Department of Oncology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.
Department of Geriatric Gastroenterology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, People's Republic of China.
Ann Surg Oncol. 2024 Dec;31(13):9321-9331. doi: 10.1245/s10434-024-16033-x. Epub 2024 Aug 23.
This study reported the safety and efficacy of a phase 2, open-label, single-arm, exploratory clinical trial of induction immunochemotherapy in patients with initially unresectable advanced esophageal squamous cell carcinoma (ESCC).
Patients underwent three cycles of induction therapy with tislelizumab, cisplatin, and 5-fluorouracil. The primary endpoints were the safety, major pathological response (MPR), and pathological complete response (pCR). Secondary endpoints included the R0 resection rate, disease-free survival (DFS), and overall survival (OS). Genomic data and immune microenvironment data were analyzed exploratively.
The treatment was safe, with a grade 3 or higher adverse event rate of 14.9% (7/47). Of the total 47 patients enrolled in the study, 19 (40.4%) achieved MPR, 12 (25.5%) achieved pCR, 4 (8.5%) achieved complete clinical response (cCR) and declined surgery, and 23 (48.94%) underwent successful resection. Median follow-up was 18 months, with a median DFS of 24 months, a median OS of 36 months. A high tumor mutation burden was associated with a better prognosis for patients who underwent surgery. Patients who achieved pCR had higher levels of immune cell infiltration and a greater proportion and concentration of tertiary lymphoid structures compared with those who experienced a major pathological response.
Tislelizumab combined with chemotherapy is effective for ESCC, yielding high cCR, pCR, surgical conversion, and R0 resection rates, and tolerable adverse events.
NCT05469061.
本研究报告了一项 2 期、开放标签、单臂、探索性临床试验的安全性和疗效，该试验在初始不可切除的晚期食管鳞状细胞癌（ESCC）患者中进行了诱导免疫化疗。
患者接受了三个周期的 tislelizumab、顺铂和 5-氟尿嘧啶诱导治疗。主要终点是安全性、主要病理缓解（MPR）和病理完全缓解（pCR）。次要终点包括 R0 切除率、无病生存（DFS）和总生存（OS）。对基因组数据和免疫微环境数据进行了探索性分析。
治疗是安全的，3 级或以上不良事件发生率为 14.9%（7/47）。在本研究中纳入的 47 名患者中，19 名（40.4%）达到 MPR，12 名（25.5%）达到 pCR，4 名（8.5%）达到完全临床缓解（cCR）并拒绝手术，23 名（48.94%）成功进行了手术切除。中位随访时间为 18 个月，中位 DFS 为 24 个月，中位 OS 为 36 个月。高肿瘤突变负担与手术患者的预后较好相关。与达到主要病理缓解的患者相比，达到 pCR 的患者具有更高水平的免疫细胞浸润以及更大比例和浓度的三级淋巴结构。
Tislelizumab 联合化疗对 ESCC 有效，可获得较高的 cCR、pCR、手术转化率和 R0 切除率，且不良反应可耐受。
NCT05469061。
