02 Oct Prior Cancer Excludes Many Patients From Lung Cancer Trials
Medical Research: What are the main findings of the study?
Dr. Gerber: Fewer than 3% of adult cancer patients in the United States are enrolled in clinical trials. Increasingly numerous and stringent eligibility criteria are a major factor limiting participation in clinical trials. We examined the longstanding and widespread practice of excluding patients with prior cancer from oncology clinical trials. This policy presumably reflects concerns that a prior cancer would interfere with the conduct, outcomes, or interpretation of a clinical trial, although there is no clear evidence supporting that assumption.
We examined more than 50 National Cancer Institute (NCI)-sponsored lung cancer clinical trials. We found that 80% excluded patients with prior cancers. This exclusion criterion was applied broadly, including to more than two-thirds of trials with non-survival endpoints. We then examined national Surveillance Epidemiology and End Results (SEER)-Medicare linked data to estimate the proportion of patients who would be excluded from these trials due to prior cancer. We found that up to 18% of potential patients are excluded for this reason alone. In large phase 3 clinical trials, that corresponds to more than 200 patients.
Medical Research: What was most surprising about the results?
Dr. Gerber: Prior cancer is quite common among patients with lung cancer, so prior cancer exclusion restricts enrollment to clinical trials considerably. Furthermore, many of the clinical trials excluding patients with prior cancer have non-survival endpoints such as radiographic response, biomarkers, or feasibility.
Medical Research: What should clinicians and patients take away from your report?
Dr. Gerber: Prior cancer is a frequent reason for exclusion from lung cancer clinical trials. Because the number of cancer survivors is growing substantially, the impact of this practice is expected to increase in the future.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Gerber: We need to learn more about the prognostic impact of a prior cancer diagnosis among patients with lung cancer. Such data will provide guidance as to whether prior cancer merits exclusion in clinical trials for this disease.