Background/Objectives: This study analyzed real-world data to assess patient characteristics, treatment patterns, and clinical outcomes in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer (eBC), as data for this patient group are limited.Methods: This was a retrospective observational cohort study of patients in a US electronic health record-derived deidentified database. Patient characteristics, treatment patterns, and clinical outcomes were analyzed overall and by risk of recurrence (high-risk versus non-high-risk).Results: Of 1290 patients, 366 (28.4%) were classified as high-risk and 924 (71.6%) as non-high-risk. At 5 years, high-risk versus non-high-risk eBC had a lower probability of invasive disease-free survival (72.3% [95% CI: 66.8–77.1%] vs. 80.7% [95% CI: 77.6–83.5%]), distant recurrence-free survival (78.7% [95% CI: 74.1–83.6%] vs. 89.3% [95% CI: 86.9–91.7%]), and overall survival (86.9% [95% CI: 82.3–90.4%] vs. 91.8% [95% CI: 89.4–93.7%]), and a shorter time to mBC diagnosis (22.6 vs. 34.1 months, respectively). Neoadjuvant therapy use increased from 18.2% in 2011–2013 to 67.3% in 2018–2021 in high-risk eBC and from 4.1% to 34.4% in non-high-risk eBC. However, 32.7% of eligible patients with high-risk eBC did not receive neoadjuvant therapy in 2018–2021. Use of post-neoadjuvant and adjuvant therapy increased in high-risk (but not non-high-risk) eBC from 81.8% in 2011–2013 to 91.8% in 2018–2021.Conclusions: High-risk HER2+ eBC manifested more aggressively than non-high-risk eBC. Utilization of neoadjuvant and (post-neo)adjuvant therapy increased over time. However, despite guideline recommendations, uptake of neoadjuvant therapy remains suboptimal.
背景/目的：本研究旨在通过分析真实世界数据，评估人表皮生长因子受体2阳性（HER2+）早期乳腺癌（eBC）患者的临床特征、治疗模式及预后结局，目前针对该患者群体的数据仍较为有限。方法：本研究为一项回顾性观察性队列研究，数据来源于美国电子健康记录去标识化数据库。研究对患者特征、治疗模式及临床结局进行了整体分析，并按复发风险（高风险与非高风险）进行分层分析。结果：在1290例患者中，366例（28.4%）被归类为高风险，924例（71.6%）为非高风险。5年随访数据显示，高风险eBC患者的无浸润性疾病生存率（72.3% [95% CI: 66.8–77.1%] vs. 80.7% [95% CI: 77.6–83.5%]）、无远处复发生存率（78.7% [95% CI: 74.1–83.6%] vs. 89.3% [95% CI: 86.9–91.7%]）及总生存率（86.9% [95% CI: 82.3–90.4%] vs. 91.8% [95% CI: 89.4–93.7%]）均低于非高风险患者，且转移性乳腺癌诊断时间更短（分别为22.6个月 vs. 34.1个月）。新辅助治疗的使用率在高风险eBC中从2011–2013年的18.2%上升至2018–2021年的67.3%，在非高风险eBC中从4.1%上升至34.4%。然而，在2018–2021年间仍有32.7%符合条件的高风险eBC患者未接受新辅助治疗。高风险eBC患者的新辅助后及辅助治疗使用率从2011–2013年的81.8%提升至2018–2021年的91.8%，而非高风险患者未见明显增长。结论：高风险HER2+ eBC的疾病进展较非高风险患者更具侵袭性。新辅助治疗及（新辅助后）辅助治疗的应用率随时间推移逐步提高，但尽管指南推荐，新辅助治疗的临床实施仍存在不足。
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