可切除食管鳞状细胞癌患者新辅助卡瑞利珠单抗联合化疗的前瞻性、单臂、开放标签研究。
Neoadjuvant camrelizumab and chemotherapy in patients with resectable esophageal squamous cell carcinoma: A prospective, single-arm, open-label study.
发表日期:2023 Sep 07
作者:
Jianping Wang, Jian Zhang, Jie Gao, Mengmeng Zhao, Zhenkai Ma
来源:
Cell Death & Disease
摘要:
食管癌(EC)是全球癌症相关死亡的主要原因,给医疗系统和患者带来巨大的压力。食管鳞状细胞癌(ESCC)是中国人群中食管癌的主要亚型。本研究旨在将新辅助治疗周期延长至4个周期,并评估新辅助卡瑞利珠单抗联合化疗治疗可切除性ESCC的疗效和安全性。纳入的患者每隔21天接受新辅助卡瑞利珠单抗(200 mg,第1天)、纳美西泮(260 mg/m2,第1天)和卡铂(剂量曲线下面积;5 mg/mL/min)连续治疗4个周期,并在第4个治疗周期第1天后的4-6周内进行手术。研究的主要终点是病理完全缓解(pCR)率。从2021年12月15日到2022年10月1日,共有35例患者纳入研究。所有患者完成了完整的4个周期治疗,并被视为适合进行手术干预。34例(97.1%)患者获得R0切除,18例(51.4%)患者显示pCR率,27例(77.1%)患者获得较大的病理学反应(MPR)。在35例患者中观察到30例(85.7%)出现肿瘤退化。多变量 logistic 回归分析进一步确认年龄(比值比(OR)= 6.710,95%置信区间(95%CI):3.512-44.403)和程序化死亡配体 1(PD-L1)(OR = 2.855,95%CI:1.181-3.079)是pCR的独立预测因子。最常见的不良事件(AE)是白细胞减少,35例患者中有23例(65.7%)经历此现象。包括2例(5.7%)患者白细胞减少和12例(34.3%)患者中性粒细胞减少的3级或更高级别的AE。未观察到手术延迟。本研究结果表明,卡瑞利珠单抗联合纳美西泮和卡铂的4个周期表现出相对较高的pCR率和可接受的安全性,为进一步评估其在可切除性ESCC中的价值提供了有力依据。
Esophageal cancer (EC) is a major cause of cancer-related deaths worldwide, bringing tremendous pressure to the healthcare system and patients. Esophageal squamous cell carcinoma (ESCC) is the main subtype of EC in the Chinese population.This study aimed to extend the neoadjuvant therapy cycle to 4 cycles and evaluate the efficacy and safety of neoadjuvant camrelizumab combined with chemotherapy for the treatment of resectable ESCC.The enrolled patients received neoadjuvant camrelizumab (200 mg, day 1), nab-paclitaxel (260 mg/m2, day 1) and carboplatin (area under curve; 5 mg/mL/min) every 21 days for 4 cycles, and surgery was performed within 4-6 weeks after the first day of the 4th treatment cycle. The primary endpoint of the study was the pathological complete response (pCR) rate.From December 15, 2021, to October 1, 2022, a total of 35 patients were enrolled in the study. All patients completed the full 4-cycle treatment and were deemed fit for surgical intervention. Thirty-four (97.1%) patients achieved R0 resection, 18 (51.4%) showed a pCR rate, and 27 (77.1%) achieved a major pathological response (MPR). Tumor degradation was observed in 30 out of 35 patients (85.7%). Multivariate logistic regression analyses further confirmed that age (odds ratio (OR) = 6.710, 95% confidence interval (95% CI): 3.512-44.403) and programmed death-ligand 1 (PD-L1) (OR = 2.855, 95% CI: 1.181-3.079) were independent predictors of pCR. The most prevalent adverse event (AE) was leukopenia, which was experienced by 23 out of 35 patients (65.7%). Grade 3 or higher AEs included leukopenia in 2 cases (5.7%) and neutropenia in 12 cases (34.3%). No delays in surgery were observed.As demonstrated in this study, the 4 cycles of camrelizumab combined with nab-paclitaxel and carboplatin, which exhibited a relatively high pCR rate and acceptable safety, suggest a strong rationale for its further evaluation in resectable ESCC.