ACTR-35. REPRESENTATION OF PATIENTS WITH CNS DISEASE IN PHASE I CLINICAL TRIALS: SINGLE CENTER EXPERIENCE

Abstract

Phase I clinical trials largely target patients with advanced or metastatic tumors. However patients with active brain metastases are often excluded from such studies that are designed to test new anticancer agents. We evaluated representation and outcomes of patients with brain metastases in clinical trials for advanced solid tumors in the New Therapeutics Program (phase I) at the West Cancer Center. We identified all patients that were enrolled in phase I studies for advanced solid tumors at the West Cancer Center from January 2010 to May 2016 and had a secondary diagnosis of “secondary malignant neoplasm of the brain and spinal cord”. We conducted a retrospective chart review of these patients to get information on the demographic, clinical and tumor characteristics as well as type of treatment and outcomes. We identified 241 patients treated on phase I clinical trial for advanced solid tumors, of which 36 patients were diagnosed with CNS metastases. Patients diagnosed post enrolment were excluded from the analysis that left just 9 patients that were enrolled in trial with known CNS metastases. 4 of these patients were enrolled in trials for lung cancer and 5 in basket trials. 7 of these patients were enrolled within the last 2 years. Patients with CNS metastases continue to be under-represented in clinical trials for advanced solid tumors. However with the availability of molecular profiling, “basket trials” and targeted therapy are new options for these patients. There is an increasing trend towards enrolment of these patients in early phase studies of drug development