新辅助放化疗加序贯替利单抗后食管癌手术治疗（CRISEC研究）：单臂、双中心、2期试验。

IF 4.9 1区医学 Q1 ONCOLOGY

Radiotherapy and Oncology Pub Date : 2025-02-18 DOI:10.1016/j.radonc.2025.110797

Jinsong Yang , Cui Liu , Zhigang Zuo , Fengjun Cao , Zhanjie Zhang , Bian Wu , You Qin , Lu Wen , Jielin Wei , Guangqin Xiao , Shijie Xing , Yue Qu , Lei Huang , Xiaolin Wang , Buhai Wang , Kunyu Yang , Ke Jiang

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引用次数: 0

摘要

背景与目的：探讨新辅助放化疗（NCRT）联合序贯tislelizumab手术治疗食管鳞状细胞癌（ESCC）的疗效和安全性。材料和方法：这项单组、双中心、2期试验招募了可切除或可能可切除的胸椎ESCC患者，接受新辅助放疗（41.4 Gy / 23次），同时化疗（白蛋白结合紫杉醇，50-100 mg/m2，卡铂，曲线下面积为2 mg/ml/min，每周一次，5次）加上顺序tislelizumab（200 mg Q3W， 3个周期），然后进行手术。主要终点为病理完全缓解（pCR）率。次要终点包括安全性、R0切除率、主要病理反应（MPR）率、无病生存期（DFS）和总生存期（OS）。结果：在2021年1月至2022年10月入组的30例患者中，24例（80.0 %）完成了计划手术，R0切除（100 %）。24例患者中，9例（37.5% %）达到pCR， 21例（87.5% %）达到MPR。10例患者（35.7 %）在替利珠单抗治疗期间出现3-4级毒性，包括淋巴细胞减少（32.1% %）、中性粒细胞减少（3.6% %）和血小板减少（3.6% %）。2例患者发生5级呕血，均归因于主动脉侵犯。3例患者（12.5 %）出现3级术后并发症，包括肺部感染（8.3 %）和声音嘶哑（4.2 %）。中位随访35.4个月后，2年OS和DFS分别为83.3 %和79.2% %。结论：ESCC NCRT后序贯tislelizumab是安全可行的。需要进一步的研究来验证这种组合方式的有效性。

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Neoadjuvant chemoradiotherapy plus sequential tislelizumab followed by surgery for esophageal carcinoma (CRISEC study): A single-arm, bicentric, phase 2 trial

Background and purpose

To explore the efficacy and safety of neoadjuvant chemoradiotherapy (NCRT) plus sequential tislelizumab followed by surgery for esophageal squamous cell carcinoma (ESCC).

Materials and methods

This single-arm, bicentric, phase 2 trial enrolled patients with resectable or potentially resectable thoracic ESCC to receive neoadjuvant radiotherapy (41.4 Gy in 23 fractions) with concurrent chemotherapy (albumin-bound paclitaxel, 50–100 mg/m², and carboplatin, area under the curve of 2 mg/ml/min, once weekly, five times) plus sequential tislelizumab (200 mg Q3W, three cycles) followed by surgery. The primary endpoint was pathologic complete response (pCR) rate. The secondary endpoints included safety, R0 resection rate, major pathologic response (MPR) rate, disease-free survival (DFS), and overall survival (OS).

Results

Of the 30 patients enrolled from January 2021 to October 2022, 24 (80.0 %) completed planned surgery and gained R0 resection (100 %). Among the 24 patients, nine (37.5 %) achieved pCR and 21 (87.5 %) achieved MPR. Ten patients (35.7 %) developed grade 3–4 toxicities during tislelizumab therapy, including lymphopenia (32.1 %), neutropenia (3.6 %), and thrombocytopenia (3.6 %). Grade 5 hematemesis occurred in two patients and both were attributed to aortic invasion. Three patients (12.5 %) developed grade 3 postoperative complications, including pulmonary infection (8.3 %) and hoarseness (4.2 %). After a median follow-up of 35.4 months, the 2-year OS and DFS rates were 83.3 % and 79.2 %, respectively.

Conclusion

Sequential tislelizumab after NCRT in ESCC is safe and feasible. Further study is warranted to validate the efficacy of this combination mode.

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来源期刊

Radiotherapy and Oncology 医学-核医学

CiteScore

10.30

自引率

10.50%

发文量

2445

审稿时长

45 days

期刊介绍： Radiotherapy and Oncology publishes papers describing original research as well as review articles. It covers areas of interest relating to radiation oncology. This includes: clinical radiotherapy, combined modality treatment, translational studies, epidemiological outcomes, imaging, dosimetry, and radiation therapy planning, experimental work in radiobiology, chemobiology, hyperthermia and tumour biology, as well as data science in radiation oncology and physics aspects relevant to oncology.Papers on more general aspects of interest to the radiation oncologist including chemotherapy, surgery and immunology are also published.