NCOG-47. SYMPTOMATOLOGY OF PRIMARY BRAIN TUMOR PATIENTS AT CLINICAL TRIAL INITIATION: SNAPSHOT FROM THE NCI NOB-NATURAL HISTORY STUDY

Clinical trial endpoints include response/survival, but also treatment tolerance and clinical benefit. Few reports exist on the frequency and type of disease-related symptoms and functions and treatment-associated symptomatic toxicities at clinical trial initiation. The MD Anderson Symptom Inventory-Brain Tumor self-reports from patients at baseline of a clinical trial initiation were retrospectively evaluated for the presence of severe ratings ( ≥ 7 for symptom, ≥ 6 for interference) of Reeve's toxicity symptoms (TS) (pain, fatigue, nausea, insomnia, anxiety, dyspnea, anorexia, depression, vomiting, neuropathy, constipation, diarrhea) and RANO-COA Collaborative core disease-related symptoms (DRS) (pain, perceived cognition, difficulty communicating, seizure, physical function, role/social functioning). A total of 137 baseline assessments from 132 patients for 10 clinical trials were evaluated. Patients were primarily white (82%) males (67%), with median age 48 years (range: 19-76), initiating treatment for a recurrent (86%) high grade (95%) tumor. Thirty-six percent reported severe TS (range: 1-9) and 48% reported DRS (range: 1-8), both with a median of 2 symptoms. All 12 TS and 7 DRS were reported as severe (TS range: 3%-23%); DRS range: 1%-25%); most common were fatigue (23%), insomnia (12%), and anxiety (10%) for TS, and role/social function-work (25%), physical function-walking (24%), and role/social function-usual activity (20%) for DRS. Those ≤ 4 weeks since recurrence more frequently reported TS (53%) or DRS (62%). TS were more common if treatment initiation closely followed a previous treatment (0-4 weeks: 45%). Baseline symptom occurrence and functional limitations and their severity at clinical trial initiation are critical to understanding tolerability and clinical benefit. For TS, baseline adjustments are warranted for anticipated symptomatic toxicities. High disease-related symptom severity necessitates symptom management and supportive care approaches for patients entering clinical trials and promotes symptomatic improvement measures as trial endpoints along with traditional measures such as tumor reduction and prolongation of survival outcomes.