信迪利单抗联合白蛋白紫杉醇+奈达铂化疗用于局部晚期食管癌术前新辅助治疗的临床观察

Clinical Observation of Sintilimab Combined with Albumin-Bound Paclitaxel and Nedaplatin in Preoperative Neoadjuvant Therapy for Locally Advanced Esophageal Cancer

目的观察信迪利单抗联合白蛋白紫杉醇+奈达铂化疗治疗局部晚期食管癌的疗效及安全性。方法回顾性分析2019年6月至2021年3月我院收治的67例局部晚期食管癌患者,按治疗方案不同,分为观察组(n=38,采用信迪利单抗联合白蛋白紫杉醇+奈达铂化疗方案)和对照组(n=29,采用白蛋白紫杉醇+奈达铂化疗方案),所有患者在接受新辅助治疗后均完成了食管癌根治切除术治疗和相应的术后辅助治疗。比较两组患者的围手术期指标,新辅助治疗后的近期疗效(包括客观缓解率、疾病控制率、病理完全缓解率),药物不良反应发生率以及患者的近期生存情况。结果观察组患者的病理完全缓解率为34.2%,对照组为6.9%,差异有统计学意义;观察组患者的客观缓解率,疾病控制率均高于对照组,差异有统计学意义(P<0.05);观察组的R0切除率高于对照组,且两组均未出现R2切除,差异有统计学意义(P<0.05);观察组与对照组的术中出血、术后住院时间及术后并发症比较,差异无统计学意义(P>0.05);观察组的手术时间短于对照组,差异有统计学意义(P<0.05);观察组与对照组药物不良反应发生率比较,差异无统计学意义(P>0.05);随访1.5年,无失访,观察组1.5年无进展生存率高于对照组,差异有统计学意义(P<0.05);观察组与对照组1.5年总生存率比较,有上升趋势,但差异无统计学意义(P>0.05)。结论信迪利单抗联合化疗用于食管癌术前新辅助治疗是安全的,可显著改善手术治疗效果,提高病理完全缓解率和改善近期生存,值得临床推广。

Objective To observe the efficacy and safety of sintilimab combined with albumin-bound paclitaxel and nedaplatin in preoperative neoadjuvant therapy for Locally advanced esophageal cancer.Methods This was a retrospective analysis of 67 patients with locally advanced esophageal cancer in our Hospital from June 2019 to March 2021.According to different treatment regimens the patients w1ere divided into the observation group(n=38,treated with sintilimab combined with albumin-bound paclitaxel+nedaplatin chemotherapy regimen)and the control group(n=29,treated with albumin-bound paclitaxel+nedaplatin chemotherapy regimen).All patients underwent radical resection of esophageal cancer after neoadjuvant therapy,and the corresponding postoperative adjuvant therapy was also completed.The perioperative indicators,short-term efficacy after neoadjuvant therapy(including objective response rate,disease control rate,pathological complete response rate),incidence of adverse drug reactions,and recent survival were compared between the two groups.Results The pathological complete response rate of the observation group was 34.2%,the control group was 6.9%,and the difference was statistically significant.Objective response rate and disease control rate of the observation group were higher than those of the control group,and the differences were statistically significant(P<0.05).The R0 resection rate of the observation group was higher than that of the control group,and no R2 resection occurred in either group,and the difference was statistically significant(P<0.05).There were no significant differences in intraoperative bleeding,postoperative hospital stay and postoperative complications between the observation group and the control group(P>0.05).The operation time of the observation group was shorter than that of the control group,and the difference was statistically significant(P<0.05).There was no significant difference in the incidence of adverse reactions between the observation group and the control group(P>0.05).The 1.5-year progression-free survival rate in the observation group was higher than that in the control group,and the difference was statistically significant(P<0.05).Compared with the control group,the 1.5-year overall survival rate of the observation group had an upward trend,but the difference was not statistically significant(P>0.05).Conclusion Sintilimab combined with chemotherapy for preoperative neoadjuvant treatment of esophageal cancer is safe and can significantly improve the surgical treatment effect,pathological complete response rate and recent survival,which is worthy of clinical promotion.