Background Gefitinib is indicated for the treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR-TK activating mutations.

Purpose To evaluate the effectiveness and safety of gefitinib in patients with NSCLC from a general hospital and compare it to the results of published studies (IPASS, INTEREST and ISEL).

Materials and methods A retrospective observational study was made of patients with NSCLC treated with gefitinib between January 2012 and September 2013. Study variables: age, sex, smoking, histology, stage, EGFR mutation, ECOG functional status, treatment line, tumour response rate based on the Response Evaluation Criteria in Solid Tumours (RECIST), progression-free survival (PFS) and toxicity. Data source: SELENE software application and clinical records.

Results 6 patients (83.33% women) with a mean age of 70.17 years (range 58–73) were evaluated. 5 were non-smokers (83.33%), while 1 was an ex-occasional smoker (16.67%). All of the tumours were mutated EGFR adenocarcinomas: stage IV (66.67%) and stage IIIB (33.33%). The ECOG score was ≤2. 3 patients (50.00%) started gefitinib 250 mg/day as first line therapy, 2 as second line treatment (33.33%), and 1 as third line treatment (16.67%). All patients showed clinical improvement (lessened dyspnoea and cough), and the first radiological study, based on the RECIST criteria, showed 5 patients to have a partial response (83.33%), while 1 presented stable disease (16.67%). The median PFS was 10 months (range 4–18) (1 patient who abandoned after 4 months due to unknown reasons was excluded). 4 patients continued with the treatment at the end of the study (66.67%). The following side effects (AEs) were observed: grade (G)1–2 diarrhoea (26.67%), G1 asthenia (20.00%), G1–2 acne (20.00%), moderate ALAT elevation (13.33%), G1 mucositis (6.67%), G1 anorexia (6.67%) and G1 conjunctivitis (6.67%). All of these effects were manageable without the need for dose reduction, except ALAT elevation, which required treatment discontinuation for 7 days.

Conclusions Gefitinib showed similar efficacy to published studies. AEs were those described, well tolerated and all reversible.

Owing to the small sample size it would be necessary to obtain a larger sample to draw definitive conclusions.

No conflict of interest.