1990年至2012年全国肺癌临床试验患者的入组趋势及差异
Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.
作者信息
Pang Herbert H, Wang Xiaofei, Stinchcombe Thomas E, Wong Melisa L, Cheng Perry, Ganti Apar Kishor, Sargent Daniel J, Zhang Ying, Hu Chen, Mandrekar Sumithra J, Redman Mary W, Manola Judith B, Schilsky Richard L, Cohen Harvey J, Bradley Jeffrey D, Adjei Alex A, Gandara David, Ramalingam Suresh S, Vokes Everett E
机构信息
Herbert H. Pang and Perry Cheng, School of Public Health, Li Ka Shing Faculty of Medicine, Hong Kong, Special Administrative Region, People's Republic of China; Herbert H. Pang, Xiaofei Wang, Ying Zhang, Thomas E. Stinchcombe, and Harvey J. Cohen, Duke University School of Medicine, Durham, NC; Melisa L. Wong, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco; David Gandara, University of California, Davis Comprehensive Cancer Center, Sacramento, CA; Apar Kishor Ganti, Veterans Affairs Nebraska Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, NE; Daniel J. Sargent and Sumithra J. Mandrekar, Mayo Clinic, Rochester, MN; Chen Hu, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; Chen Hu, Johns Hopkins University School of Medicine, Baltimore, MD; Mary W. Redman, Fred Hutchinson Cancer Research Center, Seattle, WA; Judith B. Manola, Dana-Farber Cancer Institute, Boston, MA; Richard L. Schilsky, ASCO, Alexandria, VA; Jeffrey D. Bradley, Washington University School of Medicine, St Louis, MO; Alex A. Adjei, Roswell Park Cancer Institute, Buffalo, NY; Suresh S. Ramalingam, The Winship Cancer Institute of Emory University, Atlanta, GA; and Everett E. Vokes, University of Chicago, Chicago, IL.
出版信息
J Clin Oncol. 2016 Nov 20;34(33):3992-3999. doi: 10.1200/JCO.2016.67.7088. Epub 2016 Sep 30.
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.
目的 老年、女性以及癌症患者中的种族/族裔少数群体在临床试验中的代表性不足是一个全国性问题。本研究的目的是描述肺癌试验中按年龄、性别和种族/族裔划分的入组趋势及差异。方法 我们分析了1990年至2012年期间23,006名美国国立癌症研究所合作组肺癌试验参与者以及监测、流行病学与最终结果（SEER）登记处578,476名肺癌患者的数据。根据试验人群和美国肺癌人群中各亚组的比例计算入组差异差值（EDD）和入组差异比率（EDR）。比较各人群中亚组比例随时间的年度百分比变化（APC）。结果 1990年至2012年期间，≥70岁非小细胞肺癌患者的入组差异有所改善（平行性检验，P = 0.020），2010年至2012年期间，剩余的EDD为0.22（95%CI，0.19至0.25），EDR为1.65（95%CI，1.51至1.82）。老年小细胞肺癌（SCLC）患者的入组情况未见改善，试验参与者中的APC为0.20（P = 0.714），尽管美国老年SCLC患者比例在上升（APC，0.32；P = 0.020）。肺癌女性患者的入组差异总体有所改善，到2012年差距缩小（EDD，0.03 [95%CI，0.00至0.06]；EDR，1.07 [95%CI，1.00至1.16]）。老年女性、黑人、亚裔/太平洋岛民和西班牙裔的入组差异仍然存在且无显著改善。结论 1990年至2012年期间，老年非小细胞肺癌患者和女性在肺癌试验中的代表性不足情况有显著改善，但仍需要持续努力提高老年SCLC患者和少数群体的入组率。我们的研究强调了按人口统计学和疾病亚组解决入组差异以更好地针对肺癌代表性不足患者群体的重要性。
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