716P - FOLFIRINOX for locally advanced pancreatic adenocarcinoma. Results of an AGEO multicentric prospective study

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Lysiane Marthey
Authors L. Marthey1, A. Sa-Cunha2, J.F. Blanc3, A. Cueff4, E. Francois5, I. Trouilloud6, D. Malka7, J. Bachet8, R. Coriat9, J. Taieb10
  • 1Gastroenterology, Bicêtre Hospital, 94275 - Kremlin Bicêtre/FR
  • 2Digestive Surgery, Haut Lévêque Hospital, Pessac/FR
  • 3Digestive Oncology, Saint André Hospital, Bordeaux/FR
  • 4Biostatistics And Epidemiology, Georges Leclerc Cancer Institute, Dijon/FR
  • 5Medical Oncology, Antoine Lacassagne Cancer Institute, Nice/FR
  • 6Oncologie Digestive, European Georges Pompidou Hospital, 75015 - Paris/FR
  • 7Oncology, Gustave Roussy Cancer Institute, Villejuif/FR
  • 8Gastroenterology, Pitié-Salpêtrière Hospital, Paris/FR
  • 9Oncology Department, Cochin Hospital, 75014 - Paris/FR
  • 10Oncologie Digestive, Hopital Europeen Georges Pompidou, 75015 - Paris/FR

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.

Methods

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).

Results

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

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. (1) Conroy et al. NEJM 2011; 364: 1817

Disclosure

All authors have declared no conflicts of interest.