OBJECTIVES Food and Drug Administration (FDA) approved crizotinib for advanced ROS1-rearranged (ROS1+) non-small-cell lung cancer (NSCLC) patients due to a single-arm study PROFILE 1001. However, there is no direct comparison between crizotinib and platinum-pemetrexed chemotherapy. MATERIALS AND METHODS Clinical data of advanced ROS1+NSCLC patients treated with first-line crizotinib or platinum-pemetrexed chemotherapy between August 2010 and December 2017 were analyzed. RESULTS Seventy-seven patients were eligible, including 30 (39.0%) in the crizotinib group and 47 (61.0%) in the platinum-pemetrexed chemotherapy group. The median follow-up was 28.1 months (95% confidence interval [CI]: 19.2-39.0). The objective response rate (ORR) of crizotinib (86.7%, 95% CI: 73.3-96.7) was higher than that of platinum-pemetrexed chemotherapy (44.7%, 95% CI: 29.8-57.4, P < .001). The disease control rate (DCR) was 96.7% (95% CI: 90.0-100) in the crizotinib group and 85.1% (95% CI: 74.5-95.7) in the chemotherapy group (P = .140). Significantly longer progression-free survival (PFS) was observed in the patients treated with crizotinib (18.4 months, 95% CI: 6.4-30.3) versus platinum-pemetrexed chemotherapy (8.6 months, 95% CI: 6.9-10.3, P < .001). Overall survival (OS) was also compared between the two groups and no significant difference was seen (Not reach vs 28.4 months [95% CI: 20.7-36.0], P = .176). Notably, a total of 37 patients have treatment crossover after the failure of first-line treatment. Among those patients, difference in OS was not statistically significant between seven patients who have given first-line crizotinib (38.6 months, 95% CI: 0-81.0) and 30 patients who have given platinum-pemetrexed chemotherapy initially (32.8 months, 95% CI: 11.9-53.8, P = .805). CONCLUSIONS Our results suggested that first-line crizotinib had higher ORR and longer PFS than platinum-pemetrexed chemotherapy in patients with advanced ROS1+NSCLC, but the differences were not observed for OS.

中文翻译：

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晚期 ROS1 重排非小细胞肺癌患者的一线克唑替尼与铂类培美曲塞化疗。

目标 由于一项单臂研究 PROFILE 1001，食品和药物管理局 (FDA) 批准了克唑替尼用于晚期 ROS1 重排 (ROS1+) 非小细胞肺癌 (NSCLC) 患者。然而，克唑替尼和铂金之间没有直接比较-培美曲塞化疗。材料与方法 分析 2010 年 8 月至 2017 年 12 月期间接受一线克唑替尼或铂类培美曲塞化疗的晚期 ROS1+NSCLC 患者的临床资料。结果 77 名患者符合条件，包括克唑替尼组 30 名 (39.0%) 和铂-培美曲塞化疗组 47 名 (61.0%)。中位随访时间为 28.1 个月（95% 置信区间 [CI]：19.2-39.0）。克唑替尼的客观缓解率（ORR）（86.7%，95% CI：73.3-96.7）高于铂类培美曲塞化疗（44.7%，95% CI：73.3-96.7）。29.8-57.4，P < .001）。克唑替尼组的疾病控制率 (DCR) 为 96.7%（95% CI：90.0-100），化疗组为 85.1%（95% CI：74.5-95.7）（P = .140）。与铂类培美曲塞化疗（8.6 个月，95% CI：6.9-10.3，P < .001）相比，接受克唑替尼（18.4 个月，95% CI：6.4-30.3）治疗的患者的无进展生存期（PFS）显着更长）。还比较了两组的总生存期 (OS)，没有发现显着差异（未达到与 28.4 个月 [95% CI：20.7-36.0]，P = .176）。值得注意的是，共有 37 名患者在一线治疗失败后进行了治疗交叉。在这些患者中，7 名接受一线克唑替尼治疗的患者的 OS 差异无统计学意义（38.6 个月，95% CI：0-81。0) 和 30 名最初接受铂类培美曲塞化疗的患者（32.8 个月，95% CI：11.9-53.8，P = .805）。结论 我们的结果表明，在晚期 ROS1+NSCLC 患者中，一线克唑替尼比铂类培美曲塞化疗具有更高的 ORR 和更长的 PFS，但未观察到 OS 的差异。