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Outcome benefits of bevacizumab biosimilar (SIBP04) combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer patients with EGFR mutation: subgroup analysis of a prospective, randomized phase III clinical trial.

Authors :
Qu, Aidong
Zhang, Shiying
Zou, Hongxia
Li, Sixiu
Chen, Dandan
Zhang, Yaowen
Li, Songsong
Zhang, Huijun
Yang, Ji
Yang, Yunkai
Huang, Yubao
Li, Xiuling
Zhang, Yuntao
Source :
Journal of Cancer Research & Clinical Oncology; Nov2023, Vol. 149 Issue 14, p12713-12721, 9p
Publication Year :
2023

Abstract

Purpose: SIBP04 is a bevacizumab biosimilar, and bevacizumab combined with carboplatin and paclitaxel in advanced non-squamous non-small-cell lung cancer (nsqNSCLC) has been recommended as the first-line treatment choice. However, the efforts of bevacizumab combined with carboplatin and paclitaxel for nsqNSCLC patients with EGFR mutation remained unclear. Here we report an EGFR mutation subgroup analysis of a prospective, randomized phase III clinical trial (NCT05318443). Methods: In this randomized, double-blind, multi-center, parallel controlled, phase III clinical trial, locally advanced, metastatic NSCLC patients were enrolled, and EGFR expression was examined and considered as a stratification factor. All patients received 4 to 6 cycles of paclitaxel and carboplatin plus SIBP04 or bevacizumab 15 mg/kg intravenously followed by SIBP04 15 mg/kg maintenance until intolerable toxicity, disease progression or death. Patients with EGFR mutation and wild-type were assessed for progression-free survival (PFS) and overall survival (OS). Results: EGFR expression was examined in 398 NSCLC patients (142 with EGFR mutation, 256 with EGFR wild type). PFS in EGFR mutation patients was significantly longer than EGFR wild-type patients (10.91 vs. 7.82 months; HR = 0.692, 95% CI 0.519–0.921, P = 0.011). The median OS in patients with EGFR mutation was not reached while that of EGFR wild-type group was 17.54 months (HR = 0.398, 95% CI 0.275–0.575, P < 0.001). However, there were no significant differences in objective response rate (61.97% vs. 55.86%, P = 0.237) or disease control rate (90.14% vs. 89.84%, P = 0.925). Conclusion: Bevacizumab combined with chemotherapy significantly prolonged the PFS and OS of advanced nsqNSCLC patients with EGFR mutation. [ABSTRACT FROM AUTHOR]

Details

Language :
English
ISSN :
01715216
Volume :
149
Issue :
14
Database :
Complementary Index
Journal :
Journal of Cancer Research & Clinical Oncology
Publication Type :
Academic Journal
Accession number :
173106574
Full Text :
https://doi.org/10.1007/s00432-023-05103-4