Enrollment of Racial Minorities in Clinical Trials: Old Problem Assumes New Urgency in the Age of Immunotherapy.
Enrollment of Racial Minorities in Clinical Trials: Old Problem Assumes New Urgency in the Age of Immunotherapy.
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DOI：
10.1200/edbk_100021
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发表时间：
2019-01-01
期刊：
影响因子：
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通讯作者：
Owonikoko, Taofeek K
中科院分区：
文献类型：
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作者：
Nazha, Bassel;Mishra, Manoj;Owonikoko, Taofeek K
美国少数族裔在癌症临床试验中的代表性不足。本综述评估了在当前癌症免疫治疗时代，少数患者参与临床试验的差异的影响。导致美国监管机构批准免疫检查点抑制剂的关键试验的招募显示少数族裔群体的代表性较差。具体来说，我们发现黑人患者在多项支持批准免疫检查点抑制剂治疗肺癌的试验中占所有患者的不到4%。在肾细胞癌和其他肿瘤类型中进行的试验中观察到类似的代表性不足。由于免疫疗法的功效仅在一部分患者中观察到，因此使用预测性生物标志物来鉴定应答者沿着新策略以将益处扩展至更大的患者亚组是当前积极研究的领域。少数患者在免疫治疗临床试验中的代表性不足可能会使结果差异永久化，因为在开发用于真实的世界的新治疗算法以指导免疫治疗的最佳使用时，未考虑该亚群的宿主和肿瘤的独特生物学。
Minority U.S. populations are underrepresented in cancer clinical trials. This review appraises the impact of the disparity in clinical trial participation by minority patients in the current era of cancer immunotherapy. Enrollment on pivotal trials leading to U.S. regulatory approval of immune checkpoint inhibitors showed poor representation of minority ethnic groups. Specifically, we found that black patients constitute less than 4% of all patients enrolled across multiple trials that supported the approval of immune checkpoint inhibitors for the treatment of lung cancer. Similar underrepresentation was observed for trials conducted in renal cell carcinoma and other tumor types. Since efficacy of immunotherapy is only observed in a subset of patients, the use of predictive biomarkers to identify responders along with new strategies to expand the benefit to a larger subset of patients are current areas of active investigation. The inadequate representation of minority patients on immunotherapy clinical trials could perpetuate outcome disparity because the unique biology of the host and the tumors from this subpopulation is not accounted for as new treatment algorithms to guide optimal use of immunotherapy are developed for use in the real world.