title: Efficacy of Prophylactic G-CSF in Patients Receiving FOLFIRINOX: A Preliminary Retrospective Study.
abstract: OBJECTIVE
  Recent guidelines have adopted an incidence of febrile neutropenia (FN) threshold of 20% for the use of prophylactic granulocyte colony-stimulating factor (G-CSF). In a Japanese phase II study of a combination chemotherapy regimen consisting of oxaliplatin, irinotecan, fluorouracil and leucovorin (FOLFIRINOX) for Japanese patients with advanced pancreatic cancer, the incidence of FN and severe neutropenia were 24.7% and 77.8%, respectively, without G-CSF prophylaxis. The aim of this retrospective study was to investigate the incidence of FN or severe neutropenia induced by full-dose FOLFIRINOX administration with G-CSF prophylaxis during the first cycle of treatment.
  
  
  METHODS
  Patients with advanced pancreatic cancer who received FOLFIRINOX with G-CSF prophylaxis during the first cycle of treatment from January 2014 to August 2014 were investigated and the frequency of adverse events during the first cycle was measured.
  
  
  RESULTS
  Among seven patients who received FOLFIRINOX, six patients met the eligibility criteria. The patient characteristics were as follows: median age (range), 57 (50-66); men/women, 3/3; performance status 0/1, 2/4. Grade 3/4 hematological adverse events were as follows: leukopenia in 33% of the patients, neutropenia in 33% of the patients, thrombocytopenia in 33% of the patients and FN in 17% of the patients. One patient was heterozygous for the UGT1A1*6 and UGT1A1*28 polymorphisms and experienced FN. Grade3/4 non-hematological adverse events were as follows: anorexia in 33% of the cases and nausea in 50% of the cases.
  
  
  CONCLUSIONS
  Although the present study was retrospective and small, the simultaneous administration of G-CSF might be effective for the prevention of severe neutropenia and FN in patients treated with FOLFIRINOX.
authors.affiliation: Cancer Chemotherapy Center, Osaka Medical College Hospital, Japan.
authors.forename: Tetsuji
authors.initials: T
authors.lastname: Terazawa
authors.forename: Masahiro
authors.initials: M
authors.lastname: Goto
authors.forename: Takahiro
authors.initials: T
authors.lastname: Miyamoto
authors.forename: Ken
authors.initials: K
authors.lastname: Asaishi
authors.forename: Fukutaro
authors.initials: F
authors.lastname: Shimamoto
authors.forename: Shin
authors.initials: S
authors.lastname: Kuwakado
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Nishitani
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kii
authors.forename: Kazuhide
authors.initials: K
authors.lastname: Higuchi
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D015994:Incidence; D002955:Leucovorin / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009503:Neutropenia / Q000139:chemically induced* / Q000188:drug therapy; D010190:Pancreatic Neoplasms / Q000150:complications / Q000188:drug therapy*; D012189:Retrospective Studies
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D002955:Leucovorin; D005472:Fluorouracil