Vorinostat in solid and hematologic malignancies.
Vorinostat in solid and hematologic malignancies.
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DOI：
10.1186/1756-8722-2-31
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发表时间：
2009-07-27
影响因子：
28.5
通讯作者：
Rizvi S
中科院分区：
文献类型：
--
作者：
Siegel D;Hussein M;Belani C;Robert F;Galanis E;Richon VM;Garcia-Vargas J;Sanz-Rodriguez C;Rizvi S
组蛋白去乙酰酶抑制剂Volinostat(Zolinza®)于2006年10月被美国食品和药物管理局批准用于治疗皮肤T细胞淋巴瘤患者的皮肤症状，这些患者在接受或接受两种系统治疗后出现进展性、持续性或复发性疾病。这篇综述总结了有关涡流调节剂在实体和血液系统恶性肿瘤中应用的证据，并整理了涡流抑制剂临床试验计划的耐受性数据。来自498名实体或血液系统恶性肿瘤患者的联合涡流控制器临床试验数据显示，涡流发生器作为单一治疗或联合治疗的耐受性良好。与单一药物相关的不良反应(AEs)最常见的是乏力(61.9%)、恶心(55.7%)、腹泻(49.3%)、食欲减退(48.1%)和呕吐(32.8%)，3/4级药物相关不良事件包括乏力(12.0%)、血小板减少(10.6%)、脱水(7.3%)和血小板减少(5.3%)。在联合治疗中，最常见的药物相关不良反应是恶心(48.4%)、腹泻(40.8%)、乏力(34.4%)、呕吐(31.2%)和厌食(20.4%)。在第一阶段试验中，与涡流调节剂联合使用的耐受性通常很好，初步证据表明，作为单一疗法或与其他系统疗法联合使用，抗癌活性在一系列恶性肿瘤中都有。正在进行和计划中的研究将进一步评估涡旋抑制剂在多种恶性肿瘤类型患者中的联合治疗的潜力，包括与放射的联合治疗，包括非小细胞肺癌、多形性胶质母细胞瘤、多发性骨髓瘤和骨髓增生异常综合征。
Vorinostat (Zolinza®), a histone deacetylase inhibitor, was approved by the US Food and Drug Administration in October 2006 for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma who have progressive, persistent or recurrent disease on or following two systemic therapies. This review summarizes evidence on the use of vorinostat in solid and hematologic malignancies and collated tolerability data from the vorinostat clinical trial program. Pooled vorinostat clinical trial data from 498 patients with solid or hematologic malignancies show that vorinostat was well tolerated as monotherapy or combination therapy. The most commonly reported drug-related adverse events (AEs) associated with monotherapy (n = 341) were fatigue (61.9%), nausea (55.7%), diarrhea (49.3%), anorexia (48.1%), and vomiting (32.8%), and Grade 3/4 drug-related AEs included fatigue (12.0%), thrombocytopenia (10.6%), dehydration (7.3%), and decreased platelet count (5.3%). The most common drug-related AEs observed with vorinostat in combination therapy (n = 157, most of whom received vorinostat 400 mg qd for 14 days) were nausea (48.4%), diarrhea (40.8%), fatigue (34.4%), vomiting (31.2%), and anorexia (20.4%), with the majority of AEs being Grade 2 or less. In Phase I trials, combinations with vorinostat were generally well tolerated and preliminary evidence of anticancer activity as monotherapy or in combination with other systemic therapies has been observed across a range of malignancies. Ongoing and planned studies will further evaluate the potential of vorinostat in combination therapy, including combinations with radiation, in patients with diverse malignancy types, including non-small-cell lung cancer, glioblastoma multiforme, multiple myeloma, and myelodysplastic syndrome.
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