Folfirinox for Locally Advanced Pancreatic Adenocarcinoma. Results of an Ageo Multicenter Prospective Study

Abstract

Background: The FOLFIRINOX regimen improves survival when compared to gemcitabine as first line treatment for patients ( pts) with metastatic pancreatic cancer (1). There is no such data in non resecable, non metastatic, locally advanced pancreatic adenocarcinoma (LAPA). The aim of this study was to evaluate the safety and efficacy of FOLFIRINOX in this setting. Method(s): From February 2010 to February 2012, all pts from eleven French hospitals, who started FOLFIRINOX for a pathologically proven LAPA were included in a prospective database. Non resectability was determined by each local multidisciplinary staff. The absence of metastases was assessed by TAP CT-scans. FOLFIRINOX was administered every 2 weeks (oxaliplatin 85 mg/m2; irinotecan 180 mg/m2; leucovorin 400 mg/m2; fluorouracil 400 mg/m2 as bolus and 2400 mg/m2 as 46-hour continuous infusion). Result(s): Seventy seven pts were enrolled. We report the preliminary analysis of the first 53 pts as data collection is still ongoing. Patients characteristics were M/F: 30/23; median age 63 (46-79); PS 0/1/2 : 24/28/1. twenty one pts had a bilary stent before starting treatment. The median number of cycles administered was 5 (1-30). There were no treatment-related deaths and 8% of pts stopped treatment because of toxicity. Grade 3-4 toxicities were neutropenia (15%), nausea (13%), diarrhea (8%), anemia (2%), and thrombopenia (2%). Grade 2-3 sensitive neuropathy occured in 19% of pts. Dose reduction was necessary in 28% and prophylactic GCSF was used in 86% of pts. Partial response rate was 30% [95 CI% 17%-43%], and 53% of pts showed stable disease [95% CI 39%-67%], resulting in a disease control rate of 83% [95% CI 73%-93%]. Closure external radiotherapy was performed in 62% of pts and 32% underwent surgical resection of their tumour. With a median follow up of 8.5 months [95% CI 7-11], median overall and progression free survivals have not been reached. One year overall and progression free survival rates were 80% [95% CI 57%-92%] and 54% [95% CI 29%-74%], respectively. Conclusion(s): FOLFIRINOX in LAPA seems efficient with a manageable toxicity profile and led to secondary potentially curative surgery in approximately one third of the pts. These promising results are encouraging to test this regimen in a phase 3 trial.