title: Feasibility, tolerability, and efficacy of the concurrent addition of erlotinib to thoracic radiotherapy in locally advanced unresectable non-small-cell lung cancer: a Phase II trial.
abstract: OBJECTIVE
  Although many studies have confirmed the synergic effects of combining chemotherapy (CT) and radiotherapy (RT), clinical data evaluating safety and efficacy of erlotinib in combination with RT in locally advanced non-small-cell lung cancer (NSCLC) are limited. The aim of this study was to determine the feasibility, tolerability, and efficacy of the concurrent addition of erlotinib to the standard three-dimensional conformal thoracic RT in patients with unresectable or locally advanced NSCLC who are not candidates for receiving standard CT.
  
  
  METHODS
  Feasibility and tolerability, assessed by evaluating adverse events (AEs), and effectiveness, by calculating progression-free survival (PFS), overall survival (OS), cancer-specific survival (CSS), and objective response rate (ORR), were analyzed in 30 patients receiving RT alone and 60 receiving RT and erlotinib.
  
  
  RESULTS
  Erlotinib with RT showed an extended CSS and a higher rate of complete responses compared with RT alone. No differences between groups were found regarding OS, PFS, and ORR. AEs were significantly higher in the combined treatment, which mainly included cutaneous toxicity, dyspnea, fatigue, hyporexia, diarrhea, and infection. Erlotinib did not increase the toxicity produced by RT.
  
  
  CONCLUSIONS
  The combination of erlotinib with RT produced, in our study, a scarce clinical benefit in the treatment of unresectable or locally advanced NSCLC, limited to complete responses and longer CSS rate compared with RT alone. Increased toxicity events were associated with combined therapy, which mainly included cutaneous toxicity. In our opinion, further studies in molecularly unselected lung cancer patients treated with EGFR TKIs and RT are not indicated. The use of biomarkers for the identification of patients that are most likely to benefit from this treatment is an essential next step in the research of this condition.
authors.affiliation: Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain.
authors.forename: Enrique
authors.initials: E
authors.lastname: Martínez
authors.affiliation: Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain.
authors.forename: Maite
authors.initials: M
authors.lastname: Martínez
authors.affiliation: Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain.
authors.forename: Mikel
authors.initials: M
authors.lastname: Rico
authors.affiliation: Radiation Oncology Services, Hospital of Navarra, Pamplona, Spain.
authors.forename: Berta
authors.initials: B
authors.lastname: Hernández
authors.affiliation: Medical Oncology Department, Clinical Hospital of Barcelona, Barcelona, Spain.
authors.forename: Francesc
authors.initials: F
authors.lastname: Casas
authors.affiliation: Medical Oncology Department, Clinical Hospital of Barcelona, Barcelona, Spain.
authors.forename: Nuria
authors.initials: N
authors.lastname: Viñolas
authors.affiliation: Department of Radiation Oncology, Jiménez Díaz Foundation, Madrid, Spain.
authors.forename: Ana
authors.initials: A
authors.lastname: Pérez-Casas
authors.affiliation: Department of Radiation Oncology, Jiménez Díaz Foundation, Madrid, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Dómine
authors.affiliation: Department of Radiation Oncology, University Hospital of Donostia, San Sebastian, Spain.
authors.forename: Julián
authors.initials: J
authors.lastname: Mínguez
keywords: concurrent; erlotinib; non-small-cell lung cancer; radiotherapy