FOLFIRINOX in the real-world setting: The multicentric experience of six Canadian institutions.

Abstract

367 Background: FOLFIRINOX has emerged as a new standard for patients with performance status ECOG 0-1 in metastatic pancreatic cancer and non-randomized studies also support this regimen in locally advanced disease. This regimen is however associated with significant toxicity. The purpose of this study was to assess efficacy and toxicity outside of a clinical trial, including community hospitals. Methods: We conducted a retrospective study of patients with pancreatic adenocarcinoma who received FOLFIRINOX between January 2011 and June 2013 in six institutions in the province of Quebec, Canada. Patients' characteristics, objective response, survival and toxicities were collected. Results: Forty-six patients were included (23 metastatic and 23 locally advanced). Median age was 59 years. Tumor was localized at the head in 65% of patients and 41 % had a biliary stent. Median overall survival was 12,6 months and survival at one year was 61% for metastatic patients. Survival at one year was 95% for locally advanced pancreatic cancer patients and no one with locally advanced tumor became candidate for curative surgery after FOLFIRINOX. Hospitalization rate was 54% with sepsis being the leading cause. There were three treatment-related deaths (7%) and two of them occurred after the first cycle. Neutropenia grade ≥ 3 was observed in 33% of patients and four patients had febrile neutropenia (9 %) with 61% of patients receiving colony stimulating factors (CSFs) for primary prophylaxis. Three patients had cholangitis and diarrhea grade ≥ 3 occurred in 15% of patients. Five patients (11%) experienced transient dysarthria during Irinotecan administration. Conclusions: Survival in our cohort is comparable with data reported by previous studies. However, toxicities were significant and higher than reported. These data highlight the importance of patient selection and support the universal use of CSFs in this population.