710P - FIRGEM, a sequential FOLFIRI.3 (CPT-11 plus folinic acid plus 5-FU) followed by gemcitabine or gemcitabine alone in patients with previously untreat...

Date 30 September 2012
Event ESMO Congress 2012
Session Poster presentation II
Topics Anticancer agents
Pancreatic Cancer
Therapy
Biological Therapy
Presenter Isabelle Trouilloud
Authors I. Trouilloud1, A.C. Dupont-Gossard2, P. Artru3, T. Lecomte4, M. Gauthier5, T. Aparicio6, A. Thirot-Bidault7, D. Malka8, F. Bonnetain9, J. Taieb1
  • 1Oncologie Digestive, Hopital Europeen Georges Pompidou, 75015 - Paris/FR
  • 2Hepato-gastro-enterologie, CHU Jean Minjoz, 25000 - Besancon/FR
  • 3Oncologie Digestive, Hopital Prive Jean Mermoz, 69008 - Lyon/FR
  • 4Hepato-gastro-enterologie, Hopital Trousseau, 37000 - Tours/FR
  • 5Biostatistic Unit, Georges-François Leclerc Cancer Center, 21000 - Dijon/FR
  • 6Hopital Avicenne, 93300 - Bobigny/FR
  • 7Hepato-gastro-enterologie, Bicetre hopspital, 94270 - Kremlin-Bicetre/FR
  • 8Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 9Biostatistic And Epidemiological Unit(ea 4184), Centre Georges François Leclerc, 21000 - Dijon/FR

Abstract

Background

CPT-11 showed modest activity and tolerability in metastaic pancreatic cancer (MPA). We developed a new strategy to improve efficacy and tolerability of CPT-11 based regimen in MPA patients (pts).

Methods

Chemotherapy-naive pts with histologically proven MPA, bilirubin levels < 1.5 ULN and performance status (PS) 0-1 were randomized in a phase II trial to receive either FOLFIRI.3 (CPT-11 90 mg/m2 as a 60-min infusion on day (D) 1, leucovorin 400 mg/m2 as a 2-hr infusion on day 1, followed by 5-FU 2000 mg/m2 as a 46-hr infusion and CPT-11 90 mg/m2, repeated on D3, at the end of the 5-FU infusion, every 2 weeks) for 2 months alternarting with Gemcitabine (G) (1000 mg/m2 at a fixed dose rate of 10 mg/m2/min on D1, D8, D15, D29, D36 and D43) for 2 months (arm A) or G alone (arm B). Using Fleming design the primary end point was rate of progression free survival (PFS) at 6 months from (H0) 25% over (H1) 45% needing to include 49 pts/arm.

Results

Between 2007 and 2011, 98 pts were enrolled (males: 59, median age: 62 years, PS 0: 32%). Median follow-up was 23 months. Grade 3-4 toxicities per pts (%) in arm A/B were diarrhea 13/0, nausea-vomiting 11/4, neutropenia 51/25 and febrile neutropenia 4/0. No toxic death occurred. Response rate were 40 and 11% as disease control rate (CR + PR + SD) were 73 and 52% in arm A and B, respectively. The primary endpoint of the trial was met with rate of PFS at 6 months of 48% (95% CI: 33-63) in arm A while in arm B PFS was 30% (95% CI: 17 - 44). One year PFS was 23% (95%CI: 11.5-36) and 11% (95%CI: 4-21), respectively.

Conclusions

FIRGEM strategy is feasible and efficient with a manageable toxicity profile in good condition pts with MPA. A phase III trial comparing this strategy with the FOLFIRINOX triplet therapy focusing on quality of life should now be performed.

Disclosure

All authors have declared no conflicts of interest.