Recent research at the UT Southwestern Medical Center has found that a high percentage of patients are excluded from lung cancer clinical trials as a consequence of previous cancer history.
The study, published in the Journal of the National Cancer Institute and titled “Impact of Prior Cancer on Eligibility for Lung Cancer Clinical Trials”, examined more than 50 lung cancer trials, and concluded that more than 80% excluded patients with a history of prior cancer.
According to the authors, even though previous cancer incidence should not interfere with the experimental treatment or clinical trial outcomes, many times it can be the only reason for study ineligibility.
“The resulting impact on study accrual is sobering. The proportion of potential patients excluded due to prior cancer per trial ranged up to 18 percent, with the estimated absolute number of excluded patients per trial ranging up to 207”, Dr. David Gerber, lead author of the study, Associate Professor of Internal Medicine in the division of Hematology and Oncology, co-leader of the Experimental Therapeutics Program and co-director of the Lung Disease Oriented Team at the Harold C. Simmons Cancer Center at UT Southwestern, stated in a University press release.
Dr. Gerber estimated that in the future, these figures will tend to go up, since the current number of cancer survivors in the U.S. alone is more than 13 million, a four-fold increase during the last 30 years.
The research team analyzed lung cancer trials conducted by the Eastern Cooperative Oncology Group (ECOG), a National Cancer Institute (NCI)-funded organization that designs and conducts cancer clinical trials.
They found that 43% of the trials did not accept patients who had a previous cancer diagnosed within 5 years of the beginning of the trial, 16% did not accept patients with active cancer, 14% excluded patients with any history of cancer and 7% did not accept enrollment if an individual had cancer within the past two to three years.
Additionally, the investigators found that less than 2% of adults enroll in clinical trials, with reasons ranging from rigorous eligibility criteria to limited access to clinical trials and lack of patient interest.
“If future studies demonstrate that prior cancer does not limit lung cancer treatment options or adversely impact clinical outcomes, modifying or eliminating this longstanding and arbitrary exclusion policy in lung cancer clinical trials may result in more generalizable results, faster accrual, higher completion rates, and the delivery of better treatments to more patients sooner. Because clinical trial design is relatively centralized, we believe that implementation of such changes could occur rapidly,” Dr. Gerber concluded in the press release.