放化疗联合免疫一线治疗局部晚期或转移性食管鳞癌的初步分析

A preliminary analysis of chemoradiotherapy combined with immunotherapy as first-line treatment for locally advanced or metastatic esophageal squamous cell carcinoma

目的评估放化疗联合免疫一线治疗局部晚期或转移性食管鳞癌(LA/M ESCC)患者的疗效和预后因素。方法回顾性分析单中心符合入组条件的57例LA/M ESCC患者,分析其近期疗效、生存情况、预后因素、治疗后失败模式和治疗相关不良反应等情况。结果全组患者1、2、3年总生存(OS)率和无进展生存(PFS)率分别为86.0%、57.5%、53.9%和61.4%、31.0%、31.0%;中位OS值未达到,中位PFS为15.0个月(95%CI:10.77~19.23);患者总有效率(ORR)为80.7%(46/57),疾病控制率(DCR)为94.7%(54/57)。多因素分析结果显示,患者年龄、临床分期、免疫治疗周期数和近期疗效为影响患者OS的独立预后因素(HR=0.25、2.58、0.35、4.05,P<0.05),而临床分期和近期疗效为影响患者PFS的独立因素(HR=2.27、1.97,P<0.05)。免疫药物与放化疗联合模式、照射范围对患者OS和PFS的差异均无统计学意义(P>0.05)。共有32例患者出现治疗后失败,二次治疗后1、2年OS率分别为55.7%和25.3%,中位14.0个月(95%CI:5.17~22.83)。治疗期间及治疗结束后出现≥2级治疗相关不良反应共26例。结论放化疗联合免疫一线治疗对局部晚期或转移性食管鳞癌患者有效且安全;其治疗后失败模式仍是局部区域复发和远处转移;免疫药物和放化疗联合治疗模式值得进一步的研究。

Objective To evaluate the efficacy and prognostic factors of radiotherapy combined with immunotherapy as the first-line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma(LA/M ESCC).Methods A single-center,retrospective analysis was conducted for the recent efficacy,survival,prognostic factors,post-treatment failure modes,and treatment-related adverse reactions of 57 LA/M ESCC patients eligible for enrollment.Results The entire group of patients had 1-,2-,and 3-year overall survival(OS)of 86.0%,57.5%,and 53.9%,respectively and 1-,2-,and 3-year progression-free survival(PFS)of 61.4%,31.0%,and 31.0%,respectively.The median OS was not reached,and the median PFS was 15.0(95%CI:10.77-19.23)months.These patients had an overall response rate(ORR)of 80.7%(46/57)and a disease control rate(DCR)of 94.7%(54/57).As indicated by the result of the multivariate analysis,the independent prognostic factors affecting the OS of the patients included their age,clinical stage,number of immunotherapy cycles,and recent efficacy(HR=0.25,2.58,0.35,4.05,P<0.05),and the independent factors influencing the PFS of the patients included their clinical stage and recent efficacy(HR=2.27,1.97,P<0.05).There were no statistically significant differences in the effects of irradiation ranges and the combination modes of immunologic drugs and chemoradiotherapy on both OS and PFS of the patients(P>0.05).A total of 32 patients suffered post-treatment failure.After the second treatment,they had 1-and 2-year OS of 55.7%and 25.3%,respectively,with median OS of 14.0(95%CI:5.17-22.83)months.A total of 26 cases experienced treatment-associated adverse reactions of grades 2 or higher during and after treatment.Conclusions The combination of radiotherapy and immunotherapy is effective and safe as the first-line treatment for LA/M ESCC patients.The post-treatment failure modes still include local recurrence and distant metastasis.Therefore,such combination merits further investigation.