Department of Thoracic Surgery, Guangdong Provincial People's Hospital, Guangdong Academy of Medical Sciences, Guangzhou, China.
Shantou University Medical College, Shantou, China.
Front Immunol. 2022 Jul 13;13:935374. doi: 10.3389/fimmu.2022.935374. eCollection 2022.
The present study sets out to evaluate the feasibility, safety, and effectiveness of conversion surgery following induction immunochemotherapy for patients with initially unresectable locally advanced esophageal squamous cell carcinoma (ESCC) in a real-world scenario.
In this multi-center, real-world study (NCT04822103), patients who had unresectable ESCC disease were enrolled across eight medical centers in China. All patients received programmed death receptor-1 (PD-1) inhibitor plus chemotherapy every 3 weeks for at least two cycles. Patients with significant relief of cancer-related clinical symptoms and radiological responsive disease were deemed surgical candidates. Feasibility and safety profile of immunochemotherapy plus conversion surgery, radiological and pathological tumor responses, as well as short-term survival outcomes were evaluated. Moreover, data of an independent ESCC cohort receiving induction chemotherapy (iC) were compared.
One hundred and fifty-five patients were enrolled in the final analysis. Esophagectomy was offered to 116 patients, yielding a conversion rate of 74.8%. R0 resection rate was 94%. Among the 155 patients, 107 (69.0%) patients experienced at least one treatment-related adverse event (TRAE) and 45 (29.0%) patients reported grade 3 and above TRAEs. Significant differences in responsive disease rate were observed between iC cohort and induction immunochemotherapy (iIC) cohort [objective response rate: iIC: 63.2% vs. iC: 47.7%, p = 0.004; pathological complete response: iIC: 22.4% vs. iC: 6.7%, p = 0.001). Higher anastomosis fistula rate was observed in the iC group (19.2%) compared with the iIC group (4%). Furthermore, Significantly higher event-free survival was observed in those who underwent conversion surgery.
Our results supported that conversion surgery following immunochemotherapy is feasible and safe for patients with initially unresectable locally advanced ESCC. Both radiological and pathological response rates were significantly higher in the iIC cohort compared with those in the traditional iC cohort.
本研究旨在评估诱导免疫化疗后行转化手术治疗初诊局部晚期不可切除食管鳞癌(ESCC)患者的可行性、安全性和有效性。
本多中心真实世界研究(NCT04822103)纳入了中国 8 家医疗中心的不可切除 ESCC 患者。所有患者均接受程序性死亡受体-1(PD-1)抑制剂联合化疗,每 3 周为一个周期,至少进行两个周期。肿瘤相关临床症状显著缓解且影像学显示疾病有反应的患者被视为手术候选者。评估了免疫化疗联合转化手术的可行性和安全性、影像学和病理学肿瘤反应以及短期生存结果。此外,还比较了接受诱导化疗(iC)的独立 ESCC 队列的数据。
最终有 155 例患者纳入分析。116 例患者接受了食管切除术,转化率为 74.8%。R0 切除率为 94%。在 155 例患者中,有 107 例(69.0%)患者至少发生了一次与治疗相关的不良事件(TRAE),45 例(29.0%)患者报告了 3 级及以上 TRAE。iC 队列与诱导免疫化疗(iIC)队列之间的疾病缓解率存在显著差异[客观缓解率:iIC:63.2% vs. iC:47.7%,p = 0.004;病理完全缓解率:iIC:22.4% vs. iC:6.7%,p = 0.001]。iC 组吻合口瘘发生率高于 iIC 组(19.2% vs. 4%)。此外,接受转化手术的患者的无事件生存率显著提高。
我们的结果支持免疫化疗后行转化手术治疗初诊局部晚期不可切除 ESCC 是可行和安全的。与传统 iC 队列相比,iIC 队列的影像学和病理学反应率均显著提高。