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Comparative survival and safety analysis of cisplatin based regimens in gall bladder cancer patients: A retrospective cohort study

Aim: This is a retrospective cohort study of patients who were treated with different regimens of adjuvant chemotherapy after cholecystectomy due to Gall Bladder Cancer (GBC).

Patients and Methods: Data of GBC Patients registered between January 2011 to January 2015 at Mahavir Cancer Sansthan treated with 5-FU plus Cisplatin and Gemcitabine plus Cisplatin as adjuvant chemotherapy were reviewed retrospectively. Eighty patients were enrolled and data was analysed for overall survival and progression free survival. Causality, preventability and severity of Adverse Drug Reactions (ADRs) were also evaluated.

Results: Forty patients were assigned with 5FU-Cis and Gem-Cis each. 5FU-Cis gave more ADRs than Gem-Cis. Incidence of ADRs in 5FU-Cis regimen was 62.5% and that of Gem-Cis was 40%. According Modified Hartwig and Siegel scale, “80%” of ADRs shown by 5FU-Cis were moderately severe. Based on Modified Schumock & Thornton Preventability scale, 5FU-Cis and Gem-Cis showed “90%” and “80%” Not Preventable ADRs respectively. As per WHO-UMC Causality assessment scale, “80%” were certain with 5FU-Cis. Gem-Cis showed a mean OS of 11.2 months (95% CI, 10.6-11.8) and mean PFS of 7.4 months (95% CI, 7.3-8.4). 5FU-Cis had a mean OS of 8.1 months (95% CI, 7.7-8.4) and mean PFS of 3.4 months (95% CI, 3.8-4.1).

Conclusion: Direct comparison of 5FU-Cis and Gem-Cis showed the latter regimen was superior in OS and PFS. Further prospective studies which define the efficacy and toxicity of these regimens are recommended.

Author(s): Krishna Murti, Vysakh Chandran, Arun Kumar, Vibha Ghalot, Manoj Kumar Rastogi, Biplab Pal, Krishna Pandey, Pradeep Das