Final results of a phase 2 study using continuous 5% Imiquimod cream application in the primary treatment of high-grade vulva intraepithelial neoplasia
Final results of a phase 2 study using continuous 5% Imiquimod cream application in the primary treatment of high-grade vulva intraepithelial neoplasia
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DOI：
10.1016/j.ygyno.2007.05.019
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发表时间：
2007-09-01
影响因子：
4.7
通讯作者：
Fung-Kee-Fung, Michael
中科院分区：
文献类型：
--
作者：
Le, Tien;Menard, Chantal;Fung-Kee-Fung, Michael
目标.目的：探讨5%咪喹莫特乳膏对外阴上皮内瘤变（VIN）2/3级的治疗作用。从区域阴道镜检查单位招募组织学证实VIN 2/3的患者。采用Simon两阶段II期研究设计。咪喹莫特乳膏应用于患者的异常VIN区域，使用递增剂量方案，总治疗持续时间为16周。每2周进行一次阴道镜检查评估，以评价反应。我们使用了一组接受初次手术消融治疗的VIN 2/3患者的历史队列来比较复发模式。39例患者入组研究。6名患者因副作用和不依从研究方案而退出。36例患者（92%）VIN 3。治疗耐受性良好，最常见的副作用仅为应用部位的轻微皮肤刺激。组织学完全缓解21例，部分缓解9例。采用意向治疗原则，总有效率为77%。未诊断出VIN进展或癌症。在整个研究队列的中位随访16个月时，观察到8例复发（20.5%）。相比之下，初次手术治疗患者的复发率为53.5%（p=0.013）。咪喹莫特乳膏耐受性良好，导致大多数高级别VIN病变消退。复发率似乎与初次手术消融相当。(c)2007年爱思唯尔公司All rights reserved.
Objectives. To investigate the activity of 5% Imiquimod cream in the primary treatment of vulva intraepithelial neoplasia (VIN) grade 2/3.Methods. Patients with histologically confirmed VIN 2/3 were recruited from regional colposcopy units. A Simon two-stage phase 2 study design was used. Imiquimod cream was applied over the abnormal VIN areas by the patients, using an escalating dose regimen for a total treatment duration of 16 weeks. Colposcopy assessments were performed every 2 weeks to evaluate for response. A historical cohort of VIN 2/3 patients treated with primary surgical ablation was used to compare recurrence patterns.Results. Thirty-nine patients enrolled in the study. Six patients dropped out due to side effects and non-compliance with study protocol. Thirtysix patients (92%) had VIN 3. Therapy was well tolerated with the most common observed side effects being only minor skin irritation at the application site. Histologic complete response was observed in 21 patients with partial response in another nine patients. The overall response rate was 77% using intention to treat principle. No VIN progression or cancer was diagnosed. At a median follow-up of 16 months in the whole study cohort, eight recurrences (20.5%) were observed. In comparison, the recurrence rate for primary surgically treated patients was 53.5% (p=0.013).Conclusion. Imiquimod cream was well tolerated and resulted in the regression in a majority of high-grade VIN lesions. The recurrence rate appeared to be comparable to primary surgical ablation. (c) 2007 Elsevier Inc. All rights reserved.