咪喹莫特治疗阴茎上皮内瘤变的发病率和预测因素的多中心评价。

IF 3.2 3区医学 Q1 UROLOGY & NEPHROLOGY

European Urology Open Science Pub Date : 2025-01-01 DOI:10.1016/j.euros.2024.08.020

Ofir Avitan , Laura Elst , Manon Vreeburg , Tynisha Rafael , Katja Jordanova , Niels Graafland , Kees Hendricksen , Bas W.G. van Rhijn , Henk G. van der Poel , Maarten Albersen , Oscar Brouwer

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引用次数: 0

摘要

简介和目的：咪喹莫特（IQ）是一种用于治疗阴茎上皮内瘤变（PeIN）病变的免疫调节剂。然而，IQ治疗可能伴随着令人烦恼的副作用（SEs）。迄今为止，报告这种发病率和评估对智商反应的预测因素的研究很少，而且包括小队列。本研究的主要目的是评估迄今为止报道的最大队列中对智商治疗的反应、相关的社会经济状况和反应的潜在预测因素。方法：我们在荷兰和比利时的两个高容量中心进行了一项协作回顾性研究，涉及2010年至2022年间诊断为PeIN并接受IQ治疗的患者。符合条件的患者有确诊的PeIN和至少6个月的随访。对智商的反应分为完全反应（CR）、部分反应和无反应。生成描述性统计数据，统计检验包括年龄的Mann-Whitney U检验和分类变量的Fisher精确检验。主要发现和局限性：该研究共纳入44例患者，中位年龄为65.4 岁（四分位数范围为56-72）。在这些患者中，28例（64%）达到了CR， 14例（32%）有部分缓解，2例（4.5%）没有缓解。CR亚组3年复发率为25%。治疗前的应答状态与年龄、人乳头瘤病毒状态、阴茎癌史或包皮环切术无显著相关性。50%的患者报告SEs，主要是局部疼痛、刺激和出血，12%的患者因SEs而停止治疗。CR与SE的发生率或类型无显著相关性。结论和临床意义：尽管IQ的总有效率很高，但大量患者在3 年内出现局部复发，大约一半的患者报告了SEs。我们的研究结果没有发现任何临床或病理因素或局部SEs预测治疗对IQ的反应。需要前瞻性研究来帮助预测哪些患者可能对智商有反应，以便那些不会受益的患者可以避免与这种治疗相关的社会经济状况。患者总结：我们的研究观察了对咪喹莫特（IQ）的反应，这是一种乳膏形式的免疫治疗，用于治疗阴茎癌前病变，称为阴茎上皮内瘤变。超过95%的患者对IQ有完全或部分反应，但50%的患者报告了副作用，完全反应组中25%的患者在3年内复发。需要更多的研究来帮助选择从智商治疗中获益最多的患者。

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Multicenter Evaluation of Morbidity and Predictors of Response to Imiquimod Treatment for Penile Intraepithelial Neoplasia

Introduction and objective

Imiquimod (IQ) is an immunomodulator used in the management of penile intraepithelial neoplasia (PeIN) lesions. However, IQ treatment may be associated with bothersome side effects (SEs). To date, studies reporting on this morbidity and evaluating predictors of response to IQ are scarce and included small cohorts. The primary objective of our study was to assess the response to IQ treatment, associated SEs, and potential predictors of response in the largest reported cohort to date.

Methods

We conducted a collaborative retrospective study involving patients diagnosed with PeIN and treated with IQ between 2010 and 2022 in two high-volume centers in the Netherlands and Belgium. Eligible patients had a confirmed diagnosis of PeIN and a minimum of 6-mo follow-up. Response to IQ was categorized as a complete response (CR), partial response, or no response. Descriptive statistics were generated and statistical tests included the Mann-Whitney U test for age and Fisher’s exact test for categorical variables.

Key findings and limitations

The study included a total of 44 patients, with a median age of 65.4 yr (interquartile range 56–72). Of these patients, 28 (64%) achieved a CR, while 14 (32%) had a partial response and two (4.5%) had no response. In the CR subgroup, the 3-yr recurrence rate was 25%. No significant correlation was found between response status and age, human papillomavirus status, history of penile cancer, or circumcision before treatment. Among the patients, 50% reported SEs, mainly local pain, irritation, and bleeding, and 12% discontinued treatment because of SEs. There was no significant correlation between CR and the incidence or type of SE.

Conclusions and clinical implications

Despite the high overall response rate to IQ, a significant number of patients experienced local recurrence within 3 yr, and approximately half of the patients reported SEs. Our results did not identify any clinical or pathological factors or local SEs predictive of the therapeutic response to IQ. Prospective studies are needed to help in predicting which patients are likely to respond to IQ so that those who will not benefit can be spared the SEs associated with this treatment.

Patient summary

Our study looked at responses to imiquimod (IQ), an immune-based treatment in cream format, for precancerous lesions on the penis, called penile intraepithelial neoplasia. More than 95% of patients had a complete or partial response to IQ, but 50% reported side effects, and 25% of the group with a complete response had recurrence within 3 years. More research is needed to help in selecting patients who will benefit the most from IQ treatment.

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