Medical interventions for high grade vulval intraepithelial neoplasia

Abstract

Background-Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin; its incidence is increasing in women under 50 years. VIN is graded histologically as low grade or high grade. High grade VIN is associated with infection with human papilloma virus (HPV) infection and may progress to invasive disease. There is no consensus on the optimal management of high grade VIN. The high morbidity and high relapse rate associated with surgical interventions call for a formal appraisal of the evidence available for less invasive but effective interventions for high grade VIN. Objectives-To evaluate the effectiveness and safety of medical interventions for high grade VIN. Search methods-We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 3), MEDLINE and EMBASE (up to September 2010). We also searched registers of clinical trials, abstracts of scientific meetings, reference lists of included studies and contacted experts in the field. Selection criteria-Randomised controlled trials (RCTs) that assessed medical interventions, in adult women diagnosed with high grade VIN. Data collection and analysis-Two review authors independently abstracted data and assessed risk of bias. Where possible the data were synthesised in a meta-analysis.

A Scoping Review of Treatment Outcome Measures for Vulvar Intraepithelial Neoplasia

“…This correlates with what other researchers have found. For example, 2 previous Cochrane reviews 2,3 were unable to come to any conclusions on the negative impact of VIN treatments on the QoL and/or sexual function of women with VIN, as only 1 of 6 reviewed trials collected any patient-reported outcome measures.…”

“…Experimental treatment includes the following: indole-3-carbinol, cidofovir, interferon α, and photodynamic therapy. However, there is little information to guide HCP, and women with VIN, on how to choose “the right treatment for the right person.” For example, there is no consensus among experts regarding the most effective treatment of VIN, 2,3 and there is a paucity of literature comparing the quality-of-life (QoL) outcomes of different VIN treatments 4 . Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence.…”

“…Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence. These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures 2–4 …”

“…These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures. [2][3][4] The HCP preferences often determine the specific VIN treatment. The most commonly recommended treatments are surgery or topical imiquimod.…”

A Scoping Review of Treatment Outcome Measures for Vulvar Intraepithelial Neoplasia

“…This correlates with what other researchers have found. For example, 2 previous Cochrane reviews 2,3 were unable to come to any conclusions on the negative impact of VIN treatments on the QoL and/or sexual function of women with VIN, as only 1 of 6 reviewed trials collected any patient-reported outcome measures.…”

“…Experimental treatment includes the following: indole-3-carbinol, cidofovir, interferon α, and photodynamic therapy. However, there is little information to guide HCP, and women with VIN, on how to choose “the right treatment for the right person.” For example, there is no consensus among experts regarding the most effective treatment of VIN, 2,3 and there is a paucity of literature comparing the quality-of-life (QoL) outcomes of different VIN treatments 4 . Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence.…”

“…Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence. These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures 2–4 …”

“…These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures. [2][3][4] The HCP preferences often determine the specific VIN treatment. The most commonly recommended treatments are surgery or topical imiquimod.…”

Successful treatment of high-grade vulval intra-epithelial neoplasia with imiquimod 5% in a renal transplant recipient

“…Three randomised controlled trials of imiquimod compared to placebo showed a combined complete response in 58% of patients. 6 A recent multicentre randomised phase 2 trial showed a response rate in over 45% of patients treated with imiquimod. 7 Two retrospective studies of treatment outcomes with imiquimod showed response rates of 76% and 31%.…”

A Scoping Review of Treatment Outcome Measures for Vulvar Intraepithelial Neoplasia

“…This correlates with what other researchers have found. For example, 2 previous Cochrane reviews 2,3 were unable to come to any conclusions on the negative impact of VIN treatments on the QoL and/or sexual function of women with VIN, as only 1 of 6 reviewed trials collected any patient-reported outcome measures.…”

“…Experimental treatment includes the following: indole-3-carbinol, cidofovir, interferon α, and photodynamic therapy. However, there is little information to guide HCP, and women with VIN, on how to choose “the right treatment for the right person.” For example, there is no consensus among experts regarding the most effective treatment of VIN, 2,3 and there is a paucity of literature comparing the quality-of-life (QoL) outcomes of different VIN treatments 4 . Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence.…”

“…Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence. These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures 2–4 …”

“…These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures. [2][3][4] The HCP preferences often determine the specific VIN treatment. The most commonly recommended treatments are surgery or topical imiquimod.…”

Successful treatment of high-grade vulval intra-epithelial neoplasia with imiquimod 5% in a renal transplant recipient

“…Three randomised controlled trials of imiquimod compared to placebo showed a combined complete response in 58% of patients. 6 A recent multicentre randomised phase 2 trial showed a response rate in over 45% of patients treated with imiquimod. 7 Two retrospective studies of treatment outcomes with imiquimod showed response rates of 76% and 31%.…”

A Scoping Review of Treatment Outcome Measures for Vulvar Intraepithelial Neoplasia

“…This correlates with what other researchers have found. For example, 2 previous Cochrane reviews 2,3 were unable to come to any conclusions on the negative impact of VIN treatments on the QoL and/or sexual function of women with VIN, as only 1 of 6 reviewed trials collected any patient-reported outcome measures.…”

“…Experimental treatment includes the following: indole-3-carbinol, cidofovir, interferon α, and photodynamic therapy. However, there is little information to guide HCP, and women with VIN, on how to choose “the right treatment for the right person.” For example, there is no consensus among experts regarding the most effective treatment of VIN, 2,3 and there is a paucity of literature comparing the quality-of-life (QoL) outcomes of different VIN treatments 4 . Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence.…”

“…Furthermore, the ability to analyze the evidence regarding VIN treatment outcomes is limited because of the rare nature of the disease, limited evidence resulting from clinical trials involving small sample sizes of research participants, and the low quality of this published evidence. These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures 2–4 …”

“…These data are primarily from nonrandomized, noncontrolled, and retrospective studies, there is a lack of standardized clinician-reported treatment outcome measures, and there is a notable absence of patient-reported treatment outcome measures. [2][3][4] The HCP preferences often determine the specific VIN treatment. The most commonly recommended treatments are surgery or topical imiquimod.…”

Successful treatment of high-grade vulval intra-epithelial neoplasia with imiquimod 5% in a renal transplant recipient

“…Three randomised controlled trials of imiquimod compared to placebo showed a combined complete response in 58% of patients. 6 A recent multicentre randomised phase 2 trial showed a response rate in over 45% of patients treated with imiquimod. 7 Two retrospective studies of treatment outcomes with imiquimod showed response rates of 76% and 31%.…”