title: Cisplatin plus continuous infusion vinorelbine for the treatment of advanced non-small cell lung cancer: a phase I-II study.
abstract: BACKGROUND
  In this Phase I/II trial, the maximumtolerated dose (MTD) and activity of cisplatin plus vinorelbine (VRL) administered in continuous infusion as first-line treatment of advanced non small cell lung cancer (NSCLC) was determined in 12 consecutive chemotherapy-naive patients with advanced NSCLC.
  
  
  METHODS
  The dose of cisplatin was 100 mg/m(2) in all patients, and vinorelbine was administered as an initial intravenous (iv) bolus of 8 mg/m(2) on day 1 followed by a 4-day continuous iv infusion at 4 different 24 h dose levels (DLs) to be repeated every 21 days. All 12 patients (47 cycles) were evaluable for response and toxicity.
  
  
  RESULTS
  The MTD was 8 mg/m(2) bolus followed by a continuous iv infusion of 8 mg/m(2) per day over 4 days. The dose limiting toxicities (DLT) were febrile neutropenia in 4 patients and grade 3 mucositis in 1 patient. There was less neuro-toxicity and compared to the weekly bolus scheme. There was no significant cumulative toxicity after 3 cycles. Partial responses were observed in 6 patients; an overall response rate of 50% (95% CI: 30-65%). Median time to progression was 5,5 months (95% CI: 1,5-11 months) and median survival was 11 months (95% CI: 5-20 months).
  
  
  CONCLUSIONS
  The results demonstrate that, in this setting of first-line treatment of NSCLC, cisplatin plus vinorelbine at 8 mg/m(2) bolus followed by a continuous infusion of 8 mg/m(2) per day over 4 days is the recommended schedule. Further trials would be useful to establish activity of this combination.
authors.affiliation: Medical Oncology Section, Hospital Regional Universitario Carlos Haya, Málaga, Spain. manuelcobodols@yahoo.es
authors.forename: M
authors.initials: M
authors.lastname: Cobo-Dols
authors.forename: S
authors.initials: S
authors.lastname: Gil-Calle
authors.forename: E
authors.initials: E
authors.lastname: Villar-Chamorro
authors.forename: I
authors.initials: I
authors.lastname: Alés-Díaz
authors.forename: F
authors.initials: F
authors.lastname: Carabantes-Ocón
authors.forename: J
authors.initials: J
authors.lastname: Alcalde-García
authors.forename: V
authors.initials: V
authors.lastname: Gutiérrez-Calderón
authors.forename: A
authors.initials: A
authors.lastname: Montesa-Pino
authors.forename: J J
authors.initials: JJ
authors.lastname: Bretón-García
authors.forename: M
authors.initials: M
authors.lastname: Benavides-Orgaz
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D002945:Cisplatin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D016019:Survival Analysis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine