@article{07a7bbf60e264746b65f8266914e971d,
title = "Impact of prior cancer on eligibility for lung cancer clinical trials",
abstract = "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.",
author = "Gerber, {David E.} and Laccetti, {Andrew L.} and Lei Xuan and Halm, {Ethan A.} and Pruitt, {Sandi L.}",
note = "Funding Information: For their assistance obtaining clinical trial protocols, the authors thank BilliSue Sawyer, Laura Gagnon, and Elizabeth O{\textquoteright}Conner from the Coordinating Center of the Eastern Cooperative Oncology Group (Robert L. Comis, MD, Chair), which is supported in part by Public Health Service Grant CA23318 from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services. The authors also thank Helen Mayo, MLS, from the University of Texas Southwestern Medical Center Library for her assistance performing literature searches. The authors thank M.E. Blair Holbein, PhD, BCAP, for her assistance identifying and reviewing Food and Drug Administration and NCI Cancer Therapy Evaluation Program documents. The authors also acknowledge the efforts of the Applied Research Program, NCI; the Office of Research, Development and Information, CMS; Information Management Services, Inc.; and the Surveillance, Epidemiology, and End Results Program tumor registries in the creation of the SEER-Medicare database. Funding Information: This work was supported by a National Cancer Institute (NCI) Clinical Investigator Team Leadership Award (1P30 CA142543-01 supplement to DEG), an American Cancer Society and Simmons Cancer Center Grant (ACS-IRG-02-196 to DEG), Cancer Prevention Research Institute of Texas (CPRIT R1208 to SLP), the UT Southwestern Center of Patient-Centered Outcomes Research (AHRQ 1R24HS022418-01 to EAH), and by the National Center for Advancing Translational Sciences UT Southwestern Center for Translational Medicine (U54 RFA-TR-12-006 to EAH and SLP). Publisher Copyright: {\textcopyright} The Author 2014. Published by Oxford University Press. All rights reserved.",
year = "2014",
month = nov,
day = "1",
doi = "10.1093/jnci/dju302",
language = "English (US)",
volume = "106",
journal = "Journal of the National Cancer Institute",
issn = "0027-8874",
publisher = "Oxford University Press",
number = "11",
}