Modified FOLFIRINOX for Locally Advanced and Metastatic Pancreatic Cancer Patients Resistant to Gemcitabine and S-1 in Japan: A Single Institutional Experience.

BACKGROUND/AIMS: The purpose of the present study was to evaluate the efficacy and the tolerability of modified FOLFIRINOX (mFOLFIRINOX), administered as a second-line or beyond second-line chemotherapy drug in patients with locally advanced or metastatic pancreatic cancer (PC) after the failure of both gemcitabine (GEM) and S-1.

METHODOLOGY: Treatment of mFOLFIRINOX consisted of oxaliplatin, leucovorin, irinotecan and fluorouracil; all the anticancer drugs were reduced to an 80% dose of the original regimen of FOLFIRINOX, repeated every three weeks. The primary end point was response rate (RR) and disease control rate (DCR). The secondary end points were overall survival (OS), progression-free survival (PFS), total survival time (TST), safety, and tolerability.

RESULTS: Between November 2011 and November 2013, 13 enrolled patients were treated with mFOLFIRINOX, with a median of 5 courses (range 1-33). The RR and DCR were 30.8% and 69.2%, respectively. The median OS, PFS, and TST were 176, 137, and 779 days, respectively. The 6-month and the 1-year OS was 46.1% and 23.1%, respectively. Major grade 3 or grade 4 adverse events included neutropenia (38.5%), and anorexia (25.0%).

CONCLUSIONS: mFOLFIRINOX was moderately effective in locally advanced or metastatic PC patients after the failure of both GEM and S-1.