16th EORTC-NCI-AACR Symposium on Molecular Targets, Cancer Therapeutics

28 September - 1 October 2004, Geneva, Switzerland

Abstracts

Abstract 583: Serum proteomic biomarkers of a natural product in a prospective randomized placebo-controlled clinical trial in patients at risk for lung cancer

Citation: European Journal of Cancer Supplements Volume 2, No.8, September 2004, page 177

S. Baek, D. Campos, E. Izbicka, J Jiang

Cancer Therapy and Research Center, The Institute for Drug Development, San Antonio, TX, USA

Smoking, asthma, and chronic obstructive pulmonary disease (COPD) are known risk factors for lung cancer. The disease may be preventable, but many potential chemopreventive agents have not shown clinical activity in individuals at risk for lung cancer (Van Zandvijk et al, Lung Cancer 2003, 42:S71). A novel natural product LP01 demonstrated preclinical preventive and anticancer activities, and induced time-and dose-dependent changes in serum kallikreins and proteomic patterns in human lung cancer xenograft models (Baek et al, Proc AACR/NCI/EORTC 2003).

The present study evaluated LP01 in a prospective, randomized, triple-masked, placebo-controlled, parallel-group clinical trial. In this study, lung cancer risk (1­5) was assessed based on length of addiction, asthma, and COPD, for a group of former long-term smokers (smoked >20 years, quit >1 year). This group, comprised of sixty men and women ages 35­70, received oral daily doses of 3,650 mg LP01 or placebo for 6 months.

Peripheral blood serum specimens were obtained at the baseline and after drug treatment for 2 weeks, 1 month, 2 months, 4 and 6 months. Serum proteins were resolved on IMAC3/Cu metal affinity ProteinChip arrays and analyzed by surface-enhanced ligand desorption/ionization (SELDI). There were no adverse clinical effects of the therapy. The patients were stratified by the low risk (1 to -