Huang Liang, Chen Sheng, Yao Ling, Liu Guangyu, Wu Jiong, Shao Zhiming
Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, People's Republic of China ; Department of Oncology, Shanghai Medical College, Shanghai, People's Republic of China.
Department of Breast Surgery, Fudan University Shanghai Cancer Center/Cancer Institute, Shanghai, People's Republic of China ; Department of Oncology, Shanghai Medical College, Shanghai, People's Republic of China ; Institutes of Biomedical Science, Fudan University, Shanghai, People's Republic of China.
Int J Nanomedicine. 2015 Mar 11;10:1969-75. doi: 10.2147/IJN.S77000. eCollection 2015.
Neoadjuvant chemotherapy has become standard treatment for women with locally advanced breast cancer. The aim of this study was to compare the efficacy and safety of nanoparticle albumin-bound paclitaxel (nab-paclitaxel) versus paclitaxel combined with carboplatin.
Thirty patients were treated with neoadjuvant nab-paclitaxel (125 mg/m(2), days 1, 8, and 15) and carboplatin (area under the curve =2; days 1, 8, and 15) every 21 days for four cycles. Ninety matched patients received paclitaxel (80 mg/m(2), days 1, 8, and 15) and carboplatin every 21 days for four cycles. Weekly trastuzumab is recommended for overexpression of human epidermal receptor-2. The primary endpoint was pathologic complete response (defined as ypT0/is ypN0). Matching was conducted according to six variables: body mass index, clinical tumor stage, clinical lymph node status, estrogen receptor status, HER2 status, and trastuzumab receiving rate.
Ninety percent of patients in the nab-paclitaxel group and 80% of patients in the paclitaxel group experienced a clinical objective response (complete response or partial response; P=0.450). Eight patients in the nab-paclitaxel group and 23 patients in the paclitaxel group had a pathologic complete response in the breast and axillary nodes (26.7% versus 25.6%; P=0.904). Nab-paclitaxel showed a beneficial effective trend on clinical tumor stage II (36.8% versus 15.8%; P=0.051). When trastuzumab was added to nab-paclitaxel, the pathologic complete response rate was not significantly improved more than with trastuzumab and paclitaxel (43.6% versus 39.6%; P=0.769). Carboplatin plus nab-paclitaxel or paclitaxel had similarly low pathologic complete response rates (7.7% versus 10.5%) for the luminal molecular subtype. One (50%) triple-negative patient achieved a pathologic complete response. The nab-paclitaxel regimen caused more grade 4 neutropenia than the paclitaxel regimen (56.7% versus 21.1%; P<0.001).
Our study shows that weekly nab-paclitaxel and carboplatin with or without trastuzumab resulted in a pathologic complete response rate that was not superior to the matched cohorts. Future, larger trials are needed to validate that nab-paclitaxel is beneficial for clinical tumor stage II and the triple-negative subgroup.
新辅助化疗已成为局部晚期乳腺癌女性的标准治疗方法。本研究的目的是比较纳米白蛋白结合型紫杉醇（nab-紫杉醇）与紫杉醇联合卡铂的疗效和安全性。
30例患者接受新辅助nab-紫杉醇（125mg/m²，第1、8和15天）和卡铂（曲线下面积=2；第1、8和15天）治疗，每21天为一个周期，共四个周期。90例匹配患者接受紫杉醇（80mg/m²，第1、8和15天）和卡铂治疗，每21天为一个周期，共四个周期。对于人表皮受体2过表达的患者，建议每周使用曲妥珠单抗。主要终点是病理完全缓解（定义为ypT0/is ypN0）。根据六个变量进行匹配：体重指数、临床肿瘤分期、临床淋巴结状态、雌激素受体状态、HER2状态和曲妥珠单抗使用率。
nab-紫杉醇组90%的患者和紫杉醇组80%的患者出现临床客观缓解（完全缓解或部分缓解；P=0.450）。nab-紫杉醇组8例患者和紫杉醇组23例患者在乳腺和腋窝淋巴结出现病理完全缓解（26.7%对25.6%；P=0.904）。nab-紫杉醇在临床肿瘤II期显示出有益的有效趋势（36.8%对15.8%；P=0.051）。当曲妥珠单抗添加到nab-紫杉醇中时，病理完全缓解率没有比曲妥珠单抗和紫杉醇联合使用时显著提高（43.6%对39.6%；P=0.769）。对于管腔分子亚型，卡铂加nab-紫杉醇或紫杉醇的病理完全缓解率同样较低（7.7%对10.5%）。1例（50%）三阴性患者实现了病理完全缓解。nab-紫杉醇方案比紫杉醇方案导致更多的4级中性粒细胞减少（56.7%对21.1%；P<0.001）。
我们的研究表明，每周使用nab-紫杉醇和卡铂联合或不联合曲妥珠单抗导致的病理完全缓解率并不优于匹配队列。未来需要更大规模的试验来验证nab-紫杉醇对临床肿瘤II期和三阴性亚组有益。
