702P - Standard clinical practice of FOLFIRINOX (FFX) in advanced/metastatic pancreatic cancer (PC) Patients: A Canadian retrospective registry

Date 29 September 2014
Event ESMO 2014
Session Poster Display session
Topics Anti-Cancer Agents & Biologic Therapy
Pancreatic Cancer
Presenter Jean A. Maroun
Citation Annals of Oncology (2014) 25 (suppl_4): iv210-iv253. 10.1093/annonc/mdu334
Authors J.A. Maroun1, Y. Ko2, A. Ghafoor3, P. Kavan4, M. Cripps1, D. Jonker5, R. Goel5, T.R. Asmis5, R. Goodwin1, E. Tsvetkova1, H. Marginean5
  • 1Medical Oncology, The Ottawa Hospital Cancer Centre, K1H 8L6 - Ottawa/CA
  • 2Oncology, Sunnybrook Odette Cancer Centre, Toronto/CA
  • 3Oncology, Windsor Regional Hospital (WRH), Windsor/CA
  • 4Oncology, Jewish General Hospital, McGill University, H3T 1E2 - Montreal/CA
  • 5Medical Oncology, The Ottawa Hospital Regional Cancer Centre, K1H 8L6 - Ottawa/CA

Abstract

Aim

FFX has been adopted as first-line treatment in patients with good performance status (PS) and liver function. This registry further investigates this regimen in clinical practice and collects disease outcomes in an unselected population.

Methods

This retrospective cohort study with PC patients who completed at least one cycle of FFX.

Results

132 evaluable patients with unresectable PC (metastatic 72%, locally advanced disease 28%) enrolled between December 2012 and May 2014 in 3 Canadian centers (TOHCC 53%, SRI 39%, WRH 8%); 55% were male; 42% were 65 years or older; median age was 64 years (range 24-80); 51%/33%/2%/14% had PS 0/1/2/non-evaluable, location 64% head and 36% body/tail (33% had a biliary stent). 36% patients started FFX at standard dose while 20% had more than 1 drug dose adjusted and 44% received no 5FU bolus. Patients received a median of 7.7 (range1-34) cycles of FOLFIRINOX chemotherapy. Relative dose intensity was 69% oxaliplatin, 67% irinotecan, 72% infusional 5FU. Most common grade 3+ toxicities were neutropenia 25%, febrile neutropenia 7.6%, nausea / vomiting 15%, fatigue 11%. Colony stimulating factors (G-CFS) prophylaxis was used in 27% patients (primary 14%, secondary 13%). Mean duration of follow up was 18.6 months. The median PFS and OS were respectively 5.5 mths (95%CI 3.4-6.7) and 7.5 mths (95%CI 6.3-9.5). While PFS shows no relevant variation by the FFX starting dose, OS differs if FFX dose is reduced (standard 11.4 mths 95%CI [6.5-13.1] vs. reduced 7.14 mths, 95%CI [5.5-8.1]; HR 1.67, 95%CI [1.1-2.5], p = 0.02) or if 5FU bolus is cancelled (with 5FUb 8.7 mths 95%CI [6.6-11.9] vs. without 5FUb 6.3 mths 95%CI [5.0-8.2]; HR 1.46, 95%CI [0.9-2.2], p = 0.06).

Conclusions

In our study, the majority of patients received FFX with dose modifications. When FFX was delivered as per the ACCORD study, the outcomes were comparable and associated with a reduced incidence of grade 3+ haematological toxicities showing that the toxicity is manageable. Additional analyses are underway to delineate the impact on efficacy and safety of prognostic and predictive factors (e.g. patients' age, PS, G-CSF use, systematic vs. personalized dose adjustments, RDI). Accrual continues to reach the goal of 200 patients. Supported by sanofi-aventis Canada.

Disclosure

J.A. Maroun: Advisory board and invited speaker by Sanofi; T.R. Asmis: Consultant/research funding : Sanofi; R. Goodwin: - financial support to attend conference - $1500 ad board honorarium; H. Marginean: - financial support to attend conference - $1500 ad board honorarium. All other authors have declared no conflicts of interest.