Wang Jie, Li Bin, Zhang Yawei, Luo Xiaoyang, Zhang Yiliang, Li Hang, Pan Yunjian, Shao Longlong, Zheng Shanbo, Yuan Chongze, Li Yuan, Zheng Qiang, Sun Si, Zhao Weixin, Sun Yihua
Department of Thoracic Surgery and State Key Laboratory of Genetic Engineering, Fudan University Shanghai Cancer Center, Shanghai, China.
Institute of Thoracic Oncology, Fudan University, Shanghai, China.
Int J Cancer. 2025 Apr 1;156(7):1429-1438. doi: 10.1002/ijc.35261. Epub 2024 Dec 16.
This prospective, two-cohort phase 2 trial with random allocation was conducted to evaluate the safety and efficacy of neoadjuvant tislelizumab combined with nab-paclitaxel/paclitaxel and cisplatin (TP) in patients with esophageal squamous cell carcinoma (ESCC). Patients were enrolled and randomly assigned to the nab-paclitaxel or paclitaxel cohorts at a 1:1 ratio, and received intravenous tislelizumab (200 mg, day 1) combined with cisplatin (25 mg/m, days 1-3) and either nab-paclitaxel (125 mg/m, days 1 and 8) or paclitaxel (150 mg/m, day 1) in a 21-day cycle for two cycles before surgery. The primary endpoint was the major pathological response (MPR) rate. From March 01, 2022 to April 10, 2023, 46 patients were enrolled (n = 23 in each cohort), with 42 patients receiving the full two-cycle treatments and undergoing surgery (n = 22 in the nab-paclitaxel cohort, n = 20 in the paclitaxel cohort). The MPR rate and the pCR rate in the total cohort were 44.2% (19/42) and 19.0% (8/42), respectively, with 59.1% (13/22) and 31.8% (7/22) in the nab-paclitaxel cohort and 30.0% (6/20) and 5.0% (1/20) in paclitaxel cohorts. The most common treatment-related adverse events (TRAEs) were anemia (89.1%) and alopecia (71.7%), and no significant difference in TRAEs was observed between the two cohorts. Up until March 28, 2024, the median follow-up time was 15.5 months (range of 6.0-24.3 months), and the survival analysis revealed that the patients in the nab-paclitaxel cohort had a higher event-free survival (p = .002). In conclusion, neoadjuvant tislelizumab combined with cisplatin and nab-paclitaxel, rather than cisplatin and paclitaxel, is a more effective neoadjuvant strategy for locally advanced thoracic ESCC.
这项前瞻性、双队列、随机分配的2期试验旨在评估新辅助替雷利珠单抗联合白蛋白结合型紫杉醇/紫杉醇和顺铂（TP）治疗食管鳞状细胞癌（ESCC）患者的安全性和有效性。患者入组后按1:1的比例随机分配至白蛋白结合型紫杉醇组或紫杉醇组，并在术前接受21天为一个周期、共两个周期的静脉注射替雷利珠单抗（200mg，第1天）联合顺铂（25mg/m²，第1 - 3天）以及白蛋白结合型紫杉醇（125mg/m²，第1天和第8天）或紫杉醇（150mg/m²，第1天）治疗。主要终点为主要病理缓解（MPR）率。2022年3月1日至2023年4月10日，共入组46例患者（每组23例），42例患者接受了完整的两个周期治疗并接受了手术（白蛋白结合型紫杉醇组22例，紫杉醇组20例）。总队列的MPR率和病理完全缓解（pCR）率分别为44.2%（19/42）和19.0%（8/42），白蛋白结合型紫杉醇组为59.1%（13/22）和31.8%（7/22），紫杉醇组为30.0%（6/20）和5.0%（1/20）。最常见的治疗相关不良事件（TRAEs）为贫血（89.1%）和脱发（71.7%），两组之间在TRAEs方面未观察到显著差异。截至2024年3月28日，中位随访时间为15.5个月（范围6.0 - 24.3个月），生存分析显示白蛋白结合型紫杉醇组患者的无事件生存期更高（p = 0.002）。总之，新辅助替雷利珠单抗联合顺铂和白蛋白结合型紫杉醇，而非顺铂和紫杉醇，是局部晚期胸段ESCC更有效的新辅助治疗策略。
