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首页> 外文期刊>BJOG: an international journal of obstetrics and gynaecology >Recurrence of vulval intraepithelial neoplasia following treatment with cidofovir or imiquimod: results from a multicentre, randomised, phase II II trial ( RT RT 3 VIN VIN )
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Recurrence of vulval intraepithelial neoplasia following treatment with cidofovir or imiquimod: results from a multicentre, randomised, phase II II trial ( RT RT 3 VIN VIN )

机译：用Cidofovir或Imiquimod治疗后发出外阴上皮内瘤形成：MulticEltre，随机，II期II试验的结果（RT RT 3 Vin）的结果

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摘要

Objective To compare the recurrence rates after complete response to topical treatment with either cidofovir or imiquimod for vulval intraepithelial neoplasia ( VIN ) 3. Design A prospective, open, randomised multicentre trial. Setting 32 general hospitals located in Wales and England. Population or Sample 180 patients were randomised consecutively between 21 October 2009 and 11 January 2013, 89 to cidofoovir (of whom 41 completely responded to treatment) and 91 to imiquimod (of whom 42 completely responded to treatment). Methods After 24 weeks of treatment, complete responders were followed up at 6‐monthly intervals for 24 months. At each visit, the Common Terminology Criteria for Adverse Events ( CTCAE ) v3.0 was assessed and any new lesions were biopsied for histology . Main outcome measures Time to histologically confirmed disease recurrence (any grade of VIN ). Results The median length of follow up was 18.4 months. At 18 months, more participants were VIN ‐free in the cidofovir arm: 94% (95% CI 78.2–98.5) versus 71.6% (95% CI 52.0–84.3) [univariable hazard ratio ( HR ) 3.46, 95% CI 0.95–12.60, P = 0.059; multivariable HR 3.53, 95% CI 0.96–12.98, P = 0.057). The number of grade 2+ events was similar between treatment arms (imiquimod: 24/42 (57%) versus cidofovir: 27/41 (66%), χ 2 = 0.665, P = 0.415), with no grade 4+. Conclusions Long‐term data indicates a trend towards response being maintained for longer following treatment with cidofovir than with imiquimod, with similar low rates of adverse events for each drug. Adverse event rates indicated acceptable safety of both drugs Tweetable abstract Long‐term follow up in the RT 3 VIN trial suggests cidofovir may maintain response for longer than imiquimod.
机译：目的在完全反应局部处理后比较复发率，以局部治疗与外语外阴上皮内肿瘤（VIN）3.设计前瞻性，开放，随机的多期式试验。设置32家综合医院位于威尔士和英格兰。人口或样品180名患者在2009年10月21日和2013年1月11日之间随机分配，89至Cidofoovir（其中41人完全回应治疗）和91〜Imiquimod（其中42个完全回应治疗）。方法治疗24周后，完整的响应者每间隔24个月随访。在每次访问时，评估不良事件（CTCAE）v3.0的常见术语标准，并且对组织学进行了任何新病变。主要结果测量时间以组织学证实疾病复发（任何等级的VIN）。结果后续的中位数长度为18.4个月。在18个月，更多的参与者在Cidofovir Arm中的VIN -FREE：94％（95％CI 78.2-98.5）与71.6％（95％CI 52.0-84.3）[单变危险比（HR）3.46,95％CI 0.95- 12.60，p = 0.059;多变量HR 3.53,95％CI 0.96-12.98，P = 0.057）。治疗臂之间的2级比赛数量相似（Imiquimod：24/42（57％）与Cidofovir：27/41（66％），χ2= 0.665，p = 0.415），没有4 +。结论长期数据表明，随着含Cidofovir的治疗而不是与咪喹莫德治疗相比，保持响应的趋势，具有与每种药物的相似不良事件的低速率。不良事件率表明，两种药物的可接受的安全性发布了Threedable摘要长期在RT 3 vin试验中表明Cidofovir可能保持比Imiquimod长的响应。

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