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首页> 外文期刊>The lancet oncology >Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT3VIN): A multicentre, open-label, randomised, phase 2 trial
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Activity, safety, and feasibility of cidofovir and imiquimod for treatment of vulval intraepithelial neoplasia (RT3VIN): A multicentre, open-label, randomised, phase 2 trial

机译：西多福韦和咪喹莫特治疗外阴上皮内瘤变（RT3VIN）的活性，安全性和可行性：一项多中心，开放标签，随机，2期试验

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Background: Vulval intraepithelial neoplasia is a skin disorder affecting the vulva that, if left untreated, can become cancerous. Currently, the standard treatment for patients with vulval intraepithelial neoplasia is surgery, but this approach does not guarantee cure and can be disfiguring, causing physical and psychological problems, particularly in women of reproductive age. We aimed to assess the activity, safety, and feasibility of two topical treatments-cidofovir and imiquimod-as an alternative to surgery in female patients with vulval intraepithelial neoplasia. Methods: We recruited female patients (age 16 years or older) from 32 centres to an open-label, randomised, phase 2 trial. Eligibility criteria were biopsy-proven vulval intraepithelial neoplasia grade 3 and at least one lesion that could be measured accurately. We randomly allocated patients to topical treatment with either 1% cidofovir (supplied as a gel in a 10 g tube, to last 6 weeks) or 5% imiquimod (one 250 mg sachet for every application), to be self-applied three times a week for a maximum of 24 weeks. Randomisation (1:1) was done by stratified minimisation via a central computerised system, with stratification by hospital, disease focality, and presentation stage. The primary endpoint was a histologically confirmed complete response at the post-treatment assessment visit 6 weeks after the end of treatment (a maximum of 30 weeks after treatment started). Analysis of the primary endpoint was by intention to treat. Secondary outcomes were toxic effects (to assess safety) and adherence to treatment (to assess feasibility). We present results after all patients had reached the primary endpoint assessment point at 6 weeks; 2-year follow-up of complete responders continues. This trial is registered with Current Controlled Trials, ISRCTN 34420460. Findings: Between Oct 21, 2009, and Jan 11, 2013, 180 participants were enrolled to the study; 89 patients were randomly allocated cidofovir and 91 were assigned imiquimod. At the post-treatment assessment visit, a complete response had been achieved by 41 (46%; 90% CI 37.0-55.3) patients allocated cidofovir and by 42 (46%; 37.2-55.3) patients assigned imiquimod. After 6 weeks of treatment, 156 (87%) patients (78 in each group) had adhered to the treatment regimen. Five patients in the cidofovir group and seven in the imiquimod group either withdrew or were lost to follow-up before the first 6-week safety assessment. Adverse events of grade 3 or higher were reported in 31 (37%) of 84 patients allocated cidofovir and 39 (46%) of 84 patients assigned imiquimod; the most frequent grade 3 and 4 events were pain in the vulva, pruritus, fatigue, and headache. Interpretation: Cidofovir and imiquimod were active, safe, and feasible for treatment of vulval intraepithelial neoplasia and warrant further investigation in a phase 3 setting. Both drugs are effective alternatives to surgery for female patients with vulval intraepithelial neoplasia after exclusion of occult invasive disease. Funding: Cancer Research UK.
机译：背景：外阴上皮内瘤变是一种影响外阴的皮肤疾病，如果不及时治疗，可能会致癌。当前，外阴上皮内瘤变的患者的标准治疗方法是手术，但是这种方法不能保证治愈，而且会造成容貌恶化，引起生理和心理问题，特别是在育龄妇女中。我们旨在评估女性外阴上皮内瘤变的两种局部治疗方法（西多福韦和咪喹莫特）的手术活性，安全性和可行性。方法：我们从32个中心招募了女性患者（年龄在16岁以上）参加了一项开放标签，随机，2期试验。入选标准为活检证实的外阴上皮内瘤样增生3级和至少一个可以准确测量的病变。我们随机分配患者接受1％西多福韦（以10 g试管的凝胶形式供应，持续6周）或5％咪喹莫特（每次使用250袋香囊）的局部治疗，每次3次一周，最多24周。随机（1：1）通过中央计算机系统分层最小化完成，并按医院，疾病重点和呈报阶段进行分层。主要终点是在治疗结束后6周（治疗开始后最多30周）的治疗后评估访视中经组织学确认的完全缓解。主要终点的分析是有意治疗的。次要结果是毒性作用（评估安全性）和坚持治疗（评估可行性）。所有患者均在6周达到主要终点评估点后，我们提供结果。完整的响应者的2年随访仍在继续。该试验已在当前对照试验（ISRCTN 34420460）中进行了注册。研究结果：在2009年10月21日至2013年1月11日期间，共有180名参与者参加了该研究。 89例患者被随机分配西多福韦，91例被分配咪喹莫特。在治疗后评估访视中，接受西多福韦治疗的41例（46％; 90％CI 37.0-55.3）患者和接受咪喹莫特的42例（46％; 37.2-55.3）患者获得了完全缓解。治疗6周后，有156名（87％）患者（每组78名）坚持了该治疗方案。西多福韦组中有5例患者，咪喹莫特组中有7例患者退出或失去了对患者的第一次6周安全性评估。据报道，接受西多福韦治疗的84例患者中有31例（37％）发生了3级或更高的不良反应，而接受咪喹莫特的84例患者中有39例（46％）。最常见的3级和4级事件是外阴疼痛，瘙痒，疲劳和头痛。解释：西多福韦和咪喹莫特治疗外阴上皮内瘤变活跃，安全且可行，因此需要在第3期进行进一步研究。对于排除隐匿性浸润性疾病的外阴上皮内瘤样变的女性患者，这两种药物都是有效的手术替代方法。资金来源：英国癌症研究。

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