title: Non-small cell lung cancer recurrence following surgery and perioperative chemotherapy: Comparison of two chemotherapy regimens (IFCT-0702: A randomized phase 3 final results study).
abstract: BACKGROUND
  This study compared the efficacy of docetaxel alone vs. docetaxel plus cisplatin/carboplatin in resected NSCLC patients relapsing after preoperative, adjuvant, or perioperative platinum-based chemotherapy.
  
  
  METHODS
  Patients were randomly assigned to receive docetaxel plus cisplatin/carboplatin (Arm A) or docetaxel alone (Arm B). Primary endpoint was progression-free survival (PFS). Secondary endpoints were response rate at 6 weeks, toxicity, quality of life, and overall survival (OS).
  
  
  RESULTS
  From November 2007 to August 2012, 88 patients were enrolled. Due to an unexpectedly slow accrual, the trial was prematurely stopped. Adding platinum to docetaxel caused a non-significant increase in PFS. Median PFS was 8.0 months (95% CI: 5.3-10.4) for Arm A vs. 5.6 months (95% CI: 4.0-7.3) for Arm B (HR: 0.71, 95% CI: 0.45-1.1, p=0.15). Median OS was 16.0 months (95% CI: 10.1-23.9) for Arm A vs. 12.4 months (95% CI: 8.2-19.6) for Arm B. In pre-planned subgroup analyses, a time to recurrence ≥12 months and non-squamous histology favorably influenced OS (HR: 0.51, 95% CI: 0.29-0.91, p=0.02 and HR: 0.54, 95% CI: 0.33-0.91, p=0.02, respectively). There were no unexpected adverse events, and Grade 3-4 toxicity was comparable in both groups.
  
  
  CONCLUSIONS
  Our study failed to demonstrate significant PFS improvement with the docetaxel-platinum doublet compared to single-agent docetaxel. The 3.6-month improvement in OS with the cisplatin-based doublet proves, however, appealing and merits further investigation.
authors.affiliation: Department of Thoracic Oncology, Pole Thorax Vaisseaux, CHU Grenoble and INSERM U 823, CS10217, Grenoble, France. Electronic address: DMoro.pneumo@chu-grenoble.fr.
authors.forename: Denis
authors.initials: D
authors.lastname: Moro-Sibilot
authors.affiliation: Department of Pneumology, Hôpital Sainte Musse, Toulon, France.
authors.forename: Clarisse
authors.initials: C
authors.lastname: Audigier-Valette
authors.affiliation: Department of Pneumology-Thoracic Oncology, CHU Hôpital Gabriel Montpied, Clermont-Ferrand, France.
authors.forename: Patrick
authors.initials: P
authors.lastname: Merle
authors.affiliation: Department of Pneumology, Nouvel hôpital civil, Hôpitaux universitaires de Strasbourg, Strasbourg, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Quoix
authors.affiliation: Department of Pneumology, Centre Hospitalier Lyon Sud, Pierre-Bénite, France.
authors.forename: Pierre-Jean
authors.initials: PJ
authors.lastname: Souquet
authors.affiliation: Aix Marseille Université, Assistance Publique Hôpitaux de Marseille, Multidisciplinary Oncology and Therapeutic Innovation Unit, Hôpital Nord, Centre d'investigation clinique, Marseille, France.
authors.forename: Fabrice
authors.initials: F
authors.lastname: Barlesi
authors.affiliation: Department of Pneumology, Centre hospitalier intercommunal de Créteil, Créteil, France.
authors.forename: Christos
authors.initials: C
authors.lastname: Chouaid
authors.affiliation: Pneumology, Centre Hospitalier, Le Mans, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Molinier
authors.affiliation: Institut de Cancérologie de l'Ouest, Saint-Herblain, France.
authors.forename: Jaafar
authors.initials: J
authors.lastname: Bennouna
authors.affiliation: Pneumology, AP-HP Hôpital Tenon, Paris, France.
authors.forename: Armelle
authors.initials: A
authors.lastname: Lavolé
authors.affiliation: Pneumology, CHU, Toulouse, France.
authors.forename: Julien
authors.initials: J
authors.lastname: Mazières
authors.affiliation: Department of Thoracic Oncology, Pole Thorax Vaisseaux, CHU Grenoble and INSERM U 823, CS10217, Grenoble, France.
authors.forename: Anne-Claire
authors.initials: AC
authors.lastname: Toffart
authors.affiliation: French Cooperative Thoracic Intergroup (IFCT), Paris, France.
authors.forename: Alexandra
authors.initials: A
authors.lastname: Langlais
authors.affiliation: French Cooperative Thoracic Intergroup (IFCT), Paris, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Morin
authors.affiliation: Department of Pneumology and Thoracic Oncology, CHU Caen, Côte de Nacre, Caen, France.
authors.forename: Gérard
authors.initials: G
authors.lastname: Zalcman
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008175:Lung Neoplasms / Q000401:mortality / Q000473:pathology* / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D009367:Neoplasm Staging; D059035:Perioperative Period; D016019:Survival Analysis; D016896:Treatment Outcome
keywords: Chemotherapy; Cisplatin; Docetaxel; Non-small cell lung cancer; Prognosis; Second line