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The Cochrane Database of Systematic... Jun 2019This is an updated version of the original Cochrane Review published in Issue 10, 2013.Extramammary Paget's disease is a rare form of superficial skin cancer. The most...
BACKGROUND
This is an updated version of the original Cochrane Review published in Issue 10, 2013.Extramammary Paget's disease is a rare form of superficial skin cancer. The most common site of involvement is the vulva. It is seen mainly in postmenopausal white women. Paget's disease of the vulva often spreads in an occult fashion, with margins extending beyond the apparent edges of the lesion. There is a range of interventions from surgical to non-invasive techniques or treatments. The challenges of interventions are to remove or treat disease that may not be visible, without overtreatment and with minimisation of morbidity from radical surgery. There is little consensus regarding treatment. Surgery, by default, is the most common treatment, but it is challenging to excise the disease adequately, and recurrence is common, leading to repeated operations, and destruction of anatomy. Alternative treatments of photodynamic therapy, laser therapy, radiotherapy, topical treatments or even chemotherapy have been mooted, and it is important to evaluate the available evidence. It is essential to assess whether newer cell-specific treatments, such as photodynamic therapy and imiquimod, can reduce the need for radical surgery.
OBJECTIVES
To evaluate the benefits and harms of different treatment modalities for the management of Paget's disease of the vulva.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (via Ovid) and Embase (via Ovid) up to 8 May 2018. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of review articles.
SELECTION CRITERIA
We searched for randomised controlled trials (RCTs) and well-designed non-randomised studies that compared different interventions in women with Paget's disease of the vulva, DATA COLLECTION AND ANALYSIS: Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. We found no trials and, therefore, analysed no data.
MAIN RESULTS
The search for the original version of the review identified 635 unique references. We found 31 references (which reported on 30 studies) in full text after inspection of titles and abstracts, but we excluded them all as they did not meet the inclusion criteria. However, we have included a comprehensive narrative account of studies where we identified an analysis of more than 10 women, as this forms the only evidence base in this rare disease. Surgery continues to be the mainstay of treatment in the current literature, with other treatments limited to case reports or treatment of inoperable or recurrent disease.This update between September 2013 and May 2018 identified 35 new studies. None of these met the inclusion criteria. There was only one prospective study of 5% imiquimod in recurrent Paget's disease of the vulva, which although of good quality only included eight women.
AUTHORS' CONCLUSIONS
Since the last version of the review was published there are many more cases in the literature reporting a clinical response to 5% imiquimod cream. There is one prospective study of eight women treated with 5% imiquimod for recurrent Paget's disease of the vulva, and one prospective trial of 20 women was due to be reported. This increasing evidence for the safety and efficacy of 5% imiquimod will be helpful for women and clinicians alike. Ideally, a multicentre RCT of reasonable size is needed, but ongoing publications of high-quality non-randomised prospective studies will enhance the current available literature.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Female; Humans; Imiquimod; Laser Therapy; Middle Aged; Paget Disease, Extramammary; Photochemotherapy; Randomized Controlled Trials as Topic; Vulvar Neoplasms
PubMed: 31167037
DOI: 10.1002/14651858.CD009245.pub3 -
Experimental and Therapeutic Medicine Oct 2020Vaginitis, also known as vulvovaginitis, is an inflammation of the vagina and vulva and a common disease in females. It is thought to be caused by vaginal dysbiosis and...
