title: Randomized phase III study of 3-weekly versus weekly docetaxel in pretreated advanced non-small-cell lung cancer: a Spanish Lung Cancer Group trial.
abstract: BACKGROUND
  Docetaxel is a widely accepted second-line treatment in advanced non-small-cell lung cancer (NSCLC) with a risk of myelotoxicity. This study evaluated the efficacy and toxicity profile of two docetaxel regimens in NSCLC patients who had failed first-line non-docetaxel-based chemotherapy.
  
  
  METHODS
  A total of 259 patients from 33 Spanish centers were randomized to receive either docetaxel 75 mg/m(2) administered every 3 weeks (3W arm) or docetaxel 36 mg/m(2) given weekly (1W arm) for 6 weeks followed by 2 weeks of rest. The primary end point was 1-year survival; secondary end points were median survival, time to progression, response and toxicity.
  
  
  RESULTS
  One-year survival was 27% in the 3W and 22% in the 1W arm. Median time to progression was also similar in the two arms. Median survival was 6.6 months in the 3W arm versus 5.4 months in the 1W arm (P = 0.075). Response rates were 9.3% in the 3W arm and 4.8% in the 1W arm. More patients in the 1W arm experienced mucositis [1W, nine patients (7.2%); 3W, two patients (1.6%); P = 0.032], while febrile neutropenia was significantly higher in the 3W arm [3W, 10 patients (7.8%); 1W, one patient (0.8%); P = 0.010].
  
  
  CONCLUSIONS
  Both weekly and 3-weekly docetaxel were effective and well-tolerated, with different toxicity profiles. In general, there was no indication to recommend the weekly schedule. However, the significant lower rate of febrile neutropenia observed in the weekly schedule makes it a good alternative for patients at risk of severe neutropenia.
authors.affiliation: Consorcio Hospital General Universitario de Valencia, Valencia, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Camps
authors.forename: B
authors.initials: B
authors.lastname: Massuti
authors.forename: A
authors.initials: A
authors.lastname: Jiménez
authors.forename: I
authors.initials: I
authors.lastname: Maestu
authors.forename: R García
authors.initials: RG
authors.lastname: Gómez
authors.forename: D
authors.initials: D
authors.lastname: Isla
authors.forename: J L
authors.initials: JL
authors.lastname: González
authors.forename: D
authors.initials: D
authors.lastname: Almenar
authors.forename: A
authors.initials: A
authors.lastname: Blasco
authors.forename: R
authors.initials: R
authors.lastname: Rosell
authors.forename: A
authors.initials: A
authors.lastname: Carrato
authors.forename: N
authors.initials: N
authors.lastname: Viñolas
authors.forename: N
authors.initials: N
authors.lastname: Batista
authors.forename: C García
authors.initials: CG
authors.lastname: Girón
authors.forename: A
authors.initials: A
authors.lastname: Galán
authors.forename: M
authors.initials: M
authors.lastname: López
authors.forename: R
authors.initials: R
authors.lastname: Blanco
authors.forename: M
authors.initials: M
authors.lastname: Provencio
authors.forename: P
authors.initials: P
authors.lastname: Diz
authors.forename: E
authors.initials: E
authors.lastname: Felip
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use
chemical_list: D043823:Taxoids; D000077143:Docetaxel