PCN481 METHODOLOGICAL ASPECTS OF HEALTH-RELATED QUALITY OF LIFE MEASUREMENT IN PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER IN CLINICAL TRIALS: A SYSTEMATIC REVIEW.

Abstract

HER2-positive breast cancer is characterized by the overexpression of human epidermal growth factor receptor 2 (HER2) and is associated with poor prognosis. While there is no cure for HER2-positive metastatic breast cancer (MBC), survival outcomes have improved over the last decade due to the availability of novel agents. Health-related quality of life (HRQoL) data is becoming increasingly important to understand the long-term treatment impact on patients’ well-being. This systematic review aimed to identify the methodological aspects of HRQoL measurement among HER2+ MBC patients and critically appraise their strengths and weaknesses. A comprehensive search was conducted using PubMed, Embase, and Cochrane from database initiations to March 30, 2019, to identify publications of HER2+ MBC clinical trials that have reported HRQoL data in the English language. Following the PRISMA guideline, we screened 1566 articles and identified 14 studies that met our inclusion and exclusion criteria. Seven HRQoL instruments (EORTC QLQ-C30, FACT-G, FACT-B, FACT-B TOI, EORTC QLQ-BR23, FACT-Br, and EORTC QLQ-BN20) were identified, among which FACT-Br and EORTC QLQ-BN20 were used in breast cancer with brain metastasis. Five out of the fourteen studies used more than one instrument. Across the seven instruments, EORTC QLQ-C30 (9/14 studies) was most frequently used. All publications reported HRQoL as secondary endpoints. The literature demonstrates the complementary value of HRQoL when assessing clinical effectiveness and safety outcomes. However, significant diversity in the applied HRQoL instruments, the HRQoL assessment strategies, the timing of HRQoL data collection, and the data analysis methods was noted. Notably, non-response(NR) rates to HRQoL questionnaire as high as 26-38% were observed, but the impact of NR was not discussed in most of the studies. The development of standardized best practice guidelines in breast cancer HRQoL data collection and analysis is recommended to improve data quality to assist evidence-based clinical decision making.