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喜大普奔!BRAF突变的黑色素瘤患者生存希望增加!

2015-11-13 QQduhq 译 MedSci原创

FDA批准,可将cobimetinib和vemurafenib联合使用,用于治疗转移和扩散且不能用手术切除的黑色素瘤患者或含有突变BRAF基因的肿瘤患者。

FDA批准,可将cobimetinib和vemurafenib联合使用,用于治疗转移和扩散且不能用手术切除的黑色素瘤患者或含有突变BRAF基因的肿瘤患者。Genentech公司研发Vemurafenib(通用名Zelboraf)和cobimetinib联合使用以治疗黑色素瘤。


如果黑色素瘤患者没有得到早期诊断,它可能会蔓延到身体的其他部位,即出现转移。约一半的转移性黑色素瘤患者有突变BRAF基因。 

导致黑色素瘤出现的变异基因有两种形式——BRAF V600E和BRAF V600K,这些可以通过一项经FDA批准的测试检验出来。FDA建议,医生应该在开具药物处方前对病人进行肿瘤标记物筛查以查看他们是否有突变基因。

皮肤癌是美国最常见的癌症。大部分皮肤癌是由于民众经常暴露于紫外线(UV)导致的。黑素瘤患者占所有皮肤癌患者的1/50,但是会导致大多数患者的死亡。黑色素细胞瘤可由表皮黑色素细胞,痣细胞或真皮成黑色素细胞组成。美国国家癌症研究所估计,在2015年,美国近74000人罹患黑素瘤,近10000人将死于这种疾病。 

FDA的Richard Pazdur博士认为,FDA批准两种药物联合使用用于治疗黑色素瘤很有针对性。Vemurafenib单独使用不能完全抑制含有BRAF基因的黑色素瘤患者的肿瘤细胞,使肿瘤继续增长。Cobimetinib药物可通过阻断一种被称为MEK的酶的活动,起到抑制肿瘤细胞生长的作用。 
研究人员在加州大学洛杉矶分校(UCLA)和美国、欧洲、澳大利亚和俄罗斯共135家医院近500名含有BRAF突变基因的黑色素瘤患者进行了试验。他们让所有的参与人员服用vemurafenib,并将他们分为两组:服用cobimetinib(实验组)或服用安慰剂作为对照组。他们发现,两种药物的联合使用可明显减缓肿瘤细胞的增长,且可降低民众黑色素瘤复发的风险。单一使用Vemurafenib的肿瘤患者中有25%出现了肿瘤复发趋势。

结果表明,平均而言,服用vemurafenib和cobimetinib两种药物的患者(实验组)肿瘤转移和症状恶化时间出现较晚,平均12.3月后出现肿瘤转移;相比之下,服用vemurafenib +安慰剂的对照组患者肿瘤转移症状出现较早,时长约7.2个月。此外,实验组患者的寿命更长,17月后约65%的患者存活;相比之下,对照组仅有一半的人存活。药物使用不同,对肿瘤也有不同的影响:接受药物组合的实验组患者中,约70%患者的瘤体缩小,是对照组的2倍。

联合治疗最常见的副作用是腹泻、对紫外线的敏感性、恶心、发烧和呕吐。 

这项研究对含有BRAF突变基因的黑色素瘤患者而言是福音,不仅可减轻症状,也可缩小肿瘤,同时出现的药物副作用更少。

原始出处:

Drug combination for advanced melanoma wins FDA approval,MNT,12,Nov,2015

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    2016-05-22 sunylz
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    2015-11-15 zhaojie88
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    2015-11-13 IIIi

    0

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