Retrospective research for efficacy and safety of modified FOLFIRINOX as 1st line therapy for advanced pancreatic cancer

Abstract

Background: Since the efficacy of FOLFIRINOX superior to gemcitabine was confirmed in large randomized phase III trial, FOLFIRINOX has been regarded as one of the standard first-line chemotherapies for advanced pancreatic cancer. Subsequently from the Phase II trial in Japan, FOLFIRINOX was approved in Japan at December 2013. However, high frequency of adverse events (AEs) is the problem in FOLFIRINOX. Methods: Unresectable or metastatic pancreatic cancer patients who began receiving FOLFIRINOX as 1st line chemotherapy in our facility from January 2014 to January 2015 were retrospectively analyzed for the safety and efficacy. By the reference of data about doze intensity of phase II trial in Japan, in our facility, all patients were treated with no 5-FU bolus and decreased CPT-11(150mg/m 2 ), so-called modified FOLFIRINOX(mFOLFIRINOX). Results: Total 19 patients were analyzed. Patients characteristics were as follows: median age 62 years (range 45-74), Male: female 13:6, PS 0:1 16:3. The common grade 3-4 hematological adverse events were neutropenia (68.4%), febrile neutropenia (10.5%). About non-hematological toxicities, diarrhea was 68.4% (grade 3-4: 5.3%), and peripheral sensory neuropathy was 68.4% (no grade 3-4). Median Progression-free survival was 7.56 months (95%C.I. 4.38-10.74 months). Median overall survival was not reached. Conclusions: In clinical practice, mFOLFIRINOX was manageable about toxicities and showed similar efficacy as seen in clinical trials.