ESMO 2019: Health-Related Quality of Life in a Randomized Phase 3 trial of Enzalutamide with Standard First Line Therapy for mHSPC: ENZAMET, an ANZUP-led, International, Co-Operative Group Trial - A Medical Oncologist's Perspective
HRQL was measured with the EORTC QLQ-C30 and PR25 at weeks 0, 4, 12, and then 12-weekly until clinical progression. Mixed models for repeated measures were used to calculate the least squares mean difference, 95% CI, and p-value for comparisons of the randomly assigned groups for all assessments from week 4 to 156. For each analysis of deterioration-free survival, the endpoint was defined as the earliest of death, clinical progression, cessation of study treatment, or a 10-point worsening from baseline (minimum clinically important difference on scales scored from 0 to 100) in the pertinent HRQL sub-scale: physical functioning, global health and quality of life, cognitive functioning, and fatigue.
The authors found that during the study period, individual HRQL outcomes (eg physical function, cognitive function, fatigue) were significantly worse among patients receiving enzalutamide. Notably, global health and quality of life were maintained.
A critical finding from this study, however, is that the addition of enzalutamide improved deterioration-free survival because early impairments in specific aspects of HRQL did not outweigh the subsequent benefits of delayed clinical progression, as shown below.
This new HRQL data demonstrating improvements in deterioration-free survival with the addition of enzalutamide to androgen deprivation therapy (with or without docetaxel) in men with newly diagnosed mHSPC. It also confirms this treatment regimen as a standard of care option in this clinical setting that maintains or improves patients’ global quality of life over time.
Presented by: Martin R. Stockler, MBBS, MSc, FRACP, Professor of Oncology and Clinical Epidemiology at The University of Sydney, Medical Oncologist at the Concord Repatriation General Hospital and Chris O’Brien Lifehouse RPA, and Oncology Co-Director at the NHMRC Clinical Trials Centre
Written by: Jacob Berchuck, MD, Medical Oncology Fellow at the Dana-Farber Cancer Institute (Twitter: @jberchuck) at the 2019 European Society for Medical Oncology Congress (#ESMO19), September 27th to October 1st, 2019, Barcelona, Spain
1. Davis ID, Martin AJ, Stockler MR, et al. Enzalutamide with Standard First-Line Therapy in Metastatic Prostate Cancer. N Engl J Med. 2019 Jul 11;381(2):121-131.
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