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Ipilimumab (Yervoy°) and inoperable or metastatic melanoma

机译:伊匹木单抗(Yervoy°)和不能手术或转移的黑色素瘤

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摘要

Vemurafenib is an option for patients with metastatic or inoperable melanoma carrying the BRAF V600 mutation; cytotoxic drugs have little effect in patients without this mutation (1,2).Ipilimumab (Yervoy0, Bristol-Myers Squibb), a monoclonal antibody that stimulates cytotoxic T cell proliferation and activation, was first authorised for second-line use "in previously treated adult patients", but the harm-benefit balance was uncertain (2). This restriction was removed from the marketing authorisation in late 2013, even though first-line ipilimumab therapy had not been evaluated in a randomised controlled trial at the recommended dose (3 mg/kg) (3,4). In the principal trial, comparing ipilimumab 10 mg/kg + dacarbazine versus placebo + dacarbazine, the ipilimumab combination improved the median overall survival time by a few weeks (2). The European Medicines Agency (EMA) asked the company to conduct a trial comparing the doses of 3 mg/kg and 10 mg/kg in terms of survival (3).
机译:对于携带BRAF V600突变的转移性或无法手术的黑色素瘤患者,Vemurafenib是一种选择。细胞毒性药物对没有这种突变的患者几乎没有作用(1,2)。伊匹木单抗(Yervoy0,Bristol-Myers Squibb)是一种刺激细胞毒性T细胞增殖和活化的单克隆抗体,最初被授权用于二线治疗。成年患者”,但危害与利益的平衡尚不确定(2)。即使未在推荐剂量(3 mg / kg)的随机对照试验中评估一线伊立木单抗治疗,该限制已于2013年底从销售许可中取消(3,4)。在主要试验中,将10 mg / kg的ipilimumab +达卡巴嗪与安慰剂+达卡巴嗪进行比较,将ipilimumab的组合可使中位总生存时间缩短数周(2)。欧洲药品管理局(EMA)要求该公司进行一项试验,比较生存期3 mg / kg和10 mg / kg的剂量(3)。

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    《Prescrire international》 |2015年第159期|共1页
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  • 正文语种 eng
  • 中图分类 药学;
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