Pancreatic Tumors

Annals of Surgical Oncology

, Volume 22, Issue 1, pp 295-301

First online:

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

  • L. MartheyAffiliated withDepartment of Gastroenterology, Kremlin Bicêtre Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), Paris Sud University
  • , A. Sa-CunhaAffiliated withDepartment of Digestive Surgery, Haut-Lévêque Hospital
  • , J. F. BlancAffiliated withDepartment of Gastroenterology, Saint-André Hospital
  • , M. GauthierAffiliated withDepartment of Biostatistics, Anticancer Center G.F. Leclerc
  • , A. CueffAffiliated withDepartment of Biostatistics, Anticancer Center G.F. Leclerc
  • , E. FrancoisAffiliated withDepartment of Oncology, Anticancer Center A. Lacassagne
  • , I. TrouilloudAffiliated withDepartment of Gastroenterology and Digestive Oncology, HEGP Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), Paris Descartes University, Cancer Research Personalized Medicine (CARPEM)
  • , D. MalkaAffiliated withDepartment of Oncology, Institut Gustave Roussy
  • , J. B. BachetAffiliated withDepartment of Gastroenterology, La Pitié-Salpétrière Hospital, Assistance publique-Hôpitaux de Paris (AP-HP)
    • , R. CoriatAffiliated withDepartment of Gastroenterology, Cochin Hospital, Assistance publique-Hôpitaux de Paris (AP-HP)
    • , E. TerrebonneAffiliated withDepartment of Gastroenterology, Haut-Lévêque Hospital
    • , C. De La FouchardièreAffiliated withDepartment of Oncology, Anticancer Center L. Bérard
    • , S. ManfrediAffiliated withDepartment of Gastroenterology, Pontchaillou Hospital
    • , D. SolubAffiliated withDepartment of Oncology, L. Pasteur Hospital
    • , C. LécailleAffiliated withDepartment of Gastroenterology, Polyclinique Bordeaux Nord Aquitaine
    • , A. Thirot BidaultAffiliated withDepartment of Gastroenterology, Kremlin Bicêtre Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), Paris Sud University
    • , F. CarbonnelAffiliated withDepartment of Gastroenterology, Kremlin Bicêtre Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), Paris Sud University
    • , J. TaiebAffiliated withDepartment of Gastroenterology and Digestive Oncology, HEGP Hospital, Assistance publique-Hôpitaux de Paris (AP-HP), Paris Descartes University, Cancer Research Personalized Medicine (CARPEM) Email author 

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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.