title: Carboplatin and weekly paclitaxel doublet chemotherapy compared with monotherapy in elderly patients with advanced non-small-cell lung cancer: IFCT-0501 randomised, phase 3 trial.
abstract: BACKGROUND
  Platinum-based doublet chemotherapy is recommended to treat advanced non-small-cell lung cancer (NSCLC) in fit, non-elderly adults, but monotherapy is recommended for patients older than 70 years. We compared a carboplatin and paclitaxel doublet chemotherapy regimen with monotherapy in elderly patients with advanced NSCLC.
  
  
  METHODS
  In this multicentre, open-label, phase 3, randomised trial we recruited patients aged 70-89 years with locally advanced or metastatic NSCLC and WHO performance status scores of 0-2. Patients received either four cycles (3 weeks on treatment, 1 week off treatment) of carboplatin (on day 1) plus paclitaxel (on days 1, 8, and 15) or five cycles (2 weeks on treatment, 1 week off treatment) of vinorelbine or gemcitabine monotherapy. Randomisation was done centrally with the minimisation method. The primary endpoint was overall survival, and analysis was done by intention to treat. This trial is registered, number NCT00298415.
  
  
  RESULTS
  451 patients were enrolled. 226 were randomly assigned monotherapy and 225 doublet chemotherapy. Median age was 77 years and median follow-up was 30.3 months (range 8.6-45.2). Median overall survival was 10.3 months for doublet chemotherapy and 6.2 months for monotherapy (hazard ratio 0.64, 95% CI 0.52-0.78; p<0.0001); 1-year survival was 44.5% (95% CI 37.9-50.9) and 25.4% (19.9-31.3), respectively. Toxic effects were more frequent in the doublet chemotherapy group than in the monotherapy group (most frequent, decreased neutrophil count (108 [48.4%] vs 28 [12.4%]; asthenia 23 [10.3%] vs 13 [5.8%]).
  
  
  CONCLUSIONS
  Despite increased toxic effects, platinum-based doublet chemotherapy was associated with survival benefits compared with vinorelbine or gemcitabine monotherapy in elderly patients with NSCLC. We feel that the current treatment paradigm for these patients should be reconsidered.
  
  
  BACKGROUND
  Intergroupe Francophone de Cancérologie Thoracique, Institut National du Cancer.
authors.affiliation: Service de Pneumologie, Hôpitaux Universitaires de Strasbourg, Université de Strasbourg, Strasbourg, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Quoix
authors.forename: Gérard
authors.initials: G
authors.lastname: Zalcman
authors.forename: Jean-Philippe
authors.initials: JP
authors.lastname: Oster
authors.forename: Virginie
authors.initials: V
authors.lastname: Westeel
authors.forename: Eric
authors.initials: E
authors.lastname: Pichon
authors.forename: Armelle
authors.initials: A
authors.lastname: Lavolé
authors.forename: Jérôme
authors.initials: J
authors.lastname: Dauba
authors.forename: Didier
authors.initials: D
authors.lastname: Debieuvre
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Souquet
authors.forename: Laurence
authors.initials: L
authors.lastname: Bigay-Game
authors.forename: Eric
authors.initials: E
authors.lastname: Dansin
authors.forename: Michel
authors.initials: M
authors.lastname: Poudenx
authors.forename: Olivier
authors.initials: O
authors.lastname: Molinier
authors.forename: Fabien
authors.initials: F
authors.lastname: Vaylet
authors.forename: Denis
authors.initials: D
authors.lastname: Moro-Sibilot
authors.forename: Dominique
authors.initials: D
authors.lastname: Herman
authors.forename: Jaafar
authors.initials: J
authors.lastname: Bennouna
authors.forename: Jean
authors.initials: J
authors.lastname: Tredaniel
authors.forename: Alain
authors.initials: A
authors.lastname: Ducoloné
authors.forename: Marie-Paule
authors.initials: MP
authors.lastname: Lebitasy
authors.forename: Laurence
authors.initials: L
authors.lastname: Baudrin
authors.forename: Silvy
authors.initials: S
authors.lastname: Laporte
authors.forename: Bernard
authors.initials: B
authors.lastname: Milleron
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000401:mortality; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy / Q000401:mortality; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality; D008297:Male; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D015996:Survival Rate; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D000970:Antineoplastic Agents; D003841:Deoxycytidine; D014747:Vinblastine; D016190:Carboplatin; D017239:Paclitaxel; D000077235:Vinorelbine; D000093542:Gemcitabine