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纳武利尤单抗治疗复发或难治性霍奇金淋巴瘤:真实世界经验。

Nivolumab for relapsed or refractory Hodgkin lymphoma: real-life experience.

机构信息

Division of Hematology, Department of Internal Medicine, Medipol University, Istanbul, Istanbul, Turkey.

Division of Hematology, Department of Internal Medicine, Istanbul University Istanbul Medical Faculty, Istanbul, Turkey.

出版信息

Ann Hematol. 2020 Nov;99(11):2565-2576. doi: 10.1007/s00277-020-04077-4. Epub 2020 Jun 7.

Abstract

Classical Hodgkin lymphoma (cHL) is considered a curable disease; however, in approximately one-third of the responding patients, the disease relapses following completion of therapy. One of the drugs that have been approved for the treatment of relapsed/refractory cHL is nivolumab, an immune check point inhibitor that shows its effects by blocking the programmed death 1 (PD-1) receptor. In this study, we present a retrospective "real-life" analysis of the usage of nivolumab in patients with relapsed/refractory cHL that have joined the named patient program (NPP) for nivolumab, reflecting 4 years of experience in the treatment of relapsed/refractory cHL. We present a retrospective analysis of 87 patients (median age, 30) that participated in the NPP in 24 different centers, who had relapsed/refractory cHL and were consequently treated with nivolumab. The median follow-up was 29 months, and the median number of previous treatments was 5 (2-11). In this study, the best overall response rate was 70% (CR, 36%; PR, 34%). Twenty-eight of the responding patients underwent subsequent stem cell transplantation (SCT). Among 15 patients receiving allogeneic stem cell transplantation, 9 patients underwent transplantation with objective response, of which 8 of them are currently alive with ongoing response. At the time of analysis, 23 patients remained on nivolumab treatment and the rest discontinued therapy. The main reason for discontinuing nivolumab was disease progression (n = 23). The safety profile was acceptable, with only nine patients requiring cessation of nivolumab due to serious adverse events. The 24-month progression-free and overall survival rates were 58.5% (95% CI, 0.47-0.68) and 78.7% (95% CI, 0.68-0.86), respectively. Eighteen patients died during the follow-up and only one of these was regarded to be treatment-related. With its efficacy and its safety profile, PD-1 blockers became an important treatment option in the heavily pretreated cHL patients.

摘要

经典型霍奇金淋巴瘤(cHL)被认为是一种可治愈的疾病;然而,在大约三分之一的应答患者中,疾病在完成治疗后会复发。已批准用于治疗复发/难治性 cHL 的药物之一是nivolumab,这是一种免疫检查点抑制剂,通过阻断程序性死亡 1(PD-1)受体发挥作用。在这项研究中,我们报告了参加 nivolumab 命名患者计划(NPP)的复发/难治性 cHL 患者使用 nivolumab 的回顾性“真实世界”分析结果,反映了 4 年来治疗复发/难治性 cHL 的经验。我们报告了 87 名患者(中位年龄 30 岁)的回顾性分析,这些患者参加了 24 个不同中心的 NPP,患有复发/难治性 cHL,随后接受了 nivolumab 治疗。中位随访时间为 29 个月,中位数治疗前治疗次数为 5(2-11)。在这项研究中,最佳总缓解率为 70%(完全缓解率,36%;部分缓解率,34%)。28 名应答患者随后接受了干细胞移植(SCT)。在接受异基因干细胞移植的 15 名患者中,有 9 名患者在客观缓解后接受了移植,其中 8 名患者目前仍在继续缓解。在分析时,23 名患者仍在接受 nivolumab 治疗,其余患者停止了治疗。停止 nivolumab 的主要原因是疾病进展(n = 23)。安全性特征是可以接受的,只有 9 名患者因严重不良事件而需要停止 nivolumab。24 个月无进展生存率和总生存率分别为 58.5%(95%CI,0.47-0.68)和 78.7%(95%CI,0.68-0.86)。18 名患者在随访期间死亡,其中只有 1 例与治疗相关。由于其疗效和安全性特征,PD-1 阻滞剂成为治疗复发性 cHL 的重要选择。

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