October 07, 2015
免疫治疗药物延长生存的肾癌患者
克莱顿博尔特
这是第一次,从免疫肿瘤学领域的新药物已被证明是治疗晚期肾癌,用有限的治疗方案的患者群体延长生存期。
在MD安德森的研究中,患者服用nivolumab,销售作为Opdivo,有25个月的中位生存期 - 8.7月更多给出的药物依维莫司,目前的护理标准治疗转移性肾癌患者更长。
Opdivo是免疫抑制剂检查站 - 一种药物,需要刹车断免疫系统,并允许它攻击癌细胞。它是目前用于治疗转移性黑色素瘤和晚期非小细胞肺癌。长期以来,科学家们认为,免疫不得不做出肾癌产生影响的可能性。
“到现在为止,我们一直无法治疗晚期肾癌证明这种显著生存益处。我们有一个真正的机会来改变临床实践中,当其他治疗失败的患者,说:”主要研究者Padmanee夏尔马,医学博士,博士, professor of Genitourinary Medical Oncology and Immunology.
The findings of the trial provide definitive evidence that an immune checkpoint inhibitor is a valid treatment strategy for patients with advanced kidney cancer, and supports a change in the standard-of-care treatment, Sharma said.
In addition to demonstrating increased overall survival, the trial showed that the number of patients who responded to nivolumab was higher than those treated with everolimus.
Of the 821 patients enrolled, 25% responded to nivolumab versus 5% of those treated with everolimus. Among these patients, partial responses were observed in 24% of those treated with nivolumab and 5% of patients treated with everolimus; complete responses were observed in 1% (four patients) treated with nivolumab and fewer than 1% (two patients) treated with everolimus.
Further, among patients who showed a response, the impact was “durable,” according to Sharma. For some patients, even after treatment with nivolumab ended, response to the drug continued.
“免疫系统具有记忆,所以即使治疗已停止,身体继续表现出长期的应对 - 这意味着这些患者可以过正常的生活没有进展性疾病,”夏尔马说。
Finally, the investigators observed fewer treatment-related adverse events, including fatigue and nausea, and improved quality of life, with nivolumab.
这些结果是如此显著该试验提前停止和FDA授予“突破疗法名称”到nivolumab,这意味着FDA将加快其药物的审查中晚期肾癌使用。
Read the full press release这里.