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Risks from combining two immunostimulants

机译:组合两个免疫刺激剂的风险

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As of mid-2017, it has not been proven that the combination of nivolumab with ipilimumab prolongs the life of patients with advanced stage melanoma, whereas it does more frequently expose them to the risk of serious adverse effects. In patients with metastatic or inoperable melanoma without a BRAF V600 mutation and who have not received anticancer treatment, nivolumab, an immu-nostimulatory antibody which blocks the PD-1 (programmed cell death-1) receptor, is the first choice treatment (1,2). Ipilimumab, another antibody which is also immunostimulatory, but through a different pharmacological mechanism, is approved in melanoma with an uncertain harm-benefit balance (1,3). In this situation, what is the harm-benefit balance of a combination of nivolumab with ipilimumab, as has been explicitly approved in the European summary of product characteristics (SPC) for Opdivo0 (nivolumab)? This approval was based on data from a single, double-blind, randomised trial in 945 patients. Its results showed a prolongation of the time to radiological progression of the cancer, or death, with the combination in comparison to each of the mono-therapies (2,4).The trial was still underway in mid-2017.
机译:截至2017年中期,尚未证明Nivolumab与Ipilimumab的组合延长了先进阶段黑素瘤的患者的生命,而它更频繁地将它们暴露于严重不利影响的风险。在没有BRAF V600突变的情况下,没有接受抗癌治疗的Melanoma患者,患有阻断PD-1(编程细胞死亡-1)受体的IVUM-NOSTIMULATION抗体是第一选择治疗(1, 2)。 IPILIMIMAB,另一种也是免疫刺激性的另一种抗体,但通过不同的药理学机制,在黑色素瘤中批准了黑色素瘤,其危害效益平衡(1,3)。在这种情况下,与IPILIMIMAB的Nivolumab组合的危害效益平衡是什么,如Opdivo0(Nivolumab)的欧洲产品特征(SPC)的概要明确批准?该批准基于945名患者的单一双盲,随机试验中的数据。其结果表明,与每种单疗法(2,4)相比,该结果延长了癌症的放射进展,或死亡的时间。审判在2017年中期仍然正在进行中。

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    《Prescrire international》 |2018年第190期|共1页
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  • 正文语种 eng
  • 中图分类 药学;
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