Department of Breast Surgery, Herlev and Gentofte Hospital, Copenhagen University Hospital, Gentofte Hospitalsvej 1, 2900, Hellerup, Denmark.
Department of Surgical Pathology, Zealand University Hospital, Sygehusvej 9 (postal: Sygehusvej 10), 4000, Roskilde, Denmark.
Breast Cancer Res Treat. 2022 Nov;196(1):197-206. doi: 10.1007/s10549-022-06724-y. Epub 2022 Sep 8.
The purpose of this study was to evaluate the effect of chemotherapy and trastuzumab on invasive disease-free survival (iDFS) and overall survival (OS) in patients with human epidermal growth factor receptor 2 (HER2) positive, T1abN0 breast cancer.
In the Danish Breast Cancer Group database, patients with HER2-positive, T1abN0 tumors diagnosed between 2007 and 2016 were identified. Cox proportional hazards analysis was performed to analyze the association between adjuvant chemotherapy and trastuzumab and iDFS and OS.
Of 605 patients included in the analyses, 465 patients received chemotherapy and trastuzumab and 140 patients did not. Chemotherapy and trastuzumab did not improve iDFS or OS significantly in adjusted analyses. 5-year iDFS was 92.3% vs. 89.9%, Hazard ratio (HR) 1.01 (p = 0.98), and 5-year OS was 97.4% vs. 94.3%, HR 0.60 (p = 0.15), chemotherapy and trastuzumab vs. no chemotherapy/trastuzumab. In unadjusted analyses, significant treatment benefit on OS was found in patients with T1b tumors. The largest absolute treatment benefits were found in patients with T1b tumors and estrogen receptor (ER) negative tumors, respectively, whereas treatment effects in patients with T1a tumors and ER-positive tumors, respectively, were limited.
Adjuvant chemotherapy and trastuzumab did not improve OS or iDFS significantly in patients with HER2-positive, T1abN0 breast cancers in adjusted analyses. In unadjusted analyses, significant OS benefit was found in patients with T1b tumors. The largest absolute benefit was observed in patients with T1b tumors and ER-negative tumors, respectively, whereas the effect was limited in patients with T1a tumors and ER-positive tumors, respectively.
本研究旨在评估化疗和曲妥珠单抗对人表皮生长因子受体 2（HER2）阳性、T1abN0 乳腺癌患者浸润性无病生存（iDFS）和总生存（OS）的影响。
在丹麦乳腺癌小组数据库中，确定了 2007 年至 2016 年间诊断为 HER2 阳性、T1abN0 肿瘤的患者。采用 Cox 比例风险分析来分析辅助化疗和曲妥珠单抗与 iDFS 和 OS 之间的关联。
在纳入分析的 605 例患者中，465 例患者接受了化疗和曲妥珠单抗治疗，140 例患者未接受治疗。调整分析显示，化疗和曲妥珠单抗并未显著改善 iDFS 或 OS。5 年 iDFS 分别为 92.3%和 89.9%，风险比（HR）为 1.01（p=0.98），5 年 OS 分别为 97.4%和 94.3%，HR 为 0.60（p=0.15），化疗和曲妥珠单抗与无化疗/曲妥珠单抗相比。在未调整的分析中，T1b 肿瘤患者的 OS 存在显著的治疗获益。在 T1b 肿瘤和雌激素受体（ER）阴性肿瘤患者中，观察到最大的绝对治疗获益，而在 T1a 肿瘤和 ER 阳性肿瘤患者中，治疗效果有限。
在调整分析中，辅助化疗和曲妥珠单抗并未显著改善 HER2 阳性、T1abN0 乳腺癌患者的 OS 或 iDFS。在未调整的分析中，T1b 肿瘤患者的 OS 获益显著。在 T1b 肿瘤和 ER 阴性肿瘤患者中，观察到最大的绝对获益，而在 T1a 肿瘤和 ER 阳性肿瘤患者中，治疗效果有限。
