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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 -
Clinical Hematology International Sep 2019Female recipients of hematopoietic cell transplant (HCT) may develop lower genital tract (LGT) dysplasia or new malignancies. A comprehensive systematic review to... (Review)
Review
Female recipients of hematopoietic cell transplant (HCT) may develop lower genital tract (LGT) dysplasia or new malignancies. A comprehensive systematic review to delineate the occurrence and risk factors for post-HCT LGT precancer and cancer in women was conducted via electronic search of the Cochrane Library, PubMed, Embase, Wiley Online Library, from 1990 to 2018. All studies on the risk, presentation, or incidence of LGT (cervix, vulva, vagina) precancer or cancer post-HCT were included. Reviews, case reports, meta-analysis, book chapters, and studies without the relevant clinical outcomes were excluded. Post-HCT incidence and risk factors for developing LGT precancer or cancer were assessed and determined. Twenty-two out of the original 344 studies met the selection criteria. The risk of LGT cancers in allo-HCT recipients was found to be significantly higher than in the general population, with the standardized incidence ratios of 1.5-48 for cervical cancer and from 19 to 287 for dysplasia. Our review portrays an increased risk of premalignant and malignant neoplasms of female LGT, which have an incompletely described epidemiology and outcomes. Similar to other immunocompromised states, HCT recipients require specific cervical screening guidelines and can greatly benefit from HPV vaccinations. However, there is a lack of prospective data regarding optimum cervical screening in HCT recipients and limited programs offer HPV vaccinations worldwide.
PubMed: 34595424
DOI: 10.2991/chi.d.190519.001 -
The Cochrane Database of Systematic... Nov 2014Groin dissection is commonly performed for the treatment of a variety of cancers, including melanoma, and squamous cell carcinoma of the skin, penis or vulva. It is... (Review)
Review
BACKGROUND
Groin dissection is commonly performed for the treatment of a variety of cancers, including melanoma, and squamous cell carcinoma of the skin, penis or vulva. It is uncertain whether insertion of a drain reduces complication rates, and, if used, the optimum time for drain removal after surgery is also unknown.
OBJECTIVES
To assess the current level of evidence to determine whether placement of a drain is beneficial after groin dissection in terms of reducing seroma, haematoma, wound dehiscence and wound infection rates, and to determine the optimal type and duration of drainage following groin dissection if it is shown to be beneficial.
SEARCH METHODS
In September 2014 we searched the following electronic databases using a pre-designed search strategy: the Cochrane Wounds Group Specialised Register; The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library). In November 2013 we searched Ovid MEDLINE; Ovid MEDLINE (In-Process & Other Non-Indexed Citations); Ovid EMBASE and EBSCO CINAHL. We did not restrict the search and study selection with respect to language, date of publication or study setting.
SELECTION CRITERIA
We considered all randomised controlled trials (RCTs) comparing wound drainage with no wound drainage in individuals undergoing groin dissection, where the most superior node excised was Cloquet's node (the most superior inguinal lymph node). No limits were applied to language of publication or trial location. Two review authors independently determined the eligibility of each trial.
DATA COLLECTION AND ANALYSIS
Two review authors, working independently, screened studies identified from the search; there were no disagreements.
MAIN RESULTS
We did not identify any RCTs that met the inclusion criteria for the review.
AUTHORS' CONCLUSIONS
There is a need for high quality RCTs to guide clinical practice in this under-researched area.
Topics: Adult; Drainage; Groin; Humans; Lymph Node Excision; Neoplasms
PubMed: 25387103
DOI: 10.1002/14651858.CD010933.pub2 -
Plastic and Reconstructive Surgery.... Jan 2021Tissue expansion is a versatile reconstructive technique providing well-vascularized local tissue. The current literature focuses largely on tissue expansion for breast...
BACKGROUND
Tissue expansion is a versatile reconstructive technique providing well-vascularized local tissue. The current literature focuses largely on tissue expansion for breast reconstruction and in the context of burn and pediatric skin/soft tissue replacement; however, less traditional applications are also prevalent. The aim of this study was to systematically review the utilization of tissue expansion in such less well-characterized circumstances.
