在转移性激素敏感性前列腺癌的标准治疗中加入恩杂鲁胺可改善总体生存率。在这里，我们报告了它对健康相关生活质量 (HRQL) 方面的影响。

在第 0、4、12 周和之后每 12 周使用欧洲癌症研究与治疗组织核心生活质量问卷和 QLM-PR25 评估 HRQL，直至进展。使用重复测量模型分析第 4 周至 156 周的分数，以计算组均值和差异。无恶化生存期是从随机分配到最早的死亡、临床进展、停止研究治疗或疲劳、身体机能、认知功能或整体健康和生活质量（OHQL）较基线恶化 10 分或更多). HRQL 分数范围从 0（最低可能）到 100（最高可能）。

对 1,125 名参与者中的 1,042 名 (93%) 进行了 HRQL 评估。在疲劳（5.2，95% CI，3.6 至 6.9；P < .001）、认知功能（4.0，95% CI，2.5 至 5.5；P < .001）和身体功能（2.6 ，95% CI，1.3 至 3.9；P < .001）。 3 年无恶化生存率和比较整个分布的对数秩 P 值，在 OHQL（31% 对 17%；P < .0001）、认知功能（31% 对 20%；P = .001）和身体功能（31% 对 22%；P < .001），但不疲劳（24% 对 18%；P = .16）。恩杂鲁胺对 HRQL 的影响与基线特征无关。恩杂鲁胺与自我报告的疲劳、认知功能和身体功能的恶化有关，但与 OHQL 无关。恩杂鲁胺与 OHQL、身体功能和认知功能的无恶化生存期改善相关，因为疾病进展的延迟超过了 HRQL 这些方面的早期恶化。

Abstract

Purpose: We previously reported that enzalutamide improved overall survival when added to standard of care in metastatic, hormone-sensitive prostate cancer. Here, we report its effects on aspects of health-related quality of life (HRQL).

Methods: HRQL was assessed with the European Organisation for Research and Treatment of Cancer core quality-of-life questionnaire and QLM-PR25 at weeks 0, 4, 12, and then every 12 weeks until progression. Scores from week 4 to 156 were analyzed with repeated measures modeling to calculate group means and differences. Deterioration-free survival was from random assignment until the earliest of death, clinical progression, discontinuation of study treatment, or a worsening of 10 points or more from baseline in fatigue, physical function, cognitive function, or overall health and quality of life (OHQL). HRQL scores range from 0 (lowest possible) to 100 (highest possible).

Results: HRQL was assessed in 1,042 of 1,125 participants (93%). Differences in means favored control over enzalutamide for fatigue (5.2, 95% CI, 3.6 to 6.9; P < .001), cognitive function (4.0, 95% CI, 2.5 to 5.5; P < .001), and physical function (2.6, 95% CI, 1.3 to 3.9; P < .001), but not OHQL (1.2, 95% CI, -0.2 to 2.7; P = .1). Deterioration-free survival rates at 3 years, and log-rank P values comparing the whole distributions, favored enzalutamide over control for OHQL (31% v 17%; P < .0001), cognitive function (31% v 20%; P = .001), and physical function (31% v 22%; P < .001), but not fatigue (24% v 18%; P = .16). The effects of enzalutamide on HRQL were independent of baseline characteristics.

Conclusion: Enzalutamide was associated with worsening of self-reported fatigue, cognitive function, and physical function, but not OHQL. Enzalutamide was associated with improved deterioration-free survival for OHQL, physical function, and cognitive function because delays in disease progression outweighed early deteriorations in these aspects of HRQL.

原文链接

pubmed.ncbi.nlm.nih.gov/34928708/

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