title: Multicenter phase II trial of carboplatin/vinorelbine in elderly patients with advanced non-small-cell lung cancer efficacy and impact on quality of life: Groupe Francais de Pneumo-Cancerologie Study 9902.
abstract: BACKGROUND
  Approximately 30% of lung cancer cases are diagnosed in patients > 70 years of age. Standard chemotherapy regimens are generally considered too toxic for elderly patients. We conducted a multicenter phase II trial to determine the efficacy and safety of carboplatin combined with vinorelbine every 4 weeks as first-line treatment for advanced non-small-cell lung cancer (NSCLC) in elderly patients.
  
  
  METHODS
  Patients were eligible if they were aged >OR= 70 years, had stage IIIB (with pleural effusion) or stage IV NSCLC, had a performance status of 0/1, had not previously received chemotherapy, and had normal organ function. Forty patients (31 men and 9 women) were enrolled and received 3-5 courses of treatment. Median age was 72 years (range, 70-82 years). Eighty percent of patients had stage IV NSCLC, with squamous cell (n=21), adenocarcinoma (n=12), and undifferentiated (n=7) histologies.
  
  
  RESULTS
  Forty patients were assessable for toxicity and 32 for treatment response. Among these 32 patients, 8 had a partial response (intent-to-treat response rate, 20%), and 10 (25%) had stable disease. The median survival was 7.8 months (range, 4-11.6 months). The 1- and 2-year survival rates were 25% and 7%, respectively; median time to progression was 4.3 months (range, 0.2-13.8 months). Grade 3/4 neutropenia was seen in 27 patients (68%), and grade 3/4 anemia was seen in 5 patients (13%). One patient died of febrile neutropenia during treatment. The main nonhematologic adverse effect was fatigue (grade 3/4 in 18% of patients).
  
  
  CONCLUSIONS
  Carboplatin/vinorelbine is well tolerated by elderly patients with extensive-stage NSCLC. Efficacy is low but similar to that of other treatments used in this setting.
authors.affiliation: Centre Hospitalier, Draguignan, France. herve.lecaer@ch-draguignan.fr
authors.forename: Herve
authors.initials: H
authors.lastname: LeCaer
authors.forename: Jean Yves
authors.initials: JY
authors.lastname: Delhoume
authors.forename: Pascal Andre
authors.initials: PA
authors.lastname: Thomas
authors.forename: Henri
authors.initials: H
authors.lastname: Berard
authors.forename: Dominique
authors.initials: D
authors.lastname: Paillotin
authors.forename: Jean Renaud
authors.initials: JR
authors.lastname: Barriere
authors.forename: Celine
authors.initials: C
authors.lastname: Gimenez
authors.forename: Alain
authors.initials: A
authors.lastname: Vergnenegre
authors.forename: Pierre
authors.initials: P
authors.lastname: Muller
authors.forename: Pascal
authors.initials: P
authors.lastname: Auquier
authors.forename: Maurice
authors.initials: M
authors.lastname: Perol
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005602:France / Q000453:epidemiology; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D011788:Quality of Life; D018434:Sickness Impact Profile; D013223:Statistics as Topic; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D014747:Vinblastine; D016190:Carboplatin; D000077235:Vinorelbine