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一项前瞻性、单中心、单臂、开放标签、II 期研究,评估信迪利单抗联合安罗替尼与化疗用于可切除食管癌新辅助治疗。

A prospective single-center, single-arm, open-label, phase II study of sintilimab and anlotinib combined with chemotherapy in neoadjuvant treatment of resectable esophageal cancer.

机构信息

Department of Thoracic Surgery at Tangdu Hospital, Air Force Medical University, Xi'an, China.

Department of Anesthesiology and Surgery at Tangdu Hospital, Air Force Medical University, Xi'an, China.

出版信息

Thorac Cancer. 2024 Jul;15(19):1471-1476. doi: 10.1111/1759-7714.15312. Epub 2024 May 21.

DOI:10.1111/1759-7714.15312
PMID:38770548
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11219283/
Abstract

BACKGROUND

Antiangiogenic treatment and immunochemotherapy effectively treat patients with advanced esophageal cancer. However, there remains a dearth of studies concerning neoadjuvant therapy for resectable esophageal cancer.

METHODS

The study focused on patients with T2-4NxM0 resectable esophageal carcinoma. Neoadjuvant treatment involved administering anlotinib (10 mg orally, once a day, 2 weeks on and 1 week off) for antiangiogenesis and sintilimab (200 mg) and chemotherapy for three cycles. Surgical treatment was performed 4-6 weeks after the last chemotherapy cycle was completed. The primary endpoints assessed were pathological complete response (pCR) and safety.

RESULTS

Out of the 34 screened patients, 17 were successfully enrolled in the study, and 14 completed the entire treatment process. The pCR was 35.3% (6/17). However, two patients experienced mortality. The occurring rate of grade 3 or higher complications after the surgery was 78.6% (11/14) according to Clavien-Dindo classification. Specifically, anastomotic leakage was observed in 57.1% (8/14) of the patients.

CONCLUSION

Compared to neoadjuvant chemotherapy, the current regimen demonstrated improved pCR. However, it did not show significant improvement compared to immunochemotherapy. It is essential to exercise caution when using this treatment approach in patients with esophageal cancer as it might increase postoperative complications, especially anastomotic leakage.

摘要

背景

抗血管生成治疗和免疫化疗可有效治疗晚期食管癌患者。然而,对于可切除食管癌的新辅助治疗研究仍然较少。

方法

本研究侧重于 T2-4NxM0 可切除食管癌患者。新辅助治疗包括安罗替尼(10mg,口服,每日一次,2 周给药,1 周停药)抗血管生成和信迪利单抗(200mg)及化疗 3 个周期。最后 1 个化疗周期结束后 4-6 周进行手术治疗。主要终点评估为病理完全缓解(pCR)和安全性。

结果

在筛选的 34 例患者中,17 例成功入组研究,14 例完成了整个治疗过程。pCR 为 35.3%(6/17)。然而,有 2 例患者死亡。根据 Clavien-Dindo 分级,术后发生 3 级或更高并发症的发生率为 78.6%(11/14)。具体而言,14 例患者中有 57.1%(8/14)发生吻合口漏。

结论

与新辅助化疗相比,该方案显示出改善的 pCR。然而,与免疫化疗相比,其并未显示出显著改善。在食管癌患者中使用这种治疗方法时需要谨慎,因为它可能会增加术后并发症,特别是吻合口漏。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0be7/11219283/7f07d2d21cf6/TCA-15-1471-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0be7/11219283/282c4d5227ba/TCA-15-1471-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0be7/11219283/7f07d2d21cf6/TCA-15-1471-g003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0be7/11219283/282c4d5227ba/TCA-15-1471-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/0be7/11219283/7f07d2d21cf6/TCA-15-1471-g003.jpg

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Esophageal and Esophagogastric Junction Cancers, Version 2.2023, NCCN Clinical Practice Guidelines in Oncology.《食管癌和食管胃交界癌,第2版,2023年,美国国立综合癌症网络肿瘤学临床实践指南》
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新辅助安罗替尼与化疗序贯微创食管切除术治疗局部晚期食管鳞状细胞癌患者:一项开放标签、随机、II期试验的短期结果
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