inclusion of detailed instructions for liver function test (LFT) monitoring in the US prescribing information (label). We sought to determine whether or not physicians adhere to these recommended guidelines.

Methods A retrospective observational cohort study comprising 396 women with HER2  metastatic breast cancer who initiated lapatinib between March 1, 2007 and June 30, 2010. Data were captured from electronic medical records (EMR) of communitybased oncology practices. Patients were categorized by whether they initiated lapatinib before or after the label change; LFT monitoring was evaluated using a pre- versus post-label study design. We measured the proportion of patients who had LFTs within 30 days before lapatinib initiation, LFTs during each 6-week period of treatment, and lapatinib permanently withdrawn after experiencing an extreme LFT elevation.

Results Among 396 patients, 128 (32%) initiated lapatinib pre-label change, and 268 (68%) initiated post-label change. LFTs were conducted 30 days prior to lapatinib start in 82% post-label versus 63% pre-label change patients (P greater than .001). Testing during each 6-week treatment interval was higher in post-label change patients: 81% versus 68% pre-label change patients during the first 6 weeks of therapy (P equals .004), and 83% versus 62%, respectively, during weeks 18-24 (P equals .0103). Four patients experienced a severe LFT elevation: 2 pre-label patients who resumed treatment, and 2 post-label change patients with complete discontinuation.

Conclusions We demonstrated that LFT monitoring increased after the addition of detailed LFT guidance to the lapatinib label.

*Click on the link to the left for a PDF of the full article.  

Background and objective A cumulative review of hepatobiliary abnormalities in the lapatinib clinical program resulted in inclusion of detailed instructions for liver function test (LFT) monitoring in the US prescribing information (label). We sought to determine whether or not physicians adhere to these recommended guidelines.

Methods A retrospective observational cohort study comprising 396 women with HER2  metastatic breast cancer who initiated lapatinib between March 1, 2007 and June 30, 2010. Data were captured from electronic medical records (EMR) of communitybased oncology practices. Patients were categorized by whether they initiated lapatinib before or after the label change; LFT monitoring was evaluated using a pre- versus post-label study design. We measured the proportion of patients who had LFTs within 30 days before lapatinib initiation, LFTs during each 6-week period of treatment, and lapatinib permanently withdrawn after experiencing an extreme LFT elevation.

Results Among 396 patients, 128 (32%) initiated lapatinib pre-label change, and 268 (68%) initiated post-label change. LFTs were conducted 30 days prior to lapatinib start in 82% post-label versus 63% pre-label change patients (P greater than .001). Testing during each 6-week treatment interval was higher in post-label change patients: 81% versus 68% pre-label change patients during the first 6 weeks of therapy (P equals .004), and 83% versus 62%, respectively, during weeks 18-24 (P equals .0103). Four patients experienced a severe LFT elevation: 2 pre-label patients who resumed treatment, and 2 post-label change patients with complete discontinuation.

Conclusions We demonstrated that LFT monitoring increased after the addition of detailed LFT guidance to the lapatinib label.

*Click on the link to the left for a PDF of the full article.  

Purpose To assess the feasibility of using a multimedia program to teach caregivers of Veterans with cancer how to offer basic massage for supportive care at home.

Methods Feasibility was assessed according to partner availability, compliance with watching training materials and practicing massage regularly, compliance with data collection; perceived study materials burden; clarity of instructional and other study materials. Pre- and post-massage changes in patients’ symptom scores were measured using a numerical rate scale. A semistructured exit interview was answered by patient and caregiver at the end of the study.

Results A total of 27 dyads were recruited. Veterans were 78% male. Forty-eight percent were diagnosed with hematologic malignancies (85%, advanced stage); 52% were diagnosed with solid tumors (64% advanced stage). Caregivers were 78% female; 81% were spouses. Out of the 27 pairs, 11 completed 8 weeks of data and practiced massage weekly. The majority of attrition (69%) was due to caregivers’ burden. Caregivers reported instructional  materials were clear, high quality, and easy to use. Patients were highly satisfied with receiving touch from their partners regularly. Post-massage  symptom scores showed statistically significant decreases in pain, stress/anxiety, and fatigue. Perceived burden of data collection instruments was high, particularly for patients.

Conclusion It is feasible to use the TCC program to train caregivers of Veterans with cancer to offer massage for supportive
care at home. Future studies should evaluate ways of providing support to caregivers, including offering massage to them, and
easing the burden of data collection for patients.

*For a PDF of the full article, click on the link to the left of this introduction.

Purpose To assess the feasibility of using a multimedia program to teach caregivers of Veterans with cancer how to offer basic massage for supportive care at home.

Methods Feasibility was assessed according to partner availability, compliance with watching training materials and practicing massage regularly, compliance with data collection; perceived study materials burden; clarity of instructional and other study materials. Pre- and post-massage changes in patients’ symptom scores were measured using a numerical rate scale. A semistructured exit interview was answered by patient and caregiver at the end of the study.

Results A total of 27 dyads were recruited. Veterans were 78% male. Forty-eight percent were diagnosed with hematologic malignancies (85%, advanced stage); 52% were diagnosed with solid tumors (64% advanced stage). Caregivers were 78% female; 81% were spouses. Out of the 27 pairs, 11 completed 8 weeks of data and practiced massage weekly. The majority of attrition (69%) was due to caregivers’ burden. Caregivers reported instructional  materials were clear, high quality, and easy to use. Patients were highly satisfied with receiving touch from their partners regularly. Post-massage  symptom scores showed statistically significant decreases in pain, stress/anxiety, and fatigue. Perceived burden of data collection instruments was high, particularly for patients.

Conclusion It is feasible to use the TCC program to train caregivers of Veterans with cancer to offer massage for supportive
care at home. Future studies should evaluate ways of providing support to caregivers, including offering massage to them, and
easing the burden of data collection for patients.

*For a PDF of the full article, click on the link to the left of this introduction.

Purpose To assess the feasibility of using a multimedia program to teach caregivers of Veterans with cancer how to offer basic massage for supportive care at home.

Methods Feasibility was assessed according to partner availability, compliance with watching training materials and practicing massage regularly, compliance with data collection; perceived study materials burden; clarity of instructional and other study materials. Pre- and post-massage changes in patients’ symptom scores were measured using a numerical rate scale. A semistructured exit interview was answered by patient and caregiver at the end of the study.

Results A total of 27 dyads were recruited. Veterans were 78% male. Forty-eight percent were diagnosed with hematologic malignancies (85%, advanced stage); 52% were diagnosed with solid tumors (64% advanced stage). Caregivers were 78% female; 81% were spouses. Out of the 27 pairs, 11 completed 8 weeks of data and practiced massage weekly. The majority of attrition (69%) was due to caregivers’ burden. Caregivers reported instructional  materials were clear, high quality, and easy to use. Patients were highly satisfied with receiving touch from their partners regularly. Post-massage  symptom scores showed statistically significant decreases in pain, stress/anxiety, and fatigue. Perceived burden of data collection instruments was high, particularly for patients.

Conclusion It is feasible to use the TCC program to train caregivers of Veterans with cancer to offer massage for supportive
care at home. Future studies should evaluate ways of providing support to caregivers, including offering massage to them, and
easing the burden of data collection for patients.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Patient understanding of advanced metastatic disease is central to decisions about care near death. Prior studies have focused on gender differences in communication style rather than on illness understanding.

Objectives To evaluate gender differences in terminal illness acknowledgement (TIA), understanding that the disease is incurable and the advanced stage of the disease. To evaluate gender differences in patients’ reports of discussions of life expectancy with oncology providers and its effect on differences in illness understanding.

Methods Coping with Cancer 2 patients (N 68) were interviewed before and after a visit with their oncology providers to discuss scan results.

Results At the prescan interview, there were no statistically significant gender differences in patient measures of illness understanding. At the postscan interview, women were more likely than men to recognize that their illness was incurable (Adjusted Odds Ratio, [AOR] 5.29; P .038), know that their cancer was at an advanced stage (AOR, 6.38; P, .013), and report having had discussions of life expectancy with their oncologist (AOR, 4.77; P, .021). Controlling discussions of life expectancy, women were more likely than men to report that their cancer was at an advanced stage (AOR, 9.53; P .050). Controlling for gender, discussions of life expectancy were associated with higher rates of TIA (AOR, 4.65; P, .036) and higher rates of understanding that the cancer was incurable (AOR, 4.09;  P .085).

