Department of Oncology, University Hospital Copenhagen, Rigshospitalet, Juliane Maries Vej 5, 2100, Copenhagen, Denmark; Danish Breast Cancer Group, Department of Oncology, University Hospital Copenhagen, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Danish Breast Cancer Group, Department of Oncology, University Hospital Copenhagen, Rigshospitalet, Blegdamsvej 9, 2100, Copenhagen, Denmark.
Breast. 2020 Dec;54:242-247. doi: 10.1016/j.breast.2020.10.014. Epub 2020 Nov 3.
Dual blockade with trastuzumab and pertuzumab combined with neoadjuvant chemotherapy (NACT) has been increasingly used for HER2-positive tumours >2 cm and/or with positive axillary lymph nodes in order to evaluate pathologic response and obtain better surgical management. SB3 is a registered biosimilar trastuzumab approved following a phase III trial demonstrating similar efficacy in the neoadjuvant setting as trastuzumab. However, the study was done without pertuzumab.
The database of the Danish Breast Cancer Group was used to extract data on all patients who started NACT with SB3 and pertuzumab between September 1, 2018 and August 31, 2019. The primary endpoint was pathological complete response (pCR) rate.
In total 215 patients received NACT and dual blockade. The median age was 55 (24-81). NACT used was cyclophosphamide and epirubicin followed by weekly paclitaxel (62% on six cycles, 35% on eight cycles) or other chemotherapy followed by weekly paclitaxel (3%). Overall, 56% of patients achieved pCR. 60 of 88 node-positive patients pre-NACT achieved ypN0(i-) after neoadjuvant treatment. pCR rate was significantly associated with estrogen receptor status and malignancy grade. An association with CEP17/HER2-ratio was assessed.
Real world data on dual blockade with SB3 and pertuzumab in combination with NACT in a nationwide population-based study show a pCR rate comparable to that seen in previous clinical studies.
曲妥珠单抗和帕妥珠单抗联合新辅助化疗（NACT）的双重阻断已越来越多地用于 HER2 阳性肿瘤>2cm 和/或腋窝淋巴结阳性，以评估病理反应并获得更好的手术管理。SB3 是一种注册生物类似曲妥珠单抗，在一项 III 期试验中证明在新辅助环境中与曲妥珠单抗具有相似的疗效后获得批准。然而，该研究未使用帕妥珠单抗。
丹麦乳腺癌小组的数据库被用来提取所有于 2018 年 9 月 1 日至 2019 年 8 月 31 日期间开始使用 SB3 和帕妥珠单抗进行 NACT 的患者的数据。主要终点是病理完全缓解（pCR）率。
共有 215 名患者接受了 NACT 和双重阻断治疗。中位年龄为 55 岁（24-81 岁）。使用的 NACT 是环磷酰胺和表柔比星，然后是每周紫杉醇（62%用六周期，35%用八周期）或其他化疗，然后是每周紫杉醇（3%）。总体而言，56%的患者达到了 pCR。88 例术前淋巴结阳性患者中有 60 例在新辅助治疗后达到 ypN0(i-)。pCR 率与雌激素受体状态和恶性程度显著相关。还评估了与 CEP17/HER2-比值的相关性。
在一项全国范围内基于人群的研究中，使用 SB3 和帕妥珠单抗联合 NACT 的双重阻断的真实世界数据显示，pCR 率与之前的临床研究相似。
