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Abstract：
OBJECTIVE: To analyze the safety and efficacy of orally administered metronomic capecitabine plus pyrotinib in HER2 positive metastatic breast cancer (MBC) patients, we conducted a prospective phase II study with a single-arm design.
METHODS: HER2 positive patients received oral metronomic capecitabine 500 mg three times a day and pyrotinib 400 mg per day. The primary endpoint was progression-free survival (PFS). Other endpoints included objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR) and safety.
RESULTS: The study included 50 patients with MBC that was HER2-positive, while 1 patient was excluded due to nonstandard medication. The median PFS and OS was 11.9 months (95%CI 8.8-14.6) and 29.3 months (95%CI 24.4-34.8) respectively. ORR was 34.7%, and CBR was 81.6% with 2 CR (4.1%), 15 PR (30.6%) and 23 SD (46.9%). The mPFS in first- or second-line treatment was 12.2 months. The most frequent treatment-related adverse events included hand-foot syndrome, diarrhea, vomiting and nausea. Grade 3 adverse events occurred in 15(30.6%) patients, including hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%). 1 grade 4 adverse event of diarrhea (2.0%) was observed.
CONCLUSIONS: The combination of metronomic capecitabine and pyrotinib is a promising regimen with competitive efficacy and improved tolerability in HER2 positive metastatic breast cancer patients.
METHODS: HER2 positive patients received oral metronomic capecitabine 500 mg three times a day and pyrotinib 400 mg per day. The primary endpoint was progression-free survival (PFS). Other endpoints included objective response rate (ORR), overall survival (OS), clinical benefit rate (CBR) and safety.
RESULTS: The study included 50 patients with MBC that was HER2-positive, while 1 patient was excluded due to nonstandard medication. The median PFS and OS was 11.9 months (95%CI 8.8-14.6) and 29.3 months (95%CI 24.4-34.8) respectively. ORR was 34.7%, and CBR was 81.6% with 2 CR (4.1%), 15 PR (30.6%) and 23 SD (46.9%). The mPFS in first- or second-line treatment was 12.2 months. The most frequent treatment-related adverse events included hand-foot syndrome, diarrhea, vomiting and nausea. Grade 3 adverse events occurred in 15(30.6%) patients, including hand-foot syndrome (12.2%), diarrhea (12.2%), vomiting (4.1%), and nausea (2.0%). 1 grade 4 adverse event of diarrhea (2.0%) was observed.
CONCLUSIONS: The combination of metronomic capecitabine and pyrotinib is a promising regimen with competitive efficacy and improved tolerability in HER2 positive metastatic breast cancer patients.
摘要：
目的：分析口服节拍卡培他滨联合吡罗替尼治疗HER2阳性转移性乳腺癌（MBC）患者的安全性和有效性，我们进行了一项单臂设计的前瞻性II期研究.
方法：HER2阳性患者每天3次口服节拍卡培他滨500mg和每天400mg的吡唑替尼。主要终点是无进展生存期（PFS）。其他终点包括客观反应率(ORR)，总生存期（OS），临床获益率（CBR）和安全性。
结果：该研究包括50例HER2阳性的MBC患者，1例患者因不规范用药而被排除。中位PFS和OS分别为11.9个月(95CI8.8-14.6)和29.3个月(95CI24.4-34.8)。ORR为34.7%，CBR为81.6%，2CR(4.1%)，15个PR(30.6%)和23个SD(46.9%)。一线或二线治疗的mPFS为12.2个月。最常见的治疗相关不良事件包括手足综合征，腹泻,呕吐和恶心。15例（30.6%）患者发生3级不良事件，包括手足综合征(12.2%),腹泻（12.2%），呕吐(4.1%),恶心（2.0%）。观察到1例4级腹泻不良事件（2.0％）。
结论：在HER2阳性转移性乳腺癌患者中，节拍卡培他滨和吡罗替尼联合使用是一种有前途的方案，具有竞争性疗效和提高的耐受性。
方法：HER2阳性患者每天3次口服节拍卡培他滨500mg和每天400mg的吡唑替尼。主要终点是无进展生存期（PFS）。其他终点包括客观反应率(ORR)，总生存期（OS），临床获益率（CBR）和安全性。
结果：该研究包括50例HER2阳性的MBC患者，1例患者因不规范用药而被排除。中位PFS和OS分别为11.9个月(95CI8.8-14.6)和29.3个月(95CI24.4-34.8)。ORR为34.7%，CBR为81.6%，2CR(4.1%)，15个PR(30.6%)和23个SD(46.9%)。一线或二线治疗的mPFS为12.2个月。最常见的治疗相关不良事件包括手足综合征，腹泻,呕吐和恶心。15例（30.6%）患者发生3级不良事件，包括手足综合征(12.2%),腹泻（12.2%），呕吐(4.1%),恶心（2.0%）。观察到1例4级腹泻不良事件（2.0％）。
结论：在HER2阳性转移性乳腺癌患者中，节拍卡培他滨和吡罗替尼联合使用是一种有前途的方案，具有竞争性疗效和提高的耐受性。