Conclusions Due largely to gender differences in communication, women over time have a better understanding of their illness than men. More frequent discussions of life expectancy should enhance illness understanding and reduce gender differences.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Patient understanding of advanced metastatic disease is central to decisions about care near death. Prior studies have focused on gender differences in communication style rather than on illness understanding.

Objectives To evaluate gender differences in terminal illness acknowledgement (TIA), understanding that the disease is incurable and the advanced stage of the disease. To evaluate gender differences in patients’ reports of discussions of life expectancy with oncology providers and its effect on differences in illness understanding.

Methods Coping with Cancer 2 patients (N 68) were interviewed before and after a visit with their oncology providers to discuss scan results.

Results At the prescan interview, there were no statistically significant gender differences in patient measures of illness understanding. At the postscan interview, women were more likely than men to recognize that their illness was incurable (Adjusted Odds Ratio, [AOR] 5.29; P .038), know that their cancer was at an advanced stage (AOR, 6.38; P, .013), and report having had discussions of life expectancy with their oncologist (AOR, 4.77; P, .021). Controlling discussions of life expectancy, women were more likely than men to report that their cancer was at an advanced stage (AOR, 9.53; P .050). Controlling for gender, discussions of life expectancy were associated with higher rates of TIA (AOR, 4.65; P, .036) and higher rates of understanding that the cancer was incurable (AOR, 4.09;  P .085).

Conclusions Due largely to gender differences in communication, women over time have a better understanding of their illness than men. More frequent discussions of life expectancy should enhance illness understanding and reduce gender differences.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Patient understanding of advanced metastatic disease is central to decisions about care near death. Prior studies have focused on gender differences in communication style rather than on illness understanding.

Objectives To evaluate gender differences in terminal illness acknowledgement (TIA), understanding that the disease is incurable and the advanced stage of the disease. To evaluate gender differences in patients’ reports of discussions of life expectancy with oncology providers and its effect on differences in illness understanding.

Methods Coping with Cancer 2 patients (N 68) were interviewed before and after a visit with their oncology providers to discuss scan results.

Results At the prescan interview, there were no statistically significant gender differences in patient measures of illness understanding. At the postscan interview, women were more likely than men to recognize that their illness was incurable (Adjusted Odds Ratio, [AOR] 5.29; P .038), know that their cancer was at an advanced stage (AOR, 6.38; P, .013), and report having had discussions of life expectancy with their oncologist (AOR, 4.77; P, .021). Controlling discussions of life expectancy, women were more likely than men to report that their cancer was at an advanced stage (AOR, 9.53; P .050). Controlling for gender, discussions of life expectancy were associated with higher rates of TIA (AOR, 4.65; P, .036) and higher rates of understanding that the cancer was incurable (AOR, 4.09;  P .085).

Conclusions Due largely to gender differences in communication, women over time have a better understanding of their illness than men. More frequent discussions of life expectancy should enhance illness understanding and reduce gender differences.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Symptom management medications are often compounded into topical gel formulations providing an alternative route of administration for hospice and palliative care patients. Though commonly used, transdermal absorption and bioavailability studies of these gel products are lacking. Chlorpromazine was studied because it is FDA approved for treatment of nausea and vomiting and is used off-label for treatment of agitation and delirium.

Objective The objective of this study is to determine the transdermal absorption of chlorpromazine PLO gel in healthy adults.

Methods Twenty-five milligrams of chlorpromazine in PLO gel was applied to 10 subjects’ wrists and 100 mg was applied to 1 subject’s wrist. Blood draws were completed preapplication and 1, 2, and 4 hours postapplication. This single-center unblinded study recruited healthy adults between 18 and 70 years of age. Participants were not pregnant, did not have an allergy to any component of the study medication, and were not taking a phenothiazine medication.

Results Chlorpromazine was undetected in any of the 11 subjects’ blood samples.

Limitations There is an assumption of equivalent medication absorption in healthy patients and palliative care or hospice patients.

Conclusion Rapid relief of symptoms at end of life is essential. Chlorpromazine in PLO gel may not be an effective treatment option since blood levels were undetectable at 1, 2, and 4 hours after topical application.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Symptom management medications are often compounded into topical gel formulations providing an alternative route of administration for hospice and palliative care patients. Though commonly used, transdermal absorption and bioavailability studies of these gel products are lacking. Chlorpromazine was studied because it is FDA approved for treatment of nausea and vomiting and is used off-label for treatment of agitation and delirium.

Objective The objective of this study is to determine the transdermal absorption of chlorpromazine PLO gel in healthy adults.

Methods Twenty-five milligrams of chlorpromazine in PLO gel was applied to 10 subjects’ wrists and 100 mg was applied to 1 subject’s wrist. Blood draws were completed preapplication and 1, 2, and 4 hours postapplication. This single-center unblinded study recruited healthy adults between 18 and 70 years of age. Participants were not pregnant, did not have an allergy to any component of the study medication, and were not taking a phenothiazine medication.

Results Chlorpromazine was undetected in any of the 11 subjects’ blood samples.

Limitations There is an assumption of equivalent medication absorption in healthy patients and palliative care or hospice patients.

Conclusion Rapid relief of symptoms at end of life is essential. Chlorpromazine in PLO gel may not be an effective treatment option since blood levels were undetectable at 1, 2, and 4 hours after topical application.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Symptom management medications are often compounded into topical gel formulations providing an alternative route of administration for hospice and palliative care patients. Though commonly used, transdermal absorption and bioavailability studies of these gel products are lacking. Chlorpromazine was studied because it is FDA approved for treatment of nausea and vomiting and is used off-label for treatment of agitation and delirium.

Objective The objective of this study is to determine the transdermal absorption of chlorpromazine PLO gel in healthy adults.

Methods Twenty-five milligrams of chlorpromazine in PLO gel was applied to 10 subjects’ wrists and 100 mg was applied to 1 subject’s wrist. Blood draws were completed preapplication and 1, 2, and 4 hours postapplication. This single-center unblinded study recruited healthy adults between 18 and 70 years of age. Participants were not pregnant, did not have an allergy to any component of the study medication, and were not taking a phenothiazine medication.

Results Chlorpromazine was undetected in any of the 11 subjects’ blood samples.

Limitations There is an assumption of equivalent medication absorption in healthy patients and palliative care or hospice patients.

Conclusion Rapid relief of symptoms at end of life is essential. Chlorpromazine in PLO gel may not be an effective treatment option since blood levels were undetectable at 1, 2, and 4 hours after topical application.

*For a PDF of the full article, click on the link to the left of this introduction.

ABSTRACT

Background Burnout among physicians can lead to decreased career satisfaction, physical and emotional exhaustion, and increased medical errors. In oncologists, high exposure to fatal illness is associated with burnout.

Methods The Maslach Burnout Inventory, measuring Emotional Exhaustion (EE), Depersonalization (DP), and Personal Accomplishment (PA), was administered to second-year US oncology fellows. Bivariate and multivariate analyses explored associations between burnout and fellow demographics, attitudes, and educational experiences.

Results A total of 254 fellows out of 402 eligible US fellows responded (63.2%) and 24.2% reported high EE, 30.0% reported high DP, and 26.8% reported low PA. Over half of the fellows reported burnout in at least one domain. Lower EE scores were associated with the fellows’ perceptions of having received better teaching, explicit teaching about certain end-of-life topics, and receipt of direct observation of goals-of-care discussions. Fellows who reported better overall teaching quality and more frequent observation of their skills had less depersonalization. Fellows who felt a responsibility to help patients at the end of life to prepare for death had higher PA.

Limitations This survey relies on the fellows’ self-reported perceptions without an objective measure for validation. Factors associated with burnout may not be causal. The number of analyses performed raises the concern for Type I errors; therefore, a stringent P value (.01) was used.

Conclusions Burnout is prevalent during oncology training. Higher-quality teaching is associated with less burnout among fellows. Fellowship programs should recognize the prevalence of burnout among oncology fellows as well as components of training that may protect against burnout.

*For a PDF of the full article, click on the link to the left of this introduction.

