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The Cochrane Database of Systematic... Feb 2014Cancer is a leading cause of death worldwide. Gynaecological cancers (i.e. cancers affecting the ovaries, uterus, cervix, vulva and vagina) are among the most common... (Review)
Review
BACKGROUND
Cancer is a leading cause of death worldwide. Gynaecological cancers (i.e. cancers affecting the ovaries, uterus, cervix, vulva and vagina) are among the most common cancers in women. Unfortunately, given the nature of the disease, cancer can recur or progress in some patients. Although the management of early-stage cancers is relatively straightforward, with lower associated morbidity and mortality, the surgical management of advanced and recurrent cancers (including persistent or progressive cancers) is significantly more complicated, often requiring very extensive procedures. Pelvic exenterative surgery involves removal of some or all of the pelvic organs. Exenterative surgery for persistent or recurrent cancer after initial treatment is difficult and is usually associated with significant perioperative morbidity and mortality. However, it provides women with a chance of cure that otherwise may not be possible. In carefully selected patients, it may also have a place in palliation of symptoms. The biology of recurrent ovarian cancer differs from that of other gynaecological cancers; it is often responsive to chemotherapy and is not included in this review.
OBJECTIVES
To evaluate the effectiveness and safety of exenterative surgery versus other treatment modalities for women with recurrent gynaecological cancer, excluding recurrent ovarian cancer (this is covered in a separate review).
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE up to February 2013. We also searched registers of clinical trials, abstracts of scientific meetings and reference lists of clinical guidelines and review articles and contacted experts in the field.
SELECTION CRITERIA
Randomised controlled trials (RCTs) or non-randomised studies with concurrent comparison groups that included multivariate analyses of exenterative surgery versus medical management in women with recurrent gynaecological malignancies.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed whether potentially relevant studies met the inclusion criteria. No studies were found; therefore no data were analysed.
MAIN RESULTS
The search strategy identified 1311 unique references, of which seven were retrieved in full, as they appeared to be potentially relevant on the basis of title and abstract. However, all were excluded, as they did not meet the inclusion criteria of the review.
AUTHORS' CONCLUSIONS
We found no evidence to inform decisions about exenterative surgery for women with recurrent cervical, endometrial, vaginal or vulvar malignancies. Ideally, a large RCT or, at the very least, well-designed non-randomised studies that use multivariate analysis to adjust for baseline imbalances are needed to compare exenterative surgery versus medical management, including palliative care.
Topics: Adult; Female; Genital Neoplasms, Female; Humans; Neoplasm Recurrence, Local; Pelvic Exenteration
PubMed: 24497188
DOