在晚期细胞癌 (AXIS) 中,阿克西尼布与索拉费尼布的比较有效性:一个随机的第三期试验
Brian I Rini1, Bernard Escudier, Piotr Tomczak
1Cleveland Clinic Taussig Cancer Institute, Main Campus, Euclid Avenue, Cleveland, OH 44195, USA. rinib2@ccf.org
Lancet (London, England)
|November 8, 2011
概括
与索拉费尼布相比,阿克西替尼在患有晚期细胞癌的患者中显著改善了无进展生存期 (PFS). 这项研究将axitinib定位为这种疾病的有价值的二线治疗选择.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
背景情况:
- 晚期细胞癌 (RCC) 治疗已经被抗血管原性向疗法所改变.
- 之前的第三阶段试验没有直接比较RCC中不同的向药物.
研究的目的:
- 为了比较axitinib与sorafenib的疗效,作为转移性细胞癌的二线治疗.
- 评估无进展生存期 (PFS) 作为主要终点.
主要方法:
- 一个随机的第三阶段试验,涉及723名先进RCC患者,他们在一线治疗中取得进展.
- 患者被分配给接受阿克西替尼或索拉芬尼.
- 无进展生存期 (PFS) 通过独立的放射学审查来评估.
主要成果:
- 阿克西提尼布的PFS中位数为6.7个月,相比之下,索拉芬尼布的PFS中位数为4.7个月 (危险比0.665;p<0.0001).
- 由于毒性而停止治疗的艾克西尼布 (4%) 比索拉芬尼布 (8%) 低.
- 常见的不良事件包括高血压和疲劳与阿克西替尼,和手掌 - 脚掌红色素质麻醉与sorafenib.
结论:
- 在高级RCC的二线治疗中,阿克西替尼比索拉费尼布提供了显著更长的PFS.
- 阿克西提尼布代表了晚期细胞癌患者的可行和有效的治疗选择.
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