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First-Line Treatment Patterns and Clinical Outcomes in Patients With HER2-Positive and Hormone Receptor-Positive Metastatic Breast Cancer From registHER

机译:来自registHER的HER2阳性和激素受体阳性的转移性乳腺癌患者的一线治疗方式和临床结果

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Background. 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. Methods. 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. Results. 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]: 0.22a??0.60); a nonsignificant reduction in OS time was observed (adjusted HR: 0.55, 95% CI: 0.27a??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: 0.42a??0.68); a statistically significant reduction in risk of death was observed (adjusted HR: 0.50, 95% CI: 0.36a??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: 0.54a??1.21; adjusted OS HR: 0.48, 95% CI: 0.26a??0.89). Conclusions. 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.
机译:背景。现有有限的数据描述了HER2阳性和激素受体(HR)阳性转移性乳腺癌(MBC)患者的自然病史。我们在现实环境中检查了HER2阳性,HR阳性MBC患者的一线治疗模式和临床结局。方法。 registHER是一项前瞻性,观察性队列研究,纳入的1023例HER2阳性MBC患者在入组后6个月内被诊断出,随后随访直至死亡,退出研究或2009年6月(中位随访时间:27个月)。对530例HER2阳性,HR阳性的患者的人口统计学,一线治疗方式和临床结局进行了检查。检查了无进展生存期(PFS)和总生存期(OS)。根据基线人口统计学和预后因素调整多变量分析。结果。接受曲妥珠单抗一线联合激素治疗的HER2阳性,HR阳性患者的PFS时间比仅接受激素治疗的患者显着更长(13.8 vs. 4.8个月;调整后的危险比[HR]:0.37,95%置信区间[CI] ]:0.22a≤0.60);观察到OS时间无明显减少(调整后的HR:0.55,95%CI:0.27a≤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中位PFS时间更长(20.4个月比9.5个月;校正后HR:0.53,95%CI:0.42a? 0.68);观察到死亡风险的统计学显着降低(校正后的HR:0.50,95%CI:0.36a≤0.70)。与同时使用相比,化学疗法和激素疗法的顺序使用与OS时间的改善相关(调整后的PFS HR:0.81,95%CI:0.54a≤1.21;调整后的OS HR:0.48,95%CI:0.26a≤0.89 )。结论。 HER2阳性/ HR阳性MBC患者的这些真实数据提供了证据,无论是否进行化学疗法,HRs和HER2受体的双重靶向均会显着延长PFS和OS时间。

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