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Expert Review of Vaccines Nov 2019: Safety and efficacy of prophylactic HPV vaccines against HPV infection and associated cervical cancers and precursors is well documented in the literature; however,...
: Safety and efficacy of prophylactic HPV vaccines against HPV infection and associated cervical cancers and precursors is well documented in the literature; however, their efficacy against vulval and vaginal endpoints has not been previously assessed.: Published results of trials involving licensed HPV vaccines were included. Main efficacy outcomes were histologically confirmed high-grade vulval and vaginal precancer distinguishing those associated with vaccine HPV types and any vulval and vaginal precancerous lesions. Exposure groups included women aged 15-26 or 24-45 years being initially negative for high-risk HPV (hrHPV), negative for the HPV vaccine types, and women unselected by HPV status.: Our results show that the HPV vaccines are equally highly efficacious against vulval/vaginal disease as previously noted for cervical disease. The vaccines demonstrated excellent protection against high-grade vulval and vaginal lesions caused by vaccine-related HPV types among young women who were not initially infected with hrHPV types or types included in the vaccines (vaccine efficacies more than 90%). No protection against high-grade vulval and vaginal lesions associated with HPV16/18 was observed for mid-adult women. Trials were not powered to address protection against invasive cancers.
Topics: Adolescent; Adult; Female; Humans; Middle Aged; Papillomavirus Infections; Papillomavirus Vaccines; Precancerous Conditions; Treatment Outcome; Vaginal Neoplasms; Vulvar Neoplasms; Young Adult
PubMed: 31718338
DOI: 10.1080/14760584.2019.1692658 -
BMC Cancer Jun 2019Human papilloma virus (HPV) associated cervical cancer remains a global concern particular, in Sub-Saharan Africa (SSA) where the impact is felt most. Evidence show that...
BACKGROUND
Human papilloma virus (HPV) associated cervical cancer remains a global concern particular, in Sub-Saharan Africa (SSA) where the impact is felt most. Evidence show that many other cancers such as vaginal, anal, oropharyngeal, penile are because of persistent infection with HPV especially, high-risk types.
AIM
We mapped evidence on the incidence, prevalence, mortality, and the trends of human papillomavirus-related cancers in SSA.
METHODS
A comprehensive literature search was conducted from several databases including PubMed, Google scholar, Science Direct, and CINAHL and MEDLINE via EBSCOhost as well as World Health Organization website for grey literature. Studies reporting HPV-related cancers in SSA outcomes including prevalence, incidence, mortality, and trends were included in this study. The risk of bias of the included studies were assessed using the mixed methods appraisal tool version 2011. We employed PRISMA (preferred reporting items for systematic reviews and meta-analyses) to report the search results. Thematic analysis used to reveal the emerging themes from the included studies.
RESULTS
Seventy-four (74) studies were retrieved at full article screening, eight of them (six reviews, and two quantitative study) were eligible for data extraction. The degree of agreement between the two independent reviewers following full article screening, was 86.49% agreement versus 64.57% likely by chance which constituted moderate to significant agreement (Kappa statistic = 0.62, p-value< 0.05). Of the eight included studies, four (50%) studies generalized about SSA with no country of interest; two (25%) studies were conducted in Nigeria; one (12.5%) reported about Uganda, Zambia, Guinea, Malawi Tanzania, Mali, Mozambique, Zimbabwe; and one (12.5%) reported about Ethiopia, Senegal, Zimbabwe and Uganda. These eight included studies reported evidence on more than one outcome of interest. Four studies reported about the prevalence of HPV-related cancers, seven studies reported about the incidence, four studies reported about mortality, and four studies reported about the trends of HPV-related cancers.
CONCLUSION
This study observation highlighted a gap of knowledge regarding the epidemiological data on the recent HPV prevalence in SSA, which will have a potential impact in determining the distribution of HPV on different body sites (cervix, penis, vagina, vulva, anus and oropharynx). Ongoing research projects are recommended in SSA to enhance the value of HPV, and HPV-associated cancers epidemiological data to inform strategies or/and policies on prevention, diagnosis, and treatment of HPV-related conditions.
