哌柏西利联合氟维司群治疗激素受体阳性、人表皮生长因子受体 2 阴性晚期/转移性乳腺癌日本患者的疗效和安全性。
Efficacy and Safety of Palbociclib and Fulvestrant in Japanese Patients With ER+/HER2- Advanced/Metastatic Breast Cancer.
机构信息
Division of Surgery, Saitama Medical Center, Saitama, Japan
Division of Surgery, Saitama Medical Center, Saitama, Japan.
出版信息
In Vivo. 2019 Nov-Dec;33(6):2037-2044. doi: 10.21873/invivo.11701.
Abstract
BACKGROUND/AIM: Published data have shown that palbociclib-fulvestrant can significantly improve the progression-free survival (PFS) of estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer patients, but not of Japanese patients. We conducted this retrospective study to verify the efficacy and safety of palbociclib-fulvestrant in Japanese patients.
PATIENTS AND METHODS
ER+/HER2- metastatic breast cancer patients treated with fulvestrant (n=39) or palbociclib-fulvestrant (n=31) at the Saitama Medical Center from July 2012 to November 2018 were evaluated.
RESULTS
Overall response rates (ORRs) were 2.6% (fulvestrant) and 41.9% (palbociclib-fulvestrant) (p<0.001), and clinical benefit rates (CBRs) were 23.1% and 61.3% (p=0.002), respectively. The palbociclib-fulvestrant group had significantly higher CBR and PFS (hazard ratio(HR):0.272, 95% confidence interval(95CI):0.128-0.574 for PFS). Grade 3/4 neutropenia occurred in 80.6% of the palbociclib-fulvestrant group, while febrile neutropenia was not detected.
CONCLUSION
Japanese ER+/HER2- metastatic breast cancer patients tolerated palbociclib-fulvestrant, with significantly improved clinical outcomes.
摘要
背景/目的：已有研究数据表明，哌柏西利联合氟维司群可显著改善雌激素受体阳性/人表皮生长因子受体 2 阴性（ER+/HER2-）转移性乳腺癌患者的无进展生存期（PFS），但对日本患者的疗效尚未明确。本回顾性研究旨在验证哌柏西利联合氟维司群在日本转移性乳腺癌患者中的疗效和安全性。
患者与方法
本研究纳入了 2012 年 7 月至 2018 年 11 月在埼玉医疗中心接受氟维司群（n=39）或哌柏西利联合氟维司群（n=31）治疗的 ER+/HER2-转移性乳腺癌患者。
结果
氟维司群组的总缓解率（ORR）为 2.6%，哌柏西利联合氟维司群组为 41.9%（p<0.001）；氟维司群组的临床获益率（CBR）为 23.1%，哌柏西利联合氟维司群组为 61.3%（p=0.002）。哌柏西利联合氟维司群组的 CBR 和 PFS 显著更高（PFS 的风险比（HR）为 0.272，95%置信区间（95CI）为 0.128-0.574）。哌柏西利联合氟维司群组中 80.6%的患者出现 3/4 级中性粒细胞减少症，未出现发热性中性粒细胞减少症。
结论
哌柏西利联合氟维司群在日本 ER+/HER2-转移性乳腺癌患者中具有良好的耐受性，且显著改善了患者的临床结局。
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