Hou Xinlei, Shi Xueliang, Luo Jie
Department of Thoracic Surgery, Daqing Oil Field General Hospital, Daqing, Heilongjiang 163001, P.R. China.
Department of Ophthalmology, Daqing Oil Field General Hospital, Daqing, Heilongjiang 163001, P.R. China.
Oncol Lett. 2022 May 17;24(1):215. doi: 10.3892/ol.2022.13336. eCollection 2022 Jul.
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.
卡瑞利珠单抗是一种在中国研发的新型程序性细胞死亡蛋白1（PD-1）抑制剂，在包括非小细胞肺癌（NSCLC）在内的几种晚期癌症类型中显示出良好疗效；然而，其作为NSCLC新辅助治疗方案的效用仍不明确。因此，本研究旨在探讨新辅助卡瑞利珠单抗联合化疗在局部晚期NSCLC患者中的疗效和安全性。在本前瞻性观察研究中，共分析了56例IIIA/IIIB期可切除NSCLC患者。在该队列中，31例患者接受新辅助卡瑞利珠单抗（每2周200 mg）联合紫杉醇和卡铂（PC）化疗，而另外25例患者仅接受新辅助PC化疗。分析病理反应、无病生存期（DFS）、总生存期（OS）和不良事件（AE）。与PC组相比，卡瑞利珠单抗联合PC组的完全病理缓解率（25.8%对8.3%；P=0.159）和主要病理缓解（MPR）率（61.3%对37.5%；P=0.080）更高，尽管结果无统计学意义。与PC组相比，卡瑞利珠单抗联合PC组的DFS时间显著延长（P=0.030）；然而，两组之间的OS时间无差异（P=0.251）。经多因素分析调整后，卡瑞利珠单抗联合PC方案与单独PC方案相比，独立与更高的MPR相关[比值比，5.216；95%置信区间（CI），1.178-23.086；P=0.030]，以及良好的DFS[风险比（HR），0.055；95%CI，0.007-0.442；P=0.006]和OS（HR，0.025；95%CI，0.002-0.416；P=0.010）时间。新辅助卡瑞利珠单抗联合PC方案最常见的AE是脱发（51.6%）、恶心和呕吐（45.2%）、贫血（41.9%）和疲劳（41.9%），其中大多数发生在1-2级疾病患者中。本研究结果表明，新辅助卡瑞利珠单抗联合PC化疗比单独PC化疗表现出更好的病理反应和生存情况，并且在局部晚期NSCLC患者中耐受性良好。
