Background: Gemcitabine-cisplatin doublet is a standard first-line regimen for metastatic gallbladder cancer (GBC), though prospective real-world data remains scarce. We evaluated the efficacy, safety, and prognostic factors in the North Indian patients.
Methods: Between March 2021 and December 2022, all patients with histologically proven metastatic GBC were prospectively enrolled. Eligible patients had ECOG 1-2 and adequate organ function. Gemcitabine 1000 mg/m² (days 1, 8) and cisplatin 75 mg/m² (days 1-2) were given every 3 weeks for up to 6 cycles, until progression or intolerance. Patients receiving ≥ 2 cycles were evaluable for efficacy. Responses were assessed by RECIST 1.1. Kaplan-Meier, univariate, and multivariate analyses were performed.
Results: Sixty-three patients were included in the study (Mean Age 56 years; 62% female). ORR was 63.5%; DCR 84.5%. Median PFS was 5.0 months; median OS 11.0 months. Six-month OS was 82.1%, 12-month OS 36.9%. Independent predictors of PFS included % change in CA19-9, platelet-lymphocyte ratio, alkaline phosphatase, and extra-abdominal disease. Neutropenia (any grade 73%, grade 3-4: 27%) was the most common toxicity; G-CSF was used therapeutically in 41%. Non-hematological AEs were mild-to-moderate. No treatment-related deaths occurred.
Conclusion: Gemcitabine-cisplatin remains effective and tolerable in metastatic GBC. Despite the emergence of Gemcitabine-Cisplatin with durvalumab as new standard, this prospective dataset provides valuable real-world outcomes from a high-incidence region with limited access to immunotherapy.
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