Patients With Prior Cancer Excluded From Most Lung Cancer Trials
In a study reported in the Journal of the National Cancer Institute, Gerber et al found that patients with prior cancer were excluded from most clinical trials in lung cancer, including nearly all with overall survival as a primary endpoint.
The study involved review of data from 51 lung cancer clinical trials (total target enrollment, 13,072 patients) sponsored or endorsed by the Eastern Oncology Cooperative Group. Prevalence of prior primary cancer diagnoses among lung cancer patients was estimated using the Surveillance, Epidemiology, and End Results (SEER)-Medicare linked database.
Frequency of Exclusion
Overall, 41 trials (80%) excluded patients with prior cancer diagnosis, including any prior diagnosis (14%), diagnosis within 5 years (43%), diagnosis within 2 to 3 years (7%), and diagnosis of active cancer (16%). In SEER-Medicare data on 210,509 lung cancer patients, 56% of prior cancers were diagnosed within 5 years before lung cancer diagnosis. The estimated proportion of patients excluded from lung cancer trials due to prior cancer diagnosis ranged from 0% to 18%.
Exclusion By Trial Category
Prior cancer exclusion criteria were significantly more common in the 26 trials starting in 1986 to 1999 (92%) than in the 25 trials starting in 2000 to 2013 (68%; P = .04) and in the 30 phase II trials (83%) and 17 phase III trials (88%) than in the 4 phase I/pilot trials (25%; P = .04 for trend). There were exclusion criteria for 94% of the 18 trials with overall survival as a primary endpoint and for 73% of 33 trials with other endpoints. Prior cancer exclusion criteria were also more common in the 19 trials in small cell lung cancer (89%) than in the 32 trials in non–small cell lung cancer (75%).
The investigators concluded: “A substantial proportion of patients are reflexively excluded from lung cancer clinical trials because of prior cancer. This inclusion criterion is applied widely across studies, including more than two-thirds of trials with non-survival endpoints. More research is needed to understand the basis and ramifications of this exclusion policy.”
David E. Gerber, MD, of Harold C. Simmons Cancer Center, University of Texas Southwestern Medical Center, is the corresponding author for the Journal of the National Cancer Institute article.
The study was supported by grants from the National Cancer Institute, American Cancer Society and Simmons Cancer Center, Cancer Prevention Research Institute of Texas, University of Texas Southwestern Center of Patient-Centered Outcomes Research, and National Center for Advancing Translational Sciences University of Texas Southwestern Center for Translational Medicine.
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