Topics: Africa South of the Sahara; Anus Neoplasms; Female; Humans; Incidence; Male; Oropharyngeal Neoplasms; Papillomaviridae; Papillomavirus Infections; Penile Neoplasms; Prevalence; Uterine Cervical Neoplasms; Vaginal Neoplasms
PubMed: 31185951
DOI: 10.1186/s12885-019-5781-3 -
Gynecologic Oncology Mar 2018In patients treated for early-stage squamous cell vulvar carcinoma local recurrence is reported in up to 40% after ten years. Knowledge on prognostic factors related to... (Review)
Review
BACKGROUND
In patients treated for early-stage squamous cell vulvar carcinoma local recurrence is reported in up to 40% after ten years. Knowledge on prognostic factors related to local recurrences should be helpful to select high risk patients and/or to develop strategies to prevent local recurrences.
OBJECTIVE
This systematic review aims to evaluate the current knowledge on the incidence of local recurrences in vulvar carcinoma related to clinicopathologic and cell biologic variables.
DATA SOURCES
Relevant studies were identified by an extensive online electronic search in July 2017.
STUDY ELIGIBILITY CRITERIA
Studies reporting prognostic factors specific for local recurrences of vulvar carcinoma were included.
STUDY APPRAISAL AND SYNTHESIS METHODS
Two review authors independently performed data selection, extraction and assessment of study quality. The risk difference was calculated for each prognostic factor when described in two or more studies.
RESULTS
Twenty-two studies were included; most of all were retrospective and mainly reported pathologic prognostic factors. Our review indicates an estimated annual local recurrence rate of 4% without plateauing. The prognostic relevance for local recurrence of vulvar carcinoma of all analyzed variables remains equivocal, including pathologic tumor free margin distance <8mm, presence of lichen sclerosus, groin lymph node metastases and a variety of primary tumor characteristics (grade of differentiation, tumor size, tumor focality, depth of invasion, lymphovascular space invasion, tumor localization and presence of human papillomavirus).
CONCLUSIONS
Current quality of data on prognostic factors for local recurrences in vulvar carcinoma patients does not allow evidence-based clinical decision making. Further research on prognostic factors, applying state of the art methodology is needed to identify high-risk patients and to develop alternative primary and secondary prevention strategies.
Topics: Carcinoma, Squamous Cell; Female; Groin; Gynecologic Surgical Procedures; Humans; Lymph Nodes; Lymphatic Metastasis; Margins of Excision; Neoplasm Grading; Neoplasm Invasiveness; Neoplasm Recurrence, Local; Neoplasm Staging; Papillomavirus Infections; Prognosis; Risk Factors; Vulvar Lichen Sclerosus; Vulvar Neoplasms
PubMed: 29137809
DOI: 10.1016/j.ygyno.2017.11.006 -
International Journal of Cancer Sep 2017In this updated systematic review and meta-analysis, we estimate the pooled prevalence of human papillomavirus (HPV) DNA and HPV type distribution in squamous cell... (Meta-Analysis)
Meta-Analysis Review
In this updated systematic review and meta-analysis, we estimate the pooled prevalence of human papillomavirus (HPV) DNA and HPV type distribution in squamous cell carcinoma of the vulva (vulvar cancer) and vulvar intraepithelial neoplasia (VIN). PubMed, Embase and Cochrane Library databases were used to identify studies published between 1990 and 2015 and using a PCR-based or hybrid capture test to evaluate the presence of HPV DNA in vulvar cancer or VIN. Pooled estimates of the HPV prevalence with corresponding 95% confidence intervals (CI) were calculated based on a random effects model. The I statistic was used to describe the amount of heterogeneity. In meta-regression analyses, potential sources of heterogeneity were evaluated. We identified 92 eligible papers, comprising altogether 5,015 cases of vulvar cancer (64 papers) and 2,764 cases of VIN (48 papers). The pooled prevalence of HPV in vulvar cancer was 39.7% (95% CI: 35.1-44.4%). Overall, 76.3% (95% CI: 70.1-82.1%) of VIN lesions tested HPV-positive, while the HPV prevalence in new subcategories of VIN, uVIN and dVIN, was 86.2% (95% CI: 73.5-95.5%) and 2.0% (95% CI: 0-10.0%), respectively. Substantial between-study heterogeneity was observed (vulvar cancer: I = 88.4%; VIN: I = 90.7%) with the largest variation between geographical regions. Among HPV-positive cases, the predominant high-risk HPV type was HPV16, followed by HPV33 and HPV18. HPV6 was detected as a single infection in a small subset of VIN and vulvar cancer samples. Thus, HPV vaccination targeting these HPV types may prevent a substantial number of vulvar lesions.
