Effectiveness and costs of FOLFIRINOX in the treatment of advanced pancreatic cancer in a Portuguese oncology center

Abstract

Introduction: Approximately 80% of patients with pancreatic cancer have advanced disease at the time of diagnosis. Despite its poor prognosis, systemic treatment with FOLFIRINOX (combination of oxaliplatin, irinotecan, fluorouracil and leucovorin) when compared to gemcitabine favored a selected population in terms of survival. Methods: This is a retrospective analysis of a consecutive series of patients with locally advanced non‐resectable or metastatic pancreatic adenocarcinoma who received first line chemotherapy with FOLFIRINOX between June 2011 and December 2016. Survival was calculated with Kaplan‐Meier method considering the time difference between date of first cycle and death or last observation. We evaluate the total costs per cycle and per patient and estimate the cost of hospital stay for each patient during and after treatment with FOLFIRINOX. Results: A total of 66 patients were included, with a median age of 59 (range: 35‐71); most of them were male (62,1%, n=41). Median overall survival was 9,87 months (CI 95%: 8,378‐ 11,362 months). Time till progression was 6.41 months (range: 0,67‐ 20,27 months). The rate of disease control (partial response and stable disease) was 65,1%. Median treatment duration was 5,18 months and 54,5% of patients experienced adverse events grade‐3, mainly hematologic and gastro‐intestinal. There was 1 treatment related death due to septic shock. Considering economic outcomes, the cost per cycle was 497,21e. The total costs of FOLFIRINOX regimen in our sample was 273465,50e, with 4143,41eaverage cost per patient. About 68% patients had hospital admission during treatment, with 12 average days of stay and 2000eof cost. Conclusion: Despite the small size of our population, the demographic characteristics were similar to the phase III trial. Our results in overall survival, as well as rate of disease control and time to progression, were similar to the results of the phase III randomized trial that gave the approval of FOLFIRINOX. In terms of safety profile, it was documented a high incidence of adverse effects grade 3 or 4, mainly hematologic with 7.5% of patients experiencing febrile neutropenia and there was one treatment‐related death due to septic shock. In our retrospective study, we were not able to apply costeffectiveness analysis, since we didn't have access to data regarding quality of life in this population. Besides, we can't employ cost‐effectiveness analysis to one intervention; we need a treatment group comparator like gemcitabine‐based combination to take conclusions, so this is another limitation of our work. Therefore, we can only analyze this therapeutic intervention economically. Our costs values reflected the drugs costs only, and didn't consider treatment related costs, utilities, etc. The majority of patients had at least one hospital admission during treatment, and maybe total costs were underestimated, as we didn't take into account the exams performed, number of days of antibiotic administered, intravenous fluid therapy, among other considerations. In conclusion, in this single institution, effectiveness of FOLFIRINOX was in harmony with the results of the phase III Prodige trial, at the expense of high incidence of toxicity that should be not forgotten in terms of costs and patients' quality of life.