Health-related quality of life in older patients with HER plus metastatic breast cancer: Comparing pertuzumab plus trastuzumab with or without metronomic chemotherapy in a randomised open-label phase II clinical trial

Introduction: European Organisation for Research and Treatment of Cancer (EORTC) phase II trial (75111-10114) demonstrated that combining pertuzumab with trastuzumab plus cyclophosphamide (TPM) improved median progression-free survival by seven months compared with pertuzumab and trastuzumab (TP) in older/frail patients with HER2-positive metastatic breast cancer (MBC). This publication reports the findings of the health-related quality-of-life (HRQoL) outcomes. Material and methods: HRQoL was assessed using the EORTC QLQ-C30 and the EORTC Elderly specific module (QLQ-ELD14 at baseline, week 9, 27, and 52. The primary HRQoL domains were global health status/QoL scale (GHQs), fatigue and pain. Treatment differences of >= 10 points were considered clinically significant. Correlations between change in GHQs and other HRQoL scales were obtained to identify domains impacting patients' overall perception. Results: Eighty patients were randomised to TP or TPM. Compliance with completing HRQoL forms ranged from 90% at baseline to 45% at week 52. HRQoL domains showed no statistically significant differences in the change scores over time between the two treatment arms. Improvement of >= 10 points was found at week 9 in favor of the TPM for the pain scores. This was reversed oat week 27. Sensitivity analyses, including imputation of missing data and area-under-the-curve analyses, revealed no meaningful differences between the arms for the primary HRQoL domains. ELD14 was systematically scored lower in the TPM arm. Discussion: TPM regimen in older and frail patients with HER2-positive MBC increased PFS with no impact on HRQoL. However, given the limited sample size and dropout in our study, further research is critical to confirm these results. (C) 2022 Published by Elsevier Ltd.