title: Similar survival rates with first-line gefitinib, gemcitabine, or docetaxel in a randomized phase II trial in elderly patients with advanced non-small cell lung cancer and a poor performance status (IFCT-0301).
abstract: OBJECTIVE
  We evaluated the impact of age in a randomized phase II trial that compared three first-line drugs in elderly patients with advanced non-small cell lung cancer (NSCLC) and a poor performance status (PS).
  
  
  METHODS
  Patients with advanced NSCLC with a PS of 2 or 3 were enrolled into a multicenter randomized trial: arm A, gefitinib; arm B, gemcitabine; and arm C, docetaxel. We performed subgroup analyses according to age.
  
  
  RESULTS
  Between December 2004 and June 2007, 127 patients were enrolled. Analyses were performed between the two subgroups aged <70years (younger, n=56) and ≥70years (older, n=71). Patients mainly had adenocarcinoma (46% young vs. 51%: elderly), of which 62% vs. 75% had a PS of 2, respectively. Significantly more elderly patients were women and non-smokers, and there was a non-significant trend towards more PS-2 among the elderly. Progression-free survival (PFS) was 1.4months (95% CI: 1.1-1.9) for younger compared to 2.3months (95% CI: 2.1-2.9) for elderly patients. Overall survival (OS) was 2.0months (95% CI: 1.5-2.4) and 3.7months (95% CI: 2.4-4.8), respectively. Toxicity did not differ between younger and older patients. NSCLC was better controlled in elderly patients after three cycles of monotherapy compared to younger patients (p=0.034). When adjusted for stratification criteria, age was the main prognostic factor for PFS. Adjusted HRs for PFS was 0.57 (95% CI: 0.38-0.85) for the elderly compared to patients aged <70years (p=0.004).
  
  
  CONCLUSIONS
  Older patients had a decreased risk of progression/death compared to younger patients. Single-agent chemotherapy can be considered for patients aged ≥70years with a PS of 2.
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France; Unité de Coordination Onco - Gériatrique (UCOG 93), HUPSSD - APHP, France.
authors.forename: Gaetan
authors.initials: G
authors.lastname: Des Guetz
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France; Unité de Coordination Onco - Gériatrique (UCOG 93), HUPSSD - APHP, France. Electronic address: thierry.landre@rmb.aphp.fr.
authors.forename: Thierry
authors.initials: T
authors.lastname: Landre
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Virginie
authors.initials: V
authors.lastname: Westeel
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Milleron
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Fabien
authors.initials: F
authors.lastname: Vaylet
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Thierry
authors.initials: T
authors.lastname: Urban
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Barlesi
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Souquet
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Didier
authors.initials: D
authors.lastname: Debieuvre
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Braun
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Gislaine
authors.initials: G
authors.lastname: Fraboulet
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Monnet
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Bernard
authors.initials: B
authors.lastname: Uzzan
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Molinier
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Morin
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Denis
authors.initials: D
authors.lastname: Moro-Sibilot
authors.affiliation: Intergroupe Francophone de Cancérologie Thoracique (IFCT), Paris, France.
authors.forename: Jean Francois
authors.initials: JF
authors.lastname: Morère
mesh_terms: D000328:Adult; D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000627:therapeutic use; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy / Q000401:mortality*; D003841:Deoxycytidine / Q000031:analogs & derivatives / Q000627:therapeutic use; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D000077156:Gefitinib; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000627:therapeutic use; D015996:Survival Rate; D043823:Taxoids / Q000627:therapeutic use; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D000970:Antineoplastic Agents; D011799:Quinazolines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000077156:Gefitinib; D000093542:Gemcitabine
keywords: Docetaxel; Elderly; Gefitinib; Gemcitabine; NSCLC; Performance status