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Background <p>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.</p> Methods <p>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&#xa0;mg/m² (days 1, 8) and cisplatin 75&#xa0;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.</p> Results <p>Sixty-three patients were included in the study&#xa0;(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.</p> Conclusion <p>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.</p>

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Clinical Efficacy and Safety of Gemcitabine–Cisplatin Combination in Metastatic Gallbladder Cancer: A Prospective Study from North India

  • 期刊论文

  • 发表日期：

    2025年12月3日

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  • Abhinav Dewan,
  • Vineet Talwar,
  • Varun Goel,
  • Sabeena K Choudhary,
  • Krati Mehrotra,
  • Swati Chugh,
  • Sekhar Saha,
  • Dharmishta Ashis Basu,
  • Anindya Mukherjee,
  • Rashmi Bansal,
  • Arpit Jain,
  • Shivashankara Swamy Mathighatta Shivarudraiah,
  • Mansi Sharma,
  • Pankaj Goel,
  • Rajat Saha,
  • Sumit Goyal,
  • Ullas Batra,
  • Nivedita Patnaik,
  • Dinesh Chandra Doval,
  • Ajay Kumar Dewan

摘要

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.