ASCO年度报告:2011临床肿瘤学重大进展之黑色素瘤

2011-12-23 MedSci原创 MedSci原创

  BRAF抑制剂改善进展期黑色素瘤患者生存   比较vemurafenib(V600E BRAF抑制剂)与黑色素瘤标准治疗药物达卡巴嗪的Ⅲ期研究纳入675例初治、V600E BRAF基因突变阳性、无法手术的ⅢC或Ⅳ期转移性黑色素瘤患者。   结果显示,48%的vemurafenib组患者肿瘤体积缩小,而达卡巴嗪组仅为5%;与达卡巴嗪组相比,vemurafenib组肿瘤进展风险降低74%,6个

  BRAF抑制剂改善进展期黑色素瘤患者生存

  比较vemurafenib(V600E BRAF抑制剂)与黑色素瘤标准治疗药物达卡巴嗪的Ⅲ期研究纳入675例初治、V600E BRAF基因突变阳性、无法手术的ⅢC或Ⅳ期转移性黑色素瘤患者。

  结果显示,48%的vemurafenib组患者肿瘤体积缩小,而达卡巴嗪组仅为5%;与达卡巴嗪组相比,vemurafenib组肿瘤进展风险降低74%,6个月总生存(OS)率显著提高(84%对64%)。

  基于这项研究,美国FDA于2011年8月批准vemurafenib用于V600E BRAF突变的晚期黑色素瘤患者。

  Ipilimumab联合化疗一线治疗转移性黑色素瘤改善预后

  Ⅲ临床研究证实,ipilimumab联合达卡巴嗪能够延长转移性黑色素瘤患者OS。研究纳入502例转移性黑色素瘤患者,随机分为2组接受ipilimumab+达卡巴嗪或安慰剂+达卡巴嗪治疗。结果显示,与达卡巴嗪比较,联合治疗可显著改善患者1年及3年OS率(47%对36%,21%对12%)。联合治疗组中位OS期优于化疗组(11个月对9个月)。

  随着对黑色素瘤分子机制认识的增加,将会有更多针对黑色素瘤细胞生长、侵犯和转移的新治疗方法被研发。同时,免疫治疗的进展将通过清除耐药性疾病而进一步改善疾病对治疗的长期反应性。或许,两种方式的结合将会产生出最佳的治疗方案。——美国内华达综合癌症中心萨姆洛夫斯基(Samlowski)

  西方白种人中,近50%的恶性黑色素瘤有BRAF突变,亚洲国家包括我国在内,约25%的黑色素瘤患者也有这种BRAF基因突变。Ⅱ期与Ⅲ期临床试验均证实,vemurafenib能提高晚期恶性黑色素瘤患者的反应率、无进展生存与总生存期。当然,需要特别指出的是,用药之前必需进行BRAF基因突变检测。

  该药面临的挑战之一是疗效维持时间通常仅为6~7个月,耐药后肿瘤又重新快速生长。而vemurafenib如何发生耐药,其机制与解决的办法是目前的研究热点。

  今年3月FDA批准的用于晚期黑色素瘤的新药ipilimumab属于免疫治疗范畴,而免疫治疗的主要特点是疗效的持久性,有可能可以用来克服vemurafenib的耐药问题。已经有研究尝试vemurafenib与ipilimumab进行联合用药,这有可能成为晚期黑色素瘤治疗的未来方向。

  美国FDA在过去13年间从未批准过任何治疗晚期黑色素瘤的药物,而2011年批准了2种药物用于黑色素瘤的治疗。这无疑是全球黑色素瘤专家长期不懈的努力终于结出了硕果!——北京大学肿瘤医院郭军

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    2012-08-13 quxin068
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    2012-06-18 sunylz
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