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Randomized phase III study of pemetrexed plus cisplatin vs vinorelbine plus cisplatin for completely resected stage II to IIIA nonsquamous non–small-cell lung cancer

Journal of Clinical Oncology Jul 01, 2020

Kenmotsu H, Yamamoto N, Yamanaka T, et al. - This randomized, open-label, phase III study was performed to determine whether pemetrexed plus cisplatin vs vinorelbine plus cisplatin affords an efficacious option as postoperative adjuvant chemotherapy in patients with pathologic stage II-IIIA nonsquamous non–small-cell lung cancer (NSCLC). This inquiry was performed at 50 institutions within 7 clinical study groups in Japan. Participants included cases with completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC. The participants were randomized 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 gender, age, pathologic stage, EGFR mutation, and institution. Recurrence-free survival in the modified intent-to-treat group, eliminating ineligible patients, was the primary endpoint. For vinorelbine plus cisplatin and for pemetrexed plus cisplatin, median recurrence-free survival of 37.3 months and 38.9 months, respectively, was estimated at a median follow-up of 45.2 months, with a hazard ratio of 0.98. Overall, findings did not demonstrate that pemetrexed plus cisplatin is a superior treatment option for patients with resected nonsquamous NSCLC, but did show a better tolerability of this regimen as adjuvant chemotherapy.

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