P1-186: Usefulness of autofluorescence bronchoscopy for detecting bronchial premalignant lesions

Abstract

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 hypothesis that non-toxic selenium supplementation may decrease the risk of aerodigestive cancer in persons at high risk, e.g., those with resected bronchogenic cancer. Since October 2000, the Eastern Cooperative Oncology Group (ECOG) with support from the National Cancer Institute Division of Cancer Prevention (NCI-DCP) has been conducting an intergroup 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. Pts 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 wk run-in period is required during which pts must take at least 75% of the study drug to document compliance. As of March 7, 2007, 1268 pts have enrolled out of a projected total study size of 1960 participants. Treatment is for 48 months. Study endpoints include cancer recurrence, incidence of second primary lung tumors (SPTs), and/or toxicity. Treatment appears to be extremely well tolerated in this study. As of December 2006, a total of 363 patients on randomized step have reported treatment-related toxicities. Only six of them reported toxicities of grade 3 or higher as a worst toxicity. 133 grade 3, 4, or 5 severe adverse events have been reported with no difference between study drug and placebo. A total of six cooperative groups are participating in this ambitious project. Selenium appears to be very well tolerated in this setting. Accrual is projected to continue until 1960 pts have enrolled or until 90 SPTs have occurred.