Topical bexarotene therapy for patients with refractory or persistent early-stage cutaneous T-cell lymphoma: Results of the phase III clinical trial
Topical bexarotene therapy for patients with refractory or persistent early-stage cutaneous T-cell lymphoma: Results of the phase III clinical trial
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DOI：
10.1016/s0190-9622(03)01475-0
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发表时间：
2003-11-01
影响因子：
13.8
通讯作者：
Reich, SD
中科院分区：
文献类型：
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作者：
Heald, P;Mehlmauer, M;Reich, SD
目的：我们试图确定局部贝沙罗汀（Targretin，配体制药公司，拉霍亚，加利福尼亚州）凝胶1%的安全性和有效性在难治性或持续性早期皮肤T细胞lymphoma.Methods：我们进行了一项多国，开放标签，III期研究50例IA至IIA期皮肤T细胞淋巴瘤。主要终点分类为总体完全缓解率和部分缓解率，以2项指标中较高者为准：医生对临床状况的总体评估或指数病变疾病严重程度的综合评估。医生对临床状况的总体评估、索引病变疾病严重程度的综合评估和主要终点分类的总体应答率分别为44%、46%、分别为54%。可能与研究药物相关的最常见不良事件为轻度至中度刺激性皮炎、瘙痒症、疼痛（即，主要为给药部位烧灼感）和皮肤疾病（例如，皮肤炎症、表皮脱落和新发病变）。有没有严重的治疗相关的不良事件。结论：局部贝沙罗汀凝胶一般耐受性良好，并表现出实质性的疗效在难治性或持续性早期皮肤T细胞淋巴瘤患者。
Objectives: We sought to determine the safety and efficacy of topical bexarotene (Targretin; Ligand Pharmaceuticals, La Jolla, Calif) gel 1% in patients with refractory or persistent early-stage cutaneous T-cell lymphoma.Methods: We conducted a multinational, open-label, phase III study of 50 patients with stage IA to IIA cutaneous T-cell lymphoma. The primary end point classification was the overall complete and partial response rate by the higher of 2 measures: the Physician's Global Assessment of Clinical Condition or the Composite Assessment of Index Lesion Disease Severity.Results: The overall response rates for the Physician's Global Assessment of Clinical Condition, Composite Assessment of Index Lesion Disease Severity, and primary end point classification were 44%, 46%, and 54%, respectively. The most common adverse events possibly related to study medication were mild to moderate irritant dermatitis, pruritus, pain (ie, primarily burning at application site), and skin disorder (eg, skin inflammation, excoriation, and new lesions). There were no serious treatment-related adverse events.Conclusions: Topical bexarotene gel was generally well tolerated and demonstrated substantial efficacy in patients with refractory or persistent early-stage cutaneous T-cell lymphoma.