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卡瑞利珠单抗联合化疗新辅助治疗局部晚期食管鳞癌的回顾性队列研究。

Neoadjuvant camrelizumab plus chemotherapy in locally advanced oesophageal squamous cell carcinoma: a retrospective cohort study.

机构信息

Department of Cardiothoracic Surgery, the First Affiliated Hospital of Chongqing Medical University, Chongqing, 400016, China.

出版信息

BMC Surg. 2023 May 9;23(1):114. doi: 10.1186/s12893-023-02023-5.

Abstract

BACKGROUND

Neoadjuvant therapy is recommended to improve the prognosis of oesophageal squamous cell carcinoma (ESCC). As a PD-1 inhibitor developed in China, camrelizumab is more accessible and available for Chinese ESCC patients. Camrelizumab plus neoadjuvant chemotherapy has shown promising efficacy with acceptable toxicity for resectable ESCC in the NIC-ESCC2019 trial. However, this was a single-arm trial, so we conducted a retrospective cohort study to compare neoadjuvant camrelizumab plus chemotherapy with neoadjuvant chemotherapy alone in terms of the safety and efficacy in patients with locally advanced ESCC.

METHODS

Between January 2017 and December 2021, patients with stage II-IVa ESCC who received neoadjuvant therapy at the First Affiliated Hospital of Chongqing Medical University and underwent radical oesophagectomy were enrolled in our study. These included 19 patients who received neoadjuvant chemotherapy plus camrelizumab (group 1) and 40 patients who only received neoadjuvant chemotherapy (group 2).

RESULTS

The baseline characteristics of the patients were comparable between the two groups. The pathological complete response (pCR) rate in group 1 was significantly higher than that in group 2 (26.3% vs. 2.5%, P = 0.018). All patients in group 1 achieved complete resection (R0), compared with 39 (97.5%) patients in group 2. Adverse events occurred in 16 (84%) patients in group 1 versus 35 (87.5%) patients in group 2. No grade ≥ 4 adverse events occurred in either group. No significant difference was found in surgical outcomes or postoperative complications. The 90-day mortality rate was comparable between the two groups (1 patient died in group 1 versus 2 patients in group 2).

CONCLUSIONS

Neoadjuvant camrelizumab plus chemotherapy followed by surgery was associated with a promising pCR rate and a manageable safety profile for patients with locally advanced ESCC.

摘要

背景

新辅助治疗被推荐用于改善食管鳞状细胞癌(ESCC)的预后。卡瑞利珠单抗是一种由中国开发的 PD-1 抑制剂,对于中国 ESCC 患者来说,更易获得和可用。在 NIC-ESCC2019 试验中,卡瑞利珠单抗联合新辅助化疗在可切除的 ESCC 患者中显示出有前景的疗效和可接受的毒性。然而,这是一项单臂试验,因此我们进行了一项回顾性队列研究,以比较局部晚期 ESCC 患者新辅助卡瑞利珠单抗联合化疗与单纯新辅助化疗的安全性和疗效。

方法

2017 年 1 月至 2021 年 12 月,在重庆医科大学第一附属医院接受新辅助治疗并接受根治性食管切除术的 II-IVa 期 ESCC 患者被纳入本研究。这些患者包括接受新辅助化疗加卡瑞利珠单抗(组 1)的 19 例患者和仅接受新辅助化疗(组 2)的 40 例患者。

结果

两组患者的基线特征无差异。组 1 的病理完全缓解(pCR)率明显高于组 2(26.3% vs. 2.5%,P=0.018)。组 1 的所有患者均达到完全切除(R0),而组 2 的 39 例患者中只有 39 例(97.5%)达到 R0。组 1 有 16 例(84%)患者发生不良事件,组 2 有 35 例(87.5%)患者发生不良事件。两组均未发生≥4 级不良事件。手术结果和术后并发症无显著差异。两组 90 天死亡率相当(组 1 有 1 例患者死亡,组 2 有 2 例患者死亡)。

结论

新辅助卡瑞利珠单抗联合化疗后手术治疗局部晚期 ESCC 患者的 pCR 率较高,安全性可管理。

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Efficacy and safety of camrelizumab in combination with neoadjuvant chemotherapy for ESCC and its impact on esophagectomy.
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Analysis of camrelizumab in neoadjuvant chemotherapy for esophageal cancer: A retrospective cohort study.
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