Topics: Carcinoma in Situ; Carcinoma, Squamous Cell; DNA, Viral; Europe; Female; Genotype; Humans; North America; Papillomaviridae; Papillomavirus Infections; Prevalence; Vulvar Neoplasms
PubMed: 28577297
DOI: 10.1002/ijc.30821 -
International Journal of Gynaecology... Feb 2017Women and girls who have undergone type III female genital mutilation (FGM) may suffer urologic complications such as recurrent urinary tract infections, obstruction,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Women and girls who have undergone type III female genital mutilation (FGM) may suffer urologic complications such as recurrent urinary tract infections, obstruction, stones, and incontinence.
OBJECTIVE
To assess the effectiveness of deinfibulation for preventing and treating urologic complications in women and girls living with FGM.
SEARCH STRATEGY
The following major databases were searched from inception to August 2015: Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, SCOPUS, Web of Science, and ClinicalTrials.gov without language restrictions.
SELECTION CRITERIA
Randomized controlled studies (RCTs) or observational studies with controls were considered.
DATA COLLECTION AND ANALYSIS
We screened the results of the search independently for potentially relevant studies and applied inclusion and exclusion criteria for the full texts of the relevant studies.
RESULTS
No RCTs were found. We found three case reports and a retrospective case review, all of which were excluded.
CONCLUSION
There is no evidence on the use of deinfibulation to improve urologic complications among women with type III FGM. Current clinical practice may be informed by anecdotal evidence from case reports. Appropriate RCTs and observational studies with comparison groups in countries where FGM is common are needed. PROSPERO registration: CRD42015024901.
Topics: Anti-Bacterial Agents; Catheterization; Cicatrix; Circumcision, Female; Female; Humans; Reoperation; Urinary Calculi; Urinary Incontinence; Urinary Tract Infections; Vulva
PubMed: 28164295
DOI: 10.1002/ijgo.12045 -
Gynecologic Oncology Feb 2017Treatment of locally advanced vulva cancer (LAVC) remains challenging. Due to the lack of randomised trials many questions regarding the indications for different... (Review)
Review
Locally advanced vulva cancer: A single centre review of anovulvectomy and a systematic review of surgical, chemotherapy and radiotherapy alternatives. Is an international collaborative RCT destined for the "too difficult to do" box?
INTRODUCTION
Treatment of locally advanced vulva cancer (LAVC) remains challenging. Due to the lack of randomised trials many questions regarding the indications for different treatment options and their efficacy remain unanswered.
METHODS
In this retrospective study we provide the largest published series of LAVC patients treated with anovulvectomy, reporting oncological outcomes and morbidity. Additionally, a systematic literature review was performed for all treatment options 1946-2015.
RESULTS
In our case series, 57/70 (81%) patients were treated in the primary setting with anovulvectomy and 13 patients underwent anovulvectomy for recurrent disease. The median overall survival (OS) was 69months (1-336) with disease specific survival of 159months (1-336). Following anovulvectomy for primary disease, time to progression and OS were significantly higher in node negative disease (10 vs. 96months; 19 vs. 121months, p<0.0001). Post-surgical complications were observed in 36 (51.4%), the majority of which were Grade I/II infections. There was one peri-operative death. Review of the literature showed that chemotherapy, radiotherapy or combination treatments are alternatives to surgery. Evidence relating to all of these consisted mostly of small retrospective series, which varied considerably in terms of patient characteristics and treatment schedules. Significant patient and treatment heterogeneity prevented meta-analysis with significant biases in these studies. It was unclear if survival or morbidity was better in any one group with a lack of data reporting complications, quality of life, and long term follow-up. However, results for chemoradiation are encouraging enough to warrant further investigation.
