Ncog-01. baseline patient-reported outcomes in an ongoing phase iii trial of pre-operative srs versus post-operative srs for brain metastases

Abstract In ongoing phase III randomized trial (NCT03741673) evaluating risk of LMD in patients with brain metastasis, patients are stratified by tumor size, location, and histology, and randomized to pre- versus post-operative SRS. Exploratory endpoints include patient reported outcomes (PROs) assessing symptoms (MDASI-BT) and health status (EQ-5D-5L). Characteristics of patients (N=40) with pre-treatment baseline include: mean (SD): age 59.3(11.4) years; 2.6(2.2) mets; 15.2(10.3) cc brain met volume; median KPS: 90 (range: 70-100). On the MDASI-BT, 22.5%, 47.5%, 27.5%, 12.5%, and 80% reported no symptoms on the Cognitive, Neurologic, Affective, Constitutional, and Gastrointestinal Factors, respectively. The median factor score was <1 on all factors. Neurologic (r=-.35, p=.03) and Constitutional Factors (r=-0.34, p=.03) correlated with KPS. There was no correlation between MDASI-BT Factors and number/volume of metastases. On the EQ-5D-5L, patients reported no problems with Mobility (45%), Self-Care (72.5%), Usual Activities (62.5%), Pain/Discomfort (55%), and Anxiety/Depression (52.5%). Nearly twenty-eight percent reported no problems in any domain. KPS correlated with Mobility (r=-.48, p< 0.01), Self-Care (r=-.49, p< 0.01), and Usual Activities (r=-.44, p< 0.01). There was no association between EQ-5D-5L items and number/volume of metastases. Patients’ baseline rating of current health on a 0-100 scale (VAS) ranged from 30-100 (mean (SD)=72.25 (19.18)). VAS correlated most with Anxiety/Depression (r=-.40, p=.01). VAS also correlated significantly with MDASI-BT Affective Factor (r=-.541, p< .001) but not with Cognitive or Neurologic Factors. There was no correlation between VAS and KPS or number/volume of metastases. As previously reported, objective measures of cognitive function are associated with disease characteristics. PROs were associated with performance status but not disease characteristics. Mood was more strongly associated with patients’ self-perception of overall health status than clinical or disease characteristics. At baseline, a high proportion of patients report no adverse symptoms, suggesting use of these outcomes is best suited to trials measuring worsening of symptoms.