Randomized Phase Ii Trial Of Radiotherapy With Or Without Erlotinib In Patients With Locally Advanced Or Unresectable Non-Small Cell Lung Cancer

The standard treatment for patients with unresectable or locally advanced NSCLC is radiotherapy. Erlotinib (Tarceva®) is an oral EGFR TKI, that has shown activity in recurrent and metastatic NSCLC. This phase II study aims to assess and compare the toxicity and activity of the addition to erlotinib to radiotherapy. Patients with stage IA-IIIB medically inoperable or unresectable NSCLC, good performance status, measurable disease by RECIST criteria, and written informed consent were enrrolled into this prospective randomized phase II study. Arm A consisted in thoracic 3D radiotherapy (66 Gy in 33 fractions during 6 weeks). Arm B was erlotinib 150 mg po qd starting and given concurrently with 3D radiotherapy (66 Gy in 33 fractions during 6 weeks). Treatment with erlotinib was maintained for 6 months. A total of 17 pts have been randomized from March 2006 to the moment of this analysis. Complete data for 13 pts are available (8 Arm A, 5 Arm B). All pts were caucasian men. Pretreatment characteristics, including age, ECOG PS, smoking habits, histological features, and stage were similar. The incidence of acute esophagitis and other radiotherapy related toxicities was similar in the two arms of treatment. Detailed information about skin toxicity is available for three patienes with 2 patients having dermatitis in the radiation area (one arm A one arm B) and one patient with an exanthema out of the radiation area (arm B) probably related to erlotinib. No dose reductions of erlotinib were necessary. The addition of erlotinib to radiotherapy in the treatment of this patients population is feasible and does not appear to increase in-field toxicities. Data on survival will be presented. Study is ongoing.