从疗效到机制,达拉非尼+曲美替尼治疗中国黑色素瘤患者更具优势

2019-12-02 佚名 肿瘤资讯

国际黑色素瘤协会(The Society for Melanoma Research,SMR)年会在美国盐湖城举办。年会期间,达拉非尼 + 曲美替尼(dabrafenib + trametinib)治疗中国晚期BRAF突变阳性的皮肤和肢端黑色素瘤患者的研究结果更新作为late breaking以壁报形式展示,值得关注的是研究PFS结果从2018年公布的7.9个月更新为10.3个月,令人鼓舞。特别邀

国际黑色素瘤协会(The Society for Melanoma Research,SMR)年会在美国盐湖城举办。年会期间,达拉非尼 + 曲美替尼(dabrafenib + trametinib)治疗中国晚期BRAF突变阳性的皮肤和肢端黑色素瘤患者的研究结果更新作为late breaking以壁报形式展示,值得关注的是研究PFS结果从2018年公布的7.9个月更新为10.3个月,令人鼓舞。特别邀请中山大学附属肿瘤医院丁娅教授解读相关研究成果。

靶向治疗,黑色素瘤迎来多项进展

BRAF基因是黑色素瘤最重要的驱动基因之一。目前全球已有3个BRAF抑制剂上市(维莫非尼、达拉非尼、encorafenib),对应也有3个MEK抑制剂(考比替尼、曲美替尼、binimetib)。

既往研究显示,BRAF抑制剂单药用于BRAF V600突变的晚期黑色素瘤,ORR约50%,PFS为5.1个月到6.9个月,中位OS约为13.6个月。一系列研究显示BRAF抑制剂联合MEK抑制剂治疗晚期黑色素瘤,ORR可以提高到70%,中位PFS达到11个月 ~ 14.9个月,中位OS超过22个月。在生存获益方面,BRAF抑制剂+MEK抑制剂也具有拖尾效应,COMBI-d/v汇总分析中患者5年生存率可以达到34%。在伴有BRAF突变的晚期黑色素瘤患者中,BRAF抑制剂的靶向治疗显着优于传统的细胞毒药物,且双靶联合方案优于单靶方案。

达拉非尼 + 曲美替尼治疗中国晚期皮肤和肢端黑色素瘤患者

东亚人群和高加索人群黑色素瘤的分型存在显着差异。高加索人群主要是皮肤黑色素瘤,而东亚人群多为肢端、黏膜黑色素瘤。不同分型黑色素瘤的生物学行为截然不同,BRAF突变率亦存在差异,因此东亚人群与高加索人群对免疫治疗、靶向治疗的疗效可能存在差异。

2018年SMR年会报道达拉非尼 + 曲美替尼治疗东亚患者的相关研究结果,ORR达到61%,与国际数据类似,但中位PFS 7.9个月短于国外研究数据。究其原因,可能由于中国研究入组患者多为后线治疗,其中二线及以上比例达到84%;且PS评分≥1分的患者占65%,而国外同类研究入组患者均为一线治疗,PS评分0分的患者约占70%。另外可能还与人种、突变亚型相关。随访仍在继续,2019年更新的数据显示,ORR达到65.9%,PFS达到10.3个月,与国外研究数据相仿。而由于中国研究入组患者基线状况较国外研究差,提示中国患者可能从达拉非尼 + 曲美替尼的联合方案获益同样甚至更多。期待后续更多研究成果的报道。

作用机制,达拉非尼 + 曲美替尼更强抑制MAPK通路

MAPK通路是肿瘤发生发展中非常重要的信号通路。BRAF基因是黑色素瘤最重要驱动基因之一,最常见的突变位点为BRAF V600E, BRAF突变黑色素瘤进展迅速,易出现内脏转移和脑转移。

BRAF抑制剂是BRAF V600特异性抑制剂,而MEK抑制剂则可以抑制MEK1和MEK2。单纯抑制BRAF容易通过多个途径引起耐药,其中之一是由于下游ERK磷酸化水平的降低,可通过负反馈机制激活RAS/RAF/BRAF通路,进一步增强MEK和ERK磷酸化,出现BRAF抑制剂耐药。而抑制BRAF以后,可以通过旁路激活MAPK通路,与BRAF抑制剂的皮肤毒性有关。因此联合抑制BRAF和MEK,可以延缓耐药、减少不良反应的发生,临床试验亦已证实。因此国际指南上将双靶联合作为Ⅰ类证据推荐。

丁娅,医学博士,硕士生导师,副主任医师,广东省抗癌协会黑色素瘤专业委员会常委,广东省健康管理协会肿瘤防治专委会常委,广东省医院协会肿瘤生物治疗专委会秘书,CSCO黑色素瘤专家委员会青委会委员,中国抗癌协会肿瘤临床化疗专业委员会委员,中国肿瘤防治联盟皮肤与软组织肿瘤专委会委员,广东省抗癌协会生物治疗专委会委员,广东省临床医学学会肿瘤学专业委员会委员。

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    2020-06-09 sunylz
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    2019-12-03 内科新手

    谢谢梅斯提供这么好的信息,学到很多

    0

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    2019-12-03 肿肿

    机制研究离临床仍然有距离,不过与临床结合思考,仍然有帮助的,不能仅仅是纯临床思维,转化思维同样重要

    0

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