Quality-of-life methodology in hormone receptor–positive advanced breast cancer: Current tools and perspectives for the future

Fatima Cardoso*, David Cella, Galina Velikova, Victoria Harmer, Eva Schumacher-Wulf, Julie Rihani, Ana Casas, Nadia Harbeck

*Corresponding author for this work

Research output: Contribution to journalReview articlepeer-review

Abstract

Health-related quality of life (HRQOL) is increasingly recognized as important when evaluating cancer treatments. The use, reporting, and analysis of patient-reported outcome measures (PROMs), however, are not standardized in clinical trials and are often poorly implemented in clinical practice. We report the results of a systematic literature review (PubMed search: January 1, 2000 to August 15, 2020) of PROM use, reporting, and analysis in phase 3 clinical trials of hormone receptor–positive (HR+) advanced breast cancer (ABC). Further inspection of cyclin-dependent kinase 4/6 (CDK4/6) inhibitor publications was performed to examine PROMs in the HR+/human epidermal growth factor receptor 2–negative setting. A total of 88 results were identified in the initial search; 32 were included in the final analysis. Among included studies, most (66%) had been published in the last 5 years (2015 to 2020). CDK4/6 inhibitors (38%) were the most common agents reported. No clear standard for PROM use, reporting, or analysis was found. The most common PROMs were European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30; 59%) and the Functional Assessment of Cancer Therapy–Breast (FACT-B; 34%). Important differences, among studies that reported them, ranged from 5 to 10 points for the EORTC QLQ-C30 and 8 points for the FACT-B total score. This review showed that a lack of clear consistency remains for PROM use, reporting, and analysis in phase 3 clinical trials of HR+ ABC. However, HRQOL is of high interest in the literature, including for CDK4/6 inhibitors.

Original languageEnglish (US)
Article number102321
JournalCancer Treatment Reviews
Volume102
DOIs
StatePublished - Jan 2022

Keywords

  • CDK4/6 inhibitor
  • Health-related quality of life
  • Hormone receptor–positive advanced breast cancer
  • Patient-reported outcomes

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging

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