Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study
Ropeginterferon alfa-2b versus standard therapy for polycythaemia vera (PROUD-PV and CONTINUATION-PV): a randomised, non-inferiority, phase 3 trial and its extension study
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DOI：
10.1016/s2352-3026(19)30236-4
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发表时间：
2020-03-01
影响因子：
24.7
通讯作者：
Kiladjian, Jean-Jacques
中科院分区：
文献类型：
--
作者：
Gisslinger, Heinz;Klade, Christoph;Kiladjian, Jean-Jacques
PROUD-PV和CONTINUATION-PV试验旨在比较新型单聚干扰素ropeginterferon α -2b和羟基脲，真性红细胞增多症患者的标准治疗，超过3年的治疗。方法PROUD-PV及其扩展研究continue - pv是在欧洲48家诊所进行的随机、对照、开放标签的3期试验。根据世卫组织2008年标准诊断的18岁或以上早期真性红细胞增多症（无细胞减少治疗史或既往羟基脲治疗少于3年）患者符合条件。患者按1:1的比例随机分配至ropeg干扰素α -2b组（每2周皮下注射，起始剂量为100 μ g）或羟基脲组（口服起始剂量为500 mg/天）。1年后，患者可以选择进入试验的延伸部分，即continue - pv。PROUD-PV的主要终点是在脾脏大小正常（纵向直径为0.45 mm）的情况下，ropeg干扰素α -2b与羟基脲在完全血液学反应方面的非劣效性
Background The PROUD-PV and CONTINUATION-PV trials aimed to compare the novel monopegylated interferon ropeginterferon alfa-2b with hydroxyurea, the standard therapy for patients with polycythaemia vera, over 3 years of treatment.Methods PROUD-PV and its extension study, CONTINUATION-PV, were phase 3, randomised, controlled, open-label, trials done in 48 clinics in Europe. Patients were eligible if 18 years or older with early stage polycythaemia vera (no history of cytoreductive treatment or less than 3 years of previous hydroxyurea treatment) diagnosed by WHO's 2008 criteria. Patients were randomly assigned 1:1 to ropeginterferon alfa-2b (subcutaneously every 2 weeks, starting at 100 mu g) or hydroxyurea (orally starting at 500 mg/day). After 1 year, patients could opt to enter the extension part of the trial, CONTINUATION-PV. The primary endpoint in PROUD-PV was non-inferiority of ropeginterferon alfa-2b versus hydroxyurea regarding complete haematological response with normal spleen size (longitudinal diameter of