title: Gefitinib versus vinorelbine in chemotherapy-naive elderly patients with advanced non-small-cell lung cancer (INVITE): a randomized, phase II study.
abstract: OBJECTIVE
  This phase II, open-label, parallel-group study compared gefitinib with vinorelbine in chemotherapy-naïve elderly patients with advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Chemotherapy-naïve patients (age >or= 70 years) were randomly assigned to gefitinib (250 mg/d orally) or vinorelbine (30 mg/m(2) infusion on days 1 and 8 of a 21-day cycle). The primary end point was progression-free survival (PFS). Secondary end points were overall survival (OS), objective response rate (ORR), quality of life (QOL), pulmonary symptom improvement (PSI), and tolerability. Exploratory end points included epidermal growth factor receptor (EGFR) gene copy number by fluorescent in situ hybridization (FISH).
  
  
  RESULTS
  Patients were randomly assigned to gefitinib (n = 97) or to vinorelbine (n = 99). Hazard ratios (HR; gefitinib v vinorelbine) were 1.19 (95% CI, 0.85 to 1.65) for PFS and 0.98 (95% CI, 0.66 to 1.47) for OS. ORR and disease control rates were 3.1% (95% CI, 0.6 to 8.8) and 43.3% (for gefitinib) and 5.1% (95% CI, 1.7 to 11.4) and 53.5% (for vinorelbine), respectively. Overall QOL improvement and PSI rates were 24.3% and 36.6% (for gefitinib) and 10.9% and 31.0% (for vinorelbine), respectively. In the 54 patients who were EGFR FISH-positive, HRs were 3.13 (95% CI, 1.45 to 6.76) for PFS and 2.88 (95% CI, 1.21 to 6.83) for OS. There were fewer treatment-related grade 3 to 5 adverse events with gefitinib (12.8%) than with vinorelbine (41.7%).
  
  
  CONCLUSIONS
  There was no statistical difference between gefitinib and vinorelbine in efficacy in chemotherapy-naïve, unselected elderly patients with advanced NSCLC, but there was better tolerability with gefitinib. Individuals who were EGFR FISH-positive benefited more from vinorelbine than from gefitinib; this unexpected finding requires further study.
authors.affiliation: Department of Medical Oncology, Perugia Hospital, S Andrea delle Fratte, 06156 Perugia, Italy. lcrino@unipg.it
authors.forename: Lucio
authors.initials: L
authors.lastname: Crinò
authors.forename: Federico
authors.initials: F
authors.lastname: Cappuzzo
authors.forename: Petr
authors.initials: P
authors.lastname: Zatloukal
authors.forename: Martin
authors.initials: M
authors.lastname: Reck
authors.forename: Milos
authors.initials: M
authors.lastname: Pesek
authors.forename: Joyce C
authors.initials: JC
authors.lastname: Thompson
authors.forename: Hugo E R
authors.initials: HE
authors.lastname: Ford
authors.forename: Fred R
authors.initials: FR
authors.lastname: Hirsch
authors.forename: Marileila
authors.initials: M
authors.lastname: Varella-Garcia
authors.forename: Serban
authors.initials: S
authors.lastname: Ghiorghiu
authors.forename: Emma L
authors.initials: EL
authors.lastname: Duffield
authors.forename: Alison A
authors.initials: AA
authors.lastname: Armour
authors.forename: Georgina
authors.initials: G
authors.lastname: Speake
authors.forename: Michael
authors.initials: M
authors.lastname: Cullen
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D018450:Disease Progression; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D011799:Quinazolines / Q000627:therapeutic use*; D016019:Survival Analysis; D014747:Vinblastine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000970:Antineoplastic Agents; D011799:Quinazolines; D014747:Vinblastine; D000077235:Vinorelbine; D000077156:Gefitinib