METHODS
The authors conducted a systematic review of all publications describing non-breast applications of tissue expansion. Variables regarding expander specifications, expansion process, and complications were collected and further analyzed.
RESULTS
A total of 565 publications were identified. Of these, 166 publications described tissue expansion for "less traditional" indications, which fell into 5 categories: ear reconstruction, cranioplasty, abdominal wall reconstruction, orthopedic procedures, and genital (penile/scrotal and vaginal/vulva) reconstruction. While lower extremity expansion is known to have high complication rates, tissue expander failure, infection, and exposure rates were in fact highest for penile/scrotal (failure: 18.5%; infection: 15.5%; exposure: 12.5%) and vaginal/vulva (failure: 20.6%; infection: 10.3%; exposure: 6.9%) reconstruction.
CONCLUSIONS
Tissue expansion enables index operations by providing additional skin before definitive reconstruction. Tissue expanders are a valuable option along the reconstructive ladder because they obviate the need for free tissue transfer. Although tissue expansion comes with inherent risk, aggregate outcome failures of the final reconstruction are similar to published rates of complications without pre-expansion. Thus, although tissue expansion requires a staged approach, it remains a valuable option in facilitating a variety of reconstructive procedures.
PubMed: 33564595
DOI: 10.1097/GOX.0000000000003378 -
International Journal of Gynaecology... May 2015Clitoral reconstruction is a new surgical technique for women who have undergone female genital mutilation/cutting (FGM/C). (Review)
Review
BACKGROUND
Clitoral reconstruction is a new surgical technique for women who have undergone female genital mutilation/cutting (FGM/C).
OBJECTIVES
To review evidence on the safety and efficacy of clitoral reconstruction.
SEARCH STRATEGY
PubMed and Cochrane databases were searched for articles published in any language from database inception until May 2014. Search terms related to FGM/C and clitoral reconstruction were used in various combinations.
SELECTION CRITERIA
Studies of any design that reported on safety or clinical outcomes (e.g. appearance, pain, sexual response, or patient satisfaction) associated with clitoral reconstruction after FGM/C were included.
DATA COLLECTION AND ANALYSIS
Evidence was summarized and systematically assessed via a standard data abstraction form.
MAIN RESULTS
Four of 269 identified articles were included. They were fair to poor in quality. Summary measures could not be computed owing to heterogeneity. The studies reported on immediate surgical complications, clitoral appearance, dyspareunia or chronic pain, and clitoral function postoperatively via non-standardized scales.
CONCLUSIONS
Women who request clitoral reconstruction should be informed about the scarcity of evidence available. Additional research is needed on the safety and efficacy of the procedure to identify both long-term outcomes and which women might benefit.
Topics: Circumcision, Female; Clitoris; Female; Gynecologic Surgical Procedures; Humans
PubMed: 25638712
DOI: 10.1016/j.ijgo.2014.11.008 -
Vaginal labiaplasty: current practices and a simplified classification system for labial protrusion.Plastic and Reconstructive Surgery Mar 2015Vaginal labiaplasty has been described for the management of functional and aesthetic problems associated with protrusion of the labia minora. Despite increasing numbers... (Review)
Review
BACKGROUND
Vaginal labiaplasty has been described for the management of functional and aesthetic problems associated with protrusion of the labia minora. Despite increasing numbers of procedures performed, there is a paucity of data to guide treatment paradigms. This systematic review aims to establish a simple, unifying classification scheme for labial protrusion and summarize current labiaplasty techniques and practices.
METHODS
A systematic literature review was performed using the PubMed database. Additional articles were selected after reviewing references of identified articles.
