title: Randomized open-label non-comparative multicenter phase II trial of sequential erlotinib and docetaxel versus docetaxel alone in patients with non-small-cell lung cancer after failure of first-line chemotherapy: GFPC 10.02 study.
abstract: BACKGROUND
  Concomitant administration of erlotinib with standard chemotherapy does not appear to improve survival among patients with non-small-cell lung cancer (NSCLC), but preliminary studies suggest that sequential administration might be effective.
  
  
  OBJECTIVE
  To assess the efficacy and tolerability of second-line sequential administration of erlotinib and docetaxel in advanced NSCLC.
  
  
  METHODS
  In an open-label phase II trial, patients with advanced NSCLC, EGFR wild-type or unknown, PS 0-2, in whom initial cisplatin-based chemotherapy had failed were randomized to sequential erlotinib 150 mg/d (day 2-16)+docetaxel (75 mg/m(2) d1) (arm ED) or docetaxel (75 mg/m(2) d1) alone (arm D) (21-day cycle). The primary endpoint was the progression-free survival rate at 15 weeks (PFS 15). Secondary endpoints included PFS, overall survival (OS), the overall response rate (ORR) and tolerability. Based on a Simon optimal two-stage design, the ED strategy was rejected if the primary endpoint was below 33/66 patients at the end of the two Simon stages.
  
  
  RESULTS
  147 patients were randomized (median age: 60±8 years, PS 0/1/2: 44/83/20 patients; males: 78%). The ED strategy was rejected, with only 18 of 73 patients achieving PFS15 in arm ED at the end of stage 2 and 17 of 74 patients in arm D. In arms ED and D, respectively, median PFS was 2.2 and 2.5 months and median OS was 6.5 and 8.3 months.
  
  
  CONCLUSIONS
  Sequential erlotinib and docetaxel was not more effective than docetaxel alone as second-line treatment for advanced NSCLC with wild-type or unknown EGFR status.
authors.affiliation: Department of Pneumology, Quesnay Hospital, Mantes La Jolie, France. Electronic address: jb.auliac@ch-mantes-la-jolie.fr.
authors.forename: J B
authors.initials: JB
authors.lastname: Auliac
authors.affiliation: Department of Pneumology, Saint Antoine Hospital, Paris, France.
authors.forename: C
authors.initials: C
authors.lastname: Chouaid
authors.forename: L
authors.initials: L
authors.lastname: Greillier
authors.affiliation: Multidisciplinary Oncology and Therapeutic Innovations, AP-HM, Marseilles, France.
authors.forename: L
authors.initials: L
authors.lastname: Greiller
authors.affiliation: Service de pneumologie, CHI, Creteil, France.
authors.forename: I
authors.initials: I
authors.lastname: Monnet
authors.affiliation: CH de Draguignan, Draguignan, France.
authors.forename: H
authors.initials: H
authors.lastname: Le Caer
authors.affiliation: CH Villefranche Sur Saone, Villefranche-sur-Saone, France.
authors.forename: L
authors.initials: L
authors.lastname: Falchero
authors.affiliation: Pneumology, CHU Pontchaillou, Rennes, France.
authors.forename: R
authors.initials: R
authors.lastname: Corre
authors.affiliation: CHU Morvan, Brest, France.
authors.forename: R
authors.initials: R
authors.lastname: Descourt
authors.affiliation: Hôpital Charles Nicolle, Rouen, France.
authors.forename: S
authors.initials: S
authors.lastname: Bota
authors.affiliation: Pneumology, HIA, Toulon, France.
authors.forename: H
authors.initials: H
authors.lastname: Berard
authors.affiliation: Centre Paul Strauss, Strasbourg, France.
authors.forename: R
authors.initials: R
authors.lastname: Schott
authors.affiliation: CHD La Roche Sur Yon, La Roche Sur Yon, France.
authors.forename: A
authors.initials: A
authors.lastname: Bizieux
authors.affiliation: Institut de Cancérologie de la Loire, Saint Priest En Jarez, France.
authors.forename: P
authors.initials: P
authors.lastname: Fournel
authors.affiliation: CEBIMER, CHU limoges, Limoges, France.
authors.forename: A
authors.initials: A
authors.lastname: Labrunie
authors.affiliation: CEBIMER, CHU limoges, Limoges, France.
authors.forename: B
authors.initials: B
authors.lastname: Marin
authors.affiliation: CHU Limoges, Limoges, France.
authors.forename: A
authors.initials: A
authors.lastname: Vergnenegre
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D008297:Male; D008875:Middle Aged; D011799:Quinazolines / Q000008:administration & dosage; D019233:Retreatment; D012307:Risk Factors; D043823:Taxoids / Q000008:administration & dosage; D017211:Treatment Failure; D016896:Treatment Outcome
chemical_list: D011799:Quinazolines; D043823:Taxoids; D000077143:Docetaxel; D000069347:Erlotinib Hydrochloride
keywords: Docetaxel; Epithelial growth factor wild-type status; Erlotinib; Non-small-cell lung cancer; Second-line