A Study of Response to First Line Chemotherapy with Cisplatin and Gemcitabine in Indian Patients with Advanced Gall Bladder Carcinoma

Abstract

Aim: To evaluate the response to first line chemotherapy with Cisplatin and Gemcitabine among patients with advanced Gall bladder carcinoma using RECIST criteria (Indian Council of Medical Research, 2001). Study Design: Observational which was conducted at Departments of Oncology at the Command Hospital (Central Command), Lucknow between August 2014 to July 2015. All patients presenting to this center with histologically proven advanced carcinoma of gall bladder was screened for eligibility for inclusion in the study. Place and Duration of Study: Departments of Oncology at the Command Hospital (Central Command), Lucknow between August 2014 to July 2015. Methodology: Hematological/biochemical assessment was performed followed by histopathological (FNAC/Biopsy), radiological (CT/MRI/MRCP) and immunohistochemical (CA19.9) evaluations. Type of initial management (PTBD/Stenting), if any was noted. All the eligible patients was administered standard chemotherapy (Cisplatin 25/sqm & Gemcitabine 1000/sqm, both drugs on Dl &D8 in a 21 day cycle). Details of chemotherapy in terms of cycles planned and cycles administered was recorded. Radiological response was evaluated and expressed in terms of RECIST criteria. Results: A total of 30 patients falling in sampling frame and completing 6 months of treatment protocol were enrolled in the study. At 3 months, maximum (n=14; 46.7%) had a progressive disease. There were 7 (23.3%) showing a partial response, 2 (6.7%) had stable disease. A total of 5 (16.7%) patients expired during this period. A total of 2 (6.7%) patients were lost to follow up/discontinued treatment. At 6 months, majority (60%) had progressive disease (in fact all the patients alive and remaining in the study had progressive disease). A total of 7 (23.3%) expired and 5 (16.7%) were lost to follow up. Conclusion: Statistically, there was a significant difference in outcome at 3 and 6 months. Median survival duration was found to be 4.97 months with statistical significance (p = 0.025) was strong.