A phase III randomized double blind chemoprevention trial of selenium supplementation in persons with resected stage I non small cell lung cancer: A year-six update.

B150

Selenium in the form of selenized yeast was reported by Clark et al. to have possible lung cancer chemopreventive benefits based on a secondary observation emanating from a large skin cancer prevention trial. (JAMA 1996; 276: 1957-1963). Since that time, epidemiologic, in vitro, and therapeutic research studies have continued to support the hope that non-toxic selenium supplementation may decrease the risk of aerodigestive cancer in persons at high risk, e.g., those with resected bronchogenic cancer. Beginning in October 2000, the Eastern Cooperative Oncology Group (ECOG) with support from the National Cancer Institute Division of Cancer Prevention (NCI DCP) began a double-blind placebo controlled trial using 200 micrograms of Selenium in a 2:1 randomization versus placebo. Eligibility requirements include completely resected Stage I (T1 or T2, N0) non-small cell cancer of the lung with a minimum of 1 negative mediastinal lymph node. Patients must have normal level of selenium/vitamin intake, satisfactory liver function, a negative chest x-ray, and no other evidence of recurrence. Enrollment is allowed from 6 to 36 months post thoracotomy. A four-week run-in period is required during which patients must take at least 75% of the study drug to document compliance. As of September 18, 2006, 1,186 pts have enrolled out of projected total study size of 1,960 participants. Treatment is for 48 months. Study endpoints include incidence of second primary lung tumors and toxicity. The treatment appears to be well tolerated in this study. As of June 2006, a total of 570 patients on randomized step has reported treatment-related toxicities. Only six of them reported toxicities of grade 3 or higher as a worst toxicity. A total of six cooperative groups are participating in this ambitious project. Selenium appears to be very well tolerated in this setting.