CONCLUSIONS
There remains inadequate evidence to identify an optimal treatment for LAVC. However, there is sufficient evidence to support a trial of anovulvectomy versus chemoradiation. Discussions and consensus would be needed to determine trial criteria including the primary outcome measure. Neoadjuvant chemotherapy or radiotherapy alone may be best reserved for the palliative setting or metastatic disease.
Topics: Adult; Aged; Aged, 80 and over; Chemoradiotherapy; Female; Humans; Intersectoral Collaboration; Middle Aged; Randomized Controlled Trials as Topic; Retrospective Studies; Vulva; Vulvar Neoplasms
PubMed: 28034465
DOI: 10.1016/j.ygyno.2016.12.007 -
Medical and surgical interventions for the treatment of usual-type vulval intraepithelial neoplasia.The Cochrane Database of Systematic... Jan 2016Usual-type vulval intraepithelial neoplasia (uVIN) is a pre-cancerous condition of the vulval skin. Also known as high-grade VIN, VIN 2/3 or high-grade vulval squamous... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Usual-type vulval intraepithelial neoplasia (uVIN) is a pre-cancerous condition of the vulval skin. Also known as high-grade VIN, VIN 2/3 or high-grade vulval squamous intraepithelial lesion (HSIL), uVIN is associated with high-risk subtype human papilloma virus (HPV) infection. The condition causes distressing vulval symptoms in the majority of affected women and may progress to vulval cancer, therefore is usually actively managed. There is no consensus on the optimal management of uVIN. High morbidity and recurrence rates associated with surgical treatments make less invasive treatments highly desirable.
OBJECTIVES
To determine which interventions are the most effective, safe and tolerable for treating women with uVIN.
SEARCH METHODS
We searched the Cochrane Gynaecological Cancer Group Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL), Issue 8 2015, MEDLINE and EMBASE (up to 1 September 2015). 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 and surgical interventions in women with uVIN. If no RCTs were available, we included non-randomised studies (NRSs) with concurrent comparison groups that controlled for baseline case mix in multivariate analysis.
DATA COLLECTION AND ANALYSIS
We used Cochrane methodology with two review authors independently extracting data and assessing risk of bias. Where possible, we synthesised data in meta-analyses using random-effects methods. Network meta-analysis was not possible due to insufficient data.
MAIN RESULTS
We included six RCTs involving 327 women and five NRSs involving 648 women. The condition was variously named by investigators as uVIN, VIN2/3 or high-grade VIN. Five RCTs evaluated medical treatments (imiquimod, cidofovir, indole-3 carbinol), and six studies (one RCT and five NRSs) evaluated surgical treatments or photodynamic therapy. We judged two RCTs and four NRSs to be at a high or unclear risk of bias; we considered the others at relatively low risk of bias. Types of outcome measures reported in NRSs varied and we were unable to pool NRS data. Medical interventions: Topical imiquimod was more effective than placebo in achieving a response (complete or partial) to treatment at five to six months post-randomisation (three RCTs, 104 women; risk ratio (RR) 11.95, 95% confidence interval (CI) 3.21 to 44.51; high-quality evidence). At five to six months, a complete response occurred in 36/62 (58%) and 0/42 (0%) women in the imiquimod and placebo groups, respectively (RR 14.40, 95% CI 2.97 to 69.80). Moderate-quality evidence suggested that the complete response was sustained at one year (one RCT, nine complete responses out of 52 women (38%)) and beyond, particularly in women with smaller VIN lesions. Histologically confirmed complete response rates with imiquimod versus cidofovir at six months were 45% (41/91) and 46% (41/89), respectively (one RCT, 180 women; RR 1.00, 95% CI 0.73 to 1.37; moderate-quality evidence). Twelve-month data from this trial are awaited; however, interim findings suggested that complete responses were sustained at 12 months. Only one trial reported vulval cancer at one year (1/24 and 2/23 in imiquimod and placebo groups, respectively). Adverse events were more common with imiquimod than placebo and dose reductions occurred more frequently