TY - JOUR
T1 - Enrollment trends and disparity among patients with lung cancer in national clinical trials, 1990 to 2012
AU - Pang, Herbert H.
AU - Wang, Xiaofei
AU - Stinchcombe, Thomas E.
AU - Wong, Melisa L.
AU - Cheng, Perry
AU - Ganti, Apar Kishor
AU - Sargent, Daniel J.
AU - Zhang, Ying
AU - Hu, Chen
AU - Mandrekar, Sumithra J.
AU - Redman, Mary W.
AU - Manola, Judith B.
AU - Schilsky, Richard L.
AU - Cohen, Harvey J.
AU - Bradley, Jeffrey D.
AU - Adjei, Alex A.
AU - Gandara, David
AU - Ramalingam, Suresh S.
AU - Vokes, Everett E.
N1 - Funding Information:
Supported by Grant No. R21-AG042894 from the National Institutes of Health National Institute on Aging and the Health and Medical Research Fund of Hong Kong, and by the National Institute on Aging (Grant No.T32-AG000212 to M.L.W.). Genentech, EMD Serono, Bristol-Myers Squibb, Abbvie Pfizer (Inst), Amgen (Inst), NewLink Genetics (Inst), ARIAD Pharmaceuticals (Inst), Astex Pharmaceuticals (Inst), Bristol-Myers Squibb (Inst), Merck Serono (Inst), Merck (Inst), Janssen Biotech (Inst) Celgene (Inst), Genentech (Inst) Mevion Medical Systems (Inst), ViewRay (Inst) Travel, Accommodations, Expenses: Mevion Medical Systems AstraZeneca/MedImmune (Inst), Bristol-Myers Squibb (Inst), Clovis Oncology (Inst), Genentech (Inst), Johnson and Johnson (Inst), Eli Lilly (Inst), Merck (Inst), Novartis (Inst) We thank Suzanne Dahlberg (ECOG-ACRIN), James Dignam (NRG Oncology), Stephen L. George (Duke), Robert J. Gray (ECOG-ACRIN), Lin Gu, MS (Duke), Yating Gu (Duke), Michael LeBlanc (Southwest Oncology Group), Jeffrey P. Meyer, BS (Mayo Clinic), James Moon, MS (Southwest Oncology Group), and Rebecca Paulus, BS (NRG Oncology).
Publisher Copyright:
© 2016 by American Society of Clinical Oncology.
PY - 2016/11/20
Y1 - 2016/11/20
N2 - 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.
AB - 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.
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U2 - 10.1200/JCO.2016.67.7088
DO - 10.1200/JCO.2016.67.7088
M3 - Article
C2 - 27646951
AN - SCOPUS:84994765427
SN - 0732-183X
VL - 34
SP - 3992
EP - 3999
JO - Journal of Clinical Oncology
JF - Journal of Clinical Oncology
IS - 33
ER -