title: Randomised, multicentre phase II study assessing two doses of docetaxel (75 or 100 mg/m2) as second-line monotherapy for non-small-cell lung cancer.
abstract: BACKGROUND
  The survival benefit associated with first-line chemotherapy in advanced lung cancer led to the need for second-line chemotherapy. Docetaxel (Taxotere) has proven efficacy in both settings. This study evaluated the safety and efficacy of two doses of docetaxel in patients with non-small-cell lung cancer who had failed first-line platinum-based chemotherapy.
  
  
  METHODS
  In total, 182 patients from 24 French centres were randomised and treated with either docetaxel 75 mg/m(2) (arm A) or 100 mg/m(2) (arm B) every 3 weeks. Baseline characteristics were well balanced, except more patients in arm A had metastatic disease (91.4% versus 78.7%) and therefore the median number of sites involved for arm A was three compared with two for arm B.
  
  
  RESULTS
  Median time to treatment failure was 1.34 months [95% confidence interval (CI) 1.28-1.64] for arm A and 1.64 months (95% CI 1.34-2.62) for arm B. Median overall survival was 4.7 months (95% CI 3.8-5.9) for arm A versus 6.7 months (95% CI 4.8-7.1) for arm B. According to a blinded expert panel, disease control was achieved in 35 (43.8%) patients in arm A and 39 (49.4%) patients in arm B. More patients in arm B experienced grade 3-4 neutropenia (B: 72.7% versus A: 44.0%), asthenia (B: 20.2% versus A: 10.8%) and infection (B: 6.7% versus A: 2.2%). Three treatment-related deaths were reported in each arm.
  
  
  CONCLUSIONS
  The optimal docetaxel dosage in this second-line setting is 75 mg/m(2), as it has a more favourable safety profile and on balance a similar efficacy to the 100 mg/m(2) dose.
authors.affiliation: Hôpital Lyautey, Strasbourg, France. elisabeth.quoix@chru-strasburg.fr
authors.forename: E
authors.initials: E
authors.lastname: Quoix
authors.forename: B
authors.initials: B
authors.lastname: Lebeau
authors.forename: A
authors.initials: A
authors.lastname: Depierre
authors.forename: A
authors.initials: A
authors.lastname: Ducolone
authors.forename: D
authors.initials: D
authors.lastname: Moro-Sibilot
authors.forename: B
authors.initials: B
authors.lastname: Milleron
authors.forename: J L
authors.initials: JL
authors.lastname: Breton
authors.forename: E
authors.initials: E
authors.lastname: Lemarie
authors.forename: J L
authors.initials: JL
authors.lastname: Pujol
authors.forename: J M
authors.initials: JM
authors.lastname: Brechot
authors.forename: G
authors.initials: G
authors.lastname: Zalcman
authors.forename: D
authors.initials: D
authors.lastname: Debieuvre
authors.forename: F
authors.initials: F
authors.lastname: Vaylet
authors.forename: A
authors.initials: A
authors.lastname: Vergnenegre
authors.forename: P
authors.initials: P
authors.lastname: Clouet
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D018450:Disease Progression; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009503:Neutropenia / Q000139:chemically induced; D012449:Safety; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use*; D013997:Time Factors; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel