Treatment of Undifferentiated Vulvar Intraepithelial Neoplasia With 5% Imiquimod Cream

Wendling, J.; Saïag, Philippe; Berville-Levy, Sophie; Bourgault‐Villada, Isabelle; Clérici, T.; Moyal‐Barracco, Micheline

doi:10.1001/archderm.140.10.1220

Cited by 33 publications

(27 citation statements)

References 22 publications

(31 reference statements)

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“…The more common type of VIN (basaloid) is intimately associated with human papilloma virus infection, usually human papillomavirus (HPV) 16, whereas the other type, differentiated VIN, is not associated with HPV (2). It is difficult to treat because radical vulval surgery for a preinvasive lesion is inappropriate, and more conservative excisional treatment is frequently unsuccessful, particularly in cases of multifocal disease.…”

mentioning

confidence: 99%

Clinical and Immunologic Results of a Phase II Trial of Sequential Imiquimod and Photodynamic Therapy for Vulval Intraepithelial Neoplasia

Winters

Daayana

Lear

et al. 2008

Clinical Cancer Research

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Purpose: High-risk human papillomavirus (HPV)-associated vulval intraepithelial neoplasia (VIN) is difficult to treat by excision or ablation because of high recurrence rates. Small studies of photodynamic therapy (PDT) and imiquimod treatments have shown some success and function at least in part through stimulation of local immune responses. Indeed, there is evidence that immunosuppressed individuals have higher rates of VIN, suggesting immune control is relevant. Experimental Design: In the study, 20 women with high-grade VIN were treated with topical imiquimod and the PDT sequentially.Vulval biopsy and blood were taken pretreatment and, after imiquimod and PDT, with follow up for 1year. Clinical response was assessed by measuring lesion size. Biopsies were analyzed for HPV DNA and tumor-infiltrating lymphocytes including T regulatory cells. Results: The treatment was well-tolerated. There was an overall response rate of 55% by intention treat and 64% per protocol. The 52-week symptom response was 65% asymptomatic, compared with 5% at baseline. The nonresponders showed a significantly higher level of Tregulatory cells in the lesions after imiquimod treatment. Conclusions: The response rates are clinically relevant, and the treatment regimen was feasible for the majority. Initial nonresponders to imiquimod seem to be relatively refractory, and this may derive from their unfavorable local immune environment, in particular, the increased proportions of Tregulatory cells, possibly the limiting action and/or development of any HPV T-cell immunity. The potential benefit of this treatment is its ability to treat multifocal disease.

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mentioning

confidence: 99%

Clinical and Immunologic Results of a Phase II Trial of Sequential Imiquimod and Photodynamic Therapy for Vulval Intraepithelial Neoplasia

Winters

Daayana

Lear

et al. 2008

Clinical Cancer Research

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“…Reports of successful treatment of anogenital SCC in situ, including vulvar intraepithelial neoplasia, penile intraepithelial neoplasia and anal intraepithelial neoplasia with topical imiquimod have become increasingly frequent [52][53][54][55][56]. A recent meta-analysis investigating the response of anogenital SCC in situ to topical imiquimod therapy showed pooled complete response rates of 51, 70 and 48% for vulvar, penile and anal intraepithelial neoplasia, respectively [57].…”

Section: Topical Imiquimodmentioning

confidence: 99%

Topical Antineoplastic Agents in the Treatment of Mucocutaneous Diseases

Grossberg

Gaspari

2011

Topical Applications and the Mucosa

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Topical antineoplastic agents have a well-established role in the treatment of several dermatological conditions. Their use in the treatment of mucosal skin disease also has gained increasing recognition. Topical 5-fluorouracil (5-FU), an antimetabolite, and imiquimod, an immunomodulatory agent with antitumor properties, are the two principal topical antineoplastic agents used in the treatment of mucocutaneous diseases. Although the vast majority of their mucosal uses are currently not approved by the Federal Drug Administration, there are numerous case series, open-label studies and randomized controlled trials supporting their uses in the treatment of mucocutaneous diseases. Both topical 5-FU and imiquimod have been successfully utilized in the treatment of a wide range of mucosal diseases, including actinic cheilitis, Bowen's disease of the anal and vulvar mucosa, and genital and perianal condyloma. Reports of their uses in the treatment of mucocutaneous diseases indicate that these agents can be safely administered, though adverse effects such as local inflammation may be augmented when these agents are applied to mucosal surfaces. Additionally, locally acting intralesional chemotherapeutic agents, such as bleomycin and interferon, have well-defined applications in the treatment of mucosal skin diseases such as condyloma acuminata. As further studies are conducted, these topical and intralesional neoplastic agents, in addition to emerging agents that are in various stages of development, such as Toll-like receptor 9 agonists and ingenol mebutate, may play an increasingly important role in the future treatment of mucocutaneous diseases.

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“…62 These findings are similar to those reported for imiquimod treatment of intraepithelial neoplasia of the vulva. 63,64 Although preliminary results demonstrating high response rates make this an attractive approach, its use has been limited by local side effects, including irritation, burning, and erosions, which adversely affect patient compliance. 63,65 However, a recent systematic review of imiquimod in the treatment of anogenital warts identified a treatment withdrawal rate of < 5 percent.…”

Section: Treatmentmentioning

confidence: 99%

“…63,64 Although preliminary results demonstrating high response rates make this an attractive approach, its use has been limited by local side effects, including irritation, burning, and erosions, which adversely affect patient compliance. 63,65 However, a recent systematic review of imiquimod in the treatment of anogenital warts identified a treatment withdrawal rate of < 5 percent. 66 Although adverse effects are not uncommon, treatment often can be reinitiated after a brief break in therapy.…”

Section: Treatmentmentioning

confidence: 99%