Duke Cancer Institute, Durham, NC.
Clin Breast Cancer. 2013 Dec;13(6):416-20. doi: 10.1016/j.clbc.2013.08.003. Epub 2013 Oct 4.
Triple negative metastatic breast cancer can be difficult to treat with primarily cytotoxic options. Nab-paclitaxel has demonstrated improved PFS and tolerability compared with standard cremophor-solubilized paclitaxel; based on this, we examined the efficacy and safety of combining weekly nab-paclitaxel with carboplatin and bevacizumab in TNMBC.
In this phase II, multicenter trial, patients with first-line TNMBC received nab-paclitaxel (100 mg/m(2)) and carboplatin (area under the curve = 2) on days 1, 8, 15, and bevacizumab (10 mg/kg) on days 1 and 15 of a 28-day cycle. The primary end point was safety and tolerability and secondary end points included PFS, ORR, and CBR. PFS was calculated using the Kaplan-Meier method.
Between July 16, 2007, and October 3, 2011, 34 patients were enrolled at 4 centers. Median age was 50.0 (range, 30-76) years and 77% (n = 26) of patients received previous adjuvant therapy. Median PFS was 9.2 months (95% confidence interval [CI], 7.8-25.1 months). The CBR was 94% (95% CI, 80%-99%), and ORR was 85% (95% CI, 69%-95%) for the combination. The regimen was well tolerated with the most common grade 3/4 adverse events being neutropenia (n = 18; 53%) and thrombocytopenia (n = 6; 18%), with other serous events including 1 grade 3 and 1 grade 4 thrombotic event and 1 febrile neutropenia.
The combination of nab-paclitaxel, bevacizumab, and carboplatin as first-line treatment for TNMBC was efficacious and well tolerated. The PFS, CBR, and ORR, and tolerability of the regimen, compares favorably with other standard first-line therapies.
三阴性转移性乳腺癌(TNMBC)的治疗较为困难,主要采用细胞毒性药物。与标准的聚氧乙烯蓖麻油紫杉醇相比,纳米紫杉醇显示出改善的无进展生存期(PFS)和耐受性;基于此,我们研究了在 TNMBC 中联合使用每周纳米紫杉醇、卡铂和贝伐珠单抗的疗效和安全性。
在这项 II 期、多中心试验中,一线治疗的 TNMBC 患者接受nab-紫杉醇(100mg/m²)和卡铂(曲线下面积 [AUC] 2),第 1、8、15 天给药,贝伐珠单抗(10mg/kg),第 1 和 15 天给药,每 28 天为一个周期。主要终点是安全性和耐受性,次要终点包括 PFS、客观缓解率(ORR)和疾病控制率(CBR)。使用 Kaplan-Meier 方法计算 PFS。
2007 年 7 月 16 日至 2011 年 10 月 3 日,4 个中心共纳入 34 例患者。中位年龄为 50.0 岁(范围,30-76 岁),77%(n=26)的患者接受过辅助治疗。中位 PFS 为 9.2 个月(95%置信区间 [CI],7.8-25.1 个月)。联合治疗的 CBR 为 94%(95%CI,80%-99%),ORR 为 85%(95%CI,69%-95%)。该方案耐受性良好,最常见的 3/4 级不良事件为中性粒细胞减少症(n=18;53%)和血小板减少症(n=6;18%),其他浆液事件包括 1 例 3 级和 1 例 4 级血栓事件以及 1 例发热性中性粒细胞减少症。
nab-紫杉醇、贝伐珠单抗和卡铂联合作为 TNMBC 的一线治疗是有效和耐受良好的。该方案的 PFS、CBR、ORR 和耐受性与其他标准一线治疗相比具有优势。