Vaginitis, also known as vulvovaginitis, is an inflammation of the vagina and vulva and a common disease in females. It is thought to be caused by vaginal dysbiosis and improved by probiotics. Bacterial vaginosis (BV) and vulvovaginal candidiasis (VVC) are the major types of vaginal infections. The present systematic review and meta-analysis aimed to clarify the efficacy of probiotics in the treatment of common vaginal infections in non-pregnant females. Literature on randomized controlled trials and two-armed prospective studies on any intervention with probiotics published until December 24th, 2018 was searched in the PubMed, Cochrane and EMBASE databases. The outcomes of interest were recurrence rate, cure rate, remission rate and normal vaginal flora restoration. Finally, a total of 30 studies on bacterial vaginosis (BV) and/or VVC were included and stratified into 3 study types based on treatment design as follows: Type I, antibiotic/probiotics vs. antibiotics/antifungals (22 studies); Type II, probiotics vs. placebo (5 studies); Type III, probiotics vs. antibiotics (3 studies). The type I studies comprised 1,788 non-pregnant females and had the highest inter-study comparability in post-treatment follow-up design and meta-analysis outcome data. Probiotics interventions were significantly associated with a lower recurrence rate of vaginitis [pooled odds ratio (OR)=0.27, 95% CI: 0.18-0.41, P<0.001] and higher cure/remission rate (pooled OR=2.28, 95% CI: 1.20-4.32, P=0.011). However, a significant increase in normal vaginal flora after probiotic treatment was observed only in BV (pooled OR=4.55, 95% CI: 1.44-14.35, P=0.01). In addition, supportive but heterogeneous results were obtained from the 6-month follow-up data of Type-I studies, different infection types and supplementary analysis of Type-II studies. In conclusion, probiotics have a significant short-term effect in the treatment of common vaginal infections in non-pregnant females. In order to evaluate the long-term effects of probiotics in common vaginal infections, it is worthwhile to perform higher-quality clinical trials in the future.
PubMed: 32855726
DOI: 10.3892/etm.2020.9090 -
Frontiers in Oncology 2024Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic...
INTRODUCTION
Vulvar cancer carries a favourable prognosis in early stages. However, therapeutic options for advanced or recurrent cases are limited despite a variety of therapeutic modalities, such as extensive surgical resection, chemotherapy, and radiotherapy. The most important emerging treatment modalities are immune checkpoint inhibitors. This systematic review and meta-analysis aims to assess the efficacy and safety of pembrolizumab, an immune checkpoint inhibitor, in women with advanced vulvar cancer.
MATERIALS AND METHODS
Following a comprehensive search, review, and appraisal, two relevant single-arm studies were included. Meta-analysis was conducted using R4.3.0 software and RStudio 2023.03.0, presenting the overall effect size with a 95% confidence interval. Heterogeneity was assessed using I and the Cochrane Q χ2 statistics.
RESULTS
Out of 154 studies screened for eligibility, two single-arm studies involving 119 patients receiving pembrolizumab for advanced vulvar cancer were included. The pooled objective response rate (ORR) was overall 10% (95% CI: 0.00-0.84) and 9% (95% CI: 0.00-0.89) in the PD-L1 positive subgroup. In the intention-to-treat (ITT) population, 31% (95% CI: 0.04-0.85) exhibited any clinical benefit (complete response, partial response, or stable disease). In the ITT population at six months, progression-free survival (PFS) was 19% (95% CI: 0.01-0.82), and overall survival (OS) was 48% (95% CI: 0.08-0.90). At 12 months, PFS decreased to 9% (95% CI: 0.00-0.85), and OS was 33% (95% CI: 0.04-0.85). No statistically significant heterogeneity was observed in PFS and OS analyses.
DISCUSSION AND CONCLUSION
This study suggests that one-third of women with advanced or recurrent vulvar cancer may, without the influence of PD-L1 status, benefit from pembrolizumab treatment despite a decline in both PFS and OS at 12 months. These findings provide support for considering pembrolizumab in the treatment paradigm for this specific subset of cancer patients.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier CRD42023391888.
PubMed: 38440225
DOI: 10.3389/fonc.2024.1352975 -
Surgical Laparoscopy, Endoscopy &... Oct 2016Natural orifice transluminal endoscopic surgery (NOTES) is an endoscopic technique whereby surgical interventions can be performed with a flexible endoscope passed... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
Natural orifice transluminal endoscopic surgery (NOTES) is an endoscopic technique whereby surgical interventions can be performed with a flexible endoscope passed through a natural orifice (mouth, vulva, urethra, anus) then through a transluminal opening of the stomach, vagina, bladder, or colon. Although in the early stage of research and development, NOTES has been clinically applied across the globe, above all the transvaginal cholecystectomy is among the most frequently performed procedures. In the existing 2 types of transvaginal routes, the hybrid NOTES cholecystectomy (NC) is more likely to be accepted. However, there has been controversy regarding the safety outcomes of hybrid NC in comparison with classical laparoscopic cholecystectomy (LC). The primary objective of this meta-analysis is to compare the characteristics between NC and classical LC.