ABSTRACT

Background Burnout among physicians can lead to decreased career satisfaction, physical and emotional exhaustion, and increased medical errors. In oncologists, high exposure to fatal illness is associated with burnout.

Methods The Maslach Burnout Inventory, measuring Emotional Exhaustion (EE), Depersonalization (DP), and Personal Accomplishment (PA), was administered to second-year US oncology fellows. Bivariate and multivariate analyses explored associations between burnout and fellow demographics, attitudes, and educational experiences.

Results A total of 254 fellows out of 402 eligible US fellows responded (63.2%) and 24.2% reported high EE, 30.0% reported high DP, and 26.8% reported low PA. Over half of the fellows reported burnout in at least one domain. Lower EE scores were associated with the fellows’ perceptions of having received better teaching, explicit teaching about certain end-of-life topics, and receipt of direct observation of goals-of-care discussions. Fellows who reported better overall teaching quality and more frequent observation of their skills had less depersonalization. Fellows who felt a responsibility to help patients at the end of life to prepare for death had higher PA.

Limitations This survey relies on the fellows’ self-reported perceptions without an objective measure for validation. Factors associated with burnout may not be causal. The number of analyses performed raises the concern for Type I errors; therefore, a stringent P value (.01) was used.

Conclusions Burnout is prevalent during oncology training. Higher-quality teaching is associated with less burnout among fellows. Fellowship programs should recognize the prevalence of burnout among oncology fellows as well as components of training that may protect against burnout.

*For a PDF of the full article, click on the link to the left of this introduction.

ABSTRACT

Background Burnout among physicians can lead to decreased career satisfaction, physical and emotional exhaustion, and increased medical errors. In oncologists, high exposure to fatal illness is associated with burnout.

Methods The Maslach Burnout Inventory, measuring Emotional Exhaustion (EE), Depersonalization (DP), and Personal Accomplishment (PA), was administered to second-year US oncology fellows. Bivariate and multivariate analyses explored associations between burnout and fellow demographics, attitudes, and educational experiences.

Results A total of 254 fellows out of 402 eligible US fellows responded (63.2%) and 24.2% reported high EE, 30.0% reported high DP, and 26.8% reported low PA. Over half of the fellows reported burnout in at least one domain. Lower EE scores were associated with the fellows’ perceptions of having received better teaching, explicit teaching about certain end-of-life topics, and receipt of direct observation of goals-of-care discussions. Fellows who reported better overall teaching quality and more frequent observation of their skills had less depersonalization. Fellows who felt a responsibility to help patients at the end of life to prepare for death had higher PA.

Limitations This survey relies on the fellows’ self-reported perceptions without an objective measure for validation. Factors associated with burnout may not be causal. The number of analyses performed raises the concern for Type I errors; therefore, a stringent P value (.01) was used.

Conclusions Burnout is prevalent during oncology training. Higher-quality teaching is associated with less burnout among fellows. Fellowship programs should recognize the prevalence of burnout among oncology fellows as well as components of training that may protect against burnout.

*For a PDF of the full article, click on the link to the left of this introduction.

Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.

Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.

Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.

Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.

Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.

Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.

*Click on the link to the left for a PDF of the full article.

Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.

Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.

Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.

Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.

Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.

Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.

*Click on the link to the left for a PDF of the full article.

Background Within community oncology practices, the regimens used for treatment of postmenopausal women with human epidermal growth factor receptor 2- and hormone receptor-positive metastatic breast cancer (MBC) may vary.

Objective A retrospective observational study was conducted to examine treatment patterns in HER2-/HR-positive patients initiating first-line treatment in a community oncology setting.

Methods Using US Oncology’s iKnowMed electronic health records (EHRs), postmenopausal HER2-/HR-positive patients who had been newly diagnosed with MBC between January 1, 2007 and June 30, 2010 were identified and stratified by visceral crisis.

Results We identified 347 postmenopausal HER2-/HR-positive patients, of whom 258 (74%) did not have evidence of visceral crisis. Chemotherapy plus targeted plus hormone therapy was the most frequently used treatment strategy (33%). Trastuzumab was the most frequently used HER2-targeted therapy (77% and 66% with and without visceral crisis, respectively); followed by lapatinib. Paclitaxel (24%, nonvisceral; 39% visceral) and letrozole (26%, nonvisceral; 28% visceral) were the most frequently used chemotherapy and endocrine therapies, respectively. Over time, trastuzumab use decreased whereas lapatinib use increased.

