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Publications

Journal Article Clinical Trial, Phase III Randomized Controlled Trial Multicenter Study Comparative Study Ppublish

PubMed: 40378359 DOI: 10.1200/JCO-24-02210

PRODIGE 29-UCGI 26 (NEOPAN): A Phase III Randomized Trial Comparing Chemotherapy With FOLFIRINOX or Gemcitabine in Locally Advanced Pancreatic Carcinoma.

J Clin Oncol 43(20):2255-2264

Authors: Michel Ducreux, Romain Desgrippes, Yves Rinaldi, Frédéric Di Fiore, Rosine Guimbaud, Ludovic Evesque, Jean-Baptiste Bachet, Pierre Vanelslander, Thierry Lecomte, Olivier Capitain, Aurélie Parzy, Marion Bolliet, Pierre-Luc Etienne, Julien Forestier, Farid El Hajbi, Anne-Laure Bignon, Valérie Lebrun-Ly, Nicolas De Sousa Carvalho, Matthieu Texier, Olivier Bouche

Affiliations

  • Gustave Roussy Cancer Center, Tumor Cells Dynamics, INSERM U1279, Université Paris-Saclay, Villejuif, France.
  • Hepato-Gastroenterology and Digestive Oncology Department, Centre Hospitalier de Saint Malo, Saint Malo, France.
  • Oncology, Hôpital Européen, Marseille, France.
  • Gastroenterology, CHU Hôpitaux de Rouen-Charles Nicolle, Rouen, France.
  • Digestive Oncology, Centre Hospitalier Rangueil, Toulouse, France.
  • Medical Oncology, Centre Antoine Lacassagne, Nice, France.
  • Sorbonne University, Hepato-Gastroenterology Department, Groupe Hospitalier Pitié Salpetrière, APHP, Paris, France.
  • Gastroenterology, Hôpital Saint Claude, Saint Quentin, France.
  • Hepatogastroenterology and Digestive Oncology Departement, Hôpital Trousseau, Chambray-Les-Tours, France.
  • Medical Oncology, Institut de Cancérologie de l'Ouest-Centre Paul Papin, Angers, France.
  • Digestive Pathology, Centre Francois Baclesse, Caen, France.
  • Gastroenterology, Hôpitaux Civils de Colmar, Colmar, France.
  • Medical Oncology, Hôpital Privé des Côtes d'Armor, Plerin sur Mer, France.
  • Medical Oncology, Hôpital Edouard Herriot, Lyon, France.
  • Urology and Digestive Oncology, Centre Oscar Lambret, Lille, France.
  • Gastroenterology, CHU Côte de Nacre, Caen, France.
  • Medical Oncology, CHU de Limoges, Limoges, France.
  • R&D, UNICANCER, Paris, France.
  • Biostatistics, Gustave Roussy Institut de Cancérologie, Villejuif, France.
  • Digestive Oncology Department, CHU Reims, Reims, France.

Abstract

PURPOSE

More than 30% of patients with pancreatic cancer are unresectable because of the local extension with a median overall survival (OS) of <1 year. Combination of fluorouracil (FU), oxaliplatin, and irinotecan (FOLFIRINOX) is superior to gemcitabine in the treatment of metastatic pancreatic cancer, but standard of care remains gemcitabine in locally advanced pancreatic cancer (LAPC).

METHODS

Patients with histologically proven LAPC not suitable for surgery, Eastern Cooperative Oncology Group WHO performance status (PS) ≤1 were eligible. Random assignment was stratified by center, tumor localization (pancreas head yes/no), WHO PS (0 v 1), and age (≤60 years v >60 years). Patients received FOLFIRINOX or gemcitabine for 6 months. The primary end point was progression-free survival (PFS). Main secondary end points were OS, time to treatment failure, quality of life, and safety. One hundred seventy patients (142 events) were needed to detect an increase of 3 months in PFS with 80% power (log-rank test, 5% two-sided α).

RESULTS

One hundred seventy one patients age 35-84 years were included and followed for a maximum of 5 years. With a median follow-up of 59.6 months (95% CI, 42.3 to not reached), 168 events were observed and the median PFS was 9.7 months (95% CI, 7.0 to 11.7) with FOLFIRINOX versus 7.7 months (95% CI, 6.2 to 9.2) with gemcitabine, hazard ratio (HR), 0.7 (95% CI, 0.5 to 1.0), P = .04. The median OS was 15.7 months (95% CI, 11.9 to 20.4) in the FOLFIRINOX group versus 15.4 months (95% CI, 11.7 to 18.6) in the gemcitabine group, HR, 1.02 (95% CI, 0.73 to 1.43), P = .95.

CONCLUSION

Results confirm that FOLFIRINOX improves PFS significantly compared with gemcitabine and is well tolerated in LAPC. No significant difference in OS was observed between both groups.

MeSH

Pancreatic Neoplasms, Neoplasms, Drug Therapy, Therapeutics, Medical Oncology, Chemotherapy

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