title: Second-line paclitaxel/carboplatin versus vinorelbine/carboplatin in patients who have advanced non-small-cell lung cancer pretreated with non-platinum-based chemotherapy: a multicenter randomized phase II study.
abstract: OBJECTIVE
  This study evaluates the activity and toxicity of the paclitaxel/carboplatin (PC) doublet versus vinorelbine/carboplatin (VC) doublet as second-line treatment in patients who have advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients pretreated with front-line docetaxel and gemcitabine were randomized to receive either PC (n = 75), which consisted of paclitaxel at a dose of 140 mg/m(2) and carboplatin area under the curve (AUC3), or VC (n = 78), which consisted of vinorelbine at a dose of 45 mg/m(2) orally and carboplatin AUC3; both drugs were administered on days 1 and 15.
  
  
  RESULTS
  The overall response rate was 18.6% (95% confidence interval, 9.85%-27.49%; one complete and 13 partial responses) in the PC arm and 7.7% (95% confidence interval, 1.78%-13.61%; one complete and five partial responses) in the VC arm (P = .056). Median time to tumor progression was 3.5 months (range, 0.3 - 23.73 months) and 3.07 months (range, 0.37-18.5) in the PC and VC arm, respectively (P = .287). Median overall survival was 7.83 months (range, 0.3-45.03 months) and 7.60 months (range, 0.5-30.27 months) for PC and VC arms, respectively (P value = .633). Chemotherapy was well-tolerated and grade III/IV toxicities were relatively infrequent. No toxic deaths were observed.
  
  
  CONCLUSIONS
  Platinum-based doublets with either paclitaxel or vinorelbine in patients with advanced/metastatic NSCLC pretreated with front-line docetaxel/gemcitabine show comparable efficacy when used in the second-line setting.
authors.affiliation: Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: Athanasios G
authors.initials: AG
authors.lastname: Pallis
authors.forename: Kostas
authors.initials: K
authors.lastname: Syrigos
authors.forename: Athanasios
authors.initials: A
authors.lastname: Kotsakis
authors.forename: Niki
authors.initials: N
authors.lastname: Karachaliou
authors.forename: Aris
authors.initials: A
authors.lastname: Polyzos
authors.forename: Vassilis
authors.initials: V
authors.lastname: Chandrinos
authors.forename: Ioannis
authors.initials: I
authors.lastname: Varthalitis
authors.forename: Charalambos
authors.initials: C
authors.lastname: Christophyllakis
authors.forename: Alexandros
authors.initials: A
authors.lastname: Ardavanis
authors.forename: Lambros
authors.initials: L
authors.lastname: Vamvakas
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Vardakis
authors.forename: Zacharenia
authors.initials: Z
authors.lastname: Saridaki
authors.forename: George
authors.initials: G
authors.lastname: Samonis
authors.forename: Stylianos
authors.initials: S
authors.lastname: Giassas
authors.forename: Vassilis
authors.initials: V
authors.lastname: Georgoulias
authors.forename: Sophia
authors.initials: S
authors.lastname: Agelaki
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D014747:Vinblastine; D016190:Carboplatin; D017239:Paclitaxel; D000077235:Vinorelbine; D000093542:Gemcitabine