Limitation The heterogeneity in the regimens prescribed precluded large sample sizes for robust statistical analyses to link specific therapeutic combinations with outcomes.

Conclusion Community oncologists use a variety of treatments in postmenopausal women with HER2-/HR-positive MBC. Although a combination of chemotherapy, targeted HER2 therapy, and hormone therapy were the most common first-line therapies used, contrary to treatment guidelines, a large proportion of patients received no chemotherapy in the first-line setting.

*Click on the link to the left for a PDF of the full article.

Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al

Background Coenzyme Q₁₀ (CoQ₁₀) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ₁₀ in female breast cancer patients with the primary objective of determining CoQ₁₀ ’s effects on self-reported fatigue, depression, and quality of life (QOL).

Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ₁₀ or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ₁₀ and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ₁₀ levels in the CoQ₁₀ and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ₁₀ levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ₁₀ and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).

Conclusions Supplementation with conventional doses of CoQ₁₀ led to sustained increases in plasma CoQ₁₀ levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

*For a PDF of the full article, click on the link to the left of this introduction.

Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al

Background Coenzyme Q₁₀ (CoQ₁₀) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ₁₀ in female breast cancer patients with the primary objective of determining CoQ₁₀ ’s effects on self-reported fatigue, depression, and quality of life (QOL).

Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ₁₀ or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ₁₀ and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ₁₀ levels in the CoQ₁₀ and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ₁₀ levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ₁₀ and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).

Conclusions Supplementation with conventional doses of CoQ₁₀ led to sustained increases in plasma CoQ₁₀ levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

*For a PDF of the full article, click on the link to the left of this introduction.

Glenn J. Lesser, MD, Doug Case, PhD, Nancy Stark, RN, PhD, et al

Background Coenzyme Q₁₀ (CoQ₁₀) is a common antioxidant supplement with known cardioprotective effects and potential anticancer benefits.

Objectives We performed a randomized, double-blind, placebo-controlled study of oral CoQ₁₀ in female breast cancer patients with the primary objective of determining CoQ₁₀ ’s effects on self-reported fatigue, depression, and quality of life (QOL).

Methods Eligible women with newly diagnosed breast cancer and planned adjuvant chemotherapy were randomized to oralsupplements of 300 mg CoQ₁₀ or placebo, each combined with 300 IU vitamin E, divided into 3 daily doses. Treatment wascontinued for 24 weeks. Blood tests, QOL measures, and levels of plasma CoQ₁₀ and vitamin E were obtained at baseline and at 8,16, and 24 weeks. Mixed-effects models were used to assess treatment differences in outcomes over time.

Results Between September 2004 and March 2009, 236 women were enrolled. Treatment arms were well balanced with respect to age(range, 28-85 years), pathologic stage (stage 0, 91%; stage I, 8%; stage II, 1%), ethnicity (white, 87%; black, 11%; Hispanic, 2%), and planned therapy. Baseline CoQ₁₀ levels in the CoQ₁₀ and placebo arms were 0.70 and 0.73 g/mL, respectively; the 24-week CoQ₁₀ levels were 1.83 and 0.79g/mL, respectively. There were no significant differences between the CoQ₁₀ and placebo arms at 24 weeks for scores on the Profile of Mood States–Fatigue questionnaire (least squares means, 7.08 vs 8.24, P = .257), the Functional Assessment of Chronic Illness Therapy–Fatigue tool (37.6 vs 37.6, P = .965), the Functional Assessment of Cancer Therapy–Breast Cancer instrument (111.9 vs 110.4, P = .577), or the Center for Epidemiologic Studies–Depression scale (11.6 vs 12.3, P = .632).

Conclusions Supplementation with conventional doses of CoQ₁₀ led to sustained increases in plasma CoQ₁₀ levels but did not result in improved self-reported fatigue or QOL after 24 weeks of treatment.

*For a PDF of the full article, click on the link to the left of this introduction.

George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD

Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.

Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.

Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.

Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.

Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.

*For a PDF of the full article, click on the link to the left of this introduction.

George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD

Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.

Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.

Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.

Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.

Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.

*For a PDF of the full article, click on the link to the left of this introduction.

George Dranitsaris, BPharm, PhD, Nathaniel Bouganim, MD, Carolyn Milano, Lisa Vandermeer, MSc, Susan Dent, MD, Paul Wheatley-Price, MD, Jenny Laporte, RN, Karen-Ann Oxborough, RN, and Mark Clemons, MD

Background Even with modern antiemetic regimens, up to 20% of cancer patients suffer from moderate to severechemotherapy-induced nausea and vomiting (CINV) (grade 2). We previously developed chemotherapy cycle–based risk predictive models forgrade 2 acute and delayed CINV. In this study, the prospective validation of the prediction models andassociated scoring systems is described.

Objective Our objective was to prospectively validate prediction models designed to identify patients at high risk for moderate tosevere CINV.

Methods Patients receiving chemotherapy were provided with CINV symptom diaries. Prior to each cycle of chemotherapy, the acute and delayed CINV scoring systems were used to stratify patients into low- and high-risk groups. Logistic regression was used tocompare the occurrence of grade 2 CINV between patients considered by the model to be at high vs low risk. The external validity of each system was assessed via an area under the receiver operating characteristic (AUROC) curve analysis.

Results Outcome data were collected from 97 patients following 401 cycles of chemotherapy. The incidence of grade 2 acute and delayed CINV was 13.5% and 21.4%, respectively. There was a significant correlation between the risk score and the probability of developing acute and delayed CINV following chemotherapy. Both the acute and delayed scoring systems had good predictive accuracy when applied to the validation sample (acute, AUROC = 0.70, 95% CI, 0.62– 0.77; delayed, AUROC = 0.75, 95% CI, 0.69 – 0.80). Patients who were identified as high risk were 3.1 (P = .006) and 4.2 (P < .001) times more likely to develop grade 2 acute and delayed CINV than were those identified as low risk.

Conclusion This study demonstrates that the scoring systems are able to accurately identify patients at high risk for acute and delayed CINV.

*For a PDF of the full article, click on the link to the left of this introduction.

Kevin P. High, MD, MS; Doug Case, PhD;  MD, David Hurd, MD; Bayard Powell, MD; Glenn Lesser, MD; Ann R. Falsey, MD; Robert Siegel, MD; Joanna Metzner-Sadurski, MD; John C. Krauss, MD; Bernard Chinnasami, MD, George Sanders, MD, Steven Rousey, MD, Edward G. Shaw, MD

*For a PDF of the full article and accompanying commentary by Paul Sloan, click on the links to the left of this introduction.

Kevin P. High, MD, MS; Doug Case, PhD;  MD, David Hurd, MD; Bayard Powell, MD; Glenn Lesser, MD; Ann R. Falsey, MD; Robert Siegel, MD; Joanna Metzner-Sadurski, MD; John C. Krauss, MD; Bernard Chinnasami, MD, George Sanders, MD, Steven Rousey, MD, Edward G. Shaw, MD

*For a PDF of the full article and accompanying commentary by Paul Sloan, click on the links to the left of this introduction.

Kevin P. High, MD, MS; Doug Case, PhD;  MD, David Hurd, MD; Bayard Powell, MD; Glenn Lesser, MD; Ann R. Falsey, MD; Robert Siegel, MD; Joanna Metzner-Sadurski, MD; John C. Krauss, MD; Bernard Chinnasami, MD, George Sanders, MD, Steven Rousey, MD, Edward G. Shaw, MD

*For a PDF of the full article and accompanying commentary by Paul Sloan, click on the links to the left of this introduction.

Highlights from the 2012 Annual Meeting of the American Society of Clinical Oncology 48th Annual Meeting

*For a PDF of the full article, click on the link to the left of this introduction.

Highlights from the 2012 Annual Meeting of the American Society of Clinical Oncology 48th Annual Meeting

*For a PDF of the full article, click on the link to the left of this introduction.

Highlights from the 2012 Annual Meeting of the American Society of Clinical Oncology 48th Annual Meeting

*For a PDF of the full article, click on the link to the left of this introduction.