克里唑蒂尼
医学
ROS1型
内科学
危险系数
中止
肿瘤科
临床终点
临床试验
队列
人口
置信区间
癌症
肺癌
腺癌
环境卫生
恶性胸腔积液
作者
Robert C. Doebele,Laura Mezquita Pérez,Huong Trinh,Michael Martinec,Reynaldo Martina,Todd Riehl,Matthew Krebs,Neal J. Meropol,William Wong,Gracy Crane
标识
DOI:10.2217/cer-2021-0131
摘要
Aim: Generating direct comparative evidence in prospective randomized trials is difficult for rare diseases. Real-world cohorts may supplement control populations. Methods: Entrectinib-treated adults with advanced ROS1 fusion-positive NSCLC (n = 94) from Phase I/II trials (ALKA-372-001 [EudraCT2012-00148-88], STARTRK-1 [NCT02097810], and STARTRK-2 [NCT02568267]) were compared with a real-world crizotinib-treated cohort (n = 65). Primary end point, time-to-treatment discontinuation (TTD); secondary end points, PFS and OS. Results: Median (95% CI) weighted TTD: 12.9 (9.9-17.4) months for entrectinib; 8.8 (6.2-9.9) months for crizotinib (weighted hazard ratio: 0.72 [0.51-1.02]). Median OS with entrectinib was not reached, weighted median OS with crizotinib was 18.5 (15.1-19.9) months. Conclusion: Entrectinib administered in clinical trials may be associated with longer TTD than a real-world crizotinib population.
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