Abstract
The research study was designed to compare the safety and efficacy of the regimen of 5-flurouracil with cisplatin of investigational armwith the reference regimen of gemcitabine with cisplatin for the treatment of gallbladder cancer. Atotal of 60 patients were enrolled in the study. Out of 30 patients enrolledinarm-A (Gemcitabine withCisplatin) and 30 patients enrolledin arm-B (5-Flurouracilwith Cisplatin) for safety assessment. For the efficacy evaluation total of 16 patients enrolled which is equally divided in both arm. Total 150 cycles of chemotherapy were given to each arm of patients. Both armswere well balanced with respect to age, stage of disease and measurability. The overall response rate (ORR) was 62.5% in arm-A compared to 50% in arm-B (p = 0.34). Whereas 95% confidence interval (CI) for the efficacy was found 46.25-8.74% vs32.67-67.32% between arm-A and arm-B. The most prevalent toxicities were found anemia (p < 0.05), neutropenia (p < 0.05) leucopenia (p<0.05) and thrombocytopenia (p < 0.05) and it occurred at a higher rate in arm-B than in arm-A of various grades. There was no statistically significant efficacy & toxicity for gemcitabine and cisplatin with 5-flurouracil and cisplatin however there was an overall more benefit in arm-A patients than arm-B patients.