Tombal Bertrand, Collins Sean, Morgans Alicia K, Hunsche Elke, Brown Bruce, Zhu Emily, Bossi Alberto, Shore Neal
Institut de Recherche clinique, Université catholique de Louvain, Brussels, Belgium.
Department of Radiation Medicine, Medstar Georgetown University Hospital, Washington, DC, USA.
Eur Urol. 2023 Dec;84(6):579-587. doi: 10.1016/j.eururo.2023.09.007. Epub 2023 Oct 11.
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.
DESIGN, SETTING, AND PARTICIPANTS: 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.
在HERO研究中，口服促性腺激素释放激素受体拮抗剂relugolix可将晚期前列腺癌（PCa）男性患者的睾酮抑制至去势水平。由于晚期PCa及其治疗会影响患者的日常生活，因此了解全身治疗对患者健康相关生活质量（HRQOL）的影响至关重要。
报告HERO研究中接受relugolix治疗的患者与接受亮丙瑞林治疗的患者在治疗期和睾酮恢复期间的HRQOL。
设计、设置和参与者：对934例晚期PCa患者进行了一项3期随机对照研究。
患者按2:1随机分组，接受每日一次口服120 mg relugolix或每3个月注射一次亮丙瑞林，共48周。在一个患者亚组中评估睾酮恢复情况。
HRQOL评估基于欧洲癌症研究与治疗组织（EORTC）生活质量问卷（EORTC QLQ-C30）和前列腺癌模块（EORTC QLQ-PR25），分别在治疗期和睾酮恢复阶段进行。在一项事后分析中，评估了HRQOL恶化的预测因素。
在EORTC QLQ-C30或EORTC QLQ-PR25工具中，从基线到治疗结束时两组的变化无统计学显著差异。在睾酮恢复阶段，relugolix的激素治疗相关症状评分低于亮丙瑞林，这表明与治疗停止后睾酮恢复更快的治疗相关的激素相关症状负担更低。局限性包括睾酮恢复组患者数量较少。
口服relugolix是一种治疗选择，患者报告的HRQOL与亮丙瑞林相似，为雄激素剥夺治疗提供了一种口服选择，且能更快降低睾酮水平。
在晚期前列腺癌男性患者中，relugolix与亮丙瑞林的健康相关生活质量相似。
