Center for Oncology Research and Treatment, PA, Dallas, TX 75230, USA.
Clin Breast Cancer. 2011 Apr;11(2):121-8. doi: 10.1016/j.clbc.2011.03.007. Epub 2011 Apr 11.
Weekly administration of nanoparticle albumin-bound (nab) paclitaxel as a first-line treatment for metastatic breast cancer (MBC) has not been fully investigated. The addition of trastuzumab, a monoclonal antibody against human epidermal growth factor receptor 2 (HER2), is less understood. This phase II study evaluated the efficacy and safety of weekly nab paclitaxel in the first-line MBC setting. Patients whose tumors overexpressed HER2 also received trastuzumab.
Patients with locally advanced or metastatic breast cancer received nab paclitaxel (125 mg/m(2)) by 30-minute intravenous infusion weekly for 3 of 4 weeks. Patients who were HER2-positive received concurrent trastuzumab.
Seventy-two patients were enrolled; HER2 expression was detected in 22 patients. The overall response rate (ORR) was 42.2% (95% CI, 30%-55%); 5 patients had a complete response (CR) and 22 patients had a partial response (PR). Additionally, 17 patients experienced stable disease (SD), providing an overall benefit (CR + PR + SD) of 68.8%. Patients with HER2-positive tumors had an ORR of 52.4%; the ORR was 38.1% in the HER2-negative population (P = .3). Median progression-free survival was 14.5 months (range, 1-49.3 months) and survival rates at 1 year and 2 years were 69% and 62%, respectively. The most commonly observed toxicities were pain (64%), fatigue (58%), sensory neuropathy (54%), infection (46%), nausea (38%), alopecia (33%), and anemia (33%).
Our findings demonstrate that weekly nab paclitaxel has a favorable safety profile and is well tolerated as a first-line treatment for MBC. An ORR of 42% and an overall benefit of 69% is extremely encouraging, particularly in the HER2-positive population where 52% of patients responded.
每周给予纳米白蛋白结合紫杉醇（nab）作为转移性乳腺癌（MBC）一线治疗尚未得到充分研究。曲妥珠单抗（一种针对人表皮生长因子受体 2（HER2）的单克隆抗体）的加入则了解较少。这项 II 期研究评估了每周 nab 紫杉醇在 MBC 一线治疗中的疗效和安全性。肿瘤过表达 HER2 的患者还接受曲妥珠单抗治疗。
局部晚期或转移性乳腺癌患者接受 nab 紫杉醇（125mg/m²），30 分钟静脉输注，每 4 周的 3 周内每周一次。HER2 阳性患者接受曲妥珠单抗联合治疗。
共纳入 72 例患者；22 例患者检测到 HER2 表达。总缓解率（ORR）为 42.2%（95%CI，30%-55%）；5 例患者完全缓解（CR），22 例患者部分缓解（PR）。此外，17 例患者疾病稳定（SD），总体获益（CR+PR+SD）为 68.8%。HER2 阳性肿瘤患者的 ORR 为 52.4%；HER2 阴性患者的 ORR 为 38.1%（P=0.3）。中位无进展生存期为 14.5 个月（范围 1-49.3 个月），1 年和 2 年生存率分别为 69%和 62%。最常见的毒性反应是疼痛（64%）、乏力（58%）、感觉神经病变（54%）、感染（46%）、恶心（38%）、脱发（33%）和贫血（33%）。
我们的研究结果表明，每周 nab 紫杉醇具有良好的安全性，耐受性良好，可作为 MBC 的一线治疗。42%的 ORR 和 69%的总体获益非常令人鼓舞，尤其是在 HER2 阳性患者中，52%的患者有反应。
