Four-Year Follow-Up of Trastuzumab Plus Adjuvant Chemotherapy for Operable Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Joint Analysis of Data From NCCTG N9831 and NSABP B-31
Four-Year Follow-Up of Trastuzumab Plus Adjuvant Chemotherapy for Operable Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer: Joint Analysis of Data From NCCTG N9831 and NSABP B-31
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DOI：
10.1200/jco.2011.35.0868
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发表时间：
2011-09-01
影响因子：
45.3
通讯作者：
Wolmark, Norman
中科院分区：
文献类型：
--
作者：
Perez, Edith A.;Romond, Edward H.;Wolmark, Norman
目的曲妥珠单抗是一种针对人表皮生长因子受体 2 (HER2) 的人源化单克隆抗体。辅助曲妥珠单抗的临床益处已在四项大型试验的中期分析中得到证实。北中央癌症治疗组 (NCCTG) N9831 组间试验和国家外科辅助乳腺和肠道项目 (NSABP) B-31 试验的联合分析的初步数据于 2005 年报告。无病生存 (DFS) 和总生存 (OS) 的长期随访结果正在等待。 患者和方法 HER2 阳性可手术乳腺癌患者被随机分配至阿霉素联合治疗组在 NCCTG N9831 和 NSABP B-31 试验中，先使用环磷酰胺，然后使用紫杉醇联合或不联合曲妥珠单抗。两项试验的相似设计允许将来自对照组和含曲妥珠单抗组的数据合并到联合分析中。结果在中位随访 3.9 年时，DFS 事件率继续出现高度统计显着性下降，有利于含曲妥珠单抗组 (P < .001)。同样，含曲妥珠单抗组的死亡率继续显着降低 39%（P < 0.001）。结论这些数据表明，随着时间的推移，辅助曲妥珠单抗具有一致的 DFS 和 OS 优势，迄今为止报告的最长随访时间。临床益处继续超过不良反应的风险。 J 临床肿瘤杂志 29：3366-3373。 (C) 2011 年美国临床肿瘤学会
PurposeTrastuzumab is a humanized monoclonal antibody against the human epidermal growth factor receptor 2 (HER2). The clinical benefits of adjuvant trastuzumab have been demonstrated in interim analyses of four large trials. Initial data of the combined analysis of the North Central Cancer Treatment Group (NCCTG) N9831 Intergroup trial and National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 trial were reported in 2005. Long-term follow-up results on disease-free survival (DFS) and overall survival (OS) have been awaited.Patients and MethodsPatients with HER2-positive operable breast cancer were randomly assigned to doxorubicin plus cyclophosphamide followed by paclitaxel with or without trastuzumab in the NCCTG N9831 and NSABP B-31 trials. The similar design of both trials allowed data from the control and trastuzumab-containing arms to be combined in a joint analysis.ResultsAt 3.9 years of median follow-up, there continues to be a highly statistically significant reduction in DFS event rate in favor of the trastuzumab-containing arm (P < .001). Similarly, there continues to be a statistically significant 39% reduction in death rate in favor of the trastuzumab-containing arm (P < .001).ConclusionThese data demonstrate consistent DFS and OS advantages of adjuvant trastuzumab over time, with the longest follow-up reported to date. The clinical benefits continue to outweigh the risks of adverse effects. J Clin Oncol 29:3366-3373. (C) 2011 by American Society of Clinical Oncology