Efficacy and safety of camrelizumab (a PD-1 inhibitor) combined with chemotherapy as a neoadjuvant regimen in patients with locally advanced non-small cell lung cancer

卡瑞利珠单抗(PD-1 抑制剂)联合化疗作为新辅助治疗方案治疗局部晚期非小细胞肺癌的疗效和安全性

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作者:Xinlei Hou, Xueliang Shi, Jie Luo

Abstract

Camrelizumab is a novel programmed cell death protein 1 (PD-1) inhibitor developed in China that exhibits good efficacy in several advanced cancer types, including non-small cell lung cancer (NSCLC); however, its utility as a neoadjuvant regimen in NSCLC remains unclear. Thus, the present study aimed to explore the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy in patients with locally advanced NSCLC. A total of 56 patients with stage IIIA/IIIB resectable NSCLC were analyzed in the present prospective observational study. Amongst the cohort, 31 patients underwent neoadjuvant camrelizumab (200 mg every 2 weeks) plus paclitaxel and carboplatin (PC) chemotherapy, while another 25 cases underwent neoadjuvant PC chemotherapy alone. The pathological response, disease-free survival (DFS) time, overall survival (OS) time and adverse events (AEs) were analyzed. The complete pathological response (25.8 vs. 8.3%; P=0.159) and major pathological response (MPR) (61.3 vs. 37.5%; P=0.080) rates were higher in the camrelizumab plus PC group compared with the findings in the PC group, although the results were not statistically significant. DFS time was significantly prolonged in the camrelizumab plus PC group compared with that in the PC group (P=0.030); however, there was no difference in OS time between these two groups (P=0.251). Following adjustment by multivariate analysis, the camrelizumab plus PC regimen versus the PC regimen alone was independently associated with higher MPR [odds ratio, 5.216; 95% confidence interval (CI), 1.178-23.086; P=0.030], and favorable DFS [hazard ratio (HR), 0.055; 95% CI, 0.007-0.442; P=0.006] and OS (HR, 0.025; 95% CI, 0.002-0.416; P=0.010) times. The most common AEs of the neoadjuvant camrelizumab plus PC regimen were alopecia (51.6%), nausea and vomiting (45.2%), anemia (41.9%) and fatigue (41.9%), the majority of which occurred in patients with grade 1-2 disease. The present results indicated that neoadjuvant camrelizumab plus PC chemotherapy exhibited a superior pathological response and survival profile to PC chemotherapy alone, and was well tolerated in patients with locally advanced NSCLC.

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