吡咯替尼联合白蛋白结合型紫杉醇治疗HER2阳性晚期乳腺癌的疗效与安全性：一项真实世界研究。
Efficacy and safety of pyrotinib in combination with albumin‑bound paclitaxel for the treatment of HER2‑positive advanced breast cancer: A real‑world study.
作者信息
Yang Lixian, Zheng Lei, Kong Fanting, Tian Xinli, Zhang Shiyu, Pu Pengpeng
机构信息
Department of Breast Surgery, Xingtai People's Hospital, Xingtai, Hebei 054000, P.R. China.
Medical Research Center, Xingtai Medical College, Xingtai, Hebei 054000, P.R. China.
出版信息
Oncol Lett. 2023 Jun 6;26(1):312. doi: 10.3892/ol.2023.13898. eCollection 2023 Jul.
The present study aimed to determine the efficacy and safety of pyrotinib in combination with albumin-bound paclitaxel in patients with HER2-positive advanced breast cancer (ABC). A total of 48 patients diagnosed with HER2-positive ABC were included in the present study, and these patients were prescribed a combination of pyrotinib and albumin-bound paclitaxel in routine clinical practice. During a 21-day cycle, the standard dosage of pyrotinib was 400 mg single dose/day, which was administered orally, and 130 mg/m/day albumin-bound paclitaxel on days 1, 8 and 15, which was administered by intravenous drip. The primary efficacy endpoint was progression-free survival (PFS) and the secondary efficacy endpoint was overall response rate (ORR), which was defined as the percentage of patients with complete remission or partial remission. Safety indicators were also observed in the present study. The results of the present study demonstrated that the median PFS (mPFS) was 8.1 months for all patients, ranging from 3.3-10.6 months. Patients receiving pyrotinib as second-line therapy exhibited a longer mPFS of 8.5 months compared with those receiving it as third- or higher-line therapy (mPFS, 5.9 months). In 17 patients with brain metastases, mPFS was 7.3 months, ranging from 4.8-10.1 months. The results of the present study also demonstrated that the ORR for the 48 patients was 33.3%. Notably, diarrhea was the most common grade 3-4 adverse event, occurring in 22.9% of patients, followed by neutropenia (6.3%), leukopenia (4.2%) and anemia (4.2%). Collectively, the results of the present study indicated that pyrotinib-based treatment is effective for patients with HER2 ABC, including those who have previously been treated with trastuzumab. Thus, the combination of pyrotinib with albumin-bound paclitaxel is recommended due to high levels of efficacy, convenience and tolerability.
本研究旨在确定吡咯替尼联合白蛋白结合型紫杉醇治疗人表皮生长因子受体2（HER2）阳性晚期乳腺癌（ABC）患者的疗效和安全性。本研究共纳入48例诊断为HER2阳性ABC的患者，这些患者在常规临床实践中接受了吡咯替尼和白蛋白结合型紫杉醇的联合治疗。在21天的周期内，吡咯替尼的标准剂量为每日单次口服400 mg，白蛋白结合型紫杉醇在第1、8和15天的剂量为130 mg/m²/天，通过静脉滴注给药。主要疗效终点为无进展生存期（PFS），次要疗效终点为总缓解率（ORR），定义为完全缓解或部分缓解患者的百分比。本研究还观察了安全性指标。本研究结果表明，所有患者的中位PFS（mPFS）为8.1个月，范围为3.3 - 10.6个月。接受吡咯替尼作为二线治疗的患者mPFS为8.5个月，长于接受三线或更高线治疗的患者（mPFS为5.9个月）。在17例脑转移患者中，mPFS为7.3个月，范围为4.8 - 10.1个月。本研究结果还表明，48例患者的ORR为33.3%。值得注意的是，腹泻是最常见的3 - 4级不良事件，发生在22.9%的患者中，其次是中性粒细胞减少（6.3%）、白细胞减少（4.2%）和贫血（4.2%）。总体而言，本研究结果表明，以吡咯替尼为基础的治疗对HER2阳性ABC患者有效，包括那些先前接受过曲妥珠单抗治疗的患者。因此，由于疗效高、便利性和耐受性好，推荐吡咯替尼与白蛋白结合型紫杉醇联合使用。
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