Objective: Data is lacking about FOLFIRINOX use for advanced pancreatic ductal adenocarcinoma in emerging countries. The objective of this study was to report outcomes of effi cacy and safety in the setting of a South American institution. Methods: Patients treated with FOLFIRINOX for metastatic or locally advanced pancreatic cancer at Instituto do Câncer do Estado de São Paulo (Brazil), between November 2012 and January 2016 were retrospectively reviewed. Baseline characteristics, safety, response and overall survival were analyzed. Results: Sixty-one patients were enrolled (metastatic disease: 31). Median age was 61 years (range 37-74), and 88.5% had ECOG 0 or 1; 90.2% had T3 or T4 tumors and 36.1% had node-positive disease. FOLFIRINOX was given as the fi rst-line treatment in 88.5% of patients, and was discontinued due to disease progression (55.7%), limiting toxicity (31.1%) or maximum benefi t (13.1%). Median number of cycles was 10 (range 1-32). Dose reductions occurred in 81.9%. Grade 3 or 4 toxicity were found in 60.6% and were mainly hematological (36%), neuropathy (19.6%), fatigue (8.2%) and diarrhea (14.7%). Two patients had febrile neutropenia. Hospitalization during treatment occurred in 31.1% of cases, with three potential treatment-related deaths. Median overall survival was 16.26 in the full cohort; 13.6 in patients with metastatic disease, and 18.7 months in locally advanced disease. The response rate was 39.3% (32.2% in metastatic disease and 43.3% in locally advanced disease). Conclusion: Despite the high prevalence of grade 3 or 4 toxicities, FOLFIRINOX showed effi cacy for the treatment of patients with advanced pancreatic adenocarcinoma, and is an excellent treatment option in emerging countries.
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