title: Vinorelbine-based regimens as salvage treatment in patients with advanced non-small cell lung cancer: two parallel multicenter phase II trials.
abstract: Two parallel phase II trials were conducted in order to evaluate the efficacy and toxicity of vinorelbine-ifosfamide (VNB-IFX) and vinorelbine-carboplatin (VNB-C) combinations as salvage treatment in patients with advanced non-small cell lung cancer (NSCLC).
  
  
  METHODS
  Patients failing platinum-based front-line chemotherapy were enrolled in the VNB-IFX trial while patients failing non-platinum-containing chemotherapy were treated with VNB-C. Twenty-nine patients were treated with VNB-IFX [median age: 59 years; performance status, PS (WHO) 0--1: 72% and disease stage IV: 79%] and 37 with VNB-C [median age: 61 years; PS (WHO) 0--1: 51% and stage IV: 84%]. Patients received vinorelbine 25 mg/m(2) i.v. on days 1 and 8 and ifosfamide 1.6 g/m(2) i.v. on days 8--10 with uroprotective mesna, in cycles of 28 days. G-CSF (5 microg/kg/day s.c.) was administered prophylactically on days 11--16 or until hematological recovery. The VNB-C regimen consisted of carboplatin 300 mg/m(2) on day 1 and vinorelbine 30 mg/m(2) on days 1 and 8 every 28 days.
  
  
  RESULTS
  Twenty-six patients were evaluable for response in the VNB-IFX trial and 29 in the VNB-C. Overall response rates (intent-to-treat analysis) were 3% (1 patient; duration of response: 3 months) for the VNB-IFX and 16% (median duration of response: 7.5 months) for the VNB-C combination. The median time to progression and survival for patients receiving VNB-IFX were 4.5 and 6 months (1-year survival: 19%), respectively; the corresponding values for VNB-C were 9.0 and 8.5 months (1-year survival: 38%). The median survival of patients achieving stable disease was 10 (VNB-IFX) and 14.5 (VNB-C) months. Grade 3--4 neutropenia occurred in 4 (13%) of the patients treated with VNB-IFX; all cases were complicated with fever. Grade 3--4 neutropenia was documented in 13 (35%) patients in the VNB-C trial; 6 (16%) developed neutropenic fever. There were no treatment-related deaths. Non-hematologic toxicity for the VNB-IFX and VNB-C regimens was mild with grade 2--3 peripheral neurotoxicity occurring in 3 (10%) and 7 (19%) patients, and grade 2--3 asthenia in 11 (38%) and 18 (48%) patients, respectively.
  
  
  CONCLUSIONS
  Both combinations were associated with a tolerable toxicity profile. VNB-C demonstrated notable activity in patients previously treated with a taxane-based regimen, whilst VNB-IFX failed to produce a significant response rate in patients treated with platinum-containing chemotherapy. Stabilization of disease was associated with a favorable survival in both studies.
authors.affiliation: Department of Medical Oncology, University General Hospital of Heraklion, Greece.
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: A
authors.initials: A
authors.lastname: Harpidou
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: E
authors.initials: E
authors.lastname: Sarra
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.forename: E
authors.initials: E
authors.lastname: Papadakis
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D016879:Salvage Therapy; D014747:Vinblastine / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D000077235:Vinorelbine