Gut 59:1527-1534 doi:10.1136/gut.2010.216135
  • Pancreas
  • Paper

Combination 5-fluorouracil, folinic acid and cisplatin (LV5FU2-CDDP) followed by gemcitabine or the reverse sequence in metastatic pancreatic cancer: final results of a randomised strategic phase III trial (FFCD 0301)

Open Access
  1. for the Fédération Francophone de Cancérologie Digestive
  1. 1Assistance Publique-Hôpitaux de Marseille, Hôpital Timone, Université de la Méditerranée, Marseille, France
  2. 2Unité de Biostatistique et de Méthodologie FFCD, INSERM U866, Dijon, France
  3. 3Centre Val D'Aurelle, Montpellier, France
  4. 4Assistance Publique-Hôpitaux de Paris, Hôpital Ambroise Paré, Boulogne, UFR médecine PIFO, Université Versailles Saint-Quentin, France
  5. 5Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Université de la Méditerranée, Marseille, France
  6. 6Department of Medical Oncology, Centre E Marquis, Rennes and European University in Brittany, Rennes, France
  7. 7Hôpital Huriez, CHRU, Lille, France
  8. 8CHU Grenoble, France
  9. 9Hopital Beaujon, Clichy, France
  10. 10Centre François Leclerc, Dijon, France
  11. 11CHU, Rouen, France
  12. 12Centre Hospitalier Régional, Orléans, France
  13. 13CIC 9502, AP-HM, Marseille, France
  1. Correspondence to Laetitia Dahan, Service d'Oncologie Digestive, Pôle Oncologie-Spécialités, CHU Timone, 264 rue Saint Pierre, 13385 Marseille cedex 5, France; laetitia.dahan{at}
  1. Contributors Manuscript writing: LD and FB. Review: LD, FB, JLR, EM, PR, JLL, SC, PH, BC, JFS. Data management: FB, LD. Protocol writing: JFS, JLL, PH, PR, LB, MY, EM, BC, LD, FB. Investigators: LD, MY, EM, MG, JLR, SC, JMP, PH, BC, PM, JLL, PR, LB, JFS. Administrative support: LB. Final responsibility for the decision to submit for publication: LD and FB.

  • Received 20 April 2010
  • Accepted 8 June 2010


Purpose Gemcitabine is the standard chemotherapy for patients with metastatic pancreatic adenocarcinoma. Although the 5-fluorouracil (5FU), folinic acid and cisplatin combination (LV5FU2-CDDP) is an option, the optimal order of the regimens must be determined. The first strategic phase III trial comparing LV5FU2-CDDP followed by gemcitabine versus gemcitabine followed by LV5FU2-CDDP was conducted.

Methods Patients with metastatic pancreatic adenocarcinoma, performance status (PS) 0–2, without prior chemotherapy were randomly assigned (1:1) to receive either LV5FU2-CDDP followed by gemcitabine at disease progression or toxicity (Arm A), or the opposite sequence (Arm B). 202 patients had to be included and 170 deaths had to be observed to detect an expected improvement in median overall survival (OS) from 6.5 to 10 months in Arm A (two-sided α = 5% and β = 20%).

Results 202 patients were included (Arm A, 102; Arm B, 100). Median age, male/female ratio, PS 0–1 and previous surgery were similar in the two arms. After a median follow-up of 44 months, median OS in Arm A was 6.6 months versus 8.0 months in Arm B (p = 0.85). Median progression-free survival was similar between Arms A and B. More grade 3/4 toxicities were observed when LV5FU2-CDDP was administered as a first-line treatment compared with gemcitabine: 79% versus 64% (p = 0.018).

Conclusion This trial did not show any strategic advantage to using LV5FU2-CDDP as a first-line treatment and suggests that gemcitabine remains the standard first-line treatment. Sixty-one per cent of patients were able to receive a second line of chemotherapy.


  • Linked articles: 220954.

  • Presented at the 44nd annual meeting of the American Society of Clinical Oncology, 2009, Chicago.

  • L D and F B contributed equally to this work.

  • Competing interests None.

  • Ethics approval This study was conducted with the approval of the Regional Ethics Committee (Marseilles, France).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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