Age limits restrict AYA participation in relevant trials

Photo by Rhoda Baer

MUNICH—Age limits imposed in European countries can prevent adolescents and young adults (AYAs) from enrolling in appropriate clinical trials, a new study suggests.

Investigators reviewed phase 1 and 2 trials conducted over a 6-year period at a single center in France.

The results showed that adolescents were prevented from enrolling in potentially beneficial adult trials, and young adults were unable to enroll in potentially beneficial pediatric trials.

These results were presented at the ESMO 2018 Congress (abstract 424P_PR).

In Europe, the legal minimum age to participate in adult clinical trials is typically 18.

“We know, however, that certain girls will develop genetically driven breast cancers very early in life,” said Dr. Aurore Vozy, of Gustave Roussy Institut de Cancérologie in Villejuif, France.

“There are no pediatric trials for this disease, yet these patients are systematically barred from participating in the relevant adult trials. The situation is similar for some adolescents with lymphomas or sarcomas, whose tumors often resemble those of adults much more closely than those found in children.”

On the other hand, adults in their early twenties may be diagnosed with cancers most commonly seen in children. And pediatric clinical trials typically set an upper age limit of 18 or 21.

To assess the availability and accessibility of new treatments to AYA cancer patients, Dr. Vozy and her colleagues conducted a review of all phase 1 and 2 trials opened at Gustave Roussy from 2012 through 2017 for patients with solid tumors or lymphomas.

Over the 6-year period, 465 trials were open—403 adult trials and 62 pediatric trials.

Only 65 of the trials (14%) included patients between the ages of 12 and 17.

“In other words, patients in this age group had access to less than 15% of all the early phase trials at our institute,” Dr. Vozy said.

In all, there were 389 trials that were not open to adolescents, and the investigators found that 55% of these trials could have been relevant for underage patients. Twenty-eight of the trials targeted tumor types that are particularly common among teenagers.

“This means that patients have been denied access to innovative medicines which were available at the very center where they were being treated, and to which they may have had a better response than to conventional therapy,” Dr. Vozy said.

She and her colleagues also found that young adults were often unable to enroll in pediatric trials.

There were 62 pediatric trials open over the period studied, and more than half of them (n=36, 58%) did not recruit patients aged 19 to 25, even though 10 of these trials targeted tumor types that also occur in this age group.

“Raising the age bar in pediatric trials to 25 years would clearly make sense in certain cases,” Dr. Vozy said.

She argued, however, that the more pressing issue is the current age limit in adult trials.

“We know that the diseases, toxicities, and pharmacology seen in 12- to 17-year-olds are similar to what we find in adults, so it would be feasible to include these patients in adult trials at no additional risk to them,” Dr. Vozy said.

This has already been done successfully in the United States, where the minimum age for trial participation has been lowered to 12 years.

An additional measure to consider, Dr. Vozy said, is creating dedicated trial cohorts for adolescents within adult trials.

“In a context where, today, most phase 1 trials in oncology are launched with multiple study populations for different tumor types, it would be easy to cater to the specific needs of adolescents by including them in cohorts of their own,” she said.

“The main constraint is that trials which include underage patients should only be conducted in centers that also have pediatric services onsite. Adolescents may be affected by disease similarly to adults, but they still need to be treated and followed up on by pediatric specialists.”

One investigator involved in this study reported relationships with Amgen, Astellas, Astra Zeneca, Bayer, Celgene, Genentech, Ipsen, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, and Orion. All other investigators declared no conflicts of interest.

Photo by Rhoda Baer

MUNICH—Age limits imposed in European countries can prevent adolescents and young adults (AYAs) from enrolling in appropriate clinical trials, a new study suggests.

Investigators reviewed phase 1 and 2 trials conducted over a 6-year period at a single center in France.

The results showed that adolescents were prevented from enrolling in potentially beneficial adult trials, and young adults were unable to enroll in potentially beneficial pediatric trials.

These results were presented at the ESMO 2018 Congress (abstract 424P_PR).

In Europe, the legal minimum age to participate in adult clinical trials is typically 18.

“We know, however, that certain girls will develop genetically driven breast cancers very early in life,” said Dr. Aurore Vozy, of Gustave Roussy Institut de Cancérologie in Villejuif, France.

“There are no pediatric trials for this disease, yet these patients are systematically barred from participating in the relevant adult trials. The situation is similar for some adolescents with lymphomas or sarcomas, whose tumors often resemble those of adults much more closely than those found in children.”

On the other hand, adults in their early twenties may be diagnosed with cancers most commonly seen in children. And pediatric clinical trials typically set an upper age limit of 18 or 21.

To assess the availability and accessibility of new treatments to AYA cancer patients, Dr. Vozy and her colleagues conducted a review of all phase 1 and 2 trials opened at Gustave Roussy from 2012 through 2017 for patients with solid tumors or lymphomas.

Over the 6-year period, 465 trials were open—403 adult trials and 62 pediatric trials.

Only 65 of the trials (14%) included patients between the ages of 12 and 17.

“In other words, patients in this age group had access to less than 15% of all the early phase trials at our institute,” Dr. Vozy said.

