Tislelizumab联合nab-紫杉醇和顺铂作为局部晚期胸段食管鳞状细胞癌新辅助治疗中更有效的化学免疫治疗策略:一项前瞻性、双队列、2期试验

IF 5.7 2区 医学 Q1 ONCOLOGY
Jie Wang, Bin Li, Yawei Zhang, Xiaoyang Luo, Yiliang Zhang, Hang Li, Yunjian Pan, Longlong Shao, Shanbo Zheng, Chongze Yuan, Yuan Li, Qiang Zheng, Si Sun, Weixin Zhao, Yihua Sun
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引用次数: 0

摘要

这项前瞻性、随机分配的双队列2期试验旨在评估新辅助tislelizumab联合nab-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。患者以1:1的比例被随机分配到nab-紫杉醇或紫杉醇组,并在手术前接受静脉注射tislelizumab (200 mg,第1天)联合顺铂(25 mg/m2,第1-3天)和nab-紫杉醇(125 mg/m2,第1天和第8天)或紫杉醇(150 mg/m2,第1天),为期21天,周期为2个周期。主要终点为主要病理反应(MPR)率。从2022年3月1日至2023年4月10日,共纳入46例患者(每组n = 23),其中42例患者接受完整的两周期治疗并接受手术治疗(nab-紫杉醇组n = 22,紫杉醇组n = 20)。总队列的MPR率和pCR率分别为44.2%(19/42)和19.0% (8/42),nab-紫杉醇组分别为59.1%(13/22)和31.8%(7/22),紫杉醇组分别为30.0%(6/20)和5.0%(1/20)。最常见的治疗相关不良事件(TRAEs)是贫血(89.1%)和脱发(71.7%),两个队列之间TRAEs无显著差异。截至2024年3月28日,中位随访时间为15.5个月(6.0-24.3个月),生存分析显示nab-紫杉醇组患者无事件生存率更高(p = 0.002)。综上所述,新辅助tislelizumab联合顺铂和nab-紫杉醇,而不是顺铂和紫杉醇,是局部晚期胸部ESCC更有效的新辅助策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Tislelizumab combined with nab-paclitaxel and cisplatin as the more effective chemoimmunotherapy strategy in the neoadjuvant treatment of locally advanced thoracic esophageal squamous cell carcinoma: A prospective, two-cohort, phase 2 trial.

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/m2, days 1-3) and either nab-paclitaxel (125 mg/m2, days 1 and 8) or paclitaxel (150 mg/m2, 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.

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来源期刊
CiteScore
13.40
自引率
3.10%
发文量
460
审稿时长
2 months
期刊介绍: The International Journal of Cancer (IJC) is the official journal of the Union for International Cancer Control—UICC; it appears twice a month. IJC invites submission of manuscripts under a broad scope of topics relevant to experimental and clinical cancer research and publishes original Research Articles and Short Reports under the following categories: -Cancer Epidemiology- Cancer Genetics and Epigenetics- Infectious Causes of Cancer- Innovative Tools and Methods- Molecular Cancer Biology- Tumor Immunology and Microenvironment- Tumor Markers and Signatures- Cancer Therapy and Prevention
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