Abstract：
UNASSIGNED: Approximately 50-74% of patients with metastatic HER2-positive breast cancer do not respond to trastuzumab, with 75% of treated patients experiencing disease progression within a year. The combination of pyrotinib and capecitabine has showed efficacy in these patients. This study evaluates the efficacy and safety of pyrotinib combined with metronomic vinorelbine for trastuzumab-pretreated HER2-positive advanced breast cancer patients.
UNASSIGNED: In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
UNASSIGNED: From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cut-off date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% CI: 8.3-18.5). With all patients evaluated, an ORR of 38.9% (95% CI: 23.1-56.5%) and a DCR of 83.3% (95% CI: 67.2-93.6%) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs.
UNASSIGNED: Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.
UNASSIGNED: In this phase 2 trial, patients aged 18-75 years with HER2-positive advanced breast cancer who had previously failed trastuzumab treatment were enrolled to receive pyrotinib 400mg daily in combination with vinorelbine 40mg thrice weekly. The primary endpoint was progression-free survival (PFS), while secondary endpoints included objective response rate (ORR), disease control rate (DCR), overall survival (OS), and safety.
UNASSIGNED: From October 21, 2019, to January 21, 2022, 36 patients were enrolled and received at least one dose of study treatment. At the cut-off date, 20 experienced disease progression or death. With a median follow-up duration of 35 months, the median PFS was 13.5 months (95% CI: 8.3-18.5). With all patients evaluated, an ORR of 38.9% (95% CI: 23.1-56.5%) and a DCR of 83.3% (95% CI: 67.2-93.6%) were achieved. The median OS was not reached. Grade 3 adverse events (AEs) were observed in 17 patients, with diarrhea being the most common (27.8%), followed by vomiting (8.3%) and stomachache (5.6%). There were no grade 4/5 AEs.
UNASSIGNED: Pyrotinib combined with metronomic vinorelbine showed promising efficacy and an acceptable safety profile in HER2-positive advanced breast cancer patients after trastuzumab failure.
摘要：
■大约50-74%的转移性HER2阳性乳腺癌患者对曲妥珠单抗没有反应，75%的接受治疗的患者在一年内经历疾病进展。吡唑替尼和卡培他滨的组合在这些患者中显示出疗效。本研究评估了吡唑替尼联合长春瑞滨治疗曲妥珠单抗预处理的HER2阳性晚期乳腺癌患者的疗效和安全性。
■在此第二阶段试验中，纳入既往曲妥珠单抗治疗失败的年龄18~75岁的HER2阳性晚期乳腺癌患者,接受每日400mg吡唑替尼联合长春瑞滨40mg,每周三次.主要终点是无进展生存期（PFS），次要终点包括客观反应率（ORR），疾病控制率（DCR），总生存期（OS），和安全。
■从2019年10月21日至2022年1月21日，招募了36名患者，并接受了至少一个剂量的研究治疗。在截止日期，20人经历疾病进展或死亡。中位随访时间为35个月，中位PFS为13.5个月(95%CI:8.3-18.5).对所有患者进行了评估，ORR为38.9%(95%CI:23.1-56.5%),DCR为83.3%(95%CI:67.2-93.6%).未达到OS中位数。在17例患者中观察到3级不良事件（AE），腹泻是最常见的（27.8%），其次是呕吐(8.3%)和胃痛(5.6%)。没有4/5级AE。
在曲妥珠单抗治疗失败后的HER2阳性晚期乳腺癌患者中，吡罗替尼联合摇号长春瑞滨显示有希望的疗效和可接受的安全性。
■在此第二阶段试验中，纳入既往曲妥珠单抗治疗失败的年龄18~75岁的HER2阳性晚期乳腺癌患者,接受每日400mg吡唑替尼联合长春瑞滨40mg,每周三次.主要终点是无进展生存期（PFS），次要终点包括客观反应率（ORR），疾病控制率（DCR），总生存期（OS），和安全。
■从2019年10月21日至2022年1月21日，招募了36名患者，并接受了至少一个剂量的研究治疗。在截止日期，20人经历疾病进展或死亡。中位随访时间为35个月，中位PFS为13.5个月(95%CI:8.3-18.5).对所有患者进行了评估，ORR为38.9%(95%CI:23.1-56.5%),DCR为83.3%(95%CI:67.2-93.6%).未达到OS中位数。在17例患者中观察到3级不良事件（AE），腹泻是最常见的（27.8%），其次是呕吐(8.3%)和胃痛(5.6%)。没有4/5级AE。
在曲妥珠单抗治疗失败后的HER2阳性晚期乳腺癌患者中，吡罗替尼联合摇号长春瑞滨显示有希望的疗效和可接受的安全性。
