title: Efficacy and Safety of FOLFIRINOX in Locally Advanced Pancreatic Cancer. A Single Center Experience.
abstract: The management of locally advanced pancreatic cancer (LAPC) is a major challenge. Although new drugs are available for the treatment of metastatic disease, the optimal treatment of non-metastatic cases remains controversial. The role of neoadjuvant therapy is still a question of debate in this setting. The aim of the study was to prospectively collect and analyse data on efficacy and safety of a modified FOLFIRINOX regimen in LAPC patients treated in a single institution. Another major objective was to assess the capability of FOLFIRINOX to render primary non-resectable cancer to resectable. No bolus fluorouracil was given and a 20% dose reduction of oxaliplatin and irinotecan was applied. Primary G-CSF prophylaxis was applied to prevent febrile neutropenia. Thirty-two patients (mean age 60.2 years, range: 40-77 years) have been enrolled into the study. All patients had ECOG performance status of 0 or 1. Best response to therapy was stable disease (SD) or partial regression (PR) in 18 (56.2%) and 6 (18.8%) cases. Two patients (6.3%) underwent surgical resection (100% R0). The most frequent grade 3/4 adverse events were nausea (18.8%), fatigue (12.5%) and diarrhea (12.5%). The incidence of severe neutropenia was 28.1%, with only one documented case of febrile neutropenia. The probability of disease progression was 25% and 50% after 75 and 160 days with 88.4% of possibility of disease progression after 500 days. OS probability was 92.1, 71.5% and 49.5% at 180-, 365 and 540 days. Our data does not support the capability of FOLFIRINOX to render primary non-resectable cancer to resectable. However, due to the high disease control rate observed, FOLFRINOX might be recommended as first line option for the palliative treatment of LAPC. Despite reduced chemotherapy doses significant toxicity has been seen.
authors.affiliation: Department of Oncology, St. Istvan and St. Laszlo Hospital and Out-Patient Department, 5-7 Albert Flórián street, Budapest, H-1097, Hungary. lakagab@yahoo.com.
authors.forename: G
authors.identifier: http://orcid.org/0000-0003-3897-6570
authors.initials: G
authors.lastname: Lakatos
authors.affiliation: Department of Oncology, St. Istvan and St. Laszlo Hospital and Out-Patient Department, 5-7 Albert Flórián street, Budapest, H-1097, Hungary.
authors.forename: A
authors.initials: A
authors.lastname: Petranyi
authors.affiliation: First Department of Surgery, Semmelweis University, Budapest, Hungary.
authors.forename: A
authors.initials: A
authors.lastname: Szűcs
authors.affiliation: First Department of Surgery, Semmelweis University, Budapest, Hungary.
authors.forename: L
authors.initials: L
authors.lastname: Nehéz
authors.affiliation: First Department of Surgery, Semmelweis University, Budapest, Hungary.
authors.forename: L
authors.initials: L
authors.lastname: Harsanyi
authors.affiliation: Institute for Translational Medicine, University of Pécs, Pécs, Hungary.|First Department of Medicine, University of Pécs, Pécs, Hungary.|MTA-SZTE Translational Gastroenterology Research Group, University of Szeged, Szeged, Hungary.
authors.forename: P
authors.initials: P
authors.lastname: Hegyi
authors.affiliation: Department of Oncology, St. Istvan and St. Laszlo Hospital and Out-Patient Department, 5-7 Albert Flórián street, Budapest, H-1097, Hungary.
authors.forename: G
authors.initials: G
authors.lastname: Bodoky
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D021441:Carcinoma, Pancreatic Ductal / Q000188:drug therapy*; D017024:Chemotherapy, Adjuvant / Q000379:methods; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D000077146:Irinotecan; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D020360:Neoadjuvant Therapy / Q000379:methods; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects; D000077150:Oxaliplatin; D010190:Pancreatic Neoplasms / Q000188:drug therapy*
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D000077146:Irinotecan; D002955:Leucovorin; D005472:Fluorouracil; D002166:Camptothecin
keywords: FOLFIRINOX; Locally advanced; Pancreatic cancer