#A201 BBIC vs. Oral Leukoplakia: Response, Safety and Accrual: Will it Equal Success? William Armstrong,1 Westley J. Lagerberg,1 Thomas H. Taylor,1 Daniel C. Carreon,1 Diana V. Messadi,1 Jill Y. Kay,1 Ann R. Kennedy,2 Xavier S. Wan,2 Frank L. Meyskens, Jr. 1 University of California, Irvine,1 Orange, CA, University of Pennsylvania,2 Philadelphia, PA. Bowman-Birk Inhibitor Concentrate (BBIC) is currently under investigation in a Phase IIb double blinded, randomized, placebo controlled clinical trial against oral leukoplakia. Twenty subjects with complete oral examination data and six-months BBIC treatment were analyzed for clinical response. Clinical response was estimated by the relative percent change in total lesion area over the six-month period. Mean total lesion area declined from 674.4 mm2 (sd=745.85) to 368.6 mm2 (sd=506.76). The mean relative percent change in total lesion area was -42.4 % (sd=35.61), which was significantly different from the null-hypothesis expectation of zero (t = -5.321, p < 0.0001). Seven subjects showed at least a 50% reduction in total lesion area, with two complete clinical responses. The remaining subjects showed improvement below the criterion for partial response, with the exception of one subject showing zero percent change and another showing a 33% increase in total lesion area. These results are for the cohort as a whole, without regard to treatment arm, and thus seem encouraging. Twenty five of 48 randomized participants are recorded as having a total of 51 adverse events (AE), with the number per person ranging from 1 though 8 (mean = 2.04). Forty of the 51 AE (78%) were grade one (mild), while 7 (14%) were grade 2 (moderate). There were two AE each at grade 3 (severe) and grade 4 (hospitalization). No deaths were associated with this study. Thirty eight of 51 (75%) AE were considered not related or unlikely related to treatment, including all grade 3 and grade 4 AE. Of the 13 AE considered at least possibly related to treatment, 12 were grade one and 1 was grade two. Subject accrual is a major challenge in this prevention trial. One contributing factor is the population from which participants are drawn, which has a low overall incidence of tobacco use. A number of strategies have been employed to increase accrual with varying success. Most successful has been radio advertising, but this has been very expensive. Inclusion of an additional university has also boosted accrual. Community presentations to dental hygienists, continuing education activities for medical and dental professionals, recruitment letters to dental professionals, and newspaper advertising to ethnic communities at high risk of oral cancer had little to no measurable return on effort invested. Continued efforts to develop creative strategies to boost accrual are being made, including addition of staff with expertise in increasing minority recruitment. Overall, unblinded clinical response so far is encouraging and drug toxicity appears minimal. Subject accrual remains the most significant challenge for completion of this chemoprevention trial of BBIC. Frontiers in Cancer Prevention Research, 2003 AACR Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.