NHMRC Clinical Trials Centre, University of Sydney, Sydney, New South Wales, Australia.
Monash University, Melbourne, Victoria, Australia.
J Clin Oncol. 2022 Mar 10;40(8):837-846. doi: 10.1200/JCO.21.00941. Epub 2021 Dec 20.
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).
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).
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; < .001), cognitive function (4.0, 95% CI, 2.5 to 5.5; < .001), and physical function (2.6, 95% CI, 1.3 to 3.9; < .001), but not OHQL (1.2, 95% CI, -0.2 to 2.7; = .1). Deterioration-free survival rates at 3 years, and log-rank values comparing the whole distributions, favored enzalutamide over control for OHQL (31% 17%; < .0001), cognitive function (31% 20%; = .001), and physical function (31% 22%; < .001), but not fatigue (24% 18%; = .16). The effects of enzalutamide on HRQL were independent of baseline characteristics.
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.
我们曾报道过依泽替米贝联合标准治疗可改善转移性、激素敏感前列腺癌患者的总生存期。在此，我们报告其对健康相关生活质量（HRQL）的影响。
采用欧洲癌症研究与治疗组织核心生活质量问卷和 QLM-PR25 于 0、4、12 周时以及之后每 12 周评估 HRQL，直至疾病进展。采用重复测量模型分析第 4 周至 156 周的评分，以计算组均数和差异。无恶化生存时间为从随机分组到死亡、临床进展、研究治疗停药或疲劳、体力功能、认知功能或整体健康和生活质量（OHQL）恶化≥10 分的最早时间。HRQL 评分范围为 0（最低）至 100（最高）。
1042 例 1125 例患者（93%）评估了 HRQL。与对照组相比，依泽替米贝组的疲劳（5.2，95%CI，3.6 至 6.9；<0.001）、认知功能（4.0，95%CI，2.5 至 5.5；<0.001）和体力功能（2.6，95%CI，1.3 至 3.9；<0.001）的均值差异更有利，而 OHQL 无显著差异（1.2，95%CI，-0.2 至 2.7；=0.1）。3 年时的无恶化生存率和整个分布的对数秩值比较均显示，依泽替米贝组的 OHQL（31% 17%；<0.0001）、认知功能（31% 20%；=0.001）和体力功能（31% 22%；<0.001）的无恶化生存更有利，但疲劳无显著差异（24% 18%；=0.16）。依泽替米贝对 HRQL 的影响与基线特征无关。
依泽替米贝与自我报告的疲劳、认知功能和体力功能恶化相关，但与 OHQL 无关。依泽替米贝与 OHQL、体力功能和认知功能的无恶化生存率提高有关，因为疾病进展的延迟超过了这些 HRQL 方面的早期恶化。
