title: Efficacy and safety of early G-CSF administration in patients with head and neck cancer treated by docetaxel-cisplatin and 5-fluorouracil (DCF protocol): a retrospective study.
abstract: BACKGROUND
  Induction chemotherapy with docetaxel-cisplatin and 5-fluorouracil (DCF) for locally advanced head and neck cancers (HNC) is associated with a high risk of severe neutropenia or febrile neutropenia (FN). We conducted a retrospective study to evaluate the efficacy and safety of administering granulocyte colony-stimulating factor (G-CSF) on day 3 (D3) during chemotherapy (early G-CSF stimulation) versus after the end of chemotherapy, as per current guidelines (i.e., after the end of 5-FU perfusion; D7), and its impact on patient outcomes.
  
  
  METHODS
  Patients ≥19 years old, with advanced HNC who received DCF induction chemotherapy (D and P 75 mg per meter squared (mg/m(2)) on day 1 and 5-FU 750 mg/m(2)/day from D1 to D5), were included in the analysis.
  
  
  RESULTS
  Data of 70 patients were analyzed from 01 January 2003 to 01 December 2010. Mean age was 56 years (range 45 to 77 years). Thirty-six patients (51.4 %) received pegfilgrastim on D7, and 28 (40 %) started G-CSF prophylaxis during chemotherapy; 12 (17.1 %) had daily filgrastim and 16 (22.9 %) pegfilgrastim on D3. Overall response rate (ORR) was 89.6 % (three early deaths due to infectious complications; 4.3 %). The 3-year overall survival (OS) rate was 72.8 %. FN rate was 14.3 % and chemotherapy delay was 12.9 %. In the D7 G-CSF arm, incidence of grade 3-4 neutropenia (p = 0.023), FN (p = 0.029), and cycle delays (p = 0.006) was statistically higher than the "early" G-CSF arm. A decrease of OS was observed at 2 years (from 85.1 to 63.5 %) of chemotherapy discontinuation or FN (p = 0.0348).
  
  
  CONCLUSIONS
  Early administration of G-CSF is safe and seems to be more effective than D7. Future prospective trials are required to confirm our results.
authors.affiliation: Oncopharmacology-Pharmacogenetics Department, Institut de Cancérologie de l'Ouest Nantes-Angers, 2 rue Moll, 49033, Angers Cedex, France, benjamin.linot@ico.unicancer.fr.
authors.forename: B
authors.initials: B
authors.lastname: Linot
authors.forename: P
authors.initials: P
authors.lastname: Augereau
authors.forename: R
authors.initials: R
authors.lastname: Breheret
authors.forename: L
authors.initials: L
authors.lastname: Laccourreye
authors.forename: O
authors.initials: O
authors.lastname: Capitain
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000494:pharmacology*; D024221:Antineoplastic Protocols; D002945:Cisplatin / Q000009:adverse effects / Q000494:pharmacology*; D000077143:Docetaxel; D004359:Drug Therapy, Combination; D005260:Female; D005472:Fluorouracil / Q000009:adverse effects / Q000494:pharmacology*; D016179:Granulocyte Colony-Stimulating Factor / Q000009:adverse effects / Q000494:pharmacology*; D006258:Head and Neck Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D043823:Taxoids / Q000009:adverse effects / Q000494:pharmacology*
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D002945:Cisplatin; D005472:Fluorouracil