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 Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
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.