Department of Breast Oncology, Henan Provincial People's Hospital, Zhengzhou University People's Hospital, Zhengzhou, China.
Department of Breast Oncology, Henan Provincial People's Hospital, Henan University People's Hospital, Zhengzhou, China.
Front Endocrinol (Lausanne). 2022 Aug 18;13:1000704. doi: 10.3389/fendo.2022.1000704. eCollection 2022.
There is accumulating evidence support human epidermal growth factor receptor 2 ()-low as a biologically distinct subtype of breast cancer. The present study was conducted to explore whether -low expression will affect the clinical efficacy of cyclin-dependent kinase () 4/6 inhibitor for patients with hormone receptor (HR)-positive, negative metastatic breast cancer.
Patients with HR+/- metastatic breast cancer who were treated with palbociclib from January 2019 to June 2021 were retrospectively analyzed based on real-world clinical practice. -zero was defined as immunohistochemistry (IHC) 0, and -low was defined as IHC 1+ or IHC 2+/fluorescence hybridization (FISH) negative. The primary end point was progression free survival (PFS), and the secondary end points were objective response rate (ORR), disease control rate (DCR), overall survival(OS) and safety.
45 patients received palbociclib plus aromatase inhibitor (AI) or fulvestrant therapy, including 24 -zero and 21 -low patients. There were no statistically significant differences in clinicopathological characteristics between the two groups. No significant differences were observed in ORR (41.7% vs. 28.6%, P=0.360) and DCR (79.2% vs. 76.2%, P=0.811) between -zero and -low patients. And simultaneously, -zero and -low patients obtained similar median PFS (16.2m vs. 14.1m, P=0.263). The median OS was not reached. Neutropenia and leukopenia were the most common adverse events. Grade 3-4 adverse events(AEs) occurred in 58.3% and 57.1% of patients, respectively.
-low expression does not affect the clinical efficacy of palbociclib and our present study did not support incorporating -low into systemic therapy decisions for patients with HR+/- metastatic breast cancer treated with inhibitor.
越来越多的证据支持人表皮生长因子受体 2 ()-低表达作为乳腺癌的一个生物学亚型。本研究旨在探讨 -低表达是否会影响激素受体（HR）阳性、阴性转移性乳腺癌患者 cyclin 依赖性激酶（）4/6 抑制剂的临床疗效。
根据真实世界的临床实践，回顾性分析了 2019 年 1 月至 2021 年 6 月接受 palbociclib 治疗的 HR+/-转移性乳腺癌患者。-零定义为免疫组化（IHC）0，-低定义为 IHC 1+或 IHC 2+/荧光原位杂交（FISH）阴性。主要终点为无进展生存期（PFS），次要终点为客观缓解率（ORR）、疾病控制率（DCR）、总生存期（OS）和安全性。
45 例患者接受 palbociclib 联合芳香化酶抑制剂（AI）或氟维司群治疗，其中 24 例为 -零，21 例为 -低。两组患者的临床病理特征无统计学差异。-零和 -低患者的 ORR（41.7%比 28.6%，P=0.360）和 DCR（79.2%比 76.2%，P=0.811）无显著差异。同时，-零和 -低患者获得相似的中位 PFS（16.2m 比 14.1m，P=0.263）。中位 OS 未达到。中性粒细胞减少和白细胞减少是最常见的不良事件。58.3%和 57.1%的患者分别发生 3-4 级不良事件（AEs）。
-低表达并不影响 palbociclib 的临床疗效，本研究不支持将 -低纳入 HR+/-转移性乳腺癌患者接受抑制剂治疗的系统治疗决策。
