Health-Related Quality of Life in Patients with HR+/HER2- Early Breast Cancer Treated with Ribociclib Plus a Nonsteroidal Aromatase Inhibitor: Results from the NATALEE Trial.

In this study, we report health-related quality of life (HRQOL) data from NATALEE.

在这项研究中，我们报告了来自NATALEE的健康相关生活质量(HRQOL)数据。

patients_and_methods

Patients were randomized to receive ribociclib plus NSAI or NSAI alone.

患者被随机分配接受利博西利布加NSAI或仅NSAI治疗。

Patient-reported outcome scores [European Organisation for Research and Treatment of Cancer core quality of life questionnaire global health status and physical, social, and emotional functioning domains; the supplementary European Organisation for Research and Treatment of Cancer breast cancer-specific QOL questionnaire breast symptoms scale; health on a visual analog scale of the generic EuroQOL 5-level instrument; and the Hospital Anxiety and Depression Scale] were assessed.

患者报告的结果评分[欧洲癌症研究与治疗组织核心生活质量问卷全球健康状况以及身体、社会和情感功能领域；补充的欧洲癌症研究与治疗组织乳腺癌特异性生活质量问卷乳腺症状量表；通用EuroQOL 5级工具的视觉模拟健康量表；以及医院焦虑抑郁量表]已被评估。

The prespecified primary HRQOL endpoint was physical functioning.

预先设定的主要健康相关生活质量（HRQOL）终点指标是身体功能。

Mean scores and time-categorical and prespecified linear-time repeated-measure models were used to evaluate HRQOL changes during treatment.

使用平均分数、时间分类和预先设定的线性时间重复测量模型来评估治疗期间的健康相关生活质量（HRQOL）变化。

Results

HRQOL was evaluated in all patients in the ribociclib plus NSAI (n = 2,549) and NSAI alone (n = 2,552) arms.

在所有接受ribociclib联合NSAI治疗(n=2,549)和仅接受NSAI治疗(n=2,552)的患者中评估了健康相关生活质量(HRQOL)。

Compliance was high in both arms (≈93%-97%).

两组的依从性都很高（约93%-97%）。

Mean scores did not differ meaningfully from baseline for any analyzed domain.

各分析领域的平均得分与基线相比没有显著差异。

Likewise, neither a meaningful change from baseline (in either treatment arm) nor a difference between arms was observed during treatment in the time-categorical, model-adjusted mean scores for any HRQOL domains-using published thresholds for interpreting longitudinal and between-group differences, with all values being within 0.5 SD of their baseline values.

同样，在治疗期间，使用已发布的解释纵向和组间差异的阈值，对任何健康相关生活质量（HRQOL）领域的随时间分类、模型调整后的平均得分进行观察，既没有发现从基线开始的有意义的变化（在任一治疗组中），也没有发现组间差异，所有值都在其基线值的0.5个标准差范围内。

Linear-time regression analysis confirmed these findings.

线性时间回归分析证实了这些发现。

Conclusions

These analyses of NATALEE show that adding adjuvant ribociclib to an NSAI does not negatively affect HRQOL in patients with HR+/HER2- early breast cancer.

NATALEE的这些分析显示，在HR+/HER2-早期乳腺癌患者中，添加辅助性利博西利到NSAI治疗并不会对患者的生活质量产生负面影响。