Journal of gastrointestinal cancer · 2025
Clinical Efficacy and Safety of Gemcitabine-Cisplatin Combination in Metastatic Gallbladder Cancer: A Prospective Study from North India.
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Dewan Abhinav, Talwar Vineet, Goel Varun, Choudhary Sabeena K, Mehrotra Krati, Chugh Swati, Saha Sekhar, Basu Dharmishta Ashis, Mukherjee Anindya, Bansal Rashmi, Jain Arpit, Shivarudraiah Shivashankara Swamy Mathighatta, Sharma Mansi, Goel Pankaj, Saha Rajat, Goyal Sumit, Batra Ullas, Patnaik Nivedita, Doval Dinesh Chandra, Dewan Ajay Kumar
Аннотация
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.
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.