Department of Medical Oncology, Maastricht University Medical Center, PO BOX 5800, 6202 AZ, Maastricht, The Netherlands.
GROW-School for Oncology and Developmental Biology, Maastricht University, Maastricht, The Netherlands.
Breast Cancer Res Treat. 2021 Jul;188(2):571-581. doi: 10.1007/s10549-021-06178-8. Epub 2021 Mar 20.
Immediate and proper implementation of a new and more potent therapy is important to ensure that the patient achieves the best possible outcome. This study aimed to examine whether the real-world overall survival (OS) has improved in patients with human epidermal growth factor receptor 2-positive (HER2 +) advanced breast cancer (ABC) since the market release of pertuzumab and T-DM1. Furthermore, we aimed to assess the implementation and survival rates per hormone receptor (HR) subtype.
We included 493 systemically treated patients consecutively diagnosed with HER2 + ABC in 2008-2017 from the SOutheast Netherlands Advanced BREast cancer (SONABRE) Registry. Median OS was obtained using the Kaplan-Meier method and differences between periods (2008-2012 versus 2013-2017) were tested using multivariable Cox proportional hazards regression modeling. The 3-year implementation rates were estimated for any HER2-targeted therapy, pertuzumab, and T-DM1 by using the competing risk method and calculated from the date of diagnosis of ABC to start of HER2-targeted therapy of interest.
The median OS in 2008-2012 versus 2013-2017 was 28.3 versus 39.7 months in all patients (adjusted hazard ratio (adjHR) 0.85, 95%CI 0.66-1.08), 29.9 versus 36.3 months in patients with HR + /HER2 + disease (adjHR 0.97, 95%CI 0.72-1.32), and 22.7 versus 40.9 months in patients with HR-/HER2 + disease (adjHR 0.59, 95%CI 0.38-0.92). Any HER2-targeted therapy was used in 79% of patients in 2008-2012 and in 84% in 2013-2017. The use of pertuzumab and T-DM1 in 2013-2017 was 48% and 29%, respectively. For patients diagnosed with HR + /HER2 + and HR-/HER2 + disease, implementation rates in 2013-2017 were , respectively, 77% and 99% for any HER2-targeted therapy, 38% and 69% for pertuzumab, and 24% and 40% for T-DM1.
The survival of patients with HER2 + ABC improved since the introduction of pertuzumab and T-DM1. There is room for improvement in implementation of these HER2-targeted therapies, especially in patients with HR + /HER2 + disease.
确保患者获得最佳治疗效果，及时合理地采用新的强效疗法至关重要。本研究旨在探讨曲妥珠单抗和 T-DM1 上市后，人表皮生长因子受体 2 阳性（HER2+）晚期乳腺癌（ABC）患者的总生存期（OS）是否有所改善。此外，我们旨在评估根据激素受体（HR）亚型的实施率和生存率。
我们纳入了 2008 年至 2017 年间在 SOutheast Netherlands Advanced BREast cancer（SONABRE）登记处连续诊断为 HER2+ABC 的 493 例系统性治疗患者。采用 Kaplan-Meier 法计算中位 OS，并采用多变量 Cox 比例风险回归模型检验 2008-2012 年与 2013-2017 年两个时期之间的差异。采用竞争风险法估计任意 HER2 靶向治疗、曲妥珠单抗和 T-DM1 的 3 年实施率，并自 ABC 诊断之日起至开始使用感兴趣的 HER2 靶向治疗之日计算。
所有患者的中位 OS 在 2008-2012 年与 2013-2017 年分别为 28.3 个月和 39.7 个月（调整后的风险比（adjHR）为 0.85，95%CI 0.66-1.08），HR+ / HER2+疾病患者分别为 29.9 个月和 36.3 个月（adjHR 为 0.97，95%CI 0.72-1.32），HR-/HER2+疾病患者分别为 22.7 个月和 40.9 个月（adjHR 为 0.59，95%CI 0.38-0.92）。在 2008-2012 年，79%的患者接受了任意 HER2 靶向治疗，在 2013-2017 年，这一比例上升至 84%。在 2013-2017 年，曲妥珠单抗和 T-DM1 的使用率分别为 48%和 29%。对于 HR+ / HER2+和 HR-/HER2+疾病患者，在 2013-2017 年，任意 HER2 靶向治疗的实施率分别为 HR+ / HER2+患者的 77%和 HR-/HER2+患者的 99%，曲妥珠单抗的实施率分别为 HR+ / HER2+患者的 38%和 HR-/HER2+患者的 69%，T-DM1 的实施率分别为 HR+ / HER2+患者的 24%和 HR-/HER2+患者的 40%。
自曲妥珠单抗和 T-DM1 上市以来，HER2+ABC 患者的生存率有所提高。这些 HER2 靶向治疗的实施率仍有提升空间，尤其是在 HR+ / HER2+疾病患者中。
