ArticleTherapeutic advances in medical oncology2025
Nab-paclitaxel-based chemotherapy with or without anti-PD-(L)1 immunotherapy as a second-line treatment for advanced biliary tract cancer: a real-world retrospective study.
Article in Therapeutic advances in medical oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Background: Second-line options for biliary tract cancer (BTC) are limited. While nab-paclitaxel has demonstrated certain antitumor activity, evidence remains scarce. With gemcitabine-cisplatin plus anti-programmed death-ligand 1 (PD-(L)1) established as the first-line standard, the benefit of second-line immunotherapy-especially in patients without prior anti-PD-(L)1 exposure-remains unclear. Objectives: To evaluate the efficacy and safety of nab-paclitaxel-based second-line treatments for advanced BTC, and compare outcomes between regimens with and without anti-PD-(L)1. Design: This is a real-world retrospective study. Methods: This study reviewed BTC patients who received second-line nab-paclitaxel-based therapy at West China Hospital between August 2018 and August 2023. The primary endpoint was overall survival (OS) in the entire population. Secondary endpoints were progression-free survival (PFS), response rate, adverse events (AEs) in the entire population, and comparison of survival outcomes and response rate between the chemo-anti-PD-(L)1 and chemotherapy groups. Results: Among 84 patients (41 in the chemo-anti-PD-(L)1 group and 43 in the chemotherapy group), the median OS was 15.17 months (95% confidence interval (CI), 12.63-21.43), median PFS was 5.40 months (95% CI, 3.23-8.03), objective response rate (ORR) was 21.43% (95% CI, 13.22-31.74), and disease control rate (DCR) was 60.71% (95% CI, 49.45-71.20). Common grade 3-4 AEs were leukopenia (21.4%), neutropenia (17.9%), and anemia (13.1%). Hepatitis (14.6%) was the most frequent immune-related AE. Although a numerical trend favored the chemo-anti-PD-(L)1 group, no statistically significant differences were observed in OS (16.9 vs 14.6 months), PFS (7.3 vs 4.6 months), ORR (29.3% vs 13.9%), or DCR (68.3% vs 53.5%). In the entire cohort, radical surgery improved OS. In addition, patients with a baseline neutrophil-to-lymphocyte ratio ⩾3 and a ⩽30% reduction in carbohydrate antigen 19-9 from an initially elevated level during treatment had worse OS and PFS. Conclusion: Nab-paclitaxel-based regimens represent a promising second-line treatment option for BTC. Although the improvement was not statistically significant, adding anti-PD-(L)1 therapy showed a trend toward improved survival. Trial registration: ChiCTR2500096599.
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