DataSheet_4_Conversion Surgery Following Immunochemotherapy in Initially Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma—A Real-World Multicenter Study (RICE-Retro).pdf

PurposeThe 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.
Materials and MethodsIn 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.
ResultsOne 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.
ConclusionOur 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.

研究目的：本研究旨在评估真实世界场景下，初始不可切除局部晚期食管鳞状细胞癌（esophageal squamous cell carcinoma, ESCC）患者接受诱导免疫化疗后行转化手术（conversion surgery）的可行性、安全性与有效性。材料与方法：本研究为一项多中心真实世界研究（临床试验注册号：NCT04822103），共纳入中国8家医学中心的不可切除ESCC患者。所有患者每3周接受1次程序性死亡受体-1（programmed death receptor-1, PD-1）抑制剂联合化疗，治疗周期至少为2个疗程。经肿瘤相关临床症状显著缓解且影像学评估为疾病应答的患者，被列为手术候选人群。本研究评估了免疫化疗联合转化手术的可行性与安全性、影像学及病理学肿瘤应答情况，以及短期生存结局。此外，本研究还与另一组仅接受诱导化疗（induction chemotherapy, iC）的独立ESCC患者队列进行了对比。结果：最终共纳入155例患者进行最终分析。其中116例患者接受了食管切除术，转化手术转化率为74.8%，R0切除率达94%。在155例患者中，107例（69.0%）发生至少1种治疗相关不良事件（treatment-related adverse event, TRAE），45例（29.0%）报告了3级及以上TRAE。诱导免疫化疗（induction immunochemotherapy, iIC）队列与传统诱导化疗（iC）队列的疾病应答率存在显著差异：客观缓解率分别为iIC队列63.2%、iC队列47.7%（p=0.004）；病理完全缓解率分别为iIC队列22.4%、iC队列6.7%（p=0.001）。iC组的吻合口瘘发生率（19.2%）显著高于iIC组（4%）。此外，接受转化手术的患者无事件生存期显著更长。结论：本研究结果证实，对于初始不可切除的局部晚期ESCC患者，免疫化疗后行转化手术具备可行性与安全性。相较于传统iC队列，iIC队列的影像学及病理学应答率均显著更高。