title: A randomized phase III study of the docetaxel/carboplatin combination versus docetaxel single-agent as second line treatment for patients with advanced/metastatic non-small cell lung cancer.
abstract: BACKGROUND
  To compare the activity and toxicity of docetaxel/carboplatin (DC) doublet vs single agent docetaxel (D) as second-line treatment in patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients pre-treated with front-line platinum-free regimens, were randomized to receive either docetaxel/carboplatin (DC), (docetaxel 50 mg/m2; carboplatin AUC4; both drugs administered on days 1 and 15) or docetaxel single-agent (D), (docetaxel 50 mg/m2 on days 1 and 15).
  
  
  RESULTS
  Response rate was similar between the two arms (DC vs D: 10.4% vs 7.7%; p = 0.764). After a median follow-up time of 28.0 months for DC arm and 34.5 months for D arm, progression free survival (PFS) was significantly higher in the DC arm (DC vs D:3.33 months vs 2.60 months; p-value = 0.012), while no significant difference was observed in terms of overall survival (OS) (DC vs D: 10.3 months vs 7.70 months; p-value = 0.550). Chemotherapy was well-tolerated and grade III/IV toxicities were relatively infrequent. No toxic deaths were observed.
  
  
  CONCLUSIONS
  This study has not achieved its primary objective of significant OS prolongation with docetaxel/carboplatin combination over single-agent docetaxel in patients who had not received front-line docetaxel; however, the docetaxel/carboplatin combination was associated with a significant clinical benefit in terms of PFS.
authors.affiliation: Hellenic Oncology Research Group, 55 Lombardou str, 114 74 Athens, Greece.
authors.forename: Athanasios G
authors.initials: AG
authors.lastname: Pallis
authors.forename: Sophia
authors.initials: S
authors.lastname: Agelaki
authors.forename: Athina
authors.initials: A
authors.lastname: Agelidou
authors.forename: Ioannis
authors.initials: I
authors.lastname: Varthalitis
authors.forename: Kostas
authors.initials: K
authors.lastname: Syrigos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Kentepozidis
authors.forename: Georgia
authors.initials: G
authors.lastname: Pavlakou
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Emmanouel
authors.initials: E
authors.lastname: Kontopodis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D043823:Taxoids / Q000008:administration & dosage*; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin