Comparison of Efficacy and Toxicity of Gemcitabine-Cisplatin Regimen VS Gemcitabine-Capecitabine Regimen as First Line Chemotherapy in Advanced Gallbladder Carcinoma

Introduction: Gallbladder cancer (GBC) is the commonest malignancy of the biliary tract, and majority of patients with GBC in India has advanced unresectable disease. This study was undertaken to address the efficacy, the toxicity profile and the compliance of the two different gemcitabine-based chemotherapy regimens in advanced unresectable GBC. Materials and Methods: A prospective randomized study was undertaken to compare the efficacy and toxicity profiles of two gemcitabine-based doublet chemotherapy regimens, gemcitabine-cisplatin and gemcitabine-capecitabine in patients with advanced GBC. All eligible patients were recruited from Dr. B Borooah Cancer Institute, Guwahati from 20.11.2020 – 20.08.2021 and randomly assigned to one of the groups of chemotherapy in 1:1 ratio. Results: Among 250 patients with locoregionally advanced, inoperable and metastatic GBC registered at Dr B Borooah Cancer Institute, 50 patients fulfilled the criteria and were planned for recruitment for our study. After randomization, 23 patients were allotted among each of the gemcitabine-cisplatin and gemcitabine-capecitabine arms. With the median follow up time of 8 months, the median PFS (progression-free survival) and median OS (overall survival) for the entire cohort was 6 months and 8 months, respectively. Median PFS was marginally higher in the gemcitabine-cisplatin arm, in comparison to gemcitabine-capecitabine arm, but not statistically significant (6.5 months vs. 5.4 months; p = 0.793). Median OS was marginally higher in the gemcitabine-cisplatin arm, in comparison to gemcitabine-capecitabine arm, but was not statistically significant (8.5 months vs. 7.6 months; p = 0.879). The overall response rate (ORR - includes partial response [PR] and complete responses [CR]) were similar (26%) in both the arms. Non-hematological toxicities were similar with both the regimen. Hematological toxicities were found to be non-significantly higher with gemcitabine-cisplatin as compared to gemcitabine-capecitabine. Conclusion: Gemcitabine with capecitabine in advanced GBC can alternatively be considered in first line treatment with similar OS, PFS, ORR and with acceptable toxicity profile compared to gemcitabine-cisplatin, thereby avoiding cisplatin-induced long-term toxicities