title: Erlotinib in salvage treatment of patients with advanced non-small cell lung cancer: results of an expanded access programme in Poland.
abstract: OBJECTIVE
  Erlotinib and gefitinib are reversible EGFR-TKI administered orally. Results of the phase III study JBR.21 proved the clinical efficacy of erlotinib-based regimens as second- or third-line treatment of advanced NSCLC. We analyze efficacy of treatment with erlotinib in patients suffering from advanced stage NSCLC who participated in the multicentre, international phase IV study - MO 18109 TRUST (expanded access clinical program of Tarceva™ in patients with advanced stage IIIB/IV NSCLC). Our analysis was performed based on clinical data derived from centres with the largest number of patients who received erlotinib.
  
  
  METHODS
  Between May and November 2005, a total of 56 patients (19 women and 37 men) with histologic or cytologic diagnosis of NSCLC were included in the study. The histological diagnosis was: squamous-cell (n = 23), adenocarcinoma (n = 20), broncho-alveolar carcinoma (n = 2). In 11 patients the type of NSCLC was not specified.
  
  
  RESULTS
  Patients received erlotinib in a single dose of 150 mg per day. Partial response (PR), stable disease (SD) or progressive disease (PD) were observed in 5 (9%), 33 (59%) and 16 (29%) patients respectively. Median PFS was 16.0 weeks. In the study population adverse events (AE) were noted in 12 (21%) patients.
  
  
  CONCLUSIONS
  Results of the TRUST study in the Polish population confirmed the efficacy of erlotinib in advanced NSCLC after failure of prior platinum-based chemotherapy. Treatment with erlotinib was associated with longer PFS as compared to the JBR.2 study, whole TRUST study population and Italian population included in the TRUST study.
authors.affiliation: The Maria Sklodowska-Curie Memorial Cancer Centre and Institute, Department of Lung Cancer and Chest Tumours, Warsaw, Poland.
authors.forename: Dariusz M
authors.initials: DM
authors.lastname: Kowalski
authors.forename: Maciej
authors.initials: M
authors.lastname: Krzakowski
authors.forename: Rodryg
authors.initials: R
authors.lastname: Ramlau
authors.forename: Piotr
authors.initials: P
authors.lastname: Jaskiewicz
authors.forename: Anna
authors.initials: A
authors.lastname: Janowicz-Żebrowska
keywords: TRUST; erlotinib; non-small cell lung cancer; prognostic factors