Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.
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DOI：
10.1016/j.breast.2020.09.008
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发表时间：
2020-12
期刊：
影响因子：
--
通讯作者：
Nusch A
中科院分区：
文献类型：
--
作者：
Fasching PA;Beck JT;Chan A;De Laurentiis M;Esteva FJ;Jerusalem G;Neven P;Pivot X;Bianchi GV;Martin M;Chandiwana D;Lanoue B;Ridolfi A;Wang Y;Rodriguez Lorenc K;Nusch A
在激素受体阳性人表皮生长因子受体阴性晚期乳腺癌患者的MONALEESA-3 III期试验中，ribociclib联合氟维司群显著改善了无进展生存期（PFS）和总生存期（OS）。在这里，我们介绍了患者报告的试验结果，包括健康相关的生活质量（HRQOL）。患者被随机（2：1）接受ribociclib+氟维司群或安慰剂+氟维司群。使用Kaplan-Meier估计值评估至HRQOL（EORTC QLQ-C30问卷的总体健康状况[GHS]）和疼痛（BPI-SF问卷）较基线明确恶化10%的时间（TTD）;使用分层考克斯回归模型估计风险比（HR）和95% CI。在ribociclib组33%的患者中观察到EORTC-QLQ-C30 GHS恶化≥10%，而安慰剂（参比）组34%的患者中观察到EORTC-QLQ-C30 GHS恶化≥10%（TTD ≥ 10%的HR = 0.81 [95% CI，0.62-1.1]）。TTD ≥5%（HR = 0.79 [95% CI，0.61-1.0]）和TTD ≥15%（HR = 0.81 [95% CI，0.60-1.08]）的结果相似。情绪功能的TTD ≥10%（HR = 0.76 [95% CI，0.57-1.01]）倾向于支持ribociclib组，而两组之间的疲劳和疼痛结果相似。BPI-SF疼痛严重程度指数评分（HR = 0.77 [95% CI，0.57-1.05]）和最差疼痛项目评分（HR = 0.81 [95% CI，0.58-1.12]）的TTD ≥10%倾向于ribociclib vs安慰剂。与安慰剂+氟维司群相比，除了显著延长PFS和OS外，在氟维司群基础上添加ribociclib可维持HRQOL。Ribociclib +氟维司群可维持总体健康状况（GHS）。恶化时间（TTD）10%可以表示直至QOL恶化的持续时间。在GHS和情绪功能方面，使用ribociclib可延迟TTD ≥10%。Ribociclib还显示了与安慰剂相比，TTD延迟的疼痛结局趋势。
In the MONALEESA-3 Phase III trial of patients with hormone receptor–positive human epidermal growth factor receptor–negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL). Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs. Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62–1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61–1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60–1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57–1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58–1.12]) trended in favor of ribociclib vs placebo. In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL. Ribociclib + fulvestrant allowed maintenance of global health status (GHS). Time to deterioration (TTD) by 10% can convey duration until worsening of QOL. TTD ≥10% was delayed with ribociclib in GHS and emotional functioning. Ribociclib also demonstrated trends toward delayed TTD vs placebo in pain outcomes.
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影响因子：
50.5
作者：
Hortobagyi, G. N.;Stemmer, S. M.;O'Shaughnessy, J.
通讯作者：
O'Shaughnessy, J.
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3.8
作者：
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45.3
作者：
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8.4
作者：
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通讯作者：
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影响因子：
158.5
作者：
Im, S. -A.;Lu, Y. -S.;Tripathy, D.
通讯作者：
Tripathy, D.