title: Fractionated dose of cisplatin (CDDP) and vinorelbine (VNB) chemotherapy for elderly patients with advanced non-small cell lung cancer: phase II trial.
abstract: BACKGROUND
  The incidence of non-small cell lung cancer (NSCLC) is increasing among the elderly representing about 30% of NSCLC patients over 70 years old. The aim of this study was to evaluate the response, survival and tolerability of a modified schedule with cisplatin-vinorelbine in elderly patients with advanced NSCLC.
  
  
  METHODS
  Between November 2001 and March 2003, 30 patients were included into the study. Median age was 73 (range 70-77). Male/female 27/3 (90%/10%); 60% of patients were stage IV at diagnosis and only one patient presented with brain metastasis. Treatment consisted of cisplatin 30 mg/m(2) on days 1 and 8, and vinorelbine 25 mg/m(2) on days 1 and 8 every 21 days.
  
  
  RESULTS
  A total of 120 cycles were administered with a median of four cycles per patient. The most relevant WHO toxicities were: neutropenia grade 3 in 6 (20%) patients and grade 4 in 13 (43%) patients. There were three (10%) treatment-related deaths: two caused by neutropenic fever and one due to acute pulmonary oedema. No other relevant hematological and non-hematological toxicities occurred. By intention-to-treat analysis, 10 patients (33%) showed stable disease and 10 patients (33%) showed a partial response while 10 patients (33%) showed treatment failure. Median survival time was 7.4 months; 1-year survival was 36.6% and median time to progression was 5.14 months.
  
  
  CONCLUSIONS
  At this dose and schedule, the combination of vinorelbine and cisplatin obtained a response rate and survival comparable to the most active regimens. Non-hematologic toxicity was mild while neutropenia was the most relevant toxicity.
authors.affiliation: Oncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera San Giovanni Battista Molinette, Via Cherasco 15, 10126 Torino, Italy. bufluc@libero.it <bufluc@libero.it>
authors.forename: Lucio
authors.initials: L
authors.lastname: Buffoni
authors.forename: Diego
authors.initials: D
authors.lastname: Dongiovanni
authors.forename: Carla
authors.initials: C
authors.lastname: Barone
authors.forename: Camilla
authors.initials: C
authors.lastname: Fissore
authors.forename: Davide
authors.initials: D
authors.lastname: Ottaviani
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Dongiovanni
authors.forename: Raffaella
authors.initials: R
authors.lastname: Grillo
authors.forename: Angelica
authors.initials: A
authors.lastname: Salvadori
authors.forename: Nadia
authors.initials: N
authors.lastname: Birocco
authors.forename: Marina
authors.initials: M
authors.lastname: Schena
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D002945:Cisplatin / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D002945:Cisplatin; D000077235:Vinorelbine