title: Chemotherapy for elderly patients with advanced non-small-cell lung cancer: the Multicenter Italian Lung Cancer in the Elderly Study (MILES) phase III randomized trial.
abstract: BACKGROUND
  Vinorelbine prolongs survival and improves quality of life in elderly patients with advanced non-small-cell lung cancer (NSCLC). Some studies have also suggested that gemcitabine is well tolerated and effective in such patients. We compared the effectiveness and toxicity of the combination of vinorelbine plus gemcitabine with those of each drug given alone in an open-label, randomized phase III trial in elderly patients with advanced NSCLC.
  
  
  METHODS
  Patients aged 70 years and older, enrolled between December 1997 and November 2000, were randomly assigned to receive intravenous vinorelbine (30 mg/m(2) of body surface area), gemcitabine (1200 mg/m(2)), or vinorelbine (25 mg/m(2)) plus gemcitabine (1000 mg/m(2)). All treatments were delivered on days 1 and 8 every 3 weeks for a maximum of six cycles. The primary endpoint was survival. Survival curves were drawn using the Kaplan-Meier method and analyzed by the Mantel-Haenszel test. Secondary endpoints were quality of life and toxicity.
  
  
  RESULTS
  Of 698 patients available for intention-to-treat analysis, 233 were assigned to receive vinorelbine, 233 to gemcitabine, and 232 to vinorelbine plus gemcitabine. Compared with each single drug, the combination treatment did not improve survival. The hazard ratio of death for patients receiving the combination treatment was 1.17 (95% confidence interval [CI] = 0.95 to 1.44) that of patients receiving vinorelbine and 1.06 (95% CI = 0.86 to 1.29) that of patients receiving gemcitabine. Although quality of life was similar across the three treatment arms, the combination treatment was more toxic than the two drugs given singly.
  
  
  CONCLUSIONS
  The combination of vinorelbine plus gemcitabine is not more effective than single-agent vinorelbine or gemcitabine in the treatment of elderly patients with advanced NSCLC.
authors.affiliation: cgridelli@libero.it
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
authors.forename: Ciro
authors.initials: C
authors.lastname: Gallo
authors.forename: Silvio
authors.initials: S
authors.lastname: Cigolari
authors.forename: Antonio
authors.initials: A
authors.lastname: Rossi
authors.forename: Francovito
authors.initials: F
authors.lastname: Piantedosi
authors.forename: Santi
authors.initials: S
authors.lastname: Barbera
authors.forename: Francesco
authors.initials: F
authors.lastname: Ferraù
authors.forename: Elena
authors.initials: E
authors.lastname: Piazza
authors.forename: Francesco
authors.initials: F
authors.lastname: Rosetti
authors.forename: Maurizia
authors.initials: M
authors.lastname: Clerici
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
authors.forename: Sergio Federico
authors.initials: SF
authors.lastname: Robbiati
authors.forename: Luciano
authors.initials: L
authors.lastname: Frontini
authors.forename: Cosimo
authors.initials: C
authors.lastname: Sacco
authors.forename: Federico
authors.initials: F
authors.lastname: Castiglione
authors.forename: Adolfo
authors.initials: A
authors.lastname: Favaretto
authors.forename: Silvia
authors.initials: S
authors.lastname: Novello
authors.forename: Maria Rita
authors.initials: MR
authors.lastname: Migliorino
authors.forename: Giampietro
authors.initials: G
authors.lastname: Gasparini
authors.forename: Domenico
authors.initials: D
authors.lastname: Galetta
authors.forename: Rosario Vincenzo
authors.initials: RV
authors.lastname: Iaffaioli
authors.forename: Vittorio
authors.initials: V
authors.lastname: Gebbia
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D005260:Female; D006801:Humans; D007558:Italy; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D009367:Neoplasm Staging; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016019:Survival Analysis; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine