European Journal of Molecular & Clinical Medicine

Abstract

Background: This study was undertaken to assess the efficacy and safety of Gemcitabine and erlotinib combination in first line in locally advanced and metastatic (LA/M) carcinoma pancreas patients in Indian population, due to paucity of data.Aims and Objectives: The primary objective was to evaluate efficacy in terms of the objective response rate, progression free survival and overall survival. Safety data was also analyzed.Materials and Methods: In this prospective study, LA/M carcinoma pancreas patients were given standard gemcitabine plus erlotinib till progression or significant toxicities.Results: A total of 50 patients were evaluated. The median age of patients was 59.5 yrs, out of which 28 (56%) were males and 22 (44%) were females. A total of 266 cycles of treatment were administered with a median number of 6 cycles per patient. The CR was not achieved in any patient, PR in 25 (50%), SD in 13 (26%) and PD in 12 (24%) patients. Disease control rate (PR and SD) was seen in (76%) patients. The median PFS was 5.2 months. The median OS was 7.0 months. The main grade 3/4 side effects seen were Rash in 9 (18%), thrombocytopenia in 8 (16%) and Diarrhea in 9 (18%) patients. Overall survival of patients who developed grade 3/4 skin rashes was significantly longer (P = 0.013).Conclusions: Gemcitabine and erlotinib based chemotherapy regimen has good efficacy with reasonable toxicity profile in Indian advanced carcinoma pancreas patients. To the best of our knowledge, this is the first such study conducted in India.