lung cancer

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

In the July 1, 2020 edition of Journal of Clinical Oncology, Hirotsugu Kenmotsu and colleagues report on the results of a randomized phase 3 trial of Pemetrexed + Cisplatin vs Vinorelbine + Cisplatin for completely resected Stage II – IIIA nonsquamous NSCLC.

PURPOSE

pemetrexed plus cisplatin versus vinorelbine plus cisplatin as postoperative adjuvant chemotherapy in patients with stage II – IIIA nonsquamous NSCLC.

PATIENTS AND METHODS

The trial was an open label, randomized, phase 3 study conducted at 50 institutions within 7 clinical study groups in Japan. Patients who had completely resected pathologic stage II-IIIA (TNM 7th edition) nonsquamous NSCLC were randomized to 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).  Treatment was performed every 3 weeks, for 4 cycles.  Patients underwent stratification by age, sex, pathologic stage, EGFR mutation, as well as treating institution. The primary end point was recurrence-free survival in the modified intent-to-treat population, excluding ineligible patients.

Between March 2012 and August 2016, 804 patients underwent randomization (402 in the vinorelbine plus cisplatin group and 402 or in the pemetrexed plus cisplatin group). 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, the median RFS was 37.3 months for vinorelbine plus cisplatin and 38.9 months for pemetrexed plus cisplatin, with a HR of 0.98 (95% CI, 0.81 to 1.20; 1-sided P = .474). Grade 3/4 toxicities were reported more commonly 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 of the study arms. The authors concluded “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.”

Reference:

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

https://ascopubs.org/doi/full/10.1200/JCO.19.02674

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