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首页> 外文期刊>Experimental Hematology Oncology >Phase 2 study of everolimus for relapsed or refractory classical Hodgkin lymphoma
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Phase 2 study of everolimus for relapsed or refractory classical Hodgkin lymphoma

机译：everolimus对复发或难治性典型霍奇金淋巴瘤的第2阶段研究

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The current standard of care for classical Hodgkin lymphoma (HL) is multiagent chemotherapy with or without radiation. In patients who relapse or fail to respond, additional high-dose chemotherapy with autologous hematopoietic stem cell transplantation (AHSCT) can improve progression-free survival (PFS). Novel therapies are required for patients refractory to chemotherapy and AHSCT. The mammalian target of rapamycin inhibitor everolimus has shown preliminary activity in preclinical models of HL and promising efficacy in patients with relapsed or refractory HL. This was an open-label, two-stage, phase 2 study that enrolled 57 patients aged ≥?18?years with classic HL that had progressed after standard therapy. Patients received everolimus 10?mg daily until disease progression, intolerable toxicity, withdrawal of consent, or investigator decision. The primary endpoint was overall response rate; secondary endpoints included PFS, overall survival, time to response, duration of response, and safety. Overall response rate was 45.6% (95% confidence interval [CI] 32.4-59.3%); five patients (8.8%) experienced a complete response and 21 patients had a partial response (36.8%). Median PFS was 8.0?months (95% CI 5.1-11.0?months). Seven patients (12%) were long-term responders (≥?12?months). The most common study drug-related adverse events were thrombocytopenia (45.6%), fatigue (31.6%), anemia (26.3%), rash (24.6%), and stomatitis (22.8%). Everolimus 10?mg/day demonstrated favorable results in patients with heavily pretreated, relapsed, or refractory classical HL. These findings support the further evaluation of everolimus in this indication.Trial registration ClinicalTrials.gov NCT01022996. Registered November 25, 2009.
机译：目前经典霍奇金淋巴瘤（HL）的护理标准是多透明化疗，有或没有辐射。在复发或未能应对的患者中，具有自体造血干细胞移植（AHSCT）的额外的高剂量化疗可以改善无进展的存活（PFS）。患者对化疗和AHSCT难以难以进行新的疗法。哺乳动物的雷帕霉素抑制剂艾蒿的靶标在HL的临床前模型中显示了初步活性，并且对复发或难治性HL的患者有前途的疗效。这是一个开放标签，两阶段，第2期，注册了57名≥18岁的患者，患有标准治疗后的经典HL。患者每天接受艾蒿10？MG，直至疾病进展，难以忍受的毒性，撤回同意或调查员决定。主要终点是总体响应率;辅助端点包括PFS，总生存，响应时间，响应持续时间和安全。整体反应率为45.6％（95％置信区间[CI] 32.4-59.3％）;五名患者（8.8％）经历了完整的反应，21例患者有部分反应（36.8％）。中位数PFS是8.0个月（95％CI 5.1-11.0？月份）。 7名患者（12％）是长期响应者（≥12？月）。最常见的研究药物相关的不良事件是血小板减少症（45.6％），疲劳（31.6％），贫血（26.3％），皮疹（24.6％）和口腔炎（22.8％）。艾莫姆斯10？MG /天表现出患有严重预处理，复发或难治性古典HL的患者的有利结果。这些调查结果支持在此指示中进一步评估苯酮血症.Tirial注册诊断诊所.GOV NCT01022996。注册了2009年11月25日。

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