Overall Survival and Safety With Pemetrexed/Platinum ± Anti-VEGF Followed by Pemetrexed ± Anti-VEGF Maintenance in Advanced Nonsquamous Non-Small-Cell Lung Cancer: A Pooled Analysis of 4 Randomized Studies

Data from 4 randomized studies of treatment with pemetrexed/platinum +/- anti-VEGF followed by pemetrexed +/- anti-VEGF maintenance for advanced nonsquamous non-small-cell lung cancer were pooled and analyzed for overall survival and safety. No significant difference in overall survival was found between pemetrexed-only versus pemetrexed + anti-VEGF maintenance. Both maintenance therapies were tolerable across the length of treatment. Background: Before immune checkpoint blockade therapy, chemotherapy with pemetrexed maintenance was the standard of care for patients with advanced nonsquamous non-small-cell lung cancer (NSQ-NSCLC) and remains such where immunotherapy is not applicable. This pooled analysis aimed to characterize overall survival (OS) and safety of pemetrexed +/- anti-VEGF maintenance, by treatment duration. Patients and Methods: Data from 4 random-ized clinical trials (PARAMOUNT, PRONOUNCE, PointBreak, JVBL) of patients with NSQ-NSCLC receiving pemetrexed +/- anti-VEGF maintenance therapy were pooled as 2 groups (Group A: pemetrexed-only maintenance, n = 486; and Group B: pemetrexed + anti-VEGF maintenance, n = 329). OS and treatment-emergent adverse events (TEAEs) were analyzed in both groups by treatment duration. Results: Baseline characteristics were well balanced between both groups. Median OS did not significantly differ between Group A (16.1 months) and Group B (18.4 months; hazard ratio: 1.17, P = .1417). A correlation between median OS and treatment duration was numerically stronger in Group A ( r = 0.72) versus B ( r = 0.62). Across treatment groups, TEAEs were largely grade 1 to 2 and, with few exceptions, did not increase with increased treatment duration. Conclusion: There was no significant OS difference between pemetrexed-only and pemetrexed +/- anti-VEGF maintenance in patients with NSQ-NSCLC. Patients receiving pemetrexed + anti-VEGF experienced a slightly less favorable safety profile with more reported TEAEs compared to pemetrexed monother-apy. Pemetrexed +/- anti-VEGF maintenance therapy may be considered in NSQ-NSCLC, based on an individualized patient approach, particularly where immunotherapy is not clinically indicated. (C) 2021 The Authors. Published by Elsevier Inc.

Automated summary

This study pooled and analyzed data from randomized studies to compare the overall survival and safety of pemetrexed-only maintenance versus pemetrexed +/- anti-VEGF maintenance in patients with advanced nonsquamous non-small-cell lung cancer. The results showed no significant difference in overall survival between the two maintenance therapies and both were well-tolerated.