Abstract SS01-01: View from the NCI: NCI's Division of Cancer Prevention

Abstract

Abstract The Division of Cancer Prevention (DCP) was established in 1997 with the mission to plan and direct cancer prevention research including chemoprevention, nutritional science, genetic and infectious agent studies, early detection including biomarker development and validation, risk stratification, and biometry; and to coordinate community-based clinical research in cancer prevention and supportive care. Since then, there have been 42 new INDs and more than 200 publications about new prevention agents, including new classes of agents such as statins, HDAC inhibitors, NONSAIDs, p53 modulators and vaccines. One recent success is the finding that a combination of the anti-inflammatory sulindac and DFMO, pioneered by DCP, can reduce adenoma return by >95% reduction. In addition more than 50 early phase prevention trials have been conducted, expanding critical knowledge and stimulating science. More than one-third of all people in NCI's prevention, control, supportive care, and treatment trials enroll through DCP's Community Clinical Oncology Program (CCOP) network. The CCOP network initiated four large-scale phase III chemoprevention trials enrolling 87,560 participants over a 15-year period to establish the proof-of-principle that an agent can reduce a person's risk for developing cancer. Two of the trials resulted in the Food and Drug Administration drug approvals: tamoxifen and raloxifene for use in breast cancer risk reduction. A third agent, finasteride for use in prostate cancer risk reduction, is under consideration. The Early Detection Research Network, created in 2000 has made significant progress in: developing an organized effort for biomarker discovery and validation; building resources to support this effort; demonstrating the capabilities of several genomic and proteomic platforms; identifying candidate biomarkers; and undertaking multi-center validation studies. In its first 10 years, the Early Detection Research Network (EDRN) went from a ground-breaking concept to an operational success. To date, EDRN has developed more than 127 biomarkers; has launched 5 validation studies; three of which are completed, and has a number of prioritized markers ready for prevalidation and validation studies. More than 600 publications, more than 28 patents and more than 14 licenses have been generated. The Prostate, Lung, Colorectal, and Ovarian (PLCO) Cancer Screening Trial enrolled 154,934 people to evaluate the effectiveness of various screening modalities on cancer-specific mortality and created the PLCO Biorepository, an invaluable resource of data and samples that precede cancer diagnosis. Data from the screening arms of the trial have been published, providing critical data on the ability of these tests to detect cancer. Mortality data from the prostate arm was published in the NEJM in 2009. The Biorepository has been available to the entire research community since 2005, through the Etiologic and Early Markers Program (EEMS). Over 100 research projects have been approved for use of PLCO biospecimens including genome-wide association studies and environmental and life style risk association studies. The National Lung Screening Trial (NLST) was launched in 2002 and enrolled 53,456 individuals within 18 months. Participants who were current or former smokers, aged 55 to 74, were randomized to screening with either low-dose helical CT or chest x-ray. Three rounds of screening were completed by 2007 with a compliance rate of approximately 90% in both arms. Results are expected in 2011. DCP also has a robust portfolio of nutritional science research that addresses the critical need to unravel the fundamental role of food components in cancer related processes.