Maryann R. Cooper, Bassem Almalki, Kristine C. Willett
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In the phase I trial, the objective response rate was 87% (95% confidence interval [CI] = 66-97) and the rate of progression-free survival (PFS) at 24 weeks was 86% (95% CI = 62-95). The most common adverse events (AE) included rash (22%) and decreased platelet count (17%). Following extended follow-up at a median of 86 weeks, 50% of the initial responders maintained a durable response. In the phase II clinical trial, 53 patients (66.3%, 95% CI = 54.8-76.4) achieved an objective response and PFS at 6 months was 76.9% (95% CI = 64.9-85.3). The common AE were fatigue (25%), infusion-related reactions (20%), and rash (16%). After further follow-up at a median of 15.4 months, 12-month overall survival was 94.9% (median overall survival not reached). Conclusions: Nivolumab is an effective option in treating patients with relapsed/refractory cHL with an acceptable safety profile. Further studies are needed to investigate the role of nivolumab for the treatment of cHL.","PeriodicalId":16796,"journal":{"name":"Journal of Pharmacy Technology","volume":"47 1","pages":"237 - 244"},"PeriodicalIF":1.1000,"publicationDate":"2017-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Nivolumab for the Treatment of Classical Hodgkin Lymphoma\",\"authors\":\"Maryann R. Cooper, Bassem Almalki, Kristine C. Willett\",\"doi\":\"10.1177/8755122517716472\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Objective: To review nivolumab for the treatment of classical Hodgkin lymphoma (cHL). Data Sources: Literature searches were conducted in Medline (1946 to May week 3 2017), EMBASE (1974 to 2017 week 22), and Google Scholar using the terms Hodgkin lymphoma AND nivolumab. Study Selection and Data Extraction: Two clinical trials (phase I and phase II) were identified. Data Synthesis: Nivolumab inhibits programmed death receptor-1 allowing for increased T-cell mediated immune surveillance of tumors. Nivolumab was evaluated in cHL patients after failure of autologous stem cell transplantation and brentuximab vedotin consolidation. Patients received nivolumab 3 mg/kg every 2 weeks. In the phase I trial, the objective response rate was 87% (95% confidence interval [CI] = 66-97) and the rate of progression-free survival (PFS) at 24 weeks was 86% (95% CI = 62-95). The most common adverse events (AE) included rash (22%) and decreased platelet count (17%). Following extended follow-up at a median of 86 weeks, 50% of the initial responders maintained a durable response. In the phase II clinical trial, 53 patients (66.3%, 95% CI = 54.8-76.4) achieved an objective response and PFS at 6 months was 76.9% (95% CI = 64.9-85.3). The common AE were fatigue (25%), infusion-related reactions (20%), and rash (16%). After further follow-up at a median of 15.4 months, 12-month overall survival was 94.9% (median overall survival not reached). Conclusions: Nivolumab is an effective option in treating patients with relapsed/refractory cHL with an acceptable safety profile. 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引用次数: 0
摘要
目的:综述纳武单抗治疗经典霍奇金淋巴瘤(cHL)的疗效。数据来源:在Medline(1946年至2017年5月第3周)、EMBASE(1974年至2017年第22周)和谷歌Scholar中使用霍奇金淋巴瘤和尼武单抗进行文献检索。研究选择和数据提取:确定了两个临床试验(I期和II期)。数据综合:Nivolumab抑制程序性死亡受体-1,允许增加t细胞介导的肿瘤免疫监视。在自体干细胞移植和brentuximab vedotin巩固失败后的cHL患者中评估Nivolumab。患者每2周接受纳武单抗3mg /kg治疗。在I期试验中,客观缓解率为87%(95%置信区间[CI] = 66-97), 24周无进展生存率(PFS)为86% (95% CI = 62-95)。最常见的不良事件(AE)包括皮疹(22%)和血小板计数下降(17%)。在中位数为86周的延长随访后,50%的初始应答者维持了持久的应答。在II期临床试验中,53名患者(66.3%,95% CI = 54.8-76.4)获得了客观缓解,6个月的PFS为76.9% (95% CI = 64.9-85.3)。常见的AE是疲劳(25%)、输液相关反应(20%)和皮疹(16%)。进一步随访中位时间为15.4个月,12个月总生存率为94.9%(中位总生存率未达到)。结论:Nivolumab是治疗复发/难治性cHL患者的有效选择,具有可接受的安全性。需要进一步的研究来调查纳武单抗在治疗cHL中的作用。
Nivolumab for the Treatment of Classical Hodgkin Lymphoma
Objective: To review nivolumab for the treatment of classical Hodgkin lymphoma (cHL). Data Sources: Literature searches were conducted in Medline (1946 to May week 3 2017), EMBASE (1974 to 2017 week 22), and Google Scholar using the terms Hodgkin lymphoma AND nivolumab. Study Selection and Data Extraction: Two clinical trials (phase I and phase II) were identified. Data Synthesis: Nivolumab inhibits programmed death receptor-1 allowing for increased T-cell mediated immune surveillance of tumors. Nivolumab was evaluated in cHL patients after failure of autologous stem cell transplantation and brentuximab vedotin consolidation. Patients received nivolumab 3 mg/kg every 2 weeks. In the phase I trial, the objective response rate was 87% (95% confidence interval [CI] = 66-97) and the rate of progression-free survival (PFS) at 24 weeks was 86% (95% CI = 62-95). The most common adverse events (AE) included rash (22%) and decreased platelet count (17%). Following extended follow-up at a median of 86 weeks, 50% of the initial responders maintained a durable response. In the phase II clinical trial, 53 patients (66.3%, 95% CI = 54.8-76.4) achieved an objective response and PFS at 6 months was 76.9% (95% CI = 64.9-85.3). The common AE were fatigue (25%), infusion-related reactions (20%), and rash (16%). After further follow-up at a median of 15.4 months, 12-month overall survival was 94.9% (median overall survival not reached). Conclusions: Nivolumab is an effective option in treating patients with relapsed/refractory cHL with an acceptable safety profile. Further studies are needed to investigate the role of nivolumab for the treatment of cHL.
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