University of Southern California, Norris Comprehensive Cancer Center, Department of Medicine, Los Angeles, California 90033, USA.
Oncologist. 2013;18(5):501-10. doi: 10.1634/theoncologist.2012-0414. Epub 2013 May 7.
Limited data are available describing the natural history of patients with HER2-positive and hormone receptor (HR)-positive metastatic breast cancer (MBC). We examined first-line treatment patterns and clinical outcomes in patients with HER2-positive, HR-positive MBC in a real-world setting.
registHER is a prospective, observational cohort of 1,023 patients with HER2-positive MBC diagnosed within 6 months of enrollment and followed until death, disenrollment, or June 2009 (median follow-up time: 27 months). Demographics, first-line treatment patterns, and clinical outcomes were examined for 530 HER2-positive, HR-positive patients. Progression-free survival (PFS) and overall survival (OS) times were examined. Multivariate analyses adjusted for baseline demographic and prognostic factors.
HER2-positive, HR-positive patients receiving first-line trastuzumab plus hormonal therapy had significantly longer PFS times than patients who received hormonal therapy only (13.8 vs. 4.8 months; adjusted hazard ratio [HR]: 0.37, 95% confidence interval [CI]: 0.22-0.60); a nonsignificant reduction in OS time was observed (adjusted HR: 0.55, 95% CI: 0.27-1.14). Compared with patients who received first-line trastuzumab plus chemotherapy, patients who received first-line trastuzumab plus chemotherapy and hormonal therapy had longer median PFS times (20.4 months vs. 9.5 months; adjusted HR: 0.53, 95% CI: 0.42-0.68); a statistically significant reduction in risk of death was observed (adjusted HR: 0.50, 95% CI: 0.36-0.70). Sequential use of chemotherapy and hormonal therapy was associated with improved OS times when compared with concurrent use (adjusted PFS HR: 0.81, 95% CI: 0.54-1.21; adjusted OS HR: 0.48, 95% CI: 0.26-0.89).
These real-world data in patients with HER2-positive/HR-positive MBC provide evidence that, with or without chemotherapy, dual targeting of HRs and HER2 receptors is associated with significantly prolonged PFS and OS times.
目前有关人表皮生长因子受体 2（HER2）阳性和激素受体（HR）阳性转移性乳腺癌（MBC）患者自然病程的数据有限。本研究旨在观察真实世界中 HER2 阳性、HR 阳性 MBC 患者的一线治疗模式和临床结局。
registHER 是一项前瞻性、观察性队列研究，共纳入 1023 例 HER2 阳性 MBC 患者，这些患者在入组前 6 个月内确诊，随访至死亡、失访或 2009 年 6 月（中位随访时间：27 个月）。本研究对 530 例 HER2 阳性、HR 阳性患者的一线治疗模式和临床结局进行了分析。评估了无进展生存期（PFS）和总生存期（OS）。采用多变量分析对基线人口统计学和预后因素进行了调整。
接受一线曲妥珠单抗联合激素治疗的 HER2 阳性、HR 阳性患者的 PFS 时间明显长于仅接受激素治疗的患者（13.8 个月 vs. 4.8 个月；调整后的风险比[HR]：0.37，95%置信区间[CI]：0.22-0.60）；但 OS 时间未见明显缩短（调整后的 HR：0.55，95% CI：0.27-1.14）。与接受一线曲妥珠单抗联合化疗的患者相比，接受一线曲妥珠单抗联合化疗和激素治疗的患者的 PFS 时间更长（20.4 个月 vs. 9.5 个月；调整后的 HR：0.53，95% CI：0.42-0.68）；死亡风险显著降低（调整后的 HR：0.50，95% CI：0.36-0.70）。与同时使用化疗和激素治疗相比，序贯使用化疗和激素治疗与 OS 时间延长相关（调整后的 PFS HR：0.81，95% CI：0.54-1.21；调整后的 OS HR：0.48，95% CI：0.26-0.89）。
本研究真实世界数据表明，对于 HER2 阳性/HR 阳性 MBC 患者，无论是否联合化疗，双重靶向 HR 和 HER2 受体均可显著延长 PFS 和 OS 时间。
