An open label non-randomized phase II trial of erlotinib following concurrent chemo-radiotherapy as maintenance therapy in patients (p) with stage III non-small cell lung cancer (NSCLC): A Galician Lung Cancer Group study

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18501 Background: Based on recent studies, concurrent chemo-radiotherapy could be considered the standard treatment of stage III NSCLC pts without malignant effusions. Erlotinib is an oral EGFR TKI that has shown activity in recurrent and metastatic NSCLC. This phase II study aims to assess the activity and toxicity of the addition of erlotinib as a maintenance therapy in stage III NSCLC pts after a standard concurrent chemo-radiotherapy regimen. Methods: Pts with stage IIIA-IIIB (without malignant effusions) medically inoperable or unresectable NSCLC who had received concurrent chemo-radiotherapy and had no sign of progression disease after that treatment, performance status (PS) 0–2, adequate bone marrow, hepatic and renal function, measurable disease by RECIST criteria, and written informed consent were enrolled into this prospective open label one arm phase II study. Pts were treated with erlotinib 150 mg/day po for 6 months as maintenance therapy after standard concurrent chemo-radiotherapy. Primary endpoint of the study is the percentage of pts without evidence of disease progression after 6 months of erlotinib therapy. Results: A total of 28 pts have been recruited from March 2006 to the moment of this analysis. Data from 21 pts is available. All pts were caucasian, men 90%, median age 64 years (range 41–76), current/ever smokers 95,2%, PS 0–1 100%, histology adenocarcinoma 14.3%, squamous cell carcinoma 81%, other histologies 4.7% and stage IIIB 76,2%. 18 pts have been evaluable for response, 16,7% reached complete response, 11.1% partial response, 61,1% stable disease and 11,1% progression disease. 16 pts have ended treatment with erlotinib, of which 8 pts were treated during the 6 expected months, 3 stopped erlotinib due to adverse events (1 grade 3 rash, 1 grade 2 asthenia + grade 2 diarrhea and 1 grade 2 dyspnea + respiratory infection), 2 presented progression disease and 1 retired the informed consent. Conclusions: Erlotinib as maintenance therapy after standard concurrent chemo-radiotherapy treatment in stage III NSCLC p seems to be efficient and does not appear to increase toxicities. Data on survival will be presented. No significant financial relationships to disclose.