title: Real-life effectiveness of erlotinib as second-line treatment of stage IIIB/IV squamous non-small cell lung cancer: Results of the PEPiTA observational study.
abstract: Erlotinib, an inhibitor of tyrosine kinase activity of the epidermal growth factor receptor, is effective in non-small cell lung cancer (NSCLC). Data on erlotinib use in squamous NSCLC are limited. This observational study aimed at evaluating the efficacy and safety of second-line erlotinib in patients with stage IIIB/IV squamous NSCLC in a real-life setting.
  
  
  
  Patients with predominantly squamous stage IIIB/IV NSCLC, who failed first-line platinum-based therapy, were recruited and followed-up for 12 months. Patients underwent visits each trimester. Data were derived from case report forms, and functional assessment of cancer therapy-lung (FACT-L) questionnaires.
  
  
  
  A total of 152 patients were enrolled; the majority were males (90%) and mean age was 67.7 years. All patients had squamous (97%) or predominantly squamous (3%) NSCLC, of stage IIIB (21%) or IV (79%). Median progression free survival (PFS) and overall survival were 3 and 5.8 months, respectively. Disease progression was observed in the majority of the patients, mostly due to progression of primary tumour and/or metastatic sites, and led to death in 91/107 of patients. Of the 107 deaths reported, none were due to erlotinib. FACT-L questionnaires were interpretable up to the first visit and were in line with PFS data, showing a relatively good quality of life up to Month 3 (mean total score=78.8). No new or unexpected safety issues were reported.
  
  
  
  The results of this real-life cohort study like those of previous phase III/IV subgroups study analyses indicate that erlotinib is a valuable option for second-line treatment of stage IIIB/IV squamous NSCLC.
authors.affiliation: Centre Hospitalier Intercommunal de Créteil, Créteil, France. Electronic address: isabelle.monnet@chicreteil.fr.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Monnet
authors.affiliation: Centre Hospitalier Sainte Musse, Toulon, France.
authors.forename: Clarisse
authors.initials: C
authors.lastname: Audigier-Valette
authors.affiliation: Hôpital Louis Pradel, Institut de Cancérologie des Hospices Civils de Lyon, Bron, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Girard
authors.affiliation: Centre Hospitalier Universitaire Dupuytren, Limoges, France.
authors.forename: Alain
authors.initials: A
authors.lastname: Vergnenègre
authors.affiliation: Centre Hospitalier du Mans, Le Mans, Cedex 9 France, France.
authors.forename: Olivier
authors.initials: O
authors.lastname: Molinier
authors.affiliation: Centre Hospitalier Lyon-Sud, Pierre Bénite, France.
authors.forename: Pierre Jean
authors.initials: PJ
authors.lastname: Souquet
authors.affiliation: Centre Hospitalier de Meaux, Meaux, France.
authors.forename: François
authors.initials: F
authors.lastname: Blanchon
authors.affiliation: Centre Hospitalier Régional Universitaire, Besançon, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Bonnetain
authors.affiliation: Roche France S.A.S, Boulogne-Billancourt, France.
authors.forename: Naila
authors.initials: N
authors.lastname: Taguieva-Pioger
authors.affiliation: Centre Hospitalier Universitaire de Poitiers, Poitiers, France.
authors.forename: Corinne
authors.initials: C
authors.lastname: Lamour
authors.affiliation: Service de Pneumologie Hôpital Tenon, 4 Rue de la Chine, 75020 Paris, France.
authors.forename: Marie
authors.initials: M
authors.lastname: Wislez
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology*; D000069347:Erlotinib Hydrochloride / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009367:Neoplasm Staging; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011788:Quality of Life; D019233:Retreatment; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D000069347:Erlotinib Hydrochloride
keywords: Erlotinib; Observational; Progression-free survival; Squamous non-small cell lung cancer; Stage IIIB/IV