RESULTS
The search returned 247 articles. After applying inclusion criteria to identify prospective and retrospective studies evaluating different techniques, outcomes, complications, and patient satisfaction, 19 articles were selected. Labiaplasty of the labia minora was described in 1949 patients. Seven different surgical techniques were used for labiaplasty, including deepithelialization, direct excision, W-shaped resection, wedge resection, composite reduction, Z-plasty, and laser excision. Patient satisfaction rates for each technique ranged from 94 to 100 percent. The most common postoperative complication for all techniques was wound dehiscence (4.7 percent). Key areas for perioperative patient management were defined.
CONCLUSIONS
Labiaplasty is safe and carries a high satisfaction rate. However, current practices remain exceedingly diverse. The authors propose a simplified classification system based on the distance of the lateral edge of the labia minora from that of the labia majora, rather than from the introitus. Key areas for perioperative patient management include patient anesthesia, resection technique used, wound closure, and postoperative care. Further randomized studies using a standardized classification system are required to better compare different techniques and establish best practices.
Topics: Female; Humans; Hypertrophy; Plastic Surgery Procedures; Vulva; Vulvar Diseases
PubMed: 25719696
DOI: 10.1097/PRS.0000000000001000 -
Surgical Oncology Mar 2016Squamous cell carcinoma (SCC) of the vulva is the fourth most common gynecological cancer, usually staged with the TNM or FIGO systems. Since 2009, FIGO staging has... (Meta-Analysis)
Meta-Analysis Review
Squamous cell carcinoma (SCC) of the vulva is the fourth most common gynecological cancer, usually staged with the TNM or FIGO systems. Since 2009, FIGO staging has taken the extranodal extension (ENE) of lymph node metastases into account. ENE is defined as the spread of a lymph node metastasis into surrounding soft tissue. Although the TNM and FIGO systems acknowledge the importance of ENE in SCC, no comprehensive studies have analyzed the prognostic impact of this parameter. We therefore queried the PubMed and SCOPUS databases from their inception up until 04/01/2015, adopting no language restrictions: all prospective studies reporting on prognostic parameters in patients with vulvar SCC, and comparing participants with and without ENE were eligible for our analysis. Data were summarized using risk ratios (RR) for the number of deaths/recurrences and hazard ratios (HR) for the time-dependent risk related to ENE positivity, adjusting for potential confounders. Among 859 hits, 13 studies were found eligible and were included in our meta-analysis. Compared with ENE-negative (ENE-) cases, the ENE-positive (ENE+) patients had significantly higher rates of all-cause mortality (6 studies: RR = 3.18; 95%CI: 2.02-5.00, p < 0.0001, I(2) = 56%), cancer-specific mortality (3 studies: RR = 2.03; 95%CI: 1.12-3.69, p = 0.02, I(2) = 80%), and recurrence (4 studies: RR = 2.69, 95%CI: 1.61-3.76, p < 0.0001, I(2) = 57%). Using HRs after adjusting for potential confounders, ENE + carried a significantly higher risk of all-cause mortality (6 studies: HR = 3.08, 95%CI: 1.73-5.48, p < 0.0001, I(2) = 66%), and recurrence (5 studies: HR = 3.93, 95%CI: 2.33-6.62, p < 0.0001, I(2) = 28%). Our meta-analysis clarifies the prognostic significance of ENE in vulvar SCC, also pointing to its implications for gross sampling, histology and oncological staging.
Topics: Carcinoma, Squamous Cell; Female; Humans; Lymph Nodes; Prognosis; Vulvar Neoplasms
PubMed: 26394825
DOI: 10.1016/j.suronc.2015.09.005 -
Journal of Ethnopharmacology Feb 2024The genus Alchemilla L. (lady's mantle) comprises 1000 species, of which more than 300 have been characterized from Europe. Notably, as folk medicines, Alchemilla... (Review)
Review
ETHNOPHARMACOLOGICAL RELEVANCE
The genus Alchemilla L. (lady's mantle) comprises 1000 species, of which more than 300 have been characterized from Europe. Notably, as folk medicines, Alchemilla species have long been prescribed for the treatment of dysmenorrhea, pruritus vulvae, menopausal complaints, and related diseases in women. This review summarizes the traditional uses, highlights promising plant species, and focuses on phytochemical and biological studies to highlight future areas of research.
