Uptake and effectiveness of FOLFIRINOX for advanced pancreas cancer: A population-based study.

245 Background: While FOLFIRINOX is a standard treatment option for advanced pancreas cancer there is little data describing utilization and effectiveness in routine clinical practice. Here we report practice patterns and outcomes in the general population of Ontario, Canada. Methods: Using the Ontario Cancer Registry and New Drug Funding Program we identified all patients with pancreas cancer treated with palliative intent gemcitabine or FOLFIRINOX in Ontario during 2006-2014. FOLFIRINOX became available in Ontario’s single-payer health system in November 2011. Gemcitabine cases were classified as pre-FOLFIRINOX era (2006-2010) or post-FOLFIRINOX era (2011-2014). Cases treated with peri-operative chemotherapy were excluded. Comparisons of proportions between study groups were made using the chi-square test. Overall survival (OS) was measured from date of chemotherapy initiation. Results: During 2006-2014, 3826 patients in Ontario were treated with Gemcitabine (n=3042) or FOLFIRINOX (n=784) chemotherapy for advanced pancreas cancer. Uptake of FOLFIRINOX increased from 41% (206/505) of treated cases in 2012 to 56% (274/486) of treated cases in 2014. Among patients treated after 2011, median age was 69 and 63 years for Gemcitabine and FOLFIRINOX respectively (p<0.001). The proportion of treated cases who received FOLFIRINOX varied considerably across geographic regions (from 26% to 58%, p<0.001). Median number of FOLFIRINOX cycles delivered was 6 (median 10 cycles in pivotal RCT). Median OS of patients treated with Gemcitabine was 5.0 months in 2006-2010 and 4.8 months in 2011-2014. Median OS of FOLFIRINOX patients treated in 2011-2014 was 8.2 months (median 11.1 months in pivotal RCT). Conclusions: Use of FOLFIRINOX in the general population has increased since 2011 with a resulting decrease in use of Gemcitabine. However, outcomes achieved with FOLFIRINOX in Ontario demonstrate a substantial efficacy-effectiveness gap between survival in the pivotal clinical trial and survival in routine practice.