化疗联合程序性死亡蛋白1抗体治疗在食管鳞状细胞癌新辅助治疗真实世界中的疗效及安全性

Efficacy and safety of neoadjuvant chemotherapy combined with PD-1 antibody for esophageal squamous cell carcinoma in the real world

目的评估真实世界中新辅助化疗联合程序性死亡蛋白1(PD-1)抗体治疗对局部晚期可切除、边界或潜在可切除食管鳞状细胞癌(简称鳞癌)的有效率和安全性。方法2020年4月至2021年3月在南京大学医学院附属鼓楼医院行化疗联合PD-1抗体新辅助治疗的局部晚期可切除、边界或潜在可切除食管鳞癌患者28例,根据美国癌症联合会第8版临床TNM分期标准,Ⅱ期、Ⅲ期、ⅣA期、ⅣB期和分期不明者分别有1、15、10、1和1例。治疗方案为紫杉类药物与铂类药物或氟尿嘧啶的双药化疗联合PD-1抗体治疗。2个周期后对患者进行疗效评估,并对适合手术者行手术治疗。结果28例患者中,分别有1、21、5和1例患者完成了1、2、3、4个周期化疗联合PD-1抗体治疗。客观缓解率为71.4%(20/28),疾病控制率为100%(28/28)。3级以上不良反应发生率为21.4%(6/28),其中中性粒细胞减少3例,白细胞减少1例,血小板减少1例,免疫性肝炎1例。无治疗相关死亡。23例患者完成了手术治疗,R0切除率为87.0%(20/23),其中13例患者术后病理分期降至Ⅰ期,病理完全缓解率为17.3%(4/23),原发灶病理完全缓解率为21.7%(5/23)。4例在完成新辅助治疗后行根治性放化疗,1例达到部分缓解后拒绝后续治疗。结论对于局部晚期可切除、边界或潜在可切除食管鳞癌患者,新辅助化疗联合PD-1抗体治疗有效率高,安全性良好,是一种有潜力的治疗方式。

Objective To evaluate the efficacy and safety of neoadjuvant chemotherapy combined with programmed death-1(PD-1)antibody in operable,borderline or potentially resectable locally advanced esophageal squamous cell carcinoma(ESCC)in the real world.Methods The study retrospectively analyzed 28 patients with operable or potentially resectable locally advanced ESCC patients treated with preoperative chemotherapy combined with PD-1 inhibitor in Nanjing Drum Tower Hospital,Affiliated Hospital of Nanjing University Medical School from April 2020 to March 2021.According to the clinical TNM staging system of the 8th edition of the American Joint Committee on Cancer,there were 1,15,10,1 and 1 case of stageⅡ,Ⅲ,ⅣA,ⅣB and unknown stage respectively.The treatment was two cycle of dual drug chemotherapy regimen including taxane plus platinum or fluorouracil combined with PD-1 antibody followed by tumor response assessment and surgery if the patient was eligible for resection.Results Of the 28 patients,1,2,3 and 4 cycles of chemotherapy combined with PD-1 antibody treatment completed in 1,21,5,and 1 patient,respectively.Objective response rate(ORR)was 71.4%(20/28),and disease control rate(DCR)was 100%(28/28).The incidence of adverse events exceeding grade 3 levels was 21.4%(6/28),including 3 neutropenia,1 leukopenia,1 thrombocytopenia and 1 immune hepatitis.There was no treatment-related death.Of the 23 patients underwent surgery,R0 resection rate was 87.0%(20/23),13 patients had down staged to the T1-2N0M0 I stage,the pCR rate was 17.3%(4/23),and the pCR rate of primary tumor was 21.7%(5/23).Four patients received definitive chemoradiotherapy.One patient rejected surgery and other treatment after achieved PR response.Conclusion Neoadjuvant chemotherapy combined PD-1 inhibitor is safe and has high efficacy in operable,borderline or potentially resectable locally advanced ESCC,and it is a promising regimen.