Dataset Information

Association of Retinoic Acid Receptor ? Gene With Onset and Progression of Lichen Sclerosus-Associated Vulvar Squamous Cell Carcinoma.

ABSTRACT: Importance:Molecular alterations in lichen sclerosus-associated vulvar squamous cell carcinoma (LS-VSCC) are largely unknown. Objective:To determine whether the retinoic acid receptor ? (RAR?) tumor-suppressor gene is involved in the onset and/or progression of LS-VSCC. Design, Setting, and Participants:The case-control study, conducted at University-Hospital of Ferrara, Italy, included 20 LS-VSCC (mean [SD] age, 75 [3] years) and 20 cancer-associated vulvar LS (caVLS; mean [SD] age, 62 [11] years) formalin-fixed embedded tissue specimens, 20 cancer-free vulvar LS (cfVLS), and 20 normal skin fresh specimens from diagnostic biopsies and women surgically treated for nonmalignant skin lesions, respectively. RAR? gene expression and promoter methylation were investigated in LS-VSCC and caVLS adjacent to VSCC specimens, and in cfVLS and normal skin specimens, as controls, by RT-Q real-time polymerase chain reaction (PCR) analysis, and sequencing of PCR-amplified bisulfite-treated DNA. c-Jun expression, an RAR? pathway-related gene, was also investigated. Main Outcomes and Measures:RAR? expression, correlation with its promoter methylation and c-Jun expression, and association with onset or progression of LS-VSCC. Results:In LS-VSCC, RAR? messenger RNA was 3.4-, 3.6-, and 4.8-fold lower than in caVLS (P?=?.001), cfVLS (P?=?.005), and normal skin (P?

SUBMITTER: Rotondo JC

PROVIDER: S-EPMC6128494 | biostudies-literature | 2018 Jul

REPOSITORIES: biostudies-literature

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Association of Retinoic Acid Receptor β Gene With Onset and Progression of Lichen Sclerosus-Associated Vulvar Squamous Cell Carcinoma.

Rotondo John Charles JC Borghi Alessandro A Selvatici Rita R Mazzoni Elisa E Bononi Ilaria I Corazza Monica M Kussini Jacqueline J Montinari Elena E Gafà Roberta R Tognon Mauro M Martini Fernanda F

JAMA dermatology 20180701 7

<h4>Importance</h4>Molecular alterations in lichen sclerosus-associated vulvar squamous cell carcinoma (LS-VSCC) are largely unknown.<h4>Objective</h4>To determine whether the retinoic acid receptor β (RARβ) tumor-suppressor gene is involved in the onset and/or progression of LS-VSCC.<h4>Design, setting, and participants</h4>The case-control study, conducted at University-Hospital of Ferrara, Italy, included 20 LS-VSCC (mean [SD] age, 75 [3] years) and 20 cancer-associated vulvar LS (caVLS; mean ...[more]

PMID: 29898214

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Project description:ObjectiveTo estimate the efficacy of fractionated carbon dioxide (CO2) laser therapy for vulvar lichen sclerosus.MethodsWe conducted a prospective, double-blind, randomized, sham-controlled, trial conducted in a clinic specializing in vulvar disorders. The study participants were 40 women with active vulvar lichen sclerosus confirmed with biopsy who were abstaining from topical and systemic treatments for at least 4 weeks before enrollment. Women were randomized in a 1:1 ratio to receive either five sham laser treatments or five fractionated CO2 treatments in a 24-week period. Study participants, treating clinicians, and the evaluating pathologist were blinded. The primary endpoint was the change in the histopathology scale score between pretreatment and posttreatment biopsies. We estimated 20 per group for 80% power to detect a 40% reduction in the histopathology scale score with up to 10% attrition. A secondary endpoint was the change in the validated CSS (Clinical Scoring System for Vulvar Lichen Sclerosus).ResultsFrom November 2018 to June 2020, 40 women were randomized to participate in the trial, and 37 women (19 fractionated CO2, 18 sham) were included in an intention-to-treat (ITT) analysis. Three women were excluded from the ITT analysis because they did not have posttreatment biopsies and, therefore, a posttreatment histopathology scale score could not be obtained. There was a 0.20 reduction (improvement) in histopathology scale score from baseline in the active treatment group (95% CI -1.1, 0.80, P=.74) and a 0.1 increase from baseline in the sham treatment group (95% CI -0.90, 1.0, P=.91). The change in histopathology scale score between the active and sham arm was not statistically significant (95% CI -1.14, 1.06, P=.76).ConclusionFractionated CO2 is not an effective monotherapy treatment for vulvar lichen sclerosus.Clinical trial registrationClinicalTrials.gov, NCT03665584.Funding sourceAdditional funding for this study was supplied by El.En Group, Florence, Italy, the manufacturer of the laser used in this study. In addition, El.En Group supplied the laser used in the study.

Dataset Information

Association of Retinoic Acid Receptor ? Gene With Onset and Progression of Lichen Sclerosus-Associated Vulvar Squamous Cell Carcinoma.

Publications

Association of Retinoic Acid Receptor β Gene With Onset and Progression of Lichen Sclerosus-Associated Vulvar Squamous Cell Carcinoma.

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