Patient-tailored FOLFIRINOX in the first-line treatment of patients (pts) with advanced pancreatic cancer (PC).

Abstract

499 Background: FOLFIRINOX is an effective reference regimen in the 1st line treatment of advanced PC, despite its high level of toxicity. We report recent data from pts treated with this regimen at Paul Brousse university hospital. Methods: From January to December 2016, 37 pts with advanced PC received patient-tailored FOLFIRINOX as 1st line intent to treat chemotherapy. The first 1 to 3 courses were administered without irinotecan if initial serum bilirubin was ≥ 1.5 x upper limit of normal. Oxaliplatin was stopped for severe sensory neuropathy. Initial dose reductions were made according to pt profile (e.g., age, comorbidity) and later due to toxicity. The treatment was continued until surgery or disease progression. Endpoints were time to progression (TTP), overall survival (OS), objective response rate (ORR) and secondary complete resection (R0R1). Results: There were 22 male (59%) and 15 female pts (41%) aged 44 to 81 years (median: 64). They had locally-advanced (18 pts, 49%) and metastatic PC (19 pts, 51%). PC was head, body, tail located in 24 (65%), 8 (22%) and 5 pts (14%) respectively. Biliary stent was placed in 22 pts (59%). Pts had a performance status (PS) of 0 (60%) or 1 (40%). Median treatment duration was 20 weeks for oxaliplatin, 22 weeks for irinotecan, 23 weeks for 5FU. At the cut-off on April 27th 2017, protocol was ongoing for 11 pts (30%). Median number of cycles was 9 (2-20). Median dose intensity was 29 mg/m2/w for oxaliplatin, 57 mg/m2/w for irinotecan and 886 mg/m2/w for 5FU. We observed 4 CR (11%), 12 PR (32%), 12 SD (32%) and 5 PD (14%). Four pts were not evaluable. ORR was 43%, disease control rate 75%, 11 pts (30%) underwent R0R1 resection. After a median follow-up of 8 months (1 - 16), median TTP and OS were not reached. TTP was associated with body location (HR = 3.5 [95% CL, 1.1-11.0], p = 0.033) and disease stage (HR = 10.5 [2.2-49.5], p = 0.003), a trend was observed with biliary stent placement (HR = 0.4 [0.1-1.1], p = 0.067). Conclusions: Modified FOLFIRINOX with patient-tailored dose adaptations seems to offer better results in pts with advanced PC compared with classic FOLFIRINOX. This strategy deserves prospective evaluation to further improve clinical outcomes in the management of advanced PC.