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Published in: Annals of Surgical Oncology 1/2015

01-01-2015 | Pancreatic Tumors

FOLFIRINOX for Locally Advanced Pancreatic Adenocarcinoma: Results of an AGEO Multicenter Prospective Observational Cohort

Authors: L. Marthey, MD, A. Sa-Cunha, MD, PhD, J. F. Blanc, MD, PhD, M. Gauthier, A. Cueff, E. Francois, MD, I. Trouilloud, MD, D. Malka, MD, PhD, J. B. Bachet, MD, PhD, R. Coriat, MD, PhD, E. Terrebonne, MD, C. De La Fouchardière, MD, S. Manfredi, MD, D. Solub, MD, C. Lécaille, MD, A. Thirot Bidault, MD, F. Carbonnel, MD, PhD, J. Taieb, MD, PhD

Published in: Annals of Surgical Oncology | Issue 1/2015

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Abstract

Background

First-line treatment with FOLFIRINOX significantly increases overall survival (OS) in patients with metastatic pancreatic adenocarcinoma (PA) compared with gemcitabine. The aim of this observational cohort was to evaluate the tolerability and efficacy of this regimen in unresectable locally advanced PA (LAPA).

Patients and Methods

From February 2010 to February 2012, all consecutive patients from 11 French centers treated by FOLFIRINOX for a histologically proven LAPA were prospectively enrolled. Unresectability was defined independently by each center’s multidisciplinary staff at diagnosis. Absence of metastatic disease was confirmed by chest-abdomen-pelvis computed tomography scan. FOLFIRINOX was delivered every 2 weeks as previously reported until progressive disease, major toxicity, or consolidation treatment by radiotherapy and/or surgery.

Results

Seventy-seven patients were enrolled. They received a median number of five cycles (1–30). Grade 3–4 toxicities were neutropenia (11 %), nausea (9 %), diarrhea (6 %), fatigue (6 %), and anemia (1 %). Grade 2–3 sensory neuropathy occurred in 25 % of patients. No toxic death was reported and only 6 % of patients had to stop treatment because of toxicity. Disease control rate was 84 with 28 % of objective response (Response Evaluation Criteria in Solid Tumors). Seventy-five percent of patients received a consolidation therapy: 70 % had radiotherapy and 36 % underwent a surgical resection, with a curative intent. Within the whole cohort, 1-year OS rate was 77 % (95 % CI 65–86) and 1-year progression-free survival rate was 59 % (95 % CI 46–70).

Conclusion

First-line FOLFIRINOX for LAPA seems to be effective and have a manageable toxicity profile. These promising results will have to be confirmed in a phase III randomized trial.
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Metadata
Title
FOLFIRINOX for Locally Advanced Pancreatic Adenocarcinoma: Results of an AGEO Multicenter Prospective Observational Cohort
Authors
L. Marthey, MD
A. Sa-Cunha, MD, PhD
J. F. Blanc, MD, PhD
M. Gauthier
A. Cueff
E. Francois, MD
I. Trouilloud, MD
D. Malka, MD, PhD
J. B. Bachet, MD, PhD
R. Coriat, MD, PhD
E. Terrebonne, MD
C. De La Fouchardière, MD
S. Manfredi, MD
D. Solub, MD
C. Lécaille, MD
A. Thirot Bidault, MD
F. Carbonnel, MD, PhD
J. Taieb, MD, PhD
Publication date
01-01-2015
Publisher
Springer US
Published in
Annals of Surgical Oncology / Issue 1/2015
Print ISSN: 1068-9265
Electronic ISSN: 1534-4681
DOI
https://doi.org/10.1245/s10434-014-3898-9

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