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- W2955722261 abstract "Introduction: Metastatic GBC is a deadly disease and the role of maintenance gemcitabine is unknown in this disease. We investigated the effects of gemcitabine maintenance on progression-free survival (PFS) and overall survival (OS) in patients with metastatic Gallbladder cancer (GBC). Methods: 60 patients with unresectable or metastatic GBC having ongoing response to treatment with initial 6 cycles of gemcitabine and a platinum-based doublet chemotherapy were prospectively randomized on day 21 of 6th cycle in 1:1 fashion to receive either maintenance gemcitabine 1g/m2 intravenously on day 1 and day 8 of three weekly cycle or observation. Survival analysis was done by the Kaplan-Meier method and comparisons by log-rank test. P value of < 0.05 was taken as significant. Results: Out of 60 patients, a total of 56 were available for final analysis. The median PFS was 4.7 months (3.1-6.3) in arm A and 2.6 months (2.4-2.8) in arm B, HR 0.196 (95% CI 0.1-0.39), P < 0.001. Median OS in Arm A was 12.4 months (9.15-15.6) as opposed to 9.9 months (8.29-11.5) in Arm B, HR 0.76 (95%CI 0.43-1.35), P = 0.354. The grade 3 or 4 side effects in maintenance arm were transamnitis (17.9%), thrombocytopenia (17.8%), neutropenia (14.2%) and febrile neutropenia (7.1%). Conclusion: Maintenance gemcitabine therapy in unresectable/metastatic GBC patients responding to first-line gemcitabine and platinum treatment contributes to increased PFS with minimal and manageable side effects." @default.
- W2955722261 created "2019-07-12" @default.
- W2955722261 creator A5029636462 @default.
- W2955722261 date "2019-07-01" @default.
- W2955722261 modified "2023-09-27" @default.
- W2955722261 title "Role of maintenance gemcitabine in advanced and metastatic carcinoma gall bladder" @default.
- W2955722261 doi "https://doi.org/10.1093/annonc/mdz155.062" @default.
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- W2955722261 hasPublicationYear "2019" @default.
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