在PALOMA-4试验中，接受哌柏西利加来曲唑治疗的亚洲ER+/HER2-晚期乳腺癌患者报告的生活质量
Patient-reported quality of life in Asian patients with ER+/HER2- advanced breast cancer treated with palbociclib plus letrozole in the PALOMA-4 trial.
作者信息
Xu Binghe, Hu Xichun, Li Wei, Sun Tao, Shen Kunwei, Huang ChiunSheng, Sriuranpong Virote, Ngan Roger Kc, Chia Yee H, Reisman Arlene, Zhao Huadong, Shen Jiayun, Broughton Edward
机构信息
Department of Medical Oncology, National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing 100021, China.
Department of Medical Oncology, Fudan University Shanghai Cancer Center, Shanghai 200032, China.
出版信息
Chin Med J (Engl). 2024 Dec 19. doi: 10.1097/CM9.0000000000003122.
BACKGROUND
Palbociclib plus an aromatase inhibitor is approved for treatment of patients with ER+/HER2- advanced breast cancer (ABC). In the PALOMA-4 trial, adding palbociclib to letrozole prolonged median progression-free survival in Asian women with ER+/HER2- ABC. Here, we report patient-reported outcomes (PROs) from PALOMA-4.
METHODS
PALOMA-4 was a randomized, double-blind, phase 3 trial of palbociclib plus letrozole vs. placebo plus letrozole treatment in postmenopausal Asian women with ER+/HER2- ABC. PROs were longitudinally assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) and EuroQoL 5D three level (EQ-5D-3L) questionnaires. Group comparisons were analyzed using longitudinal, mixed-effects models.
RESULTS
Patients were randomly assigned to palbociclib plus letrozole (n = 169) or placebo plus letrozole (n = 171) treated groups. No significant between-arm differences in change from baseline were observed in FACT-B and its subscales, or the EQ-5D-3L index. A significant, but not clinically meaningful difference was observed in change from baseline in mean EQ-VAS score favoring palbociclib plus letrozole (3.36; 95% confidence interval [CI], 0.88-5.83; P = 0.008). When patients from both arms were combined, significant differences in the mean change from baseline for FACT-B total were observed favoring treatment responders vs. non-responders (3.84; 95% CI, 0.33-7.36; P = 0.032) and for the Breast Cancer Subscale favoring patients without disease progression vs. those with progression (0.97; 95% CI, 0.05-1.89; P = 0.038).
CONCLUSIONS
Quality of life was maintained when palbociclib was added to letrozole in Asian women with ABC. These findings are consistent with PALOMA-2 results and support the use of palbociclib as first-line treatment in postmenopausal Asian patients with ER+/HER2- ABC.
REGISTRATION
clinicaltrials.gov, NCT02297438.
背景
帕博西尼联合芳香化酶抑制剂已被批准用于治疗雌激素受体阳性/人表皮生长因子受体2阴性（ER+/HER2-）的晚期乳腺癌（ABC）患者。在PALOMA-4试验中，对于ER+/HER2-的ABC亚洲女性患者，在来曲唑基础上加用帕博西尼可延长中位无进展生存期。在此，我们报告PALOMA-4试验中患者报告的结局（PROs）。
方法
PALOMA-4是一项随机、双盲、3期试验，在绝经后ER+/HER2-的ABC亚洲女性患者中，比较帕博西尼联合来曲唑与安慰剂联合来曲唑的治疗效果。使用癌症治疗功能评估-乳腺癌（FACT-B）问卷和欧洲五维健康量表三级（EQ-5D-3L）问卷对PROs进行纵向评估。采用纵向混合效应模型进行组间比较分析。
结果
患者被随机分配至帕博西尼联合来曲唑治疗组（n = 169）或安慰剂联合来曲唑治疗组（n = 171）。在FACT-B及其子量表或EQ-5D-3L指数方面，未观察到两组间从基线变化的显著差异。在平均EQ-VAS评分从基线的变化方面，观察到有利于帕博西尼联合来曲唑组的显著差异，但无临床意义（3.36；95%置信区间[CI]，0.88 - 5.83；P = 0.008）。当将两组患者合并分析时，观察到FACT-B总分从基线的平均变化在治疗反应者与无反应者之间存在显著差异（3.84；95%CI，0.33 - 7.36；P = 0.032），在乳腺癌子量表方面，疾病无进展患者与有进展患者之间存在显著差异（0.97；95%CI，0.05 - 1.89；P = 0.038）。
结论
在ABC亚洲女性患者中，来曲唑加用帕博西尼时生活质量得以维持。这些发现与PALOMA-2的结果一致，支持将帕博西尼作为绝经后ER+/HER2-的ABC亚洲患者的一线治疗药物。
注册信息
clinicaltrials.gov，NCT02297438
Zotero 插件