37 – Benefit-Risk Assessment and Risk Management
Modeling the Probability of Second Cancer in Controlled Clinical Trials
Kao-Tai Tsai
Celgene Corporation
Due to the advancement of medical technologies and cancer care, the long-term survival of cancer patients have been substantially increased. For some patients, increases in survival have been offset by the long-term late effects of cancer and its treatment. One of the most life-threatening sequelae is the diagnosis of a new malignant cancer. The number of patients with multiple primary cancers is growing with second new cancer now representing approximately 16\% cancers reported to the SEER Program of NCI. Second cancers reflect not only the late effects of therapy but also the influence of shared etiologic factors, genetic susceptibility, environmental exposures, cancer drug exposure, and older age, etc. In this research, we attempt to outline a framework to model the patient-level probability of the occurrence of new cancer malignancies using demographics, efficacy, and safety data which are commonly collected in clinical trials.
