PDF(Pubmed)
Abstract：
OBJECTIVE: It has been observed that the prognosis of patients with HER2-positive metastatic breast cancer has improved significantly with HER2-targeted agents. However, there is still a lack of evidence regarding first-line anti-HER2 treatment options for patients who have received adjuvant and/or neoadjuvant trastuzumab for HER2-positive metastatic breast cancer. Besides, there are no reliable markers that can predict the efficacy of anti-HER2 treatment in these patients.
METHODS: Patients who have received adjuvant and/or neoadjuvant trastuzumab for HER2-positive metastatic breast cancer were enrolled. Pyrotinib plus albumin-bound paclitaxel were used as first-line treatment. The primary endpoint was the objective response rate (ORR). The safety profile was also assessed. In order to explore predictive biomarkers using Olink technology, blood samples were collected dynamically.
RESULTS: From December 2019 to August 2023, the first stage of the study involved 27 eligible patients. It has not yet reached the median PFS despite the median follow-up being 17.8 months. Efficacy evaluation showed that the ORR was 92.6%, and the DCR was 100%. Adverse events of grade 3 or higher included diarrhoea (29.6%), leukopenia (11.1%), neutropenia (25.9%), oral mucositis (3.7%), and hand-foot syndrome (3.7%). Toll-like receptor 3 (TLR3) and Proto-oncogene tyrosine-protein kinase receptor (RET) were proteins with significant relevance to PFS in these patients.
CONCLUSIONS: This study demonstrates that pyrotinib plus albumin-bound paclitaxel as a first-line treatment regimen shows good efficacy and manageable safety for patients who have received adjuvant and/or neoadjuvant trastuzumab for HER2-positive metastatic breast cancer. Besides, a significant association was identified between the expression levels of TLR3 and RET and the PFS in patients.
METHODS: Patients who have received adjuvant and/or neoadjuvant trastuzumab for HER2-positive metastatic breast cancer were enrolled. Pyrotinib plus albumin-bound paclitaxel were used as first-line treatment. The primary endpoint was the objective response rate (ORR). The safety profile was also assessed. In order to explore predictive biomarkers using Olink technology, blood samples were collected dynamically.
RESULTS: From December 2019 to August 2023, the first stage of the study involved 27 eligible patients. It has not yet reached the median PFS despite the median follow-up being 17.8 months. Efficacy evaluation showed that the ORR was 92.6%, and the DCR was 100%. Adverse events of grade 3 or higher included diarrhoea (29.6%), leukopenia (11.1%), neutropenia (25.9%), oral mucositis (3.7%), and hand-foot syndrome (3.7%). Toll-like receptor 3 (TLR3) and Proto-oncogene tyrosine-protein kinase receptor (RET) were proteins with significant relevance to PFS in these patients.
CONCLUSIONS: This study demonstrates that pyrotinib plus albumin-bound paclitaxel as a first-line treatment regimen shows good efficacy and manageable safety for patients who have received adjuvant and/or neoadjuvant trastuzumab for HER2-positive metastatic breast cancer. Besides, a significant association was identified between the expression levels of TLR3 and RET and the PFS in patients.
摘要：
目的：已经观察到HER2阳性转移性乳腺癌患者的预后使用HER2靶向药物显着改善。然而,对于接受过HER2阳性转移性乳腺癌辅助和/或新辅助曲妥珠单抗治疗的患者,仍缺乏关于一线抗HER2治疗方案的证据.此外,没有可靠的标志物可以预测抗HER2治疗在这些患者中的疗效.
方法：纳入接受过HER2阳性转移性乳腺癌辅助和/或新辅助曲妥珠单抗治疗的患者。使用吡罗替尼加白蛋白结合的紫杉醇作为一线治疗。主要终点是客观缓解率(ORR)。还评估了安全性。为了探索使用Olink技术的预测性生物标志物，血液样本是动态收集的。
结果：从2019年12月到2023年8月，研究的第一阶段涉及27名符合条件的患者。尽管中位随访时间为17.8个月，但尚未达到中位PFS。疗效评价显示ORR为92.6%,DCR为100%。3级或更高的不良事件包括腹泻（29.6％），白细胞减少症（11.1%），中性粒细胞减少症（25.9%），口腔黏膜炎(3.7%),和手足综合症(3.7%)。Toll样受体3（TLR3）和原癌基因酪氨酸蛋白激酶受体（RET）是与这些患者PFS显着相关的蛋白质。
结论：这项研究表明，对于接受过HER2阳性转移性乳腺癌辅助和/或新辅助曲妥珠单抗治疗的患者，吡托替尼联合白蛋白结合型紫杉醇作为一线治疗方案显示出良好的疗效和可控制的安全性。此外,TLR3和RET的表达水平与患者PFS之间存在显著关联.
方法：纳入接受过HER2阳性转移性乳腺癌辅助和/或新辅助曲妥珠单抗治疗的患者。使用吡罗替尼加白蛋白结合的紫杉醇作为一线治疗。主要终点是客观缓解率(ORR)。还评估了安全性。为了探索使用Olink技术的预测性生物标志物，血液样本是动态收集的。
结果：从2019年12月到2023年8月，研究的第一阶段涉及27名符合条件的患者。尽管中位随访时间为17.8个月，但尚未达到中位PFS。疗效评价显示ORR为92.6%,DCR为100%。3级或更高的不良事件包括腹泻（29.6％），白细胞减少症（11.1%），中性粒细胞减少症（25.9%），口腔黏膜炎(3.7%),和手足综合症(3.7%)。Toll样受体3（TLR3）和原癌基因酪氨酸蛋白激酶受体（RET）是与这些患者PFS显着相关的蛋白质。
结论：这项研究表明，对于接受过HER2阳性转移性乳腺癌辅助和/或新辅助曲妥珠单抗治疗的患者，吡托替尼联合白蛋白结合型紫杉醇作为一线治疗方案显示出良好的疗效和可控制的安全性。此外,TLR3和RET的表达水平与患者PFS之间存在显著关联.
