Stanford Cancer Center, Stanford, CA, USA.
Leuk Lymphoma. 2013 Feb;54(2):284-9. doi: 10.3109/10428194.2012.711829. Epub 2012 Aug 17.
Patients with cutaneous T-cell lymphoma (CTCL) frequently experience severe pruritus that can significantly impact their quality of life. Romidepsin is approved by the US Food and Drug Administration (FDA) for the treatment of patients with CTCL who have received at least one prior systemic therapy, with a reported objective response rate of 34%. In a phase 2 study of romidepsin in patients with CTCL (GPI-04-0001), clinically meaningful reduction in pruritus (CMRP) was evaluated as an indicator of clinical benefit by using a patient-assessed visual analog scale. To determine the effect of romidepsin alone, confounding pruritus treatments including steroids and antihistamines were prohibited. At baseline, 76% of patients reported moderate-to-severe pruritus; 43% of these patients experienced CMRP, including 11 who did not achieve an objective response. Median time to CMRP was 1.8 months, and median duration of CMRP was 5.6 months. Study results suggest that the clinical benefit of romidepsin may extend beyond objective responses.
患有皮肤 T 细胞淋巴瘤（CTCL）的患者经常会经历严重的瘙痒，这会极大地影响他们的生活质量。罗米地辛已被美国食品和药物管理局（FDA）批准用于治疗至少接受过一次系统治疗的 CTCL 患者，其客观缓解率为 34%。在一项罗米地辛治疗 CTCL 患者的 2 期研究（GPI-04-0001）中，使用患者评估的视觉模拟量表，将瘙痒的临床意义减轻（CMRP）作为临床获益的指标进行评估。为了确定罗米地辛的单独作用，禁止使用包括皮质类固醇和抗组胺药在内的可能导致瘙痒的混淆治疗。在基线时，76%的患者报告有中重度瘙痒；其中 43%的患者出现 CMRP，包括 11 例未达到客观缓解的患者。CMRP 的中位时间为 1.8 个月，CMRP 的中位持续时间为 5.6 个月。研究结果表明，罗米地辛的临床获益可能超出客观缓解。
