title: Second-line treatment with vinorelbine and carboplatin in patients with advanced non-small cell lung cancer. A multicenter phase II study.
abstract: OBJECTIVE
  A phase II study was conducted to evaluate the efficacy and toxicity of vinorelbine-carboplatin (VNB-C) combination as a salvage treatment in patients with advanced non-small cell lung cancer (NSCLC) progressing after or failing previous non-platinum, taxane-based treatment.
  
  
  METHODS
  Thirty-seven patients with cytologically or histologically confirmed NSCLC were enrolled. VNB 30 mg/m(2) was administered on days 1 and 8 and C 300 mg/m(2) on day 1 every 28 days. G-CSF (5 microg/kg per day s.c.) was used prophylactically on days 10-15 in case of grade 3-4 neutropenia or febrile neutropenia after the first cycle.
  
  
  RESULTS
  Twenty-nine patients were evaluable for response and all were evaluable for toxicity. In an intention-to-treat analysis, two (5%) complete and four (11%) partial responses were documented for an overall response rate of 16% (95% CI, 4.49-28.84%). Eleven (30%) patients experienced disease stabilisation and 20 (54%) disease progression. The median duration of response was 7.5 months, the median TTP was 9 months, and the median survival was 8.5 months. Patients with objective remission and stable disease had a statistically significant survival benefit over patients with disease progression. Grade 3 and 4 neutropenia occurred in three (8%) and ten (27%) patients, respectively, and six cases (16%) were complicated with fever. Grade 4 thrombocytopenia was documented in one (3%) patient. Non-hematological toxicity was mild, with grade 2 and 3 asthenia reported in 18 (48%) patients. No treatment-related deaths occurred.
  
  
  CONCLUSIONS
  VNB-C combination is well tolerated and retains a notable degree of activity in NSCLC patients progressing after previous non-platinum, taxane-based treatment. Moreover, it confers tumour growth control in a significant proportion of patients, and this seems to be associated with a survival benefit for them.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, PO Box 1352, Heraklion 71110, Crete, Greece. georgsec@med.uch.gr
authors.forename: S
authors.initials: S
authors.lastname: Agelaki
authors.forename: H
authors.initials: H
authors.lastname: Bania
authors.forename: C
authors.initials: C
authors.lastname: Kouroussis
authors.forename: G
authors.initials: G
authors.lastname: Blazoyiannakis
authors.forename: J
authors.initials: J
authors.lastname: Souglakos
authors.forename: X
authors.initials: X
authors.lastname: Tsiafaki
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: A
authors.initials: A
authors.lastname: Rapti
authors.forename: N
authors.initials: N
authors.lastname: Androulakis
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.forename: E
authors.initials: E
authors.lastname: Papadakis
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008875:Middle Aged; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine