SCI

6 August 2024

Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial

（IF: Nat Med., 58.7）

  • Qin J, Xue L, Hao A, Guo X, Jiang T, Ni Y, Liu S, Chen Y, Jiang H, Zhang C, Kang M, Lin J, Li H, Li C, Tian H, Li L, Fu J, Zhang Y, Ma J, Wang X, Fu M, Yang H, Yang Z, Han Y, Chen L, Tan L, Dai T, Liao Y, Zhang W, Li B, Chen Q, Guo S, Qi Y, Wei L, Li Z, Tian Z, Kang X, Zhang R, Li Y, Wang Z, Chen X, Hou Z, Zheng R, Zhu W, He J, Li Y. Neoadjuvant chemotherapy with or without camrelizumab in resectable esophageal squamous cell carcinoma: the randomized phase 3 ESCORT-NEO/NCCES01 trial. Nat Med. 2024 Jul 2. 

  • Correspondence: hejie@cicams.ac.cn; liyin@cicams.ac.cn

Recent single-arm studies involving neoadjuvant camrelizumab, a PD-1 inhibitor, plus chemotherapy for resectable locally advanced esophageal squamous cell carcinoma (LA-ESCC) have shown promising results. This multicenter, randomized, open-label phase 3 trial aimed to further assess the efficacy and safety of neoadjuvant camrelizumab plus chemotherapy followed by adjuvant camrelizumab, compared to neoadjuvant chemotherapy alone. A total of 391 patients with resectable thoracic LA-ESCC (T1b-3N1-3M0 or T3N0M0) were stratified by clinical stage (I/II, III or IVA) and randomized in a 1:1:1 ratio to undergo two cycles of neoadjuvant therapy. Treatments included camrelizumab, albumin-bound paclitaxel and cisplatin (Cam+nab-TP group; n = 132); camrelizumab, paclitaxel and cisplatin (Cam+TP group; n = 130); and paclitaxel with cisplatin (TP group; n = 129), followed by surgical resection. Both the Cam+nab-TP and Cam+TP groups also received adjuvant camrelizumab. The dual primary endpoints were the rate of pathological complete response (pCR), as evaluated by a blind independent review committee, and event-free survival (EFS), as assessed by investigators. This study reports the final analysis of pCR rates. In the intention-to-treat population, the Cam+nab-TP and Cam+TP groups exhibited significantly higher pCR rates of 28.0% and 15.4%, respectively, compared to 4.7% in the TP group (Cam+nab-TP versus TP: difference 23.5%, 95% confidence interval (CI) 15.1–32.0, P < 0.0001; Cam+TP versus TP: difference 10.9%, 95% CI 3.7–18.1, P = 0.0034). The study met its primary endpoint of pCR; however, EFS is not yet mature. The incidence of grade ≥3 treatment-related adverse events during neoadjuvant treatment was 34.1% for the Cam+nab-TP group, 29.2% for the Cam+TP group and 28.8% for the TP group; the postoperative complication rates were 34.2%, 38.8% and 32.0%, respectively. Neoadjuvant camrelizumab plus chemotherapy demonstrated superior pCR rates compared to chemotherapy alone for LA-ESCC, with a tolerable safety profile.

最近，涉及卡瑞利珠单抗（一种PD-1 抑制剂）联合化疗治疗可切除的局部晚期食管鳞状细胞癌 (LA-ESCC) 的新辅助治疗的单臂研究，已显示出令人鼓舞的结果。这项多中心、随机、开放标签的3期试验旨在进一步评估新辅助卡瑞利珠单抗联合化疗继以术后辅助卡瑞利珠单抗治疗，与单独新辅助化疗相比的疗效和安全性。总共391名可切除的胸段LA-ESCC患者（T1b-3N1-3M0或T3N0M0）按照临床分期（I/II期、III期或IVA期）进行分层，并以1:1:1的比例随机接受两轮新辅助治疗。治疗方案包括卡瑞利珠单抗、白蛋白结合型紫杉醇和顺铂（Cam+nab-TP组；n=132）；卡瑞利珠单抗、紫杉醇和顺铂（Cam+TP组；n=130）；以及紫杉醇联合顺铂（TP组；n=129），然后行手术切除。Cam+nab-TP组和Cam+TP组均接受了术后卡瑞利珠单抗辅助治疗。双重主要终点是病理完全缓解率（pCR），由盲审独立审查委员会评估，以及由研究者评估的无事件生存期（EFS）。本研究报告了pCR率的最终分析结果。在意向治疗人群中，Cam+nab-TP组和Cam+TP组的pCR率分别为28.0%和15.4%，显著高于TP组的4.7%（Cam+nab-TP与TP比较：差异23.5%，95%置信区间（CI）15.1–32.0，P < 0.0001；Cam+TP与TP比较：差异10.9%，95% CI 3.7–18.1，P = 0.0034）。本研究达到了pCR的主要终点；但EFS尚未成熟。新辅助治疗期间≥3级治疗相关不良事件的发生率在Cam+nab-TP组为34.1%，Cam+TP组为29.2%，TP组为28.8%；术后并发症发生率分别为34.2%，38.8%和32.0%。新辅助卡瑞利珠单抗联合化疗在LA-ESCC中的pCR率优于单独化疗，且安全性可耐受。