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

Abstract

Background: Gemcitabine and 5 FU+folinic acid have both proved efficacy in treating patients with advanced pancreatic cancer. 

Objective: In our study, we combined the two most active agents against pancreatic cancer; gemcitabine and 5FU that were given every  2 weeks to gain the maximum benefit of both drugs and avoid the toxicity that occurs very frequently with FOLFIRINOX.

Patients and Methods: This prospective phase II study included 42 patients of metastatic cancer pancreas who met the inclusion criteria 

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 overall response rate (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 (QOL). The changes of CEA and CA19.9 levels were found to be independent predictors  of progression free survival (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 was a good alternative  option for treating metastatic pancreatic cancer, it had good efficacy and safety profile.