From the Laura and Isaac Perlmutter Cancer Center (S.C.K.), Brain Tumor Center, NYU Langone Medical Center, New York; Dana-Farber Cancer Institute (L.P.C., D.H., M.R., L.N., E.Q.L., D.A.R., P.Y.W.), Center for Neuro-Oncology; and Department of Radiology (R.H., P.U.), Brigham and Women's Hospital, Boston, MA.
Neurology. 2018 Oct 2;91(14):e1355-e1359. doi: 10.1212/WNL.0000000000006283. Epub 2018 Aug 31.
To investigate the question of whether salvage therapy with the programmed cell death protein 1 (PD-1)-blocking antibodies nivolumab or pembrolizumab with or without bevacizumab offers clinical or survival benefit in patients with recurrent high-grade gliomas (HGGs).
This was a single-institution retrospective observational study in 31 adult patients who received pembrolizumab (Keytruda) or nivolumab (Opdivo) with or without concurrent bevacizumab for recurrent high-grade glioma.
Median progression-free survival (mPFS) from first anti-PD-1 dose was 3.2 months (95% confidence interval [CI] 2.2-4.2), and there was no difference in patients receiving nivolumab (mPFS 3.8 months, 95% CI 1.7-5.8) compared to patients receiving pembrolizumab (mPFS 2.3 months, 95% CI 1.7-2.8, log rank 3.1, = 0.08). There was also no difference in mPFS if patients had previously received bevacizumab (mPFS 3.2 months, 95% CI 2-4.3) or were bevacizumab naive (mPFS 3.7, 95% CI 0-7.9, log rank 1.3, = 0.3). The median survival from date of first anti-PD-1 dose was 6.6 months (95% CI 4.2-9.1).
Salvage therapy with nivolumab or pembrolizumab with or without bevacizumab does not confer a survival benefit in this heavily pretreated unselected patient population. Until the results of the currently ongoing clinical trials become available, the use of PD-1-blocking antibodies should be considered in selected individuals only.
This retrospective observational study provides Class IV evidence that for patients with recurrent HGGs, salvage therapy with nivolumab or pembrolizumab does not significantly improve survival.
探讨程序性死亡蛋白 1(PD-1)阻断抗体纳武利尤单抗或帕博利珠单抗联合或不联合贝伐珠单抗用于复发性高级别神经胶质瘤(HGG)患者的挽救治疗是否具有临床或生存获益。
这是一项单机构回顾性观察性研究,纳入 31 例接受帕博利珠单抗(Keytruda)或纳武利尤单抗(Opdivo)联合或不联合贝伐珠单抗治疗复发性高级别神经胶质瘤的成年患者。
从首次接受抗 PD-1 药物治疗开始的中位无进展生存期(mPFS)为 3.2 个月(95%置信区间[CI] 2.2-4.2),接受纳武利尤单抗治疗的患者(mPFS 3.8 个月,95%CI 1.7-5.8)与接受帕博利珠单抗治疗的患者(mPFS 2.3 个月,95%CI 1.7-2.8,对数秩检验 3.1, = 0.08)相比,差异无统计学意义。如果患者先前接受过贝伐珠单抗(mPFS 3.2 个月,95%CI 2-4.3)或为贝伐珠单抗初治患者(mPFS 3.7 个月,95%CI 0-7.9,对数秩检验 1.3, = 0.3),mPFS 也无差异。从首次接受抗 PD-1 药物治疗开始的中位总生存期为 6.6 个月(95%CI 4.2-9.1)。
在未经选择的、大量预处理的患者人群中,纳武利尤单抗或帕博利珠单抗联合或不联合贝伐珠单抗的挽救治疗并不能带来生存获益。在目前正在进行的临床试验结果公布之前,仅应考虑在选择的个体中使用 PD-1 阻断抗体。
这项回顾性观察性研究提供了 IV 级证据,表明对于复发性 HGG 患者,纳武利尤单抗或帕博利珠单抗的挽救治疗并不能显著改善生存。