Efficacy and safety of FOLFIRINOX in patients with pancreatic metastatic cancer.

Abstract

248 Background: Efficacy and safety of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil, and leucovorin (FOLFIRINOX) is one of the gold standard in metastatic pancreatic cancer as first-line therapy for patients with PS 0-1, good haematological and renal function and a subnormal bilirubin level. Pending approval, this treatment has been allowed in Brittany (B) and Pays de la Loire (PL) respecting these criteria. Methods: Observatory of Cancer B/PL is a network of 50 private/public cancer centers focused on good practice for cancer drugs use. Our aim is to evaluate the use of FOLFIRINOX between July 2010 and June 2013 in B/PL. Sex, age, successive chemotherapeutic regimens, toxicities, response rate, progression free survival (PFS) and overall survival (OS) have been studied. Results: Data of 79 patients, treated in 2010 (37%), in 2011 (54%) or early 2012 (9%) have been studied (44 men, median age 62 years [37-74]). 64 patients were metastatic when cancer was diagnosed. Principal site of metastases was liver (73%). 17 primary tumors were resected and 15 patients received an adjuvant chemotherapy (gemcitabine (n=14)).The median number of treatment cycles was 9 [1-24]. Objective response was observed in 29 patients (37%), disease stabilization in 18 patients (23%) and progression in 18 patients (23%). During treatment, 75% of patients had a dose adjustment and 30 % had one or more dose delays. 22 patients presented grade III/IV toxicity (almost neurotoxicity or haematologic). 42 patients had a second line of treatment (mainly gemcitabine) and 7 patients a third line. The median PFS and OS were respectively 174 days IC95% [125-216] and 309 days IC 95% [229-376]. Conclusions: Our preliminary results are relatively convenient with those of Conroy et al in 2011. A higher rate of response (37% vs 32%) has been found. Concerning PFS and OS, our results are clearly worst with 174 vs 195 days and 309 vs 338 days. Our results confirm the aggressiveness of this schedule with 75% of the patients requiring a dose adjustement. Analysis of all pancreatic metastatic patients treated by FOLFIRINOX in B/PL by the Observatory of Cancer allows to assess its good use in the real life.

Retrospective comparison of the efficacy and the toxicity of standard and modified FOLFIRINOX regimens in patients with metastatic pancreatic adenocarcinoma

“…Moreover, these results have been further reproduced in a similar phase 3 trial held in India (6). Perhaps more importantly, the feasibility of FOLFIRINOX outside the setting of a clinical trial has been demonstrated and the survival figures of the pivotal trial have also been reproduced in the clinical practice (7,8).…”

FOLFIRINOX for Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma: The Royal Marsden Experience

“…6 Patients who met the PRODIGE 4/ACCORD 11 trial inclusion criteria seemed to have better outcomes than those who did not, 22 and this emphasizes the need for careful selection of patients for treatment with FOLFIRINOX. Indeed, the patients in our study who had a performance status of 2 appear to have had a worse PFS and OS, although because of the small number of patients it was not possible to analyze whether this was statistically significant.…”

Pancreatic cancer and FOLFIRINOX: a new era and new questions

“…Grade 3/4 toxicities were reported in 10 patients: nausea/vomiting in one, diarrhea in one, fatigue in three, neutropenia in four, thrombocytopenia in one, and febrile neutropenia in three—all manageable. A follow‐up study by the original investigators in the PRODIGE 4/ACCORD 11 study, based on their established criteria, showed that 81% of 242 patients required a dose reduction, but that this did not affect results (response rate 39% vs. 32%, PFS 6.5 vs. 6.4 months and OS 10.9 vs. 11.1 months) .…”