Zhang Wen, Sun Yongkun, Jiang Zhichao, Qu Wang, Gong Caifeng, Zhou Aiping
Department of Medical Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Hepatobiliary Surg Nutr. 2023 Feb 28;12(1):37-44. doi: 10.21037/hbsn-21-172. Epub 2021 Oct 18.
This study aimed to evaluate the efficacy and safety of a new combination of nab-paclitaxel plus tegafur gimeracil oteracil potassium capsule (S-1) for patients with advanced biliary tract carcinoma (BTC).
Patients were treated with nab-paclitaxel at a dose of 125 mg/m on day 1 and 8, and S-1, 80 to 120 mg/day on days 1-14 of a 21-day cycle. Treatments were repeated until disease progression or unacceptable toxicity occurred. The primary endpoint was objective response rate (ORR). The secondary endpoints were median progression-free survival (PFS), overall survival (OS), and adverse events (AEs).
The number of patients enrolled were 54, and 51 patients were evaluated for efficacy. A total of 14 patients achieved partial response (PR) with an ORR of 27.5%. The ORR varied by sites, with 53.8% (7/13) for gallbladder carcinoma, 18.4% (7/38) for cholangiocarcinoma. The most common grade 3 or 4 toxicities were neutropenia and stomatitis. The median PFS and OS were 6.0 and 13.2 months, respectively.
The combination of nab-paclitaxel with S-1 showed explicit antitumor activities and favorable safety profile in advanced BTC and could serve as a potential non-platinum and -gemcitabine-based regimen.
本研究旨在评估新型组合疗法——纳米白蛋白结合型紫杉醇联合替吉奥胶囊（S-1）治疗晚期胆管癌（BTC）患者的疗效与安全性。
患者在21天周期的第1天和第8天接受纳米白蛋白结合型紫杉醇治疗，剂量为125mg/m²，在第1 - 14天接受S-1治疗，剂量为80至120mg/天。重复治疗直至疾病进展或出现不可接受的毒性反应。主要终点为客观缓解率（ORR）。次要终点为中位无进展生存期（PFS）、总生存期（OS）和不良事件（AE）。
共纳入54例患者，其中51例患者接受了疗效评估。共有14例患者达到部分缓解（PR），客观缓解率为27.5%。客观缓解率因部位而异，胆囊癌为53.8%（7/13），胆管癌为18.4%（7/38）。最常见的3级或4级毒性反应为中性粒细胞减少和口腔炎。中位无进展生存期和总生存期分别为6.0个月和13.2个月。
纳米白蛋白结合型紫杉醇与S-1联合使用在晚期胆管癌中显示出明确的抗肿瘤活性和良好的安全性，可作为一种潜在的非铂类和非吉西他滨方案。
