立体定向放疗联合TP方案及免疫治疗对晚期寡转移食管癌的疗效及安全性分析

Efficacy and safety of stereotactic body radiotherapy combined with TP regimen and immunotherapy for advanced oligometastatic esophageal cancer

摘要:

目的 评估立体定向放疗（SBRT）联合TP化疗方案（紫杉醇和顺铂）及免疫治疗对晚期寡转移食管癌的疗效和安全性。方法 前瞻性选取2016年3月—2020年3月在苏州市立医院确诊的120例晚期寡转移食管癌患者。通过随机数字表法将患者分为治疗组和对照组，每组60例。治疗组接受SBRT联合TP化疗方案和免疫治疗；对照组仅接受TP化疗方案和免疫治疗。随访期3年。主要观察指标包括临床疗效、肿瘤标志物水平、免疫相关指标、总生存期、无进展生存期，次要观察指标为远处转移、局部复发和不良反应。结果 治疗组总有效率为95%，高于对照组的58.33%（P <0.05）。治疗组治疗前后肿瘤标志物癌胚抗原（CEA）、糖类抗原19-9（CA19-9）、细胞角蛋白片段21-1（CYFRA21-1）的差值均高于对照组（P <0.05），免疫功能指标CD4⁺/CD8⁺、程序性死亡受体（PD-1）、程序性死亡受体-配体1（PD-L1）的差值均高于对照组（P <0.05）。治疗组的无进展生存期和总生存期分别为（24.17±3.14）和（35.68±5.36）个月，均高于对照组（P < 0.05）。治疗组的远处转移率为8.33%，低于对照组的26.67%（P <0.05），两组局部复发率、总不良反应发生率比较，差异均无统计学意义（P >0.05）。结论 对于晚期寡转移食管癌患者，SBRT联合TP化疗方案及免疫治疗能显著改善临床疗效，提高总体生存期和无进展生存期，同时保持可接受的安全性。

Abstract:

Objective To investigate the efficacy and safety of stereotactic body radiotherapy (SBRT) combined with TP chemotherapy regimen (paclitaxel and cisplatin) and immunotherapy in patients with advanced oligometastatic esophageal cancer.Methods We prospectively included 120 patients diagnosed with advanced oligometastatic esophageal cancer at Suzhou Municipal Hospital from March 2016 to March 2020. Patients were divided into the treatment group and the control group using a random number table method, with 60 cases in each group. The treatment group received SBRT with the TP chemotherapy regimen and immunotherapy, while the control group received only the TP chemotherapy regimen and immunotherapy. The follow-up period was 3 years. Primary endpoints included clinical efficacy, levels of tumor markers, immune-related indicators, overall survival (OS), and progression-free survival (PFS). Secondary endpoints included distant metastasis, local recurrence, and adverse reactions.Results The overall response rate in the treatment group was 95%, significantly higher than 58.33% observed in the control group (P < 0.05). The differences in levels of tumor markers (CEA, CA19-9, and CYFRA21-1) before and after treatment were greater in the treatment group compared to the control group (P < 0.05), as were the differences in immune function indicators (the ratio of CD4⁺/CD8⁺ T cells and levels of PD-1 and PD-L1) (P < 0.05). The PFS and OS in the treatment group were (24.17 ± 3.14) months and (35.68 ± 5.36) months, respectively, and both of them were significantly higher than those in the control group (P < 0.05). The distant metastasis rate in the treatment group was 8.33%, significantly lower than 26.67% in the control group (P < 0.05), while there was no statistically significant difference in local recurrence rates or the overall incidence of adverse reactions between the two groups (P > 0.05).Conclusions For patients with advanced oligometastatic esophageal cancer, SBRT combined with the TP chemotherapy regimen and immunotherapy significantly improves clinical efficacy, and enhances OS and PFS while maintaining an acceptable safety profile.