Liu FangJie, Wang DaQuan, Rong YuMing, Wei ShiHong, SiTu Yu, Wang MengRu, Zhang HaoTing, Zhang PengXin, Zheng ShiYang, Yin ShaoHan, Xie ChuanMiao, Hu Yi, Qiu Bo, Liu Hui
Department of Radiation Oncology, State Key Laboratory of Oncology in South China, Guangdong Provincial Clinical Research Center for Cancer, Sun Yat-sen University Cancer Center, Guangzhou, China.
Guangdong Association Study of Thoracic Oncology, Guangzhou, China.
EClinicalMedicine. 2025 Apr 5;82:103184. doi: 10.1016/j.eclinm.2025.103184. eCollection 2025 Apr.
We aimed to explore the efficacy and safety of neoadjuvant toripalimab plus chemotherapy followed by concurrent chemoradiotherapy (CCRT) in locally advanced esophageal squamous cell carcinoma (ESCC).
This phase II, non-randomized, 2-cohort study enrolled patients with unresectable, stage T1-4N0-3M0-1 ESCC (M1 only includes patients with lymph node metastasis in the supraclavicular region). Patients received neoadjuvant therapy comprised of albumin-bound paclitaxel, nedaplatin and toripalimab every 3 weeks, for 2 cycles, followed by CCRT (total dose 60Gy in cohort A, 50Gy in cohort B, combined with oral capecitabine). The primary endpoint was progression-free survival (PFS). The trial is registered with ClinicalTrials.gov, NCT04844385.
Between February 26, 2021 and June 20, 2023, 124 patients were enrolled, and 118 (95.2%) patients completed treatment. The objective response rate to neoadjuvant chemo-immunotherapy was 91.9% overall, and was 93.7% in cohort A-60Gy and 93.4% in cohort B-50Gy after CCRT. With a median follow-up of 30.8 months, the 18-month PFS rates were 65.0% (95% CI, 53.9-78.3%) in cohort A-60Gy and 65.1% (95% CI, 53.7-78.8%) in cohort B-50Gy. Grade (G) 3 and G5 pneumonitis occurred in two (3.2%) and one patient (1.6%) in cohort A-60Gy, respectively, with no ≥G3 pneumonitis in cohort B-50Gy. Improvements on patient reported outcomes from baseline to 12 months post-CCRT were observed overall.
Neoadjuvant chemo-immunotherapy, radiotherapy and concurrent capecitabine achieved promising efficacy in locally advanced ESCC. Further investigation is warranted.
None.
我们旨在探讨新辅助托瑞帕利单抗联合化疗后序贯同步放化疗（CCRT）在局部晚期食管鳞状细胞癌（ESCC）中的疗效和安全性。
这项II期、非随机、双队列研究纳入了无法切除的T1-4N0-3M0-1期ESCC患者（M1仅包括锁骨上区域有淋巴结转移的患者）。患者接受新辅助治疗，每3周一次，包括白蛋白结合型紫杉醇、奈达铂和托瑞帕利单抗，共2个周期，随后进行CCRT（A队列总剂量60Gy，B队列总剂量50Gy，联合口服卡培他滨）。主要终点是无进展生存期（PFS）。该试验已在ClinicalTrials.gov注册，注册号为NCT04844385。
在2021年2月26日至2023年6月20日期间，共纳入124例患者，118例（95.2%）患者完成治疗。新辅助化疗免疫治疗的总体客观缓解率为91.9%，CCRT后A队列-60Gy为93.7%，B队列-50Gy为93.4%。中位随访30.8个月，A队列-60Gy的18个月PFS率为65.0%（95%CI，53.9-78.3%），B队列-50Gy为65.1%（95%CI，53.7-78.8%）。A队列-60Gy分别有2例（3.2%）和1例（1.6%）患者发生3级（G）和5级肺炎，B队列-50Gy无≥3级肺炎。总体观察到患者报告结局从基线到CCRT后12个月有所改善。
新辅助化疗免疫治疗、放疗及同步卡培他滨在局部晚期ESCC中取得了有前景的疗效。有必要进一步研究。
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