The aim of this study has been to investigate the potential of serum biomarkers used in clinical practice (CEA, CYFRA 21–1, SCC) together with the serum epidermal growth factor receptor (EGFR) and its associated ligands (EGF, TGF-α, HB-EGF) as outcome predictors of non-small cell lung cancer (NSCLC) patients treated with the TKI erlotinib. The pretreatment levels of these markers were evaluated through immunoassays carried out in 58 patients. The progression-free survival (PFS) and overall survival (OS) were assessed by the Kaplan-Meier method and differences between groups were compared by means of the Log-Rank test. Association of risk factors with survival was evaluated using the univariate and multivariate Cox modelling procedures. Higher CEA (>5 ng/mL) and sEGFR (>56.87 ng/mL) concentrations associated significantly with a higher overall survival. The pre-treatment sEGFR serum levels constituted an independent prognostic factor. The EGFR gene mutational status and the sEGFR level combination was the single to associate significantly with longer progression-free survival periods, in circumstances in which the EGFR gene was mutated and increased protein serum levels were detected. The overall survival as assessed through a Cox analysis revealed similar death hazards with respect to low sEGFR levels combined both with non-mutated EGFR genotypes and low CEA serum levels. Our results suggest that the pre-treatment CEA and sEGFR serum levels may provide a comparable source of information to that supplied by the EGFR gene mutational status with respect to the prognosis of erlotinib treated NSCLC patients. A combined sEGFR and CEA level appraisal could be of considerable value to select patients to undergo EGFR-TKI treatments.

To evaluate the efficacy and toxicity of erlotinib in patients with non-small cell lung cancer. Patients were selected from an outpatients' dispensing database. The time period selected was from January 2008 to January 2010. Data was collected from patient's medical history - electronic and paper based. We used Response Evaluation Criteria in Solid Tumours (RECIST) to measure response and measured time to progression and overall survival. Toxicity was evaluated according to the Common Terminology Criteria for Adverse Events (CTCAE). We found partial response in 5/46 patients and stable disease in 14/46 patients. Time to disease progression was 4.01 months (median 2.33 months) and overall survival was 5.63 months (median 4.67). The most common toxicities were rash, anorexia, asthenia, infection and gastrointestinal side effects. Patients who developed skin toxicity had a (statistically significant) greater time to progression and overall survival rate than the group that did not develop this toxicity (mean time to progression: 2.76 vs. 7.87 months; mean overall survival: 10.74 months vs. 3.98). Survival analysis findings suggest lower efficacy in our patient population in comparison with data seen in other publications, and adverse events followed the expected pattern. Although our greatest limitation was sample size, which must be kept in mind, this therapy could be an alternative for patients with non-small cell lung cancer.