Department of Clinical Pharmacy, Skaggs School of Pharmacy and Pharmaceutical Sciences, University of Colorado, Aurora, USA.
Ann Pharmacother. 2012 Oct;46(10):1340-8. doi: 10.1345/aph.1R036. Epub 2012 Sep 11.
To evaluate the efficacy and safety of romidepsin in refractory cutaneous T-cell lymphoma (CTCL).
An English-language literature search of PubMed and MEDLINE (Nov 2011-April 2012) was performed using the terms romidepsin, CTCL, and depsipeptide (FK228). The National Comprehensive Cancer Network guidelines, American Society of Clinical Oncology abstracts, American Society of Hematology abstracts, clinical trial registry, and prescribing information from the manufacturer were reviewed for additional information.
Phase 1 and 2 trials evaluating the efficacy and safety of romidepsin were reviewed with a specific focus on its use in cutaneous T-cell lymphoma. All peer-reviewed articles with clinically relevant information were evaluated for inclusion.
In advanced stage CTCL, single or combination chemotherapy regimen responses are variable and lack durability. Romidepsin is a histone deacetylase inhibitor approved for refractory cutaneous T-cell lymphoma. Romidepsin has shown an improvement in duration of response and pruritus over traditional therapy. In 2 independent Phase 2 trials, romidepsin showed an overall response rate of 34% and durable response of 13-15 months in patients with refractory CTCL. The most frequent toxicities of romidepsin include nausea, vomiting, fatigue, or myelosuppression. Clinically insignificant QT interval changes have been observed but did not correlate with a decrease in left ventricular ejection fraction, or elevated laboratory markers of myocardial damage.
Romidepsin is an effective, durable, and well-tolerated single-agent therapy in patients with refractory CTCL and should be considered for formulary addition in this population.
评估罗米地辛治疗难治性皮肤 T 细胞淋巴瘤（CTCL）的疗效和安全性。
采用罗米地辛、CTCL 和 depsipeptide（FK228）等术语，对 PubMed 和 MEDLINE（2011 年 11 月至 2012 年 4 月）的英文文献进行了检索。同时还查阅了国家综合癌症网络指南、美国临床肿瘤学会摘要、美国血液学会摘要、临床试验注册处和制造商提供的药品说明书，以获取更多信息。
对评估罗米地辛疗效和安全性的 1 期和 2 期临床试验进行了回顾，重点关注其在皮肤 T 细胞淋巴瘤中的应用。对所有具有临床相关性信息的同行评议文章进行了评估，以确定是否纳入。
在 CTCL 晚期，单一或联合化疗方案的反应各不相同，且缺乏持久性。罗米地辛是一种组蛋白去乙酰化酶抑制剂，已被批准用于治疗难治性皮肤 T 细胞淋巴瘤。罗米地辛在缓解瘙痒和延长缓解时间方面优于传统疗法。在两项独立的 2 期临床试验中，罗米地辛在难治性 CTCL 患者中总缓解率为 34%，且缓解持续时间为 13-15 个月。罗米地辛最常见的毒性反应包括恶心、呕吐、疲劳或骨髓抑制。观察到临床意义不显著的 QT 间期变化，但与左心室射血分数降低或心肌损伤的实验室标志物升高无关。
罗米地辛是一种有效、持久且耐受性良好的单一药物治疗方法，适用于治疗难治性 CTCL 患者，应考虑将其纳入该人群的处方用药。
