目的:新辅助化疗(NAC)可作为侵袭性乳腺癌(BC)的前期治疗。人表皮生长因子受体2(HER2)-低BC,定义为通过原位杂交无HER2基因扩增的免疫组织化学肿瘤评分+1或+2,缺乏关于真实世界数据(RWD)结果的信息,尤其是在NAC设置中。这个小组,由于其受体表达较低,未达到HER2阳性标准,代表了一个不同的临床类别,可能需要定制的治疗方法。
目的:本研究的目的是描述在巴西公共参考中心接受NAC治疗的HER2低状态BC患者的特征,以治疗女性肿瘤和关键结局,如病理完全缓解(pCR),总生存期(OS),和无转移生存期(MFS)。
方法:一项回顾性队列研究,基于来自巴西参考癌症中心的大型BC数据库。接受NAC的BC患者,如果他们在2011年至2020年之间诊断为HER2低状态(定义为在免疫组织化学上肿瘤评分+1或+2,但未通过原位杂交进行HER2基因扩增)并且具有关于结局的完整数据,则纳入研究.收集临床和人口统计数据,比如年龄,更年期状态,Ki-67、激素受体表达等。研究的关键结果包括pCR(定义为ypT0/TIs/ypN0),总生存率,和无转移生存期(MFS)。通过半参数Kaplan-Meier方法进行生存分析,以通过pCR状态评估OS和MFS,考虑BC诊断为索引日期。
结果:总体而言,在符合HER2低定义后,297名患者符合条件,141名患者被纳入研究。141例患者中有18例出现pCR(12.7%)。中位总生存期为8.2年,MFS中位数为2.7年。pCR的OS为83.4%,非pCR为58.1%;pCR的DFS为55.5%,非pCR为40.6%。
结论:这项研究提供了有关pCR的最新见解,操作系统,和MFS在女性HER2低BC暴露于NAC。
OBJECTIVE: Neoadjuvant chemotherapy (NAC) can be used as upfront therapy in aggressive breast cancer (BC). human epidermal growth factor receptor 2 (HER2)-low BC, defined as tumors scoring +1 or +2 on immunohistochemistry without HER2 gene amplification by in situ hybridization, lacks information on real-world data (RWD) outcomes, especially in the NAC setting. This subgroup, which does not reach the HER2 positive criteria due to its lower receptor expression, represents a distinct clinical category potentially requiring tailored therapeutic approaches.
OBJECTIVE: The objective of this study is to characterize patients with BC with HER2-low status who received NAC in a Brazilian public reference center for female tumors and key outcomes such as pathological complete response (pCR), overall survival (OS), and metastasis-free survival (MFS).
METHODS: A retrospective cohort study based on a large BC database from a reference cancer center in Brazil. Patients with BC that received NAC, diagnosed between 2011 and 2020, were included if they presented HER2-low status (defined as tumors scoring +1 or +2 on immunohistochemistry without HER2 gene amplification by in situ hybridization) and had complete data on outcomes. Clinical and demographic data were collected, such as age, menopausal status, Ki-67, hormone receptor expression and others. Key outcomes from the study comprised pCR (defined as ypT0/TIs/ypN0), overall survival, and metastasis-free survival (MFS). Survival analyses were conducted through the semiparametric Kaplan-Meier method to assess OS and MFS by pCR status, considering BC diagnosis as the index date.
RESULTS: Overall, 297 patients were eligible and 141 were included in the study after matching the HER2-low definition. The pCR was seen in 18 out of 141 patients (12.7%). The median overall survival was 8.2 years, and the median MFS was 2.7 years. The OS of pCR was 83.4% and non-pCR was 58.1%; the DFS of pCR was 55.5% and non-pCR 40.6%.
CONCLUSIONS: This study gives updated insights on pCR, OS, and MFS in women with HER2-low BC exposed to NAC.