MATERIALS AND METHODS
A meta-analysis of eligible studies comparing NC with classical LC was performed to evaluate the safety outcomes including wound complications, other postoperative complications and intraoperative conversion between the 2 groups.
RESULTS
Pooling 3 randomized controlled trials (n=157) and 7 nonrandomized trial (n=593) demonstrated that the rates of wound complications and other postoperative complications in NC group did not significantly differ from those of classical LC group [wound complications: ratio difference (RD)=-0.02, 95% confidence interval (CI) -0.04to 0.01, P=0.23; other postoperative complication: RD=-0.01; 95% CI, -0.03 to 0.02; P=0.6]. The intraoperative conversion rate in NC groups was higher than that of LC groups (RD=0.03; 95% CI, 0.01-0.06; P=0.02).
CONCLUSIONS
There is no significate difference between the safety of NC and laparoscope cholecystectomy. NC is associated with a higher rate of intraoperative conversion when compared with LC. It is worthy of further promotion and validation in clinical settings.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Cholecystectomy; Cholecystectomy, Laparoscopic; Conversion to Open Surgery; Humans; Length of Stay; Middle Aged; Natural Orifice Endoscopic Surgery; Observational Studies as Topic; Operative Time; Pain, Postoperative; Postoperative Complications; Randomized Controlled Trials as Topic; Young Adult
PubMed: 27557339
DOI: 10.1097/SLE.0000000000000284 -
American Journal of Obstetrics and... Sep 2015The aim of this study was to systematically review the findings of publications addressing the epidemiology of anal human papillomavirus (HPV) infection, anal... (Review)
Review
The aim of this study was to systematically review the findings of publications addressing the epidemiology of anal human papillomavirus (HPV) infection, anal intraepithelial neoplasia, and anal cancer in women. We conducted a systematic review among publications published from Jan. 1, 1997, to Sept. 30, 2013, to limit to publications from the combined antiretroviral therapy era. Three searches were performed of the National Library of Medicine PubMed database using the following search terms: women and anal HPV, women anal intraepithelial neoplasia, and women and anal cancer. Publications were included in the review if they addressed any of the following outcomes: (1) prevalence, incidence, or clearance of anal HPV infection, (2) prevalence of anal cytological or histological neoplastic abnormalities, or (3) incidence or risk of anal cancer. Thirty-seven publications addressing anal HPV infection and anal cytology remained after applying selection criteria, and 23 anal cancer publications met the selection criteria. Among HIV-positive women, the prevalence of high-risk (HR)-HPV in the anus was 16-85%. Among HIV-negative women, the prevalence of anal HR-HPV infection ranged from 4% to 86%. The prevalence of anal HR-HPV in HIV-negative women with HPV-related pathology of the vulva, vagina, and cervix compared with women with no known HPV-related pathology, varied from 23% to 86% and from 5% to 22%, respectively. Histological anal high-grade squamous intraepithelial lesions (anal intraepithelial neoplasia 2 or greater) was found in 3-26% of the women living with HIV, 0-9% among women with lower genital tract pathology, and 0-3% for women who are HIV negative without known lower genital tract pathology. The incidence of anal cancer among HIV-infected women ranged from 3.9 to 30 per 100,000. Among women with a history of cervical cancer or cervical intraepithelial neoplasia 3, the incidence rates of anal cancer ranged from 0.8 to 63.8 per 100,000 person-years, and in the general population, the incidence rates ranged from 0.55 to 2.4 per 100,000 person-years. This review provides evidence that anal HPV infection and dysplasia are common in women, especially in those who are HIV positive or have a history of HPV-related lower genital tract pathology. The incidence of anal cancer continues to grow in all women, especially those living with HIV, despite the widespread use of combined antiretroviral therapy.
Topics: Antiretroviral Therapy, Highly Active; Anus Diseases; Anus Neoplasms; Carcinoma in Situ; Carcinoma, Squamous Cell; Coinfection; Female; HIV Infections; Humans; Incidence; Papillomavirus Infections; Prevalence; Proctitis
PubMed: 25797230
DOI: 10.1016/j.ajog.2015.03.034 -
International Journal of Environmental... Jul 2021Vulvar lichen sclerosus (VLS) is a chronic inflammatory condition affecting the anogenital region, which may present in a prepubertal or adolescent patient. The most...
