title: A phase II study of carboplatin and paclitaxel as first line chemotherapy in elderly patients with advanced non-small cell lung cancer (NSCLC).
abstract: BACKGROUND
  Lung cancer is the leading cause of tumour-related deaths in the elderly population but the optimal management of advanced NSCLC in older patients has not been defined to date. The present phase II study was planned to evaluate the efficacy and toxicity of the combination of carboplatin and paclitaxel in elderly patients with advanced NSCLC.
  
  
  METHODS
  Patients (>70 years old) who had pathologically been proven to have a NSCLC and measurable lesions were treated with paclitaxel (175 mg/m2 for 3h) and carboplatin [area under the concentration-time curve (AUC=5)] on day 1 every 3 weeks.
  
  
  RESULTS
  Forty patients were enrolled into the study. The median age was 74 years (range, 70-78 years). Approximately 85% of the patients had stage IV and 80% had a performance status (PS) of 0-1. Nine of the 40 (22.5%; 90% CI 17.6-28.1) included patients had a partial response; one patient (2.5%; 90% CI 1.7-3.2) achieved a complete response. The overall response rate was 25% (90% CI 15.3-38.6). In addition stable disease was observed in 13 patients (32.5%; 90% CI 24.3-40.7). The median survival was 7.8 months (95% confidence interval, 5.1-11.8 months). The actual 1-year survival was 18% (95% confidence interval, 12-29%). The median time to disease progression was 4.1 months (95% CI 2.8-8.5). Overall, 37.5% of patients experienced grade 3-4 neutropenia of any duration with only two patients (5%) developing neutropenic fever. Grade 3 or 4 non-haematological toxicity was uncommon apart alopecia.
  
  
  CONCLUSIONS
  In the present phase II study the combination of paclitaxel and carboplatin has demonstrated to be active and safe in an age-selected population.
authors.affiliation: Gravina Hospital, Oncology Unit,Caltagirone, Italy.
authors.forename: Carmelo Giannitto
authors.initials: CG
authors.lastname: Giorgio
authors.forename: Alessandro
authors.initials: A
authors.lastname: Pappalardo
authors.forename: Antonio
authors.initials: A
authors.lastname: Russo
authors.forename: Dario
authors.initials: D
authors.lastname: Giuffrida
authors.forename: Daniele
authors.initials: D
authors.lastname: Santini
authors.forename: Giuseppina
authors.initials: G
authors.lastname: Petralia
authors.forename: Sergio
authors.initials: S
authors.lastname: Castorina
authors.forename: Restuccia
authors.initials: R
authors.lastname: Nunzio
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Failla
authors.forename: Roberto
authors.initials: R
authors.lastname: Bordonaro
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007558:Italy; D008175:Lung Neoplasms / Q000188:drug therapy*; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage*; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D016190:Carboplatin; D017239:Paclitaxel