PDF(Pubmed)
Abstract：
UNASSIGNED: To evaluate the efficacy and safety of a pyrotinib-based therapy for human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC) in the real world.
UNASSIGNED: Clinical data of 218 patients with HER2-positive MBC who received a pyrotinib-based therapy from January 2020 to March 2023 at the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed.
UNASSIGNED: Finally, 195 patients were included in the efficacy cohort. The median progression-free survival (PFS) in the total population is 12.4 months (95% CI, 9.8-15.0 months). More than half of the patients in the efficacy cohort received pyrotinib mono-targeted therapy (103 cases, 52.8%). Among the remaining patients, 74 (37.9%) patients chose a combined trastuzumab-targeted therapy and 17 (8.7%) chose to combine inetetamab. Median PFS in the pyrotinib group vs pyrotinib plus trastuzumab group was 10.5 months vs 20.1 months (P<0.001). The median PFS of primary trastuzumab resistance population reached to 20.1 months in pyrotinib plus trastuzumab group. Double-targets\' advantage was also observed in the brain metastases subgroup (17.9 months vs 10.0 months, P=0.386). The patients who received pyrotinib plus inetetamab as second and higher-line treatment reached a median PFS of 7.9 months (95% CI, 4.0-11.8 months). Forty-one (19.8%) of 207 patients included in the safety cohort experienced grade 3 or higher diarrhea, the most common adverse event in safety analysis, and no adverse event-related deaths.
UNASSIGNED: The combination of pyrotinib and trastuzumab demonstrated promising efficacy in the treatment of HER2-positive metastatic breast cancer, including those who had primary resistance to trastuzumab and brain metastases. Pyrotinib plus trastuzumab is expected to be a potent option in the first-line. Additionally, the concurrent administration of pyrotinib and inetetamab could be an alternative to consider in the second and higher-line treatment for metastatic breast cancer. The adverse reactions of pyrotinib were tolerable in general.
UNASSIGNED: Clinical data of 218 patients with HER2-positive MBC who received a pyrotinib-based therapy from January 2020 to March 2023 at the First Affiliated Hospital of Zhengzhou University were retrospectively analyzed.
UNASSIGNED: Finally, 195 patients were included in the efficacy cohort. The median progression-free survival (PFS) in the total population is 12.4 months (95% CI, 9.8-15.0 months). More than half of the patients in the efficacy cohort received pyrotinib mono-targeted therapy (103 cases, 52.8%). Among the remaining patients, 74 (37.9%) patients chose a combined trastuzumab-targeted therapy and 17 (8.7%) chose to combine inetetamab. Median PFS in the pyrotinib group vs pyrotinib plus trastuzumab group was 10.5 months vs 20.1 months (P<0.001). The median PFS of primary trastuzumab resistance population reached to 20.1 months in pyrotinib plus trastuzumab group. Double-targets\' advantage was also observed in the brain metastases subgroup (17.9 months vs 10.0 months, P=0.386). The patients who received pyrotinib plus inetetamab as second and higher-line treatment reached a median PFS of 7.9 months (95% CI, 4.0-11.8 months). Forty-one (19.8%) of 207 patients included in the safety cohort experienced grade 3 or higher diarrhea, the most common adverse event in safety analysis, and no adverse event-related deaths.
UNASSIGNED: The combination of pyrotinib and trastuzumab demonstrated promising efficacy in the treatment of HER2-positive metastatic breast cancer, including those who had primary resistance to trastuzumab and brain metastases. Pyrotinib plus trastuzumab is expected to be a potent option in the first-line. Additionally, the concurrent administration of pyrotinib and inetetamab could be an alternative to consider in the second and higher-line treatment for metastatic breast cancer. The adverse reactions of pyrotinib were tolerable in general.
摘要：
■评估真实世界中人类表皮生长因子受体2（HER2）阳性转移性乳腺癌（MBC）的基于吡罗替尼的疗法的疗效和安全性。
■回顾性分析2020年1月至2023年3月郑州大学第一附属医院218例HER2阳性MBC患者的临床资料。
■最后，195名患者被纳入疗效队列。总人口的中位无进展生存期（PFS）为12.4个月（95％CI，9.8-15.0个月）。疗效队列中超过一半的患者接受了吡罗替尼单靶向治疗（103例，52.8%）。在剩下的患者中，74例（37.9%）患者选择了联合曲妥珠单抗靶向治疗，17例（8.7%）患者选择了联合伊奈他单抗。吡罗替尼组与吡罗替尼加曲妥珠单抗组的平均PFS分别为10.5个月和20.1个月（P<0.001）。在pyrotinib加曲妥珠单抗组，原发性曲妥珠单抗耐药人群的中位PFS达到20.1个月。在脑转移亚组中也观察到双靶点优势(17.9个月vs10.0个月,P=0.386)。接受pyrotinib联合inetamab作为第二和更高线治疗的患者的中位PFS为7.9个月（95％CI，4.0-11.8个月）。纳入安全性队列的207例患者中有41例（19.8%）出现3级或以上腹泻，安全分析中最常见的不良事件，无不良事件相关死亡。
吡罗替尼和曲妥珠单抗联合治疗HER2阳性转移性乳腺癌具有良好的疗效，包括主要对曲妥珠单抗耐药和脑转移的患者.预计吡罗替尼加曲妥珠单抗将是一线的有效选择。此外,吡罗替尼和依奈他单抗的同时给药可能是转移性乳腺癌第二和更高线治疗中考虑的替代方案.吡唑替尼的不良反应一般可耐受。
■回顾性分析2020年1月至2023年3月郑州大学第一附属医院218例HER2阳性MBC患者的临床资料。
■最后，195名患者被纳入疗效队列。总人口的中位无进展生存期（PFS）为12.4个月（95％CI，9.8-15.0个月）。疗效队列中超过一半的患者接受了吡罗替尼单靶向治疗（103例，52.8%）。在剩下的患者中，74例（37.9%）患者选择了联合曲妥珠单抗靶向治疗，17例（8.7%）患者选择了联合伊奈他单抗。吡罗替尼组与吡罗替尼加曲妥珠单抗组的平均PFS分别为10.5个月和20.1个月（P<0.001）。在pyrotinib加曲妥珠单抗组，原发性曲妥珠单抗耐药人群的中位PFS达到20.1个月。在脑转移亚组中也观察到双靶点优势(17.9个月vs10.0个月,P=0.386)。接受pyrotinib联合inetamab作为第二和更高线治疗的患者的中位PFS为7.9个月（95％CI，4.0-11.8个月）。纳入安全性队列的207例患者中有41例（19.8%）出现3级或以上腹泻，安全分析中最常见的不良事件，无不良事件相关死亡。
吡罗替尼和曲妥珠单抗联合治疗HER2阳性转移性乳腺癌具有良好的疗效，包括主要对曲妥珠单抗耐药和脑转移的患者.预计吡罗替尼加曲妥珠单抗将是一线的有效选择。此外,吡罗替尼和依奈他单抗的同时给药可能是转移性乳腺癌第二和更高线治疗中考虑的替代方案.吡唑替尼的不良反应一般可耐受。
