Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer
Adjuvant docetaxel or vinorelbine with or without trastuzumab for breast cancer
复制标题
DOI：
10.1056/nejmoa053028
复制
发表时间：
2006-02-23
影响因子：
158.5
通讯作者：
Isola, J
中科院分区：
文献类型：
--
作者：
Joensuu, H;Kellokumpu-Lehtinen, P;Isola, J
背景：我们比较了多西他赛和长春瑞滨对早期乳腺癌的辅助治疗。HER 2/neu过度表达的肿瘤的妇女也被分配到接受伴随治疗曲妥珠单抗或没有这样的treatment.METHODS：我们随机分配1010名妇女腋窝淋巴结阳性或高危淋巴结阴性癌症接受三个周期的多西他赛或长春瑞滨，其次是（在两组）三个周期的氟尿嘧啶，表阿霉素，环磷酰胺。232名肿瘤具有扩增的HER 2/neu基因的女性被进一步分配接受或不接受9周曲妥珠单抗输注。结果：多西他赛组3年无复发生存率优于长春瑞滨组（91%比86%;复发或死亡风险比为0.58; 95%可信区间为0.40 ~ 0.85; P=0.005），但两组总生存率无差异（P=0.15）。在HER 2/neu阳性癌症患者亚组中，接受曲妥珠单抗治疗的患者比未接受抗体治疗的患者有更好的三年无复发生存率（89% vs. 78%;复发或死亡的风险比为0.42; 95%置信区间为0.21至0.83; P=0.01）。多西他赛的不良反应比长春瑞滨多。曲妥珠单抗与左心室射血分数降低或心力衰竭无关。结论：与长春瑞滨相比，多西他赛辅助治疗可提高早期乳腺癌患者的无复发生存率。短期曲妥珠单抗联合多西他赛或长春瑞滨治疗HER 2/neu基因扩增的乳腺癌女性有效。
BACKGROUND:We compared docetaxel with vinorelbine for the adjuvant treatment of early breast cancer. Women with tumors that overexpressed HER2/neu were also assigned to receive concomitant treatment with trastuzumab or no such treatment.METHODS: We randomly assigned 1010 women with axillary-node-positive or high-risk node-negative cancer to receive three cycles of docetaxel or vinorelbine, followed by (in both groups) three cycles of fluorouracil, epirubicin, and cyclophosphamide. The 232 women whose tumors had an amplified HER2/neu gene were further assigned to receive or not to receive nine weekly trastuzumab infusions. The primary end point was recurrence-free survival.RESULTS:Recurrence-free survival at three years was better with docetaxel than with vinorelbine (91 percent vs. 86 percent; hazard ratio for recurrence or death, 0.58; 95 percent confidence interval, 0.40 to 0.85; P=0.005), but overall survival did not differ between the groups (P=0.15). Within the subgroup of patients who had HER2/neu-positive cancer, those who received trastuzumab had better three-year recurrence-free survival than those who did not receive the antibody (89 percent vs. 78 percent; hazard ratio for recurrence or death, 0.42; 95 percent confidence interval, 0.21 to 0.83; P=0.01). Docetaxel was associated with more adverse effects than was vinorelbine. Trastuzumab was not associated with decreased left ventricular ejection fraction or cardiac failure.CONCLUSIONS:Adjuvant treatment with docetaxel, as compared with vinorelbine, improves recurrence-free survival in women with early breast cancer. A short course of trastuzumab administered concomitantly with docetaxel or vinorelbine is effective in women with breast cancer who have an amplified HER2/neu gene.