Participation of Older Cancer Patients in Clinical Trials

Older cancer patients are significantly underrepresented in clinical trials, and it may be time to rethink eligibility for oncology clinical trials, according to Martine Extermann, MD, PhD, professor of oncology at the University of South Florida in Tampa.

Extermann, who spoke on improving research for older patients at the 53rd Annual Meeting of the American Society for Radiation Oncology (ASTRO), said it is time to require large phase 3 trials to oversample older cancer patients (60 years of age and older) in order to reach a meaningful percentage of their cohorts. She said that by doing this it may be possible to achieve clinical trial results that are specific and pertinent to this population. Extermann said another good approach that should be adopted is to extend phase 2 and 3 trials to patients with high levels of comorbidities or functional impairment with stratified accruals or extension cohorts.

“We can give these older patients the same treatments and then watch these patients more carefully, and then analyze the efficacy and side effects separately,” said Extermann in an interview with The Oncology Nurse-APN/PA. “With this approach, the main reason for the trial would not be affected, but we would still learn about these patients. Another way to do this may be to say if the patient may not be able to tolerate the main treatment of the trial, then we can do a dose escalation in these patients who have poor function.”

She said that in addition there should be trials that are specifically designed for older cancer patients. Extermann said there needs to be a new emphasis on minimizing exclusions in cancer clinical trials. In addition, parallel trials need to be considered whenever possible, with one trial including only older cancer patients.

According to Extermann, there is currently a significant role that oncology nurses can play in removing the barriers that older cancer patients now face in trying to enter clinical trials. “The nurses can be very valuable in doing the assessments in these trials,” she said. “They can provide screening and the assessments that look at how radiation therapy may affect these older patients. We need a lot more research into how well older patients functionally tolerate chemotherapy and radiation therapy.”

She noted that there are significant barriers to addressing this issue because of financial constraints. However, she said it is time to look at funding issues when it comes to older adults, since 50% of cancers are now occurring in adults 70 and older. The latest statistics from the National Cancer Institute suggest that the number of people over age 65 with cancer will rise by about 42% over the next 10 years.