Patient-Reported Outcome Endpoints
anxiety/depression, breast cancer, toxicity, cancer, Cancer
DISEASE PROGRESSION, ADVERSE EVENT, BREAST CANCER, CANCER, CANCER
Patient-reported outcomes (PROs) were measured at baseline, and every 4 weeks for 24 weeks or at disease progression via the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ-C30), the EORTC breast cancer module (QLQ-BR23), and the European Quality of Life 5-Domain 5-Level Scale (EQ-5D-5L) health questionnaire. Missed expected menstrual periods were assessed via the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) questionnaire.The EORTC QLQ-C30 is a standardized instrument that assesses cancer-specific patient-reported global quality of life, functioning, and disease/treatment-related symptoms. Patients self-rate their self-care, activity level, pain/discomfort, and mental health during the past week by choosing responses from a 4-point Likert scale. On all EORTC scales, responses to all items are converted to a 0-to-100 scale with a standard scoring algorithm. For functional and Global Health Status/Quality of Life (GHS/QoL) scales, higher scores indicate a better level of functioning and quality of life. For symptom scales, a higher score indicates greater symptom severity.The EQ-5D-5L consists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each of which have 5 possible responses indicating the level of the problem (1, no problem; 2, slight problem; 3, moderate problem; 4, severe problem; 5, extreme problem). Results of the 5 dimensions are combined to derive an EQ-5D index score that ranges from −0.594 to 1.0 corresponding to worst and best health status (using a UK valuation based on the EQ-5D-3L).The PRO-CTCAE item library questionnaire is a PRO measure developed to evaluate symptomatic toxicity in patients on cancer clinical trials.