SCI
23 May 2020
Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non–Small-Cell Lung Cancer
Kenmotsu H, Yamamoto N, Yamanaka T, et al. Randomized Phase III Study of Pemetrexed Plus Cisplatin Versus Vinorelbine Plus Cisplatin for Completely Resected Stage II to IIIA Nonsquamous Non–Small-Cell Lung Cancer. Journal of Clinical Oncology;0:JCO.19.02674.
CORRESPONDING AUTHOR：Hirotsugu Kenmotsu, MD, PhD, Division of Thoracic Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka, 411-8777, Japan; e-mail: h.kenmotsu@scchr.jp.
PURPOSE 目的
To evaluate the efficacy of pemetrexed plus cisplatin versus vinorelbine plus cisplatin as postoperative adjuvant chemotherapy in patients with pathologic stage II-IIIA nonsquamous non–small-cell lung cancer (NSCLC).
评估培美曲塞联合顺铂与长春瑞滨联合顺铂作为病理II-IIIA期非鳞状非小细胞肺癌(NSCLC)患者术后辅助化疗的疗效。
DESIGN 设计
Comparative observational study using data collected from routine care.
使用日常诊疗中收集的数据进行观察性研究。
PATIENTS AND METHODS 患者及方法
We performed a randomized, open-label, phase III study at 50 institutions within 7 clinical study groups in Japan. Patients with completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC were randomly assigned to receive either pemetrexed (500 mg/m2, day 1) plus cisplatin (75 mg/m2, day 1) or vinorelbine (25 mg/m2, days 1 and 8) plus cisplatin (80 mg/m2, day 1) with stratification by sex, age, pathologic stage, EGFR mutation, and institution. These treatments were planned to be given every 3 weeks for 4 cycles. The primary end point was recurrence-free survival in the modified intent-to-treat population, excluding ineligible patients.
我们在日本7个临床研究组的50个机构中进行了一项随机、开放标签的III期研究。完全切除患者病理阶段II-IIIA (TNM第七版)的非鳞状NSCLC患者被随机分配接受培美曲塞(500 mg / m2,第1天)+顺铂(75 mg / m2,第1天)或长春瑞滨(25 mg / m2,第 1和第8天)加顺铂(80 mg / m2,第1天)，按性别、年龄、病理阶段,表皮生长因子受体突变,和机构进行分层。治疗计划每3周一个疗程，共4个疗程。主要终点是除外不符合条件的患者，在改良的意向治疗人群中的无复发生存。
RESULT 结果
Between March 2012 and August 2016, 804 patients were enrolled (402 assigned to vinorelbine plus cisplatin and 402 assigned to pemetrexed plus cisplatin). Of 784 eligible patients, 410 (52%) had stage IIIA disease and 192 (24%) had EGFR-sensitive mutations. At a median follow-up of 45.2 months, median recurrence-free survival was 37.3 months for vinorelbine plus cisplatin and 38.9 months for pemetrexed plus cisplatin, with a hazard ratio of 0.98 (95% CI, 0.81 to 1.20; 1-sided P 5 .474).
2012年3月至2016年8月，共入组804例患者(402例为长春瑞滨加顺铂组，402例为培美曲塞加顺铂组)。在符合条件的784名患者中，410名(52%)患者为IIIA期疾病，192名(24%)患者为EGFR敏感突变。在45.2个月的中位随访中，长春瑞滨联合顺铂的中位无复发生存期为37.3个月，培美曲塞联合顺铂的中位无复发生存期为38.9个月，危险比为0.98 (95% CI, 0.81 - 1.20;单边P值为5 .474)。
Grade 3-4 toxicities reported more frequently for vinorelbine plus cisplatin than for pemetrexed plus cisplatin were febrile neutropenia (11.6% v 0.3%, respectively), neutropenia (81.1% v 22.7%, respectively), and anemia (9.3% v 2.8%, respectively). One treatment-related death occurred in each arm.
长春瑞滨联合顺铂较培美曲塞联合顺铂报告的更频繁的3-4级毒副反应为发热性中性粒细胞减少(分别为11.6% v 0.3%)、中性粒细胞减少(分别为81.1% v 22.7%)和贫血(分别为9.3% v 2.8%)是。每组都有一例与治疗相关的死亡。
CONCLUSION 结论
Although this study failed to show the superiority of pemetrexed plus cisplatin for patients with resected nonsquamous NSCLC, this regimen showed a better tolerability as adjuvant chemotherapy.
虽然本研究未显示培美曲塞联合顺铂治疗非鳞状NSCLC的优越性，但该方案作为辅助化疗显示出更好的耐受性。
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