在未知原发性不良癌症 (CUPISCO) 中,分子导向治疗与疾病控制后的化疗:一个开放的,随机的,第二阶段的研究
Alwin Krämer1, Tilmann Bochtler2, Chantal Pauli3
1Clinical Cooperation Unit Molecular Hematology-Oncology, German Cancer Research Center (DKFZ), Heidelberg, Germany; Department of Internal Medicine V, University of Heidelberg, Heidelberg, Germany.
全面基因分析 (CGP) 引导的分子导向治疗 (MGT) 在未知原发性癌症 (CUP) 患者中显著改善了无进展生存率. 这表明CGP应该是这些患者的诊断标准.
科学领域:
- 癌症学
- 基因组学
- 临床试验
背景情况:
- 患有未知原发性癌症 (CUP) 的患者在标准化疗中表现不佳.
- 基于综合基因组分析 (CGP) 的第一线治疗对CUP的疗效尚未得到充分证实.
研究的目的:
- 将分子导向治疗 (MGT) 与标准基化疗在新诊断的,不利的,非状性CUP中进行比较.
- 确定CGP在初步工作中是否会改善现有护理标准的结果.
主要方法:
- 一个涉及全球159个地点的第二阶段前性随机试验 (CUPISCO).
- 在初始化疗后获得疾病控制的患者被随机分为3:1的MGT或继续化疗.
- 主要终点是研究人员评估的无进展生存期 (PFS).
主要成果:
- 中位数的PFS为6. 1个月的MGT与4. 4个月的化疗 (HR 0. 72; p=0. 0079).
- 相关不良事件的发生率与MGT相似或更低.
- 纳入了636名患者,其中436名患者在诱导化疗后被随机分类.
结论:
- 与标准化疗相比,基于CGP的分子导向疗法在不良的CUP中显示出更长的PFS.
- 该研究建议在初始诊断时对不良CUP的患者进行CGP.
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