苏尼提尼布用于转移性细胞癌患者
Robert J Motzer1, Brian I Rini, Ronald M Bukowski
1Department of Medicine, Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. motzerr@mskcc.org
JAMA
|June 8, 2006
概括
苏尼提尼布作为转移性细胞癌 (RCC) 患者的二线治疗有效性得到证明,这些患者在先前的细胞因子治疗中进展. 该研究证实了其抗瘤活性和可管理的安全性在这个患者群体.
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:
- 转移性细胞癌 (RCC) 的治疗选择有限,需要新的治疗策略.
- 苏尼蒂尼布酸盐是一种口服的多向氨酸激酶抑制剂,在细胞因子耐药的转移性RCC中表现出初步活性.
研究的目的:
- 评估sunitinib作为二线治疗的抗瘤疗效,用于转移的清细胞RCC患者.
- 为了确认sunitinib在患者的有效性,这些患者的疾病进展,尽管之前的细胞因子治疗.
主要方法:
- 一个开放的,单臂的多中心临床试验,涉及106名转移性清细胞RCC患者.
- 患者每天接受sunitinib 50 mg,持续4周,随后休息2周,周期为6周.
- 使用RECIST标准评估了客观反应率 (ORR) 和无进展生存率 (PFS);安全性也得到了评估.
主要成果:
- 客观应答率为34% (部分应答),中位数无进展生存时间为8.3个月.
- 常见的不良事件包括疲劳 (28%) 和腹 (20%).
- 常见的实验室异常是中性质减退 (42%),脂酶升高 (28%) 和贫血 (26%) .
结论:
- 苏尼提尼布是一种有效的单一药物,用于对细胞因子耐药的转移性清细胞RCC患者的二线治疗.
- 该药物表现出可管理的不良事件概况,支持其在该患者群体中的使用.
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