新辅助免疫治疗联合化疗治疗局部晚期可切除食管鳞状细胞癌的短期疗效观察

Short-term efficacy of neoadjuvant immunotherapy combined with chemotherapy for locally advanced resectable esophageal squamous cell carcinoma

目的评估新辅助免疫治疗联合化疗(nICT)治疗局部晚期可切除食管鳞状细胞癌(ESCC)的安全性、有效性和临床短期结果。方法回顾性分析2020年6月—2023年5月在兰州大学第二医院胸外科行McKeown食管切除术的局部晚期可切除ESCC患者的临床资料,根据患者是否接受nICT分为nICT组、单纯手术组,比较2组患者的基线资料、围手术期相关指标及术后并发症等,并评估nICT组的客观缓解率(ORR)和术后病理缓解率,记录nICT过程中的不良事件发生率。结果共纳入195例患者,其中nICT组59例,单纯手术组136例,2组患者基线资料具有可比性。相比单纯手术组手术时间(303.3±69.7)min,nICT组的手术时间(357.7±89.9)min明显延长(P<0.001);2组间R0切除率、术中出血量、淋巴结清扫数、术后并发症、胸管留置时间、术后住院时间和术后60 d死亡率等差异无统计学意义(P>0.05)。nICT组的ORR为64.4%,术后病理完全缓解率为28.8%,主要病理缓解率为39.0%,nICT期间3级治疗相关不良事件发生率为20.3%,无4级及以上不良事件发生。结论nICT后行食管切除术未增加局部晚期可切除ESCC患者的术后并发症,且不良事件可控,是局部晚期ESCC安全、可行的治疗模式。

Objective To evaluate the safety,efficacy and clincal short-term outcomes of neoadjuvant immu-nochemotherapy(nICT)in the treatment of patients with locally advanced resectable esophageal squamous cell carcinoma(ESCC).Methods A retrospective analysis was performed to consecutive patients(from June 2020 to May 2023)who underwent Mckeown esophagectomy for locally advanced resectable ESCC with or without nICT.According to the different treatments,the patients were divided into two groups:the nICT group and the surgery alone group.The baseline characteristics,perioperative indicators and incidence of post-operative complications were compared between the two.To evaluate the efficacy of nICT,objective response rate(ORR),postoperative pathological response rate and incidence of adverse events during the nICT were analyzed.Results A total of 195 patients were included in the study,with 59 in the nICT group and 136 in the surgery alone group.The baseline data of the two groups were comparable.Compared with the surgery alone group(303.3±69.7)min,operation time was significantly longer in the nICT group(357.7±89.9)min(P<0.001).However,there was no significant difference(P>0.05)between the two groups in the R0 resec-tion rate,intraoperative blood loss,number of dissected lymph nodes,postoperative complications,chest tube duration,postoperative hospital stay and 60-day mortality rate.In the nICT group,the ORR was 64.4%,patho-logical complete response rate 28.8%and the major pathological response rate 39.0%.The incidence of grade 3 treatment-related adverse events was 20.3%,and there were no≥grade 4 adverse events during the neoadju-vant therapy.Conclusion NICT followed by Mckeown esophagectomy for locally advanced ESCC did not increase postoperative complications,and adverse events were controllable.It was a safe and feasible neo-adjuvant treatment model while further multicenter prospective trials are needed to validate our results.