分析HER2低表达乳腺癌新辅助化疗效果：真实世界数据
Analyzing Neoadjuvant Chemotherapy Effects in HER2-Low Breast Cancer: Real World Data.
作者信息
Antonini Marcelo, Mattar Andre, Richter Fernanda G, Ramos Marcellus N, Teixeira Marina D, Pantarotto Nathalia N, Matta Nadia F, Amorim Andressa G, Pinheiro Denise J, Lopes Reginaldo C
机构信息
Mastology Department, Hospital do Servidor Público Estadual - Francisco Morato de Oliveira, Sao Paulo, BRA.
Mastology Department, Hospital da Mulher, Sao Paulo, BRA.
出版信息
Cureus. 2024 May 4;16(5):e59652. doi: 10.7759/cureus.59652. eCollection 2024 May.
PURPOSE
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.
STUDY 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%.
CONCLUSION
This study gives updated insights on pCR, OS, and MFS in women with HER2-low BC exposed to NAC.
目的
新辅助化疗（NAC）可作为侵袭性乳腺癌（BC）的一线治疗方法。人表皮生长因子受体2（HER2）低表达型乳腺癌，定义为免疫组化评分为+1或+2且原位杂交检测无HER2基因扩增的肿瘤，缺乏真实世界数据（RWD）结果的相关信息，尤其是在NAC治疗背景下。由于其受体表达较低而未达到HER2阳性标准的这一亚组代表了一个独特的临床类别，可能需要量身定制的治疗方法。
研究目的
本研究的目的是对在巴西一家女性肿瘤公共参考中心接受NAC治疗的HER2低表达型BC患者以及病理完全缓解（pCR）、总生存期（OS）和无转移生存期（MFS）等关键结局进行特征描述。
方法
基于巴西一家参考癌症中心的大型BC数据库进行回顾性队列研究。纳入2011年至2020年间接受NAC治疗且HER2低表达（定义为免疫组化评分为+1或+2且原位杂交检测无HER2基因扩增）并有完整结局数据的BC患者。收集临床和人口统计学数据，如年龄、绝经状态、Ki-67、激素受体表达等。研究的关键结局包括pCR（定义为ypT0/TIs/ypN0）、总生存期和无转移生存期（MFS）。生存分析通过半参数Kaplan-Meier方法进行，以按pCR状态评估OS和MFS，将BC诊断作为索引日期。
结果
总体而言，297例患者符合条件，在匹配HER2低表达定义后，141例患者纳入研究。141例患者中有18例（12.7%）出现pCR。中位总生存期为8.2年，中位MFS为2.7年。pCR患者的OS为83.4%，非pCR患者为58.1%；pCR患者的DFS为55.5%，非pCR患者为40.6%。
结论
本研究为接受NAC治疗的HER2低表达型BC女性患者的pCR、OS和MFS提供了最新见解。
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