title: Front-line paclitaxel-vinorelbine versus paclitaxel-carboplatin in patients with advanced non-small-cell lung cancer: a randomized phase III trial.
abstract: OBJECTIVE
  This randomized phase III trial of advanced or metastatic non-small-cell lung cancer (NSCLC) was designed to compare a standard treatment such as carboplatin (CRP)-paclitaxel (PCT) with a new combination, vinorelbine (VRL)-PCT-two agents acting in microtubules.
  
  
  METHODS
  Three hundred and sixty patients (stage IIIa, IIIb and IV) were included and evaluated for response rate, survival and toxicity. Arm A patients were treated with the control combination of CRP 6 AUC and PCT 175 mg/m(2) repeated every 3 weeks for six cycles, and arm B with the investigational combination of VRL 25 mg/m(2) and PCT 135 mg/m(2) repeated every 2 weeks for nine cycles. The patients were well balanced with respect to gender, disease stage and performance status. Arm A received 849 cycles (mean 4.59 per patient) and arm B 951 cycles (mean 5.39 per patient).
  
  
  RESULTS
  Complete and partial response rates were 45.95% and 42.86% for arms A and B, respectively. Median survival was 11 and 10 months, 1-year survival 42.7% and 37.85% and 2-year survival 10.12% and 19% for arms A and B, respectively. Toxicity was similar in all patients, except for neutropenia, which was significantly greater in arm B.
  
  
  CONCLUSIONS
  PCT combined with VRL produces similar (non-significant) response rates, survival and toxicity (except for neutropenia, as noted above) to standard CRP-PCT treatment in untreated advanced-stage NSCLC.
authors.affiliation: First Department of Medical Oncology, Errikos Dynan Hospital, Athens. dr-gps@ath.forthnet.gr
authors.forename: G P
authors.initials: GP
authors.lastname: Stathopoulos
authors.forename: M
authors.initials: M
authors.lastname: Veslemes
authors.forename: N
authors.initials: N
authors.lastname: Georgatou
authors.forename: D
authors.initials: D
authors.lastname: Antoniou
authors.forename: P
authors.initials: P
authors.lastname: Giamboudakis
authors.forename: K
authors.initials: K
authors.lastname: Katis
authors.forename: D
authors.initials: D
authors.lastname: Tsavdaridis
authors.forename: S K
authors.initials: SK
authors.lastname: Rigatos
authors.forename: I
authors.initials: I
authors.lastname: Dimitroulis
authors.forename: S
authors.initials: S
authors.lastname: Bastani
authors.forename: S
authors.initials: S
authors.lastname: Loukides
authors.forename: K
authors.initials: K
authors.lastname: Vergos
authors.forename: K
authors.initials: K
authors.lastname: Marossis
authors.forename: T
authors.initials: T
authors.lastname: Grigoratou
authors.forename: E
authors.initials: E
authors.lastname: Kalatzi
authors.forename: M
authors.initials: M
authors.lastname: Charalambatou
authors.forename: A
authors.initials: A
authors.lastname: Paspalli
authors.forename: P
authors.initials: P
authors.lastname: Michalopoulou
authors.forename: M
authors.initials: M
authors.lastname: Stoka
authors.forename: A
authors.initials: A
authors.lastname: Gerogianni
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*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D011788:Quality of Life; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D016190:Carboplatin; D017239:Paclitaxel; D000077235:Vinorelbine