Journal
JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE
Volume 106, Issue 11, Pages -Publisher
OXFORD UNIV PRESS INC
DOI: 10.1093/jnci/dju302
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Funding
- National Cancer Institute (NCI) Clinical Investigator Team Leadership Award [1P30 CA142543-01]
- American Cancer Society
- Simmons Cancer Center [ACS-IRG-02-196]
- Cancer Prevention Research Institute of Texas [CPRIT R1208]
- UT Southwestern Center of Patient-Centered Outcomes Research [AHRQ 1R24HS022418-01]
- National Center for Advancing Translational Sciences UT Southwestern Center for Translational Medicine [U54 RFA-TR-12-006]
- AGENCY FOR HEALTHCARE RESEARCH AND QUALITY [R24HS022418] Funding Source: NIH RePORTER
- NATIONAL CANCER INSTITUTE [U10CA021115, P30CA142543] Funding Source: NIH RePORTER
- NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES [UL1TR001105, KL2TR001103] Funding Source: NIH RePORTER
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Background In oncology clinical trials, the assumption that a prior cancer diagnosis could interfere with study conduct or outcomes results in frequent exclusion of such patients. We determined the prevalence and characteristics of this practice in lung cancer clinical trials and estimated impact on trial accrual. Methods We reviewed lung cancer clinical trials sponsored or endorsed by the Eastern Oncology Cooperative Group for exclusion criteria related to a prior cancer diagnosis. We estimated prevalence of prior primary cancer diagnoses among lung cancer patients using Surveillance Epidemiology and End Results (SEER)-Medicare linked data. We assessed the association between trial characteristics and prior cancer exclusion using chi-square analysis. All statistical tests were two-sided. Results Fifty-one clinical trials (target enrollment 13 072 patients) were included. Forty-one (80%) excluded patients with a prior cancer diagnosis as follows: any prior (14%), within five years (43%), within two or three years (7%), or active cancer (16%). In SEER-Medicare data (n = 210 509), 56% of prior cancers were diagnosed within five years before the lung cancer diagnosis. Across trials, the estimated number and proportion of patients excluded because of prior cancer ranged from 0-207 and 0%-18%. Prior cancer was excluded in 94% of trials with survival primary endpoints and 73% of trials with nonsurvival primary endpoints (P = .06). Conclusions 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 nonsurvival endpoints. More research is needed to understand the basis and ramifications of this exclusion policy.
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