Gemcitabine and cisplatin based combination chemotherapy in patients of locally advanced and metastatic gall bladder cancer: An observational study

Abstract

Background: Gallbladder carcinoma (GBC) is an aggressive cancer with a high mortality. Treatment options for advanced GBC include either palliative chemotherapy or best supportive care. Gemcitabine and platinum based chemotherapy has shown activity in biliary tract cancer, although data from exclusive gall bladder cancer patient population is lacking. Aim of this study was to evaluate the disease response, progression free survival (PFS) and overall survival (OS) to Gemcitabine and Cisplatin (Gem/Cis) based chemotherapy in locally advanced and metastatic GBC, at tertiary care centre. Method(s): Patients of gall bladder carcinoma registered at Institute of liver and biliary sciences (ILBS), New Delhi, India, from 1st January 2012 till 31st December 2014, were enrolled. Locally advanced or metastatic adenocarcinoma for Gall Bladder, chemotherapy naive, ECOG performance status of 0 to 2 and who received at least three cycles of Gem/Cis at ILBS, were included. Data of 140 patients of GBC was reviewed and 27 patients were eligible for the treatment response analysis. Information about patient's demographic data, clinical presentation, biochemical parameters, image findings, appropriate therapeutic intervention and post therapeutic response was recorded. appropriate statistical methods were applied. Survival analysis was carried out by Kaplan Meier method. Result(s): Overall response after first line Gem/Cis was 25.9 percent. The median PFS was 7.4 months (HR: 0.988; 95% CI: 5.44-9.31). The medianOS was 10.3 months(HR: 1.397; 95%; CI: 7.54-13.02). Grade-3/4 myelosuppression was seen in 18.5% (5/27) patients, grade-3 transaminitis was seen only in 3.7% (1/27) patient. Grade-3/4 vomiting or nephrotoxicity was not seen. Conclusion(s): Gemcitabine and Cisplatin is an effective and tolerable chemotherapy combination inadvanced GBC. Although there was modest improvement in survival compared to historical result but it was similar to more recent published data. Better toxicity profile observed in our study may be attributed to improvement is supportive care. Research on newer class of drug and biomarkers is required.