Vulvar lichen sclerosus (VLS) is a chronic inflammatory condition affecting the anogenital region, which may present in a prepubertal or adolescent patient. The most popular theories are its autoimmune and genetic conditioning, although theories concerning hormonal and infectious etiology have also been raised. The most common presenting symptoms of VLS is vulva pruritus, discomfort, dysuria and constipation. In physical examination, a classic "Figure 8" pattern is described, involving the labia minora, clitoral hood, and perianal region. The lesions initially are white, flat-topped papules, thin plaques, or commonly atrophic patches. Purpura is a hallmark feature of VLS. The treatment includes topical anti-inflammatory agents and long-term follow-up, as there is a high risk of recurrence and an increased risk of vulvar cancer in adult women with a history of lichen sclerosus. This article reviews vulvar lichen sclerosus in children and provides evidence-based medicine principles for treatment in the pediatric population. A systematic search of the literature shows recurrence of VLS in children. Maintenance regimens deserve further consideration.
Topics: Adolescent; Adult; Anti-Inflammatory Agents; Child; Female; Humans; Lichen Sclerosus et Atrophicus; Vulvar Diseases; Vulvar Lichen Sclerosus
PubMed: 34281089
DOI: 10.3390/ijerph18137153 -
PloS One 2015To systematically review previous studies and to evaluate the feasibility and safety of video endoscopic inguinal lymphadenectomy (VEIL) in vulvar cancer. (Review)
Review
OBJECTIVE
To systematically review previous studies and to evaluate the feasibility and safety of video endoscopic inguinal lymphadenectomy (VEIL) in vulvar cancer.
METHODS
We conducted a comprehensive review of studies published through September 2014 to retrieve all relevant articles. The PubMed, EMBASE, Web of Science, Cochrane Library, Wan Fang Data and Chinese National Knowledge Infrastructure databases were systematically searched for all relevant studies published in English or Chinese through September 2014. Data were abstracted independently by two reviewers, and any differences were resolved by consensus.
RESULTS
A total of 9 studies containing 249 VEIL procedures involving 138 patients were reviewed. Of the 249 VEIL procedures, only 1 (0.4%) was converted to an open procedure for suturing because of injury to the femoral vein. The range of operative time was 62 to 110 minutes, and the range of estimated blood loss was 5.5 to 22 ml. The range of the number of harvested lymph nodes was 7.3 to 16. The length of hospital stay varied from 7 to 13.6 days across reports. The incidence of lymph node metastasis was 19.7% (27/138), and the recurrence rate was 4.3% (3/70) within 3 to 41 months of follow-up. One or more short-term complications were documented in 18 of 138 (13.0%) patients. Complications after VEIL were observed in 14 (10.13%) patients and in 15 (6.0%) of the VEIL cases, including major lymphocyst formation in 9 (3.6%), lymphorrhea in 2 (0.8%), inguinal wound infection without wound breakdown in 3 (1.2%) and lymphedema in 1 (0.4%).
CONCLUSIONS
VEIL appears to be a feasible procedure in the management of vulvar cancer. There may be potential benefits that result in lower morbidity compared to traditional methods, but this has yet to be objectively proven.
