Treatment of Primary Vulvar Paget Disease With 5% Imiquimod Cream

Marchitelli, Claudia; Peremateu, Maria Sol; Sluga, Maria; Berasategui, Maria Teresa; Lopez, Delia Graciela; Wernicke, Alejandra; Velazco, Andrea; Gogorza, S.

doi:10.1097/lgt.0000000000000053

Cited by 26 publications

(22 citation statements)

References 17 publications

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“…Imiquimod was evaluated by 13 studies (8 cohort studies, 5 case series) in 110 patients. CR was documented in 54% of patients, and 85% achieved clinical regression of 50% or more [43][44][45][46][47][48][49][50][51][52][53][54]60]. Given the propensity of EMPD for recurrence, posttreatment histological evaluation is of great importance.…”

Section: Discussionmentioning

confidence: 99%

“…Imiquimod is an immune response modifier that stimulates innate immune pathways (via induction of inflammatory cytokines, such as IFN-α, IL-6, and TNF-α) and adaptive immune pathways, resulting in an antitumor effect [59]. Eight cohort studies (3 prospective, 5 retrospective) and 5 case series (total 110 patients) investigated the effectiveness of imiquimod for EMPD at dose schedules ranging from daily to twice weekly for a duration of 2-56 weeks [43][44][45][46][47][48][49][50][51][52][53][54]60]. Overall, 54% (95% CI, 40-67%; I 2 = 37%) of patients achieved complete response (CR) and 85% (95% CI, 74-90%; I 2 = 0%) achieved clinical regression of 50% or more.…”

Section: Imiquimodmentioning

confidence: 99%

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Nonsurgical Treatments for Extramammary Paget Disease: A Systematic Review and Meta-Analysis

et al. 2020

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Introduction: Surgery is commonly regarded as the mainstay of treatment of extramammary Paget disease (EMPD); however, nonsurgical approaches have gained popularity in recent years. Objectives: To review the published evidence for the efficacy and safety of nonsurgical modes of therapy for EMPD. Methods: A systematic review and meta-analysis of nonsurgical EMPD treatments was performed. The primary outcome was complete response (CR); secondary outcomes were clinical regression by ≥50%, adverse events, and recurrence rate. Results: The systematic review included 43 observational studies (341 patients; 7 prospective cohort studies, 19 retrospective cohort studies, and 17 cases series) evaluating 5 treatment modalities. Imiquimod (13 studies, 110 patients) administered at variable doses ranging from daily to twice weekly for 2-56 weeks demonstrated CR of 54% (95% CI, 40-67%; I 2 = 37%) and had a satisfactory safety profile. In 14 heterogeneous studies (122 patients) evaluating photodynamic therapy (PDT), only 36% (95% CI, 22-53%; I 2 = 52%) of patients achieved CR. Radiotherapy (12 studies, 67 patients) showed CR of 97%, but was associated with local and systemic side effects. Ablative lasers and topical fluorouracil and calcipotriene lacked adequate evidence of efficacy. Conclusions: Imiquimod and radiotherapy are the most appropriate nonsurgical modalities for EMPD treatment given their good efficacy and safety profile. PDT has limited efficacy but may be appropriate in selected clinical settings.

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Section: Discussionmentioning

confidence: 99%

Section: Imiquimodmentioning

confidence: 99%

Nonsurgical Treatments for Extramammary Paget Disease: A Systematic Review and Meta-Analysis

et al. 2020

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“…Most of the retrospective series have used different treatment schedules. The prospective trial of Marchitelli et al [ 35 ] used a different treatment schedule per patient. In most case studies, treatment was continued until the patient obtained a complete response.…”

Section: Discussionmentioning

confidence: 99%

“…The primary outcome variable is the response at 12 weeks after end of treatment with topical 5% imiquimod cream. The only observational study on this topic, at time of conception of this trial, reported a response in 9 of 10 women [ 35 ]. Assuming a complete response rate of 80%, a cohort size of 20 patients is sufficient to estimate the complete response rate with a standard error of 9%, using the normal approximation for the binomial distribution.…”

Section: Methodsmentioning

confidence: 99%

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The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease

Linden¹,

Meeuwis²,

Hees³

et al. 2017

JMIR Res Protoc

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BackgroundVulvar Paget disease is a rare skin disorder, which is most common in postmenopausal Caucasian women. They usually present with an erythematous plaque that may show fine or typical “cake icing” scaling or ulceration that may cause itching, pain, irritation, or a burning sensation. Although most cases are noninvasive, vulvar Paget disease may be invasive or associated with an underlying vulvar or distant adenocarcinoma. The histological evidence of so-called “Paget cells” with abundant pale cytoplasm in the epithelium confirms the diagnosis. The origin of these Paget cells is still unclear. Treatment of choice is wide local excision with negative margins. Obtaining clear surgical margins is challenging and may lead to extensive and mutilating surgery. Even then, recurrence rates are high, ranging from 15% to 70%, which emphasizes the need for new treatment options. A number of case reports, retrospective case series, and one observational study have shown promising results using the topical immune response modifier imiquimod.ObjectiveThis study aims to investigate the efficacy, safety, and immunological response in patients with noninvasive vulvar Paget disease using a standardized treatment schedule with 5% imiquimod cream.MethodsTopical 5% imiquimod cream might be an effective and safe treatment alternative for vulvar Paget disease. The Paget Trial is a multicenter observational cohort study including eight tertiary referral hospitals in the Netherlands. It is ethically approved by the Medical-Ethical Committee of Arnhem-Nijmegen and registered in the Central Committee on Research Involving Human Subjects (CCMO) Register by as NL51648.091.14. Twenty patients with (recurrent) noninvasive vulvar Paget disease will be treated with topical 5% imiquimod cream three times a week for 16 weeks. The primary efficacy outcome is the reduction in lesion size at 12 weeks after end of treatment. Secondary outcomes are safety, immunological response, and quality of life. Safety will be assessed by evaluation of adverse events and tolerability of treatment. To evaluate the immunological response, various immunological markers will be tested on biopsy specimens taken before, during, and after treatment. Quality of life will be assessed with three questionnaires taken before, during, and after treatment.ResultsFirst results are expected in the summer of 2018.Trial RegistrationClinicalTrials.gov NCT02385188; https://clinicaltrials.gov/ct2/show/NCT02385188 (Archived by WebCite at http://www.webcitation.org/6sXygHuhP).

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Vulval Paget's Disease

Linden¹

2022

Ridley's the Vulva

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Treatment of Primary Vulvar Paget Disease With 5% Imiquimod Cream

Cited by 26 publications

References 17 publications

Nonsurgical Treatments for Extramammary Paget Disease: A Systematic Review and Meta-Analysis

Nonsurgical Treatments for Extramammary Paget Disease: A Systematic Review and Meta-Analysis

The Paget Trial: A Multicenter, Observational Cohort Intervention Study for the Clinical Efficacy, Safety, and Immunological Response of Topical 5% Imiquimod Cream for Vulvar Paget Disease

Vulval Paget's Disease

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