AIM OF THE REVIEW
This literature review aims to provide a comprehensive overview of Alchemilla species, covering their botany, traditional uses, phytochemistry, and biological and pharmacological activities, and to summarize the current research status to better understand the application value of Alchemilla plants in modern phytotherapy.
MATERIALS AND METHODS
The search strategy utilized the major thematic platforms Reaxys, Web of Science, Google Scholar, Scopus, ScienceDirect, PubMed, the USDA Plant Database and Kew Science (Royal Botanic Gardens) and was performed with the term Alchemilla. These platforms were systematically searched for articles published from 1960 to 2023.
RESULTS AND DISCUSSION
Alchemilla species, as members of the Rosaceae family, produce tannins, phenolic acids, flavonoids, anthocyanins, coumarins, triterpenes and violet compounds. Effort has been made with this comprehensive review of Alchemilla plants to highlight the recent developments and milestones achieved in modern phytochemistry and phytotherapy, underlaying a broad spectrum of the activities of these plants, such as antioxidant, anti-inflammatory, neuroprotective, antimicrobial, antiobesity, cardiovascular, anticancer, and wound healing effects.
CONCLUSIONS
An increasing number of studies on the plants in the Alchemilla genus have provided data about the main constituents and their importance in modern medicine. Both in vitro and in vivo studies have indicated that Alchemilla plants possess an extensive spectrum of biological activities. Regardless of the remarkable medical potential of Alchemilla extracts, clinical studies are limited and need to be performed to produce safer and less expensive plant-based drugs.
Topics: Female; Humans; Ethnopharmacology; Plants, Medicinal; Alchemilla; Rosaceae; Anthocyanins; Phytotherapy; Plant Extracts; Phytochemicals
PubMed: 37981119
DOI: 10.1016/j.jep.2023.117439 -
Journal of the American Academy of... May 2023
Topics: Female; Humans; Vulva; Vulvar Lichen Sclerosus; Laser Therapy; Vulvar Neoplasms; Carcinoma in Situ; Precancerous Conditions; Lichen Sclerosus et Atrophicus
PubMed: 36639033
DOI: 10.1016/j.jaad.2023.01.003 -
International Journal of Gynaecology... Feb 2017Vulvar and clitoral pain are known complications of female genital mutilation (FGM). Several interventions have been used to treat these conditions. This review focuses... (Review)
Review
BACKGROUND
Vulvar and clitoral pain are known complications of female genital mutilation (FGM). Several interventions have been used to treat these conditions. This review focuses on surgical and nonsurgical interventions to improve vulvar and clitoral pain in women living with FGM.
OBJECTIVE
To evaluate the impact of nonsurgical and surgical interventions for alleviating vulvar and clitoral pain in women living with any type of FGM and to assess the associated adverse events.
SEARCH STRATEGY
The search included the following major databases: Cochrane Central Register for Controlled Trials (CENTRAL), MEDLINE, Scopus, Web of Science, and ClinicalTrials.gov. These were searched from inception until August 10, 2015 without any language restrictions.
SELECTION CRITERIA
Study designs included randomized controlled trials, cluster randomized trials, nonrandomized trials, cohort studies, case-control studies, controlled before-and-after studies, historical control studies, and interrupted time series with reported data comparing outcomes among women with FGM who were treated for clitoral or vulvar pain with either surgical or nonsurgical interventions.
DATA COLLECTION AND ANALYSIS
Two team members independently screened studies for eligibility.
RESULTS
No studies were included.
CONCLUSION
Limited information exists on management of vulvar and clitoral pain in women living with FGM. This constitutes an important area for further research.
PROSPERO REGISTRATION
CRD42015024521.
Topics: Adolescent; Adult; Analgesics; Child; Chronic Pain; Circumcision, Female; Clitoris; Cognitive Behavioral Therapy; Counseling; Female; Humans; Pain Management; Randomized Controlled Trials as Topic; Vulvodynia
PubMed: 28164286
DOI: 10.1002/ijgo.12048