Impact of Relugolix Versus Leuprolide on the Quality of Life of Men with Advanced Prostate Cancer: Results from the Phase 3 HERO Study.

Advanced prostate cancer Phase 3 clinical study Quality of life Relugolix

Journal

European urology
ISSN: 1873-7560
Titre abrégé: Eur Urol
Pays: Switzerland
ID NLM: 7512719

Informations de publication

Date de publication:
Dec 2023
Historique:
received: 05 04 2023
revised: 22 07 2023
accepted: 10 09 2023
pubmed: 14 10 2023
medline: 14 10 2023
entrez: 13 10 2023
Statut: ppublish

Résumé

Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, demonstrated testosterone suppression to castrate levels in men with advanced prostate cancer (PCa) in the HERO study. Since advanced PCa and its treatments can impact patients' daily life, it is imperative to understand the impact of systemic therapy on patient health-related quality of life (HRQOL). To report the HRQOL for patients on relugolix compared with those on leuprolide in on-treatment and testosterone recovery periods of the HERO study. A phase 3 randomized controlled study was conducted in 934 patients with advanced PCa. Patients underwent 2:1 randomization and received relugolix 120 mg orally once daily or leuprolide 3-mo injections for 48 wk. Testosterone recovery was evaluated in a patient subset. HRQOL evaluations were based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) and the Prostate Cancer Module (EORTC QLQ-PR25) during treatment and testosterone recovery phases. In a post hoc analysis, predictors of HRQOL deterioration were evaluated. No statistically significant differences between the two groups were found in changes from baseline to the end of treatment in either the EORTC QLQ-C30 or the EORTC QLQ-PR25 instrument. During the testosterone recovery phase, hormonal treatment-related symptoms scores were lower for relugolix than for leuprolide, suggesting a lower burden of hormone-related symptoms associated with a treatment that has more rapid testosterone recovery after treatment cessation. Limitations include low patient numbers in the testosterone recovery group. Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction. In men with advanced prostate cancer, relugolix had similar health-related quality of life to leuprolide.

Sections du résumé

BACKGROUND BACKGROUND
Relugolix, an oral gonadotropin-releasing hormone receptor antagonist, demonstrated testosterone suppression to castrate levels in men with advanced prostate cancer (PCa) in the HERO study. Since advanced PCa and its treatments can impact patients' daily life, it is imperative to understand the impact of systemic therapy on patient health-related quality of life (HRQOL).
OBJECTIVE OBJECTIVE
To report the HRQOL for patients on relugolix compared with those on leuprolide in on-treatment and testosterone recovery periods of the HERO study.
DESIGN, SETTING, AND PARTICIPANTS METHODS
A phase 3 randomized controlled study was conducted in 934 patients with advanced PCa.
INTERVENTION METHODS
Patients underwent 2:1 randomization and received relugolix 120 mg orally once daily or leuprolide 3-mo injections for 48 wk. Testosterone recovery was evaluated in a patient subset.
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS METHODS
HRQOL evaluations were based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (EORTC QLQ-C30) and the Prostate Cancer Module (EORTC QLQ-PR25) during treatment and testosterone recovery phases. In a post hoc analysis, predictors of HRQOL deterioration were evaluated.
RESULTS AND LIMITATIONS CONCLUSIONS
No statistically significant differences between the two groups were found in changes from baseline to the end of treatment in either the EORTC QLQ-C30 or the EORTC QLQ-PR25 instrument. During the testosterone recovery phase, hormonal treatment-related symptoms scores were lower for relugolix than for leuprolide, suggesting a lower burden of hormone-related symptoms associated with a treatment that has more rapid testosterone recovery after treatment cessation. Limitations include low patient numbers in the testosterone recovery group.
CONCLUSIONS CONCLUSIONS
Oral relugolix is a therapeutic option with similar patient-reported HRQOL to leuprolide, providing an oral option for androgen deprivation therapy associated with a more rapid testosterone reduction.
PATIENT SUMMARY RESULTS
In men with advanced prostate cancer, relugolix had similar health-related quality of life to leuprolide.

Identifiants

DOI: 10.1016/j.eururo.2023.09.007 PMID: 37833178
pubmed: 37833178
pii: S0302-2838(23)03099-3
doi: 10.1016/j.eururo.2023.09.007
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

579-587

Informations de copyright

Copyright © 2023 The Authors. Published by Elsevier B.V. All rights reserved.

Auteurs

Bertrand Tombal (B)

Institut de Recherche clinique, Université catholique de Louvain, Brussels, Belgium. Electronic address: bertrand.tombal@uclouvain.be.

Sean Collins (S)

Department of Radiation Medicine, Medstar Georgetown University Hospital, Washington, DC, USA.

Alicia K Morgans (AK)

Dana-Farber Cancer Institute, Boston, MA, USA.

Elke Hunsche (E)

Myovant Sciences GmbH, Basel, Switzerland.

Bruce Brown (B)

Myovant Sciences, Inc., Brisbane, CA, USA.

Emily Zhu (E)

Myovant Sciences, Inc., Brisbane, CA, USA.

Alberto Bossi (A)

Department of Radiotherapy, Institut Gustave Roussy, Villejuif, France.

Neal Shore (N)

Carolina Urologic Research Center, Myrtle Beach, SC, USA.

Classifications MeSH