Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes
Phase II study of capecitabine and trastuzumab combination chemotherapy in patients with HER2 overexpressing metastatic breast cancers resistant to both anthracyclines and taxanes
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DOI：
10.1007/s00280-008-0882-8
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发表时间：
2009-07-01
影响因子：
3
通讯作者：
Ohuchi, Noriaki
中科院分区：
文献类型：
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作者：
Ishida, Takanori;Kiba, Takayoshi;Ohuchi, Noriaki
本研究的目的是研究HER2过表达的转移性乳腺癌患者中卡培他滨和曲妥珠单抗的活性。2003年6月至2006年5月，40例女性可测量或可评估的转移性乳腺癌患者中，38例患者的资料进行了复习和分析。曲妥珠单抗每周2 mg/kg/d，持续90min(首次滴注4 mg/kg/d)，卡培他滨1,657 mg/m(2)/d，连续21天，随后停药7天。这个周期每28天重复一次。主要终点是总存活率，次要终点是无进展生存率和应答率。中位数为4.5个周期(范围1-9个周期)。中位年龄53岁(30-69岁)。中位总生存期为22.3个月，无进展生存期为4.1个月。1年和2年生存率分别为81.6%和47.4%。有效率18.4%(95%可信区间7.7~34.3%)。所有可评价的患者中CR2例(5.3%)，PR5例(13.2%)，SD20例(52.6%)，PD8例(21.1%)，NE 3例(7.9%)。在血液学毒性方面，1/2/3级中性粒细胞减少、1/2级贫血、1级血小板减少和1/2级肝功能障碍也很常见。没有与治疗相关的死亡报告。卡培他滨和曲妥珠单抗联合治疗HER2过表达的乳腺癌患者是有效的，耐受性良好，对蒽环类药物和紫杉烷类药物都有耐药性。
The purpose of this study was to investigate the activity of capecitabine and trastuzumab in patients with HER2-overexpressing metastatic breast caner resistant to both anthracyclines and taxanes.From June 2003 and May 2006, 40 female patients with measurable or assessable metastatic breast cancer were enrolled and data from 38 patients were reviewed extramurally and analyzed. Patients were treated with weekly trastuzumab given at a dose of 2 mg/kg/day over 90 min (4 mg/kg/day on the first infusion) and capecitabine given at a dose 1,657 mg/m(2)/day during 21 days with a subsequent pause of 7 days. This cycle was repeated every 28 days. The primary endpoint was overall survival and secondary endpoints were progression-free survival and response rate.A median of 4.5 cycles (range 1-9 cycles) were delivered. The median age was 53 (range 30-69 years). Median overall survival and progression-free survival was 22.3 and 4.1 months, respectively. Survival rate at 1 and 2 year was 81.6 and 47.4%, respectively. Response rate was 18.4% (95% CI, 7.7-34.3%). All evaluable patients have responded with two CR (5.3%), 5 PR (13.2%), 20 SD (52.6%), 8 PD (21.1%) and 3 NE (7.9%). Regarding the hematological toxicities, grade 1/2/3 neutropenia, grade 1/2 anemia, grade 1 thrombocytopenia and grade 1/2 liver dysfunction were also common. No treatment-related death was reported.The combination of capecitabine and trastuzumab is active and well-tolerated in patients with HER2-overexpressing breast caner resistant to both anthracyclines and taxanes.