信迪利单抗联合顺铂化疗用于食管癌术前新辅助治疗的效果及安全性

Efficacy and safety of sindilimab combined with cisplatin chemotherapy in preoperative neoadjuvant therapy for esophageal cancer

目的探讨信迪利单抗联合顺铂化疗用于食管癌术前新辅助治疗的效果及安全性。方法回顾性分析2020年11月至2022年12月安阳市肿瘤医院收治的105例潜在可切除局部晚期食管癌患者的临床资料,根据治疗方案将其分为对照组(52例)和观察组(53例)。对照组术前给予紫杉醇白蛋白+顺铂,观察组术前给予信迪利单抗+紫杉醇白蛋白+顺铂,化疗后两组均接受全腔镜Mackeown手术。比较两组病理完全缓解率、Karnofsky评分法(KPS)评分、食管癌患者补充量表(QLQ-OES18)评分、肿瘤标志物[鳞状上皮细胞癌相关抗原(SCC)、细胞角蛋白19片段抗原(CYFRA21-1)、癌胚抗原(CEA)、糖类抗原125(CA125)]水平、病情相关因子[血管内皮生长因子(VEGF)、转化生长因子β1(TGF-β1)、B细胞淋巴瘤因子-2(Bcl-2)]水平及不良反应发生情况。结果化疗后,观察组病理完全缓解率(33.96%,18/53)高于对照组(15.38%,8/52),P<0.05。化疗后,观察组QLQ-OES18评分低于对照组(P<0.05),两组KPS评分比较差异未见统计学意义(P>0.05)。化疗后,两组血清SCC、CYFRA21-1、CEA、CA125水平低于化疗前,且观察组低于对照组(P<0.05)。观察组化疗后血清VEGF、TGF-β1、Bcl-2水平低于对照组(P<0.05)。两组腹痛腹泻、皮疹、口腔黏膜炎、乏力发生率比较,差异未见统计学意义(P>0.05)。结论信迪利单抗联合含铂化疗用于食管癌术前能有效减轻患者临床症状,调控肿瘤标志物表达,抑制肿瘤血管新生,改善营养状况,且安全可靠。

Objective To investigate the efficacy and safety of sindilizumab combined with cisplatin chemotherapy in preoperative neoadjuvant therapy for esophageal cancer.Methods The clinical data of 105 patients with potentially resectable locally advanced esophageal cancer admitted to Anyang Cancer Hospital from November 2020 to December 2022 were retrospectively analyzed,and the patients were divided into control group(52 cases)and observation group(53 cases)according to the treatment plan.The control group was treated with paclitaxel albumin and cisplatin before operation,and the observation group was treated with sintilimab,paclitaxel albumin and cisplatin before operation.The pathological complete response rate,Karnofsky performance scale(KPS)score,quality of life questionnaire oesphegeal 18(QLQ-OES18)score,levels of tumor markers,including squamous cell carcinoma-associated antigen(SCC),cytokeratin 19 fragment antigen(CYFRA21-1),carcinoembryonic antigen(CEA)and carbohydrate antigen 125(CA125),the levels of disease-related factors,including vascular endothelial growth factor(VEGF),transforming growth factor-β1(TGF-β1)and B cell lymphoma factor-2(Bcl-2),and incidence of adverse reactions were compared between the two groups.Results After chemotherapy,the pathological complete remission rate of the observation group(33.96%,18/53)was higher than that of the control group(15.38%,8/52),P<0.05.After chemotherapy,the QLQ-OES18 score of the observation group was lower than that of the control group(P<0.05),and there was no significant difference in the KPS score between the two groups(P>0.05).After chemotherapy,the serum levels of SCC,CYFRA21-1,CEA,and CA125 in the two groups were lower than those before chemotherapy,and the observation group had lower levels than the control group(P<0.05).The levels of serum VEGF,TGF-β1 and Bcl-2 in the observation group were lower than those in the control group after chemotherapy(P<0.05).There was no significant difference in the incidences of abdominal pain,diarrhea,rash,oral mucositis,and fatigue between the two groups(P>0.05).Conclusions Sintilimab combined with cisplatin chemotherapy before surgery for esophageal cancer can effectively relieve the clinical symptoms of patients,regulate the expression of tumor markers,inhibit tumor angiogenesis,and improve nutritional status,which is safe and reliable.