title: A phase II trial of erlotinib as maintenance treatment after concurrent chemoradiotherapy in stage III non-small-cell lung cancer (NSCLC): a Galician Lung Cancer Group (GGCP) study.
abstract: OBJECTIVE
  This single arm, phase II study aims to evaluate the role of epidermal growth factor receptor-tyrosine-kinase inhibitor erlotinib as maintenance therapy following concurrent chemoradiotherapy (cCRT) in unresectable locally advanced non-small-cell lung cancer (NSCLC).
  
  
  METHODS
  Patients with unresectable stage IIIA o dry IIIB NSCLC with no evidence of tumor progression after receiving a standard cCRT regimen with curative intent were included. Oral erlotinib 150 mg/day was administered within 4-6 weeks after the end of the cCRT for a maximum of 6 months if no disease progression or intolerable toxicity occurred. Primary end point was the progression-free rate (PFR) at 6 months. Secondary end points included time to progression (TTP) and overall survival (OS).
  
  
  RESULTS
  Sixty-six patients were enrolled and received maintenance treatment with erlotinib [average: 4.5 months (95 % CI 4.0-5.0)]. PFR at 6 months was 63.5 % (41/66). With a median follow-up of 22.7 months (95 % CI 13.5-37.1), the median TTP was 9.9 months (95 % CI 6.2-12.1), and the median OS was 24.0 months (95 % CI 17.3-48.6). Most common adverse events (AEs) related to erlotinib were rash (78.8 %; 16.7 % grade 3), diarrhea (28.8 %; 1.5 % grade 3), fatigue (15.2 %; 1.5 % grade 3), anorexia (7.6 %; 1.5 % grade 3) and vomiting (4.6 %; none grade 3). Five patients (7.6 %) were withdrawn due to AEs.
  
  
  CONCLUSIONS
  Erlotinib as maintenance therapy is an active treatment after cCRT in unselected patients with stage III NSCLC, reaching a 6-month PFR of 63.5 % and a median OS of 24 months. The safety profile of maintenance erlotinib was as expected and manageable.
authors.affiliation: Medical Oncology Department, Complexo Hospitalario Universitario de Vigo (CHUVI), Vigo, Spain, joaquin.casal.rubio@sergas.es.
authors.forename: J
authors.initials: J
authors.lastname: Casal Rubio
authors.forename: J L
authors.initials: JL
authors.lastname: Fírvida-Pérez
authors.forename: M
authors.initials: M
authors.lastname: Lázaro-Quintela
authors.forename: F J
authors.initials: FJ
authors.lastname: Barón-Duarte
authors.forename: G
authors.initials: G
authors.lastname: Alonso-Jáudenes
authors.forename: L
authors.initials: L
authors.lastname: Santomé
authors.forename: F J
authors.initials: FJ
authors.lastname: Afonso-Afonso
authors.forename: M
authors.initials: M
authors.lastname: Amenedo
authors.forename: G
authors.initials: G
authors.lastname: Huidobro
authors.forename: B
authors.initials: B
authors.lastname: Campos-Balea
authors.forename: M D
authors.initials: MD
authors.lastname: López-Vázquez
authors.forename: S
authors.initials: S
authors.lastname: Vázquez
mesh_terms: D000328:Adult; D000368:Aged; D002289:Carcinoma, Non-Small-Cell Lung / Q000188:drug therapy* / Q000473:pathology; D059248:Chemoradiotherapy; D018450:Disease Progression; D018572:Disease-Free Survival; D000069347:Erlotinib Hydrochloride; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D011799:Quinazolines / Q000008:administration & dosage* / Q000009:adverse effects; D015996:Survival Rate
chemical_list: D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000069347:Erlotinib Hydrochloride