Topics: Bacterial Infections; Blood Loss, Surgical; Female; Humans; Length of Stay; Lymph Node Excision; Lymph Nodes; Lymphatic Metastasis; Lymphocele; Operative Time; Postoperative Complications; Treatment Outcome; Video-Assisted Surgery; Vulva; Vulvar Neoplasms
PubMed: 26496391
DOI: 10.1371/journal.pone.0140873 -
Cancers Feb 2021According to our systematic literature review (PRISMA guidelines), only 37 vulvar squamous cell carcinomas (VSCCs) were diagnosed during pregnancy (age range: 17-41... (Review)
Review
According to our systematic literature review (PRISMA guidelines), only 37 vulvar squamous cell carcinomas (VSCCs) were diagnosed during pregnancy (age range: 17-41 years). The tumor size range was 0.3-15 cm. The treatment was performed after (14/37, 38%), before (10/37, 27%), or before-and-after delivery (11/37, 30%). We found that 21/37 (57%) cases were stage I, 2 II (5%), 11 III (30%), and 3 IVB (8%). HPV-related features (condylomas/warts; HPV infection; high-grade squamous intraepithelial lesion) were reported in 11/37 (30%) cases. We also found that 9/37 (24%) patients had inflammatory conditions (lichen sclerosus/planus, psoriasis, chronic dermatitis). The time-to-recurrence/progression (12/37, 32%) ranged from 0 to 36 (mean 9) months. Eight women died of disease (22%) 2.5-48 months after diagnosis, 2 (5%) were alive with disease, and 23 (62%) were disease-free at the end of follow-up. Pregnant patients must be followed-up. Even if they are small, newly arising vulvar lesions should be biopsied, especially in women with risk factors (HPV, dermatosis, etc.). The treatment of VSCCs diagnosed in late third trimester might be delayed until postpartum. Elective cesarean section may prevent vulvar wound dehiscence. In the few reported cases, pregnancy/fetal outcomes seemed to not be affected by invasive treatments during pregnancy. However, clinicians must be careful; larger cohorts should define the best treatment. Definite guidelines are lacking, so a multidisciplinary approach and discussion with patients are mandatory.
PubMed: 33671249
DOI: 10.3390/cancers13040836 -
International Journal of Molecular... Nov 2022Lichen sclerosus (LS) is defined as a chronic mucocutaneous inflammatory disease with a localization predominantly to the anus and genitals (vulvar sclerosus (VLS)).... (Review)
Review
Lichen sclerosus (LS) is defined as a chronic mucocutaneous inflammatory disease with a localization predominantly to the anus and genitals (vulvar sclerosus (VLS)). Pediatric lichen sclerosus (LS) is a chronic inflammatory skin condition with predilection for the anogenital area that if untreated can lead to scarring. Vulvar LS is characterized by two peaks in incidence: it occurs in prepubertal girls and in postmenopausal women. To date, several mechanisms and risk factors have been proposed in the pathogenesis of pediatric vulvar LS; however, the etiology of this condition is still not fully understood and constitutes a challenge for scientists and clinicians. The presented research aimed to systematically review the existing literature on the pathogenesis of pediatric LS and to identify possible underlying autoimmune mechanisms and molecular networks. The clinical presentation of pediatric lichen sclerosus and available treatment modalities are also presented to acquaint a broader audience with this underdiagnosed and undertreated condition. As a result of our review, we discuss several potential mechanisms, molecules, and pathways that have been recognized in this disease. The purpose of our review was also to summarize what we can induce in further studies, which will ultimately help to identify the mechanism responsible for the disease and aid in the development of new, more effective treatment strategies for diagnosis and treatment by clinicians and researchers.
Topics: Humans; Female; Child; Lichen Sclerosus et Atrophicus; Vulva; Immune System Diseases; Genitalia; Treatment Outcome
PubMed: 36430687
DOI: 10.3390/ijms232214212 -
Journal of Clinical Medicine Jun 2023The most important causative agent of neoplasms in the anogenital area is the human papillomavirus (HPV). Due to the anatomical proximity of the genital and anus area... (Review)
Review
BACKGROUND
The most important causative agent of neoplasms in the anogenital area is the human papillomavirus (HPV). Due to the anatomical proximity of the genital and anus area and the ease with which HPV infection is transmitted, it seems that patients after the treatment of HPV-related gynecological diseases may have an increased risk of developing a second HPV-related neoplasm anal cancer. The aim of this study was to determine the risk of anal intraepithelial neoplasia (AIN) and anal cancer (AC) among patients after the treatment of HPV-related gynecological diseases.
METHODS
We conducted a comprehensive review of the available literature from multiple databases. The study was performed following and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2009 guidelines. Moreover, we assessed the quality of each study using QUADAS-2.
RESULTS
Twenty-five studies were included in the final analysis. Patients after the treatment of HPV-related gynecological diseases have a significantly higher risk of AC (mean standardized incidence ratio (SIR) = 5.387, mean incidence risk (IR) = 0.096%, mean IR per 100,000 person-years = 10.37) and AIN (mean IR = 23.683%) compared to the population risk.
CONCLUSIONS
patients with HPV-related gynecological diseases should constitute a group for which an appropriate primary and secondary screening for AC should be introduced.
PubMed: 37445251
DOI: 10.3390/jcm12134216