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ASCO2013:拉帕替尼联合紫杉醇对中国大陆HER2扩增晚期胃癌患者有效

2013-05-20 ASCO 丁香园

安徽医科大学附属第一医院孙国平证实拉帕替尼联合紫杉醇对中国大陆HER2扩增晚期胃癌患者有效TyTAN研究是一项III期临床随机对照研究,该研究旨在评估在没有接受过治疗的HER2扩增的晚期胃癌患者中,应用拉帕替尼联合紫杉醇治疗的效果。研究者注意到在中国和日本,HER2扩增的晚期胃癌的疾病特征和治疗方案都存在不同,因此本亚组分析只针对中国大陆的受试者人群。本研究所纳入的是既往接受过5-FU和/或顺铂的

安徽医科大学附属第一医院孙国平证实拉帕替尼联合紫杉醇对中国大陆HER2扩增晚期胃癌患者有效
TyTAN研究是一项III期临床随机对照研究,该研究旨在评估在没有接受过治疗的HER2扩增的晚期胃癌患者中,应用拉帕替尼联合紫杉醇治疗的效果。研究者注意到在中国和日本,HER2扩增的晚期胃癌的疾病特征和治疗方案都存在不同,因此本亚组分析只针对中国大陆的受试者人群。
本研究所纳入的是既往接受过5-FU和/或顺铂的晚期胃癌患者,并且研究者采用荧光原位杂交技术在上述患者中证实了其肿瘤组织中HER2扩增的存在,符合上述标准的受试者被按照1:1的比例随机分为两组,一组的治疗方案为每日1500mg拉帕替尼联合紫杉醇(80mg/m2,第1、8和15天,每4周一次);另一组的治疗方案为紫杉醇单药应用(80mg/m2,第1、8和15天,每4周一次)。本研究的首要终点事件是患者的总体生存率。次要终点包括无进展生存期、对治疗的总体应答率和安全性评价。研究者在中国大陆共纳入了95名HER2扩增的晚期胃癌受试者。
在TyTAN研究中,研究者指出不同治疗方案对总体生存率的影响并不存在显著差异(HR 0.84),但是研究者观察到在拉帕替尼联合紫杉醇组的受试者2个月时的总体生存率为佳。来自中国的亚组分析结果详见下表。在中国的受试者中最常见的不良反应事件与整个受试者人群中所发生的相似,包括中性粒细胞减少、腹泻、皮疹、白细胞减少、贫血和疲劳等。与总体受试者人群的汇总结果相比,中国受试者的恶心和呕吐事件发生较少。
本分析提示中国和日本患者存在较明显的地域差异。拉帕替尼联合紫杉醇方案对中国大陆受试者具有显著临床意义。但是我们还需要对这些数据进行进一步的前瞻性临床评估来确定在东亚HER+的胃癌患者群中,地域差异对疾病所造成的影响。临床研究信息:NCT00486954。

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    2013-10-01 quxin068
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