A Phase II Trial of Flouro-Gem as a First Line Treatment of Metastatic Adenocarcinoma of the Pancreas (GEFLUPAN trial)

Abstract

Abstract Background Gemcitabine and 5 FU + folinic acid both have proven activity in treatment of patients with advanced pancreatic cancer. Methods This prospective phase II study included 42 patients of metastatic cancer pancreas who met the inclusion criteria ( chemotherapy naïve, adult patients aged between 18 and 70 years, with histopathological evidence of adenocarcinoma, with radiological proof of metastatic disease, ECOG performance status (PS) ≤ 2, with adequate hematologic parameters and normal liver and kidney functions). Patients with end stage renal disease who are under regular dialysis, other histologies of pancreatic cancer, non-metastatic irresectable patients were excluded. The included patients received gemcitabine- flourouracil every 2 weeks, evaluated for response, assesed for quality of life and survival. Results The median age at diagnosis was 55 years. Males were more common (59.5%) than females. The most common site of metastasis was the liver (57.1%). Toxicity profile showed that neutropenia and thrombocytopenia were the most common forms of toxicity being high grade in 11.9% of patients. Other forms of toxicity were minimal not exceeding 5%. The ORR was 33.3% with no reported complete responses. There was a significant correlation between the change of tumor markers levels (CEA, and CA 19.9) and both response and quality of life. The changes of CEA and CA19.9 levels were found to be independent predictors of PFS. One year OS rate was 49%. The median OS was 11.3 months, while the median PFS was 8.8 months. Response was also found to be a surrogate marker for survival. Conclusions Gemcitabine- 5 FU combination is a good alternative option for treating metastatic pancreatic cancer, it had good efficacy and safety profile.