In all, there were 389 trials that were not open to adolescents, and the investigators found that 55% of these trials could have been relevant for underage patients. Twenty-eight of the trials targeted tumor types that are particularly common among teenagers.

“This means that patients have been denied access to innovative medicines which were available at the very center where they were being treated, and to which they may have had a better response than to conventional therapy,” Dr. Vozy said.

She and her colleagues also found that young adults were often unable to enroll in pediatric trials.

There were 62 pediatric trials open over the period studied, and more than half of them (n=36, 58%) did not recruit patients aged 19 to 25, even though 10 of these trials targeted tumor types that also occur in this age group.

“Raising the age bar in pediatric trials to 25 years would clearly make sense in certain cases,” Dr. Vozy said.

She argued, however, that the more pressing issue is the current age limit in adult trials.

“We know that the diseases, toxicities, and pharmacology seen in 12- to 17-year-olds are similar to what we find in adults, so it would be feasible to include these patients in adult trials at no additional risk to them,” Dr. Vozy said.

This has already been done successfully in the United States, where the minimum age for trial participation has been lowered to 12 years.

An additional measure to consider, Dr. Vozy said, is creating dedicated trial cohorts for adolescents within adult trials.

“In a context where, today, most phase 1 trials in oncology are launched with multiple study populations for different tumor types, it would be easy to cater to the specific needs of adolescents by including them in cohorts of their own,” she said.

“The main constraint is that trials which include underage patients should only be conducted in centers that also have pediatric services onsite. Adolescents may be affected by disease similarly to adults, but they still need to be treated and followed up on by pediatric specialists.”

One investigator involved in this study reported relationships with Amgen, Astellas, Astra Zeneca, Bayer, Celgene, Genentech, Ipsen, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, and Orion. All other investigators declared no conflicts of interest.

Photo by Rhoda Baer

MUNICH—Age limits imposed in European countries can prevent adolescents and young adults (AYAs) from enrolling in appropriate clinical trials, a new study suggests.

Investigators reviewed phase 1 and 2 trials conducted over a 6-year period at a single center in France.

The results showed that adolescents were prevented from enrolling in potentially beneficial adult trials, and young adults were unable to enroll in potentially beneficial pediatric trials.

These results were presented at the ESMO 2018 Congress (abstract 424P_PR).

In Europe, the legal minimum age to participate in adult clinical trials is typically 18.

“We know, however, that certain girls will develop genetically driven breast cancers very early in life,” said Dr. Aurore Vozy, of Gustave Roussy Institut de Cancérologie in Villejuif, France.

“There are no pediatric trials for this disease, yet these patients are systematically barred from participating in the relevant adult trials. The situation is similar for some adolescents with lymphomas or sarcomas, whose tumors often resemble those of adults much more closely than those found in children.”

On the other hand, adults in their early twenties may be diagnosed with cancers most commonly seen in children. And pediatric clinical trials typically set an upper age limit of 18 or 21.

To assess the availability and accessibility of new treatments to AYA cancer patients, Dr. Vozy and her colleagues conducted a review of all phase 1 and 2 trials opened at Gustave Roussy from 2012 through 2017 for patients with solid tumors or lymphomas.

Over the 6-year period, 465 trials were open—403 adult trials and 62 pediatric trials.

Only 65 of the trials (14%) included patients between the ages of 12 and 17.

“In other words, patients in this age group had access to less than 15% of all the early phase trials at our institute,” Dr. Vozy said.

In all, there were 389 trials that were not open to adolescents, and the investigators found that 55% of these trials could have been relevant for underage patients. Twenty-eight of the trials targeted tumor types that are particularly common among teenagers.

“This means that patients have been denied access to innovative medicines which were available at the very center where they were being treated, and to which they may have had a better response than to conventional therapy,” Dr. Vozy said.

She and her colleagues also found that young adults were often unable to enroll in pediatric trials.

There were 62 pediatric trials open over the period studied, and more than half of them (n=36, 58%) did not recruit patients aged 19 to 25, even though 10 of these trials targeted tumor types that also occur in this age group.

“Raising the age bar in pediatric trials to 25 years would clearly make sense in certain cases,” Dr. Vozy said.

She argued, however, that the more pressing issue is the current age limit in adult trials.

“We know that the diseases, toxicities, and pharmacology seen in 12- to 17-year-olds are similar to what we find in adults, so it would be feasible to include these patients in adult trials at no additional risk to them,” Dr. Vozy said.

This has already been done successfully in the United States, where the minimum age for trial participation has been lowered to 12 years.

An additional measure to consider, Dr. Vozy said, is creating dedicated trial cohorts for adolescents within adult trials.

“In a context where, today, most phase 1 trials in oncology are launched with multiple study populations for different tumor types, it would be easy to cater to the specific needs of adolescents by including them in cohorts of their own,” she said.

“The main constraint is that trials which include underage patients should only be conducted in centers that also have pediatric services onsite. Adolescents may be affected by disease similarly to adults, but they still need to be treated and followed up on by pediatric specialists.”

One investigator involved in this study reported relationships with Amgen, Astellas, Astra Zeneca, Bayer, Celgene, Genentech, Ipsen, Janssen, Lilly, Novartis, Pfizer, Roche, Sanofi, and Orion. All other investigators declared no conflicts of interest.