ArticleClinical and experimental medicine2025
Analysis of the effectiveness and safety of lenvatinib/bevacizumab combined with PD-1/PD-L1 inhibitors and GEMOX in the first-line treatment of advanced biliary tract carcinoma.
Article in Clinical and experimental medicine, 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
To assess the efficacy and safety of lenvatinib/bevacizumab combined with programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors and gemcitabine/oxaliplatin (GEMOX) as first-line treatments in patients with advanced biliary tract cancer (BTC). Patients with advanced BTC who received lenvatinib/bevacizumab combined with PD-1/PD-L1 inhibitors plus gemcitabine/oxaliplatin (GEMOX) chemotherapy were retrospectively screened. The primary endpoints were overall survival (OS) and progression-free survival (PFS), whereas the secondary endpoints were objective response rate (ORR), disease control rate (DCR), and safety. Prognostic factors for survival were analyzed. A total of 172 individuals were enrolled and categorized into four groups: Group A received GEMOX plus PD-1 antibody (sintilimab or camrelizumab) and lenvatinib; group B received GEMOX and PD-1 antibody (sintilimab or camrelizumab) and bevacizumab; group C received GEMOX and PD-1 antibody (sintilimab or camrelizumab); and group D received GEMOX alone. The median OS was 13.63 months (95% confidence interval [CI]: 12.37-14.89), 12.41 months (95% CI: 10.67-12.32), 11.23 months (95% CI: 9.39-13.07), and 8.86 months (95% CI: 7.28-10.44) in groups A, B, C, and D, respectively (P = 0.312). In groups A, B, C, and D, the median PFS was 12.42 months, 11.05 months, 8.89 months, and 6.02 months. A statistically significant difference was observed (t = 2, 95% CI: 11.31-13.53, P < 0.01). The ORR was 45.00% (17/40) in group A, 34.78% (16/46) in group B, 16.67% (5/30) in group C, and 17.86% (10/56) in group D. The DCR was 87.50% (35/40), 78.26% (36/46), 76.67% (23/30), and 58.93% (33/56) in groups A, B, C, and D, respectively. In addition, regression analysis showed that patients' metastasis site, whether the neutrophil-lymphocyte ratio was < 2.3, and whether chemotherapy was administered through hepatic artery embolization and was independent prognostic factors influencing median OS and PFS. Almost all patients included in the study experienced treatment-related adverse events (TRAEs) of varying degrees of severity, with grade 1-2 adverse events predominating. Lenvatinib/bevacizumab combined with programmed death-1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors and gemcitabine/oxaliplatin (GEMOX) represent an effective and tolerable regimen for advanced BTC in a multicenter retrospective real-world study.
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