曲妥珠单抗新辅助治疗 HER2 低表达乳腺癌的病理缓解和生存结局的真实世界数据。
Real-World Data on Pathological Response and Survival Outcomes After Neoadjuvant Chemotherapy in HER2-Low Breast Cancer Patients.
机构信息
Suzhou Medical College of Soochow University, Soochow, China; General Surgery, Cancer Center, Department of Breast Surgery, Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Hangzhou Medical College, Hangzhou, Zhejiang, China; Key Laboratory for diagnosis and treatment of upper limb edema and stasis of breast cancer, Hangzhou, Zhejiang, China.
Department of Urinary Surgery, Haining branch of Zhejiang Provincial People's Hospital (Affiliated People's Hospital), Jiaxing, Zhejiang, China.
出版信息
Clin Breast Cancer. 2024 Jul;24(5):463-472.e2. doi: 10.1016/j.clbc.2024.04.006. Epub 2024 Apr 14.
BACKGROUND
Data on the pathological responses and survival outcomes after neoadjuvant chemotherapy (NACT) in human epidermal growth factor receptor-2 (HER2)-low breast cancer (BC) are lacking. This study aims to investigate this topic in the real world.
METHODS
Clinicopathological data from 819 HER2-negative BC patients who underwent NACT between 2010 and 2020 were retrospectively retrieved from the Shanghai Jiaotong University Breast Cancer Database. These patients were categorized into HER2-low and HER2-0 groups. Logistic analyses were conducted to identify predictors of complete pathological response (pCR) and breast pCR. Cox regression analyses were conducted to assess the factors associated with disease-free survival (DFS) and overall survival (OS). Kaplan-Meier (K-M) curves were generated to compare DFS and OS between HER2-low BC and HER2-0 BC.
RESULTS
Of the 819 BC patients, 669 (81.7%) had HER2-low tumors, and 150 (18.3%) had HER2-0 tumors. HER2-low BC had a significantly higher ratio of ER ≥ 10%, PR ≥ 20%, and Ki67 ≥ 15% than HER2-0 BC. A significantly higher breast pCR rate was observed in HER2-low BC than in HER2-0 BC (13.6% and 7.3%, respectively, P = .036). Age, HER2 status (low or 0), Ki67, and surgery options were associated with breast pCR in HER2-negative BC. In HER2-low BC, the pCR rate of ER ≥ 10% BC was significantly lower than that of ER < 10% BC, but the DFS and OS of ER 10% BC were significantly higher. The K-M curve showed no significant differences in DFS or OS between HER2-low and HER2-0 BC. Cox regression revealed that ER expression and histological grade (III vs. I∼II) were significantly associated with survival in HER2-low BC.
CONCLUSIONS
In this real-world data (RWD) study, a significantly higher breast pCR rate was found in HER2-low BC than in HER2-0 BC, although there was no significant difference in survival. Moreover, ER expression had a significant prognostic impact on HER2-low BC.
背景
关于人表皮生长因子受体 2（HER2）低型乳腺癌（BC）新辅助化疗（NACT）后的病理反应和生存结果的数据尚缺乏。本研究旨在真实世界中对此进行研究。
方法
回顾性检索了 2010 年至 2020 年间在上海交通大学乳腺癌数据库中接受 NACT 的 819 例 HER2 阴性 BC 患者的临床病理数据。这些患者分为 HER2 低型和 HER2-0 型。进行逻辑分析以确定完全病理缓解（pCR）和乳腺 pCR 的预测因素。进行 Cox 回归分析以评估与无病生存（DFS）和总生存（OS）相关的因素。生成 Kaplan-Meier（K-M）曲线以比较 HER2 低型 BC 和 HER2-0 型 BC 的 DFS 和 OS。
结果
在 819 例 BC 患者中，669 例（81.7%）患有 HER2 低型肿瘤，150 例（18.3%）患有 HER2-0 型肿瘤。与 HER2-0 型 BC 相比，HER2 低型 BC 的 ER≥10%、PR≥20%和 Ki67≥15%的比例显著更高。与 HER2-0 型 BC 相比，HER2 低型 BC 的乳腺 pCR 率显著更高（分别为 13.6%和 7.3%，P=0.036）。年龄、HER2 状态（低或 0）、Ki67 和手术方式与 HER2 阴性 BC 的乳腺 pCR 相关。在 HER2 低型 BC 中，ER≥10%BC 的 pCR 率显著低于 ER<10%BC，但 ER 10%BC 的 DFS 和 OS 显著更高。K-M 曲线显示 HER2 低型和 HER2-0 型 BC 之间的 DFS 或 OS 无显著差异。Cox 回归显示，ER 表达和组织学分级（III 级比 I∼II 级）与 HER2 低型 BC 的生存显著相关。
结论
在这项真实世界数据（RWD）研究中，与 HER2-0 型 BC 相比，HER2 低型 BC 的乳腺 pCR 率显著更高，尽管生存无显著差异。此外，ER 表达对 HER2 低型 BC 具有显著的预后影响。
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