Published online Aug 14, 2024. doi: 10.3748/wjg.v30.i30.3564
Revised: July 8, 2024
Accepted: July 16, 2024
Published online: August 14, 2024
Processing time: 65 Days and 2 Hours
Biliary tract cancers (BTCs) are a heterogeneous group of tumors with high ma
To explore the efficacy and safety of nab-paclitaxel plus capecitabine as first-line treatment for advanced and metastatic BTCs.
This open-label, non-randomized, double-center, phase II clinical trial recruited systemic therapy-naive patients with unresectable or metastatic BTCs between April 2019 and June 2022 at Beijing Cancer Hospital and the First Hospital of China Medical University. Eligible patients were administered nab-paclitaxel (150 mg/m2, day 1) and capecitabine (2000 mg/m2, twice daily, days 1-7) in 14-day cycles until experiencing intolerable toxicity or disease progression. The primary outcome was the objective response rate (ORR). The secondary outcomes included the disease control rate (DCR), overall survival (OS), progression-free survival (PFS), and safety.
A total of 44 patients successfully completed the trial, with a median age of 64.00 years (interquartile range, 35.00-76.00), and 26 (59.09%) were females. Tumor response assessment was impeded for one patient due to premature demise from tumor hemorrhage. Among the remaining 43 patients undergoing at least one imaging assessment, the ORR was 23.26% [95% confidence interval (CI): 11.80%-38.60%], and the DCR was 69.77% (95%CI: 53.90%-82.80%). The median OS was 14.1 months (95%CI: 8.3-19.9), and the median PFS was 4.4 months (95%CI: 2.5-6.3). A total of 41 patients (93.18%) experienced at least one adverse event (AE), with 10 patients (22.73%) encountering grade ≥ 3 AEs, and the most frequent AEs of any grade were alopecia (79.50%), leukopenia (54.55%), neutropenia (52.27%), and liver dysfunction (40.91%), and no treatment-related deaths were documented.
Nab-paclitaxel plus capecitabine may be an effective and safe first-line treatment strategy for patients with advanced or metastatic BTCs.
Core Tip: Our study investigates the efficacy and safety of nab-paclitaxel plus capecitabine as first-line treatment for advanced and metastatic biliary tract cancers (BTCs). Through an open-label, non-randomized, double-center, phase II clinical trial, we enrolled systemic therapy-naive patients. Our findings demonstrate that nab-paclitaxel plus capecitabine demonstrates both acceptable efficacy and safety in patients with advanced and metastatic BTCs. This regimen shows promise as a potential novel treatment option for this patient population and warrants further validation in future trials.