ASCO 2014 ：检查点抑制剂nivolumab可持续缓解转移性肾细胞癌

2014-06-19 EGMN 爱思唯尔

第50届美国临床肿瘤学会(ASCO)年会上公布的一项I期研究显示，联合使用易普利单抗(Yervoy)和nivolumab这两种免疫检查点抑制剂可使转移性肾细胞癌(mRCC)患者获得持续缓解。在这项由约翰霍普金斯大学Sidney Kimmel综合癌症中心的Hans J. Hammers医生及其同事进行的研究中，既往未接受过治疗或接受过治疗的具有透明细胞组织学表现的mRCC患者被随机分入nivol

第50届美国临床肿瘤学会(ASCO)年会上公布的一项I期研究显示，联合使用易普利单抗(Yervoy)和nivolumab这两种免疫检查点抑制剂可使转移性肾细胞癌(mRCC)患者获得持续缓解。

在这项由约翰霍普金斯大学Sidney Kimmel综合癌症中心的Hans J. Hammers医生及其同事进行的研究中，既往未接受过治疗或接受过治疗的具有透明细胞组织学表现的mRCC患者被随机分入nivolumab 3 mg/kg+易普利单抗1 mg/kg静脉诱导治疗组(下称N3/I1组)和nivolumab 1 mg/kg +易普利单抗3 mg/kg静脉诱导治疗组(N1/I3组)，每3周治疗1次，治疗4个周期。患者在每次诱导治疗期间接受2次输注，先输注nivolumab，然后在nivolumab输注完成后至少30 min开始输注易普利单抗。在诱导治疗后，所有患者继续接受nivolumab 3 mg/kg维持治疗，每2周1次，直至出现疾病进展。

结果显示，N3/I1组21例患者中有16例(76.2%)发生治疗相关不良事件(主要终点)，N1/I3组所有23例患者均发生治疗相关不良事件。N3/I1组和N1/I3组的3级或4级不良事件发生率分别为23.8%(5例)和60.9%(14例)。未观察到与治疗相关的死亡。

3级或4级不良事件包括腹泻(N3/I1组1例，N1/I3组8例)、脂肪酶升高(N3/I1组3例，N1/I3组6例)和淀粉酶升高(N3/I1组1例，N1/I3组3例)。两组无其他3级或4级不良事件。此外，未观察到免疫治疗中常见的高级别肺部不良事件或肺炎病例。

N3/I1组和N1/I3组证实的客观缓解率(ORR)分别为43%(9例)和48%(11例)。随访40.1周时，N3/I1组患者的中位缓解持续时间为31.1周，N1/I3组患者未达到中位缓解持续时间。

在获得客观缓解的患者中，N3/I1组9例中7例和N1/I3组11例中9例患者的缓解在末次随访时仍持续存在。然而，仅N1/I3组1例患者获得完全缓解。N3/I1组和N1/I3组分别有9例和10例患者获得部分缓解。

N3/I1组和N1/I3组24周时的无进展生存率分别为65%和64%，高于既往在nivolumab单药治疗中观察到的结果。两组大部分患者的靶病变肿瘤负担均显著降低。

在获得持续缓解的患者中，N3/I1组9例中3例和N1/I3组11例中5例患者在因疾病进展之外的原因停止治疗后仍持续获得缓解。

研究者表示，这一结果促使他们计划开展III期研究，探讨这一联合治疗方案作为mRCC一线治疗的效果。

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2014-09-15 qingting

#细胞癌#

29 0
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2014-12-10 tamgche

#NIV#

32 0
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2014-10-06 jklm09

#抑制剂#

30 0
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2014-09-17 quxin068

#ASC#

31 0
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2014-10-25 snf701207

#mAb#

27 0
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2014-06-21 1249842em09(暂无昵称)

#转移性#

30 0
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2014-06-21 zhangyxzsh

#转移性肾细胞癌#

38 0

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