title: A multicentre phase II randomised trial of weekly docetaxel/gemcitabine followed by erlotinib on progression, vs the reverse sequence, in elderly patients with advanced non small-cell lung cancer selected with a comprehensive geriatric assessment (the GFPC 0504 study).
abstract: BACKGROUND
  Elderly cancer patients form a heterogeneous population in which therapeutic decision-making is often difficult. The aim of this randomised phase II trial was to evaluate the feasibility and activity of weekly docetaxel/gemcitabine (DG) followed by erlotinib after progression (arm A) vs erlotinib followed by DG after progression (arm B) in fit elderly patients with advanced non small-cell lung cancer (NSCLC).
  
  
  METHODS
  Elderly chemotherapy-naive patients with stage IIIB/IV NSCLC were selected after a comprehensive geriatric assessment (socioeconomic, cognitive, depression, ADL and IADL assessments). The primary endpoint was the time to second progression (TTP2). Overall survival (OS), the time to first progression (TTP1) and safety were secondary endpoints.
  
  
  RESULTS
  Between July 2006 and November 2008, 22 centres enrolled 100 patients. TTP2 was 7.5 and 5.8 months in arm A and arm B, respectively; TTP1 was 4.7 and 2.7 months; and the median OS time was 9.4 and 7.1 months; the respective 1-year survival rates were 36.2 and 31.4%. There was no major unexpected toxicity.
  
  
  CONCLUSIONS
  These results suggest that weekly DG, followed by erlotinib, is a promising treatment for fit elderly patients with NSCLC; the efficacy of the reverse sequence was insufficient to recommend it for EGFR-non-selected patients.
authors.affiliation: Services de Pneumologie, CH Route Montferrat 83300, Draguignan, France. herve.lecaer@ch-draguignan.fr
authors.forename: H
authors.initials: H
authors.lastname: LeCaer
authors.forename: F
authors.initials: F
authors.lastname: Barlesi
authors.forename: R
authors.initials: R
authors.lastname: Corre
authors.forename: H
authors.initials: H
authors.lastname: Jullian
authors.forename: S
authors.initials: S
authors.lastname: Bota
authors.forename: L
authors.initials: L
authors.lastname: Falchero
authors.forename: A
authors.initials: A
authors.lastname: Vergnenegre
authors.forename: C
authors.initials: C
authors.lastname: Dujon
authors.forename: J Y
authors.initials: JY
authors.lastname: Delhoume
authors.forename: C
authors.initials: C
authors.lastname: Chouaid
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D018450:Disease Progression; D000077143:Docetaxel; D004334:Drug Administration Schedule; D000069347:Erlotinib Hydrochloride; D015577:Geriatric Assessment; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D011799:Quinazolines / Q000008:administration & dosage; D043823:Taxoids / Q000008:administration & dosage; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride; D000093542:Gemcitabine