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Genentech公司发布了由国家外科辅助计划(乳房及肠)(NSABP)研究(B-31)发现的曲妥珠单抗(Herceptin)的最新心脏毒性信息,该研究是在2043名可施行手术的HER2过度表达的乳腺癌(IHC3+或FISH+)妇女的随机Ⅲ期临床试验中进行的。结果显示,随机使用曲妥珠单抗作为辅助治疗与仅使用化疗相比,心脏毒性显著增加。在2005年5月美国临床肿瘤学学会年会上,对NSABP B-31研究的安全数据进行了初步分析,包括North Central Cancer Treatment Group研究小组(N9831)和NSABP B-31的联合分析。NSABP B-31为曲妥珠单抗的部分心脏毒性进行了特征性描述,作为曲妥珠单抗治疗期间心脏检测的评估参数、心脏毒性预测和早期心脏毒性鉴别的辅助手段。NSABP B-31评估了曲妥珠单抗的标准辅助化疗。研究中对于左室射血分数(LVEF)的无症状减少,试验人员根据指导原则修订曲妥珠单抗的剂量。对于出现心脏毒性的患者,应当永久停止给药。共1019名患者随机使用曲妥珠单抗辅助治疗。据2005年4月得到的初步数据及其分析结果,6.8%的患者无法耐受曲妥珠单抗的预治疗,主要是因LVEF下降或环磷酰胺治疗中存在心脏毒性。在具有足够的心脏功能能承受曲妥珠单抗预治疗的患者中,18.6%在结束1年的治疗后,
Genentech Inc. released the latest cardiotoxicity information for Herceptin, which was found in the National Surgical Assisted Program (Breast and Bowel) (B-31) study of 2043 operable HER2 Overexpression of breast cancer (IHC3 + or FISH +) women in a randomized phase III clinical trial. The results showed that the randomized use of trastuzumab as adjuvant therapy significantly increased cardiotoxicity compared with chemotherapy alone. At the May 2005 Annual Meeting of the American Society of Clinical Oncology, a preliminary analysis of the safety data of the NSABP B-31 study was conducted, including a joint analysis of the North Central Cancer Treatment Group study group (N9831) and NSABP B-31. Part of the cardiotoxicity of trastuzumab was characterized by NSABP B-31 as an adjunct to the assessment of cardiac testing during trastuzumab treatment, prediction of cardiotoxicity, and identification of early cardiotoxicity. NSABP B-31 evaluated standard adjuvant trastuzumab. In the study, asymptomatic reduction of left ventricular ejection fraction (LVEF), the experimenter revised the dose of trastuzumab according to the guidelines. For patients with cardiotoxicity, they should be discontinued permanently. A total of 1019 patients were randomized to receive adjuvant trastuzumab. According to preliminary data obtained in April 2005 and their analysis, 6.8% of patients were unable to tolerate trastuzumab pretreatment, primarily due to decreased LVEF or cardiotoxicity in cyclophosphamide treatment. Of patients with adequate cardiac function who were able to tolerate trastuzumab, 18.6% after 1 year of treatment,