in the imiquimod group than in the placebo group (two RCTs, 83 women; RR 7.77, 95% CI 1.61 to 37.36; high-quality evidence). Headache, fatigue and discontinuation were slightly more common with imiquimod than cidofovir (moderate-quality evidence). Quality of life scores reported in one trial (52 women) were not significantly different for imiquimod and placebo. The evidence of effectiveness of topical treatments in immunosuppressed women was scant. There was insufficient evidence on other medical interventions. Surgical and other interventions: Low-quality evidence from the best included NRS indicated, when data were adjusted for confounders, that there was little difference in the risk of VIN recurrence between surgical excision and laser vaporisation. Recurrence occurred in 51% (37/70) of women overall, at a median of 14 months, and was more common in multifocal than unifocal lesions (66% versus 34%). Vulval cancer occurred in 11 women (15.1%) overall at a median of 71.5 months (9 to 259 months). The risk of vulval cancer did not differ significantly between excision and laser vaporisation in any of the NRSs; however, events were too few for robust findings. Alternative surgical procedures that might be as effective include Cavitron ultrasonic surgical aspiration (CUSA) and loop electrosurgical excision (LEEP) procedures, based on low- to very low-quality evidence, respectively. Very low-quality evidence also suggested that photodynamic therapy may be a useful treatment option.We found one ongoing RCT of medical treatment (imiquimod) compared with surgical treatment.
AUTHORS' CONCLUSIONS
Topical treatment (imiquimod or cidofovir) may effectively treat about half of uVIN cases after a 16-week course of treatment, but the evidence on whether this effect is sustained is limited. Factors predicting response to treatment are not clear, but small lesions may be more likely to respond. The relative risk of progression to vulval cancer is uncertain. However, imiquimod and cidofovir appear to be relatively well tolerated and may be favoured by some women over primary surgical treatment.There is currently no evidence on how medical treatment compares with surgical treatment. Women who undergo surgical treatment for uVIN have about a 50% chance of the condition recurring one year later, irrespective of whether treatment is by surgical excision or laser vaporisation. Multifocal uVIN lesions are at a higher risk of recurrence and progression, and pose greater therapeutic dilemmas than unifocal lesions. If occult cancer is suspected despite a biopsy diagnosis of uVIN, surgical excision remains the treatment of choice. If occult cancer is not a concern, treatment needs to be individualised to take into account the site and extent of disease, and a woman's preferences. Combined modalities may hold the key to optimal treatment of this complex disease.
Topics: Adult; Aminoquinolines; Antineoplastic Agents; Carcinoma in Situ; Cidofovir; Cytosine; Disease Progression; Female; Humans; Imiquimod; Indoles; Laser Therapy; Neoplasm Recurrence, Local; Organophosphonates; Photochemotherapy; Prospective Studies; Randomized Controlled Trials as Topic; Retrospective Studies; Treatment Outcome; Vulvar Neoplasms
PubMed: 26728940
DOI: 10.1002/14651858.CD011837.pub2 -
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 -
The Cochrane Database of Systematic... Aug 2015This is an updated version of a review first published in theCochrane Database of Systematic Reviews, Issue 4, in 2011. Vulval intraepithelial neoplasia (VIN) is a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
This is an updated version of a review first published in theCochrane Database of Systematic Reviews, Issue 4, in 2011. Vulval intraepithelial neoplasia (VIN) is a pre-cancerous condition of the vulval skin and its incidence is increasing in women under 50 years. High-grade VIN (also called usual-type VIN (uVIN) or VIN 2/3 or high-grade vulval intraepithelial lesion) is associated with human papilloma virus (HPV) infection and may progress to vulval cancer, therefore is usually actively managed. There is no consensus on the optimal management of high-grade VIN; and the high morbidity and relapse rates associated with surgical interventions make less invasive interventions highly desirable.
OBJECTIVES
To evaluate the effectiveness and safety of medical (non-surgical) 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 2015, Issue 3), MEDLINE and EMBASE (up to 30 March 2015). 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 non-surgical interventions in women diagnosed with high-grade VIN.
DATA COLLECTION AND ANALYSIS
We used Cochrane methodology with two review authors independently abstracting data and assessing risk of bias. Where possible, we synthesised data in meta-analyses using random effects methods.
MAIN RESULTS
Five trials involving 297 women with high-grade VIN (defined by trial investigators as VIN 2/3 or VIN 3 or 'high-grade' lesions) met our inclusion criteria: three trials assessed the effectiveness of topical imiquimod versus placebo; one assessed topical cidofovir versus topical imiquimod; and one assessed low- versus high-dose indole-3-carbinol in similar types of participants. Three trials were at a moderate to low risk of bias, two were at a potentially high risk of bias.Meta-analysis of the three trials comparing topical imiquimod 5% cream to placebo found that women in the active treatment group were more likely to show an overall response (complete and partial response) to treatment at five to six months compared with the placebo group (Risk Ratio (RR) 11.95, 95% confidence interval (CI) 3.21 to 44.51; participants = 104; studies = 3; I(2) = 0%; high-quality evidence). A complete response at five to six months occurred in 36/62 (58%) and 0/42 (0%) participants in the active and placebo groups, respectively (RR 14.40, 95% CI 2.97 to 69.80; participants = 104; studies = 3; I(2) = 0%). A single trial reported 12-month follow-up, which revealed a sustained effect in overall response in favour of the active treatment arm at 12 months (RR 9.10, 95% CI 2.38 to 34.77; moderate-quality evidence), with 9/24 (38%) and 0/23 (0%) complete responses recorded in the active and placebo groups respectively. Progression to vulval cancer was also documented in this trial (one versus two participants in the active and placebo groups, respectively) and we assessed this evidence as low-quality. Only one trial reported adverse events, including erythema, erosion, pain and pruritis at the site of the lesion, which were more common in the imiquimod group. Dose reductions occurred more frequently in the active treatment group compared with the placebo group (19/47 versus 1/36 participants; RR 7.77, 95% CI 1.61 to 37.36; participants = 83; studies = 2; I(2) = 0%; high-quality evidence). Only one trial reported quality of life (QoL) and there were no significant differences between the imiquimod and placebo groups.For the imiquimod versus cidofovir trial, 180 women contributed data. The overall response at six months was similar for the imiquimod and cidofovir treatment groups with 52/91 (57%) versus 55/89 (62%) participants responding, respectively (RR 0.92, 95% CI 0.73 to 1.18). A complete response occurred in 41 women in each group (45% and 46%, respectively; RR 1.00, 95% CI 0.73 to 1.37). Although not statistically different, total adverse events were slightly more common in the imiquimod group of this trial with slightly more discontinuations occurring in this group. Longer term response data from this trial are expected.The small trial comparing two doses of indole-3-carbinol contributed limited data. We identified five ongoing randomised trials of various interventions for VIN.
AUTHORS' CONCLUSIONS
Topical imiquimod appears to be a safe and effective treatment for high-grade VIN (uVIN), even though local side-effects may necessitate dose reductions. However, longer term follow-up data are needed to corroborate the limited evidence that response to treatment is sustained, and to assess any effect on progression to vulval cancer. Available evidence suggests that topical cidofovir may be a good alternative to imiquimod; however, more evidence is needed, particularly regarding the relative effectiveness on longer term response and progression. We await the longer-term response data and the results of the five ongoing trials.
Topics: Administration, Topical; Adult; Aminoquinolines; Anticarcinogenic Agents; Antineoplastic Agents; Carcinoma in Situ; Cidofovir; Cytosine; Female; Humans; Imiquimod; Indoles; Organophosphonates; Randomized Controlled Trials as Topic; Vulvar Neoplasms
PubMed: 26284429
DOI: 10.1002/14651858.CD007924.pub3 -
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