Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012

• Authors: Herbert H. Pang, School of Public Health, Li Ka Shing Faculty of Medicine, Hong Kong, Special Administrative Region, People's Republic of China; Xiaofei Wang, Duke University; Thomas E. Stinchcombe, Duke University; Melissa L. Wong, University of California San Francisco; Perry Cheng, School of Public Health, Li Ka Shing Faculty of Medicine, Hong Kong, Special Administrative Region, People's Republic of China; Apar Kishor Ganti, University of Nebraska Medical Center, Omaha, NE; Daniel J. Sargent, Mayo Clinic, Rochester, MN; Ying Zhang, Duke University; Cheng Hu, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; Sumithra J. Mandrekar, Mayo Clinic, Rochester, MN; Mary W. Redman, Fred Hutchinson Cancer Research Center; Judith B. Manola, Dana Farber Cancer Institute; Richard L. Schilsky, ASCO; Harvey J. Cohen, Duke University; Jeffrey Bradley, Emory University; Alex A. Adjei, Roswell Park Cancer Institute, Buffalo, NY; David Gandara, University of California Davis; Suresh Ramalingam, Emory University; Everett E. Vokes, University of Chicago
• Journal Title: Journal of Clinical Oncology
• Volume: Volume 34, Number 33
• Publisher: American Society of Clinical Oncology | 2016-11-20, Pages 3992-U90
• Type of Work: Article | Final Publisher PDF
• Publisher DOI: http://doi.org/10.1200/JCO.2016.67.7088
• Subjects: Health Sciences, Oncology; Biology, Biostatistics; Health Sciences, Public Health
• Keywords: Science & Technology; Life Sciences & Biomedicine; Oncology; Enhancing minorty participation; Underrepresented populations; Barriers; Older; Age; Recruitment; Strategies; Impact; Breast

Abstract

Purpose: Under-representation of elderly, women, and racial/ethnic minority patients with cancer in clinical trials is of national concern. The goal of this study was to characterize enrollment trends and disparities by age, sex, and race/ethnicity in lung cancer trials. Methods: We analyzed data for 23,006 National Cancer Institute cooperative group lung cancer trial participants and 578,476 patients with lung cancer from the SEER registry from 1990 to 2012. The enrollment disparity difference (EDD) and enrollment disparity ratio (EDR) were calculated on the basis of the proportion of each subgroup in the trial population and the US lung cancer population. Annual percentage changes (APCs) in the subgroup proportions in each population were compared over time. Results: Enrollment disparity for patients ≥ 70 years of age with non-small-cell lung cancer improved from 1990 to 2012 (test of parallelism, P = .020), with a remaining EDD of 0.22 (95% CI, 0.19 to 0.25) and EDR of 1.65 (95% CI, 1.51 to 1.82) in 2010 to 2012. No improvement was seen for elderly patients with small-cell lung cancer (SCLC), with an APC of 0.20 (P = .714) among trial participants, despite a rising proportion of elderly patients with SCLC in the US population (APC, 0.32; P = .020). Enrollment disparity for women with lung cancer improved overall, with the gap closing by 2012 (EDD, 0.03 [95% CI, 0.00 to 0.06]; EDR, 1.07 [95% CI, 1.00 to 1.16]). Enrollment disparities persisted without significant improvement for elderly women, blacks, Asians/Pacific Islanders, and Hispanics. Conclusion: Under-representation in lung cancer trials improved significantly from 1990 to 2012 for elderly patients with non-small-cell lung cancer and for women, but ongoing efforts to improve the enrollment of elderly patients with SCLC and minorities are needed. Our study highlights the importance of addressing enrollment disparities by demographic and disease subgroups to better target under-represented groups of patients with lung cancer.