Preoperative camrelizumab combined with chemotherapy for borderline resectable ESCC: A single-arm, prospective, phase 2 study.

IF 12.8 Q1 MEDICINE, RESEARCH & EXPERIMENTAL

Med Pub Date : 2024-11-08 Epub Date: 2024-08-08 DOI:10.1016/j.medj.2024.07.015

Guoqing Zhang, Teng Mu, Yan Zhang, Jia Jiao, Zheng Ding, Hang Yang, Dabo Pan, Jia Zhao, Jindong Li, Xiangnan Li

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引用次数: 0

Abstract

Background: We investigated the safety and efficacy of preoperative camrelizumab combined with chemotherapy for treating thoracic borderline resectable esophageal squamous cell carcinoma (Br-ESCC) (ChiCTR2200056728).

Methods: Patients with thoracic Br-ESCC received intravenous camrelizumab plus chemotherapy and underwent esophagectomy. The primary endpoint was the pathologic complete response (pCR) rate. We introduced computed tomography and endoscopic examination into the diagnostic criteria to increase its reproducibility. Additionally, we defined a new resection status, Rbr^+/-, for Br-ESCC.

Findings: Thirty-one patients with Br-ESCC were ultimately enrolled in this study. Overall, 71.0% (22/31) of the patients underwent esophagectomy. R0 resection was achieved in 81.8% of patients (18/22). pCR and major pathological response were observed in 40.9% (9/22) and 63.6% (14/22) of the resected patients, respectively. Eighteen R0 resection patients were redefined according to our Rbr definition; 61.1% (11/18) were classified as Rbr⁺ resection, and 38.9% (7/18) were classified as Rbr^- resection. With a median postoperative follow-up of 17.9 months, 4 patients out of 11 who underwent Rbr⁺ resection experienced local recurrence (2 of whom achieved pCR). However, no patients (0/7) who underwent Rbr^- resection experienced local recurrence.

Conclusions: Esophagectomy after neoadjuvant immunochemotherapy is a promising radical treatment for Br-ESCC. R0 resection was achieved in 81.8% of patients, and a pCR was observed in 40.9% of resected patients. Even after complete excision, Rbr⁺ resection leads to a higher rate of local recurrence in patients with Br-ESCC.

Funding: This study was supported by the Key Scientific Research Projects of the Institutions of Higher Learning in Henan Province (no. 21A320032).

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术前 Camrelizumab 联合化疗治疗边缘可切除 ESCC：一项单臂、前瞻性、2 期研究。

研究背景我们研究了术前坎瑞珠单抗联合化疗治疗胸部边缘可切除食管鳞癌（Br-ESCC）（ChiCTR2200056728）的安全性和有效性：胸腔Br-ESCC患者接受静脉注射坎瑞珠单抗加化疗，并接受食管切除术。主要终点是病理完全反应率（pCR）。我们在诊断标准中引入了计算机断层扫描和内窥镜检查，以提高其可重复性。此外，我们还为Br-ESCC定义了一种新的切除状态--Rbr+/-：本研究最终纳入了 31 名 Br-ESCC 患者。总的来说，71.0%（22/31）的患者接受了食管切除术。在切除的患者中，分别有 40.9% （9/22）和 63.6% （14/22）观察到 pCR 和主要病理反应。18例R0切除患者根据我们的Rbr定义进行了重新定义；61.1%（11/18）被归类为Rbr+切除，38.9%（7/18）被归类为Rbr-切除。术后中位随访时间为 17.9 个月，11 位接受 Rbr+ 切除术的患者中有 4 位出现局部复发（其中 2 位达到 pCR）。然而，接受Rbr-切除术的患者（0/7）均未出现局部复发：结论：新辅助免疫化疗后进行食管切除术是一种很有前景的Br-ESCC根治治疗方法。81.8%的患者实现了R0切除，40.9%的切除患者出现了pCR。即使在完全切除后，Rbr+切除术也会导致Br-ESCC患者局部复发率升高：本研究得到河南省高等学校重点科研项目（编号：21A320032）的资助。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Med MEDICINE, RESEARCH & EXPERIMENTAL-

CiteScore

17.70

自引率

0.60%

发文量

102

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