| Popis: |
Background: Anti-PD-L1/VEGF inhibition, coupled with chemotherapy, may potentiate antitumor immunity leading to enhanced clinical benefit, but it has not been investigated in advanced biliary tract cancer (BTC). We investigated the efficacy and safety of gemcitabine plus oxaliplatin (GEMOX) combined with atezolizumab and bevacizumab for advanced BTC and explore the potential biomarkers related with response. Patients and Methods: Advanced BTC patients, who received a triple combination therapy at three medical centers between March 18th, 2020 and Sep 1st, 2021, were included. Treatment response was evaluated via mRECIST and RECIST v1.1. Endpoints included the overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety. The whole exome sequencing of pathological tissues was conducted for bioinformatic analysis. Results: Thirty patients were enrolled ultimately in this study. The best ORR was 76.7% and the disease control rate was 90.0%. The median PFS was 12.0 months, and the median OS was not reached. During the treatment, 10.0% (3/30) patients suffered from ≥ grade 3 treatment-related adverse events (TRAEs). Furthermore, fever (73.3%), neutropenia (63.3%), AST and ALT level increased (50.0% and 43.3% respectively) are the most common TRAEs. Bioinformatics analysis revealed patients with altered ALS2CL had a higher ORR. Conclusion: The triple combination of atezolizumab, bevacizumab and GEMOX is potentially efficacious and safe for patients with advanced BTC. The mutation of ALS2CL is a potential predictive biomarker for the efficacy of triple combination therapy. |
