Outcomes of first-line FOLFIRINOX (FFX) versus gemcitabine and nab-paclitaxel (GN) in patients with advanced pancreatic cancer: Multi-Institutional Canadian sites experience

Abstract

Background: FOLFIRINOX (FFX) and Gemcitabine with nab‐Paclitaxel (GN) are both proven to be superior to Gemcitabine in first line treatment for advanced pancreatic cancer (APC). However, there has been no phase 3 randomized controlled trials to prove FFX is superior to GN in APC. This population‐based cohort study was conducted to compare efficacy and safety profiles of the two standard regimens in APC. Methods: In this retrospective cohort study, we evaluated all newly diagnosed patients (pts) with APC who received either FFX or GN as first line therapy during 2010‐2018 at three Canadian institutions. The primary objective was to assess survival. Secondary objective was to compare safety profile of the two regimens. Kaplan Meier method and log‐rank test were used for survival curves. Results: There were 231 eligible pts identified: 143 received FFX and 88 received GN. FFX pts were slightly younger than GN (median age: 62 (IQR: 56‐67) vs 66 (IQR: 58‐ 73) respectively). There were predominantly more males: FFX 89 (62.2%) vs GN 46 (52.3%).WHOperformance status (PS) of 0 were 38 (28.4%) vs 14 (16.5%) and 1 were 90 (67.2%) vs 65 (76.5%) respectively. The median progression‐free survival (PFS) of FFX was 5.5 months (mts) (95% CI: 5.0‐6.7) vs 5.1 mts (95% CI: 3.8‐7.1) with GN (p=0.37). The median overall survival (OS) with FFX was 9.3 mts (95% CI: 7.5 ‐ 11.1) vs. 10.2 mts (95% CI: 6.8‐11.3) with GN (p=0.81). On multivariate analysis chemotherapy regimen was not correlated with PFS or OS. There were more grade 3‐4 toxicity in FFX vs GN group: diarrhea ‐ 22 (15.4%) vs 3 (3.4%) (p=0.004), nausea ‐ 20 (14%) vs 6 (6.8%), vomiting ‐ 13 (9.1%) vs 6 (6.8%), peripheral sensory neuropathy (PSN) ‐ 8 (5.6%) vs 3 (3.4%), thrombocytopenia ‐ 28 (19.6%) vs 5 (5.7%) (p=0.003) respectively. Gr 3‐4 neutropenia rates were similar in both regimens: 23 (16%) in FFX vs 15 (17%) in GN. Conclusions: Our results revealed that FFX or GN had comparable survival and safety profiles. Given lower Gr 3‐4 toxicity profile of GN regimen, GN is likely preferable choice for majority of pts. FFX could be reserved for young high performance pts.