Smith John W, Vukelja Svetislava, Hoffman Anthony D, Jones Vicky E, McIntyre Kristi, Berrak Erhan, Song James X, O'Shaughnessy Joyce
Compass Oncology, The US Oncology Network, Portland, OR.
Texas Oncology-Tyler, The US Oncology Network, Tyler, TX.
Clin Breast Cancer. 2016 Feb;16(1):31-7. doi: 10.1016/j.clbc.2015.07.007. Epub 2015 Aug 6.
The present phase II, open-label, multicenter study explored the feasibility, safety, and tolerability of eribulin, a novel non-taxane microtubule inhibitor, plus capecitabine as adjuvant therapy.
Postmenopausal women with early-stage, human epidermal growth factor receptor 2 (HER2)-negative, estrogen-receptor (ER)-positive breast cancer received four 21-day cycles of treatment with eribulin mesylate (1.4 mg/m(2) intravenously on days 1 and 8 of each cycle) combined with capecitabine (900 mg/m(2) orally twice daily on days 1-14 of each cycle [standard schedule] or 1500 mg orally twice daily using a 7-days on/7-days off schedule [weekly schedule]). Feasibility was determined by the relative dose intensity (RDI) of the combination using prespecified criteria for 80% of patients achieving an RDI of ≥ 85%, with a lower 95% confidence boundary > 70%.
The mean RDI was 90.6%, and the feasibility rate was 81.3% among women (n = 67, mean age, 61.3 years) receiving the standard schedule and 95.6% and 100% among women (n = 10, mean age 62.3 years) receiving the weekly schedule. Dose reductions, missed doses, and withdrawals due to adverse events (most commonly hand-foot syndrome) ascribed to capecitabine led to a higher RDI (93.5% vs. 87.8%) and feasibility rate (82.8% vs. 71.9%) for eribulin than for capecitabine using the standard dosing schedule. The most common adverse events were alopecia and fatigue.
Eribulin plus capecitabine with standard or weekly dosing schedules is feasible in patients with early-stage, HER2-negative, ER-positive breast cancer. Full-dose eribulin (1.4 mg/m(2) on days 1 and 8) with capecitabine (1500 mg orally twice daily, 7 days on/7 days off) is recommended as a regimen for further evaluation.
本II期开放标签多中心研究探讨了新型非紫杉烷微管抑制剂艾瑞布林联合卡培他滨作为辅助治疗的可行性、安全性和耐受性。
绝经后早期、人表皮生长因子受体2（HER2）阴性、雌激素受体（ER）阳性乳腺癌女性患者接受四个21天周期的治疗，其中甲磺酸艾瑞布林（每个周期第1天和第8天静脉注射1.4mg/m²）联合卡培他滨（每个周期第1 - 14天口服900mg/m²，每日两次[标准方案]或采用7天用药/7天停药方案[每周方案]，每日两次口服1500mg）。可行性通过联合用药的相对剂量强度（RDI）来确定，采用预设标准，即80%的患者RDI≥85%，且95%置信区间下限>70%。
接受标准方案的女性患者（n = 67，平均年龄61.3岁）中，平均RDI为90.6%，可行性率为81.3%；接受每周方案的女性患者（n = 10，平均年龄62.3岁）中，可行性率分别为95.6%和100%。使用标准给药方案时，因卡培他滨导致的不良事件（最常见的是手足综合征）引起的剂量减少、漏服剂量和停药，使得艾瑞布林的RDI（93.5%对87.8%）和可行性率（82.8%对71.9%）高于卡培他滨。最常见的不良事件是脱发和疲劳。
艾瑞布林联合卡培他滨采用标准或每周给药方案，对于早期HER2阴性、ER阳性乳腺癌患者是可行的。推荐全剂量艾瑞布林（第1天和第8天1.4mg/m²）联合卡培他滨（每日两次口服1500mg，7天用药/7天停药）作为进一步评估的方案。
