title: Randomized phase II trial of gefitinib or gemcitabine or docetaxel chemotherapy in patients with advanced non-small-cell lung cancer and a performance status of 2 or 3 (IFCT-0301 study).
abstract: BACKGROUND
  To compare 3 treatment strategies in chemotherapy naive patients with advanced NSCLC and a PS 2-3.
  
  
  METHODS
  Patients were assigned to gefitinib 250mg daily (n=43) or to gemcitabine (1250mg/m(2) d 1, 8 q 21d) (n=42) or docetaxel (75mg/m(2) d 1 q 21d) (n=42). Treatments were taken until progression or toxicity. The primary endpoint was progression-free survival. Secondary end points were response and overall survival.
  
  
  RESULTS
  Disease control rates were 20.9%, 33.4% and 38.1%, respectively. Median PFS was 1.9 months in the gefitinib arm, 2.0 months in the gemcitabine arm and 2.0 months in the docetaxel arm (HR gemcitabine versus gefitinib: 0.74, 95%CI: [0.48; 1.16], HR docetaxel versus gefitinib: 0.67, 95%CI: [0.43; 1.05]). Median survival times were 2.2, 2.4 and 3.5 months, respectively (HR gemcitabine versus gefitinib: 0.76, 95%CI: [0.48; 1.20], HR docetaxel versus gefitinib: 0.69, 95%CI: [0.44; 1.09]). There were more grade 3-4 adverse events in the docetaxel arm when compared with either the gefitinib arm or the gemcitabine arm.
  
  
  CONCLUSIONS
  In unselected NSCLC patients with PS 2-3, gefitinib, gemcitabine and docetaxel achieved similar results. Docetaxel was associated with higher rates of adverse events.
authors.affiliation: Service d'Oncologie Médicale, AP-HP Hôpital Avicenne, Université Paris XIII, Bobigny, France.
authors.forename: Jean-François
authors.initials: JF
authors.lastname: Morère
authors.forename: Jeanne-Marie
authors.initials: JM
authors.lastname: Bréchot
authors.forename: Virginie
authors.initials: V
authors.lastname: Westeel
authors.forename: Valerie
authors.initials: V
authors.lastname: Gounant
authors.forename: Bernard
authors.initials: B
authors.lastname: Lebeau
authors.forename: Fabien
authors.initials: F
authors.lastname: Vaylet
authors.forename: Fabrice
authors.initials: F
authors.lastname: Barlési
authors.forename: Thierry
authors.initials: T
authors.lastname: Urban
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Souquet
authors.forename: Didier
authors.initials: D
authors.lastname: Debieuvre
authors.forename: Laurence
authors.initials: L
authors.lastname: Baudrin
authors.forename: Gérard
authors.initials: G
authors.lastname: Zalcman
authors.forename: Franck
authors.initials: F
authors.lastname: Morin
authors.forename: Bernard
authors.initials: B
authors.lastname: Milleron
authors.forename: Denis
authors.initials: D
authors.lastname: Moro-Sibilot
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D000077143:Docetaxel; D005260:Female; D000077156:Gefitinib; D006801:Humans; D017567:Karnofsky Performance Status; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011799:Quinazolines / Q000008:administration & dosage / Q000009:adverse effects; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D000093542:Gemcitabine
chemical_list: D011799:Quinazolines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000077156:Gefitinib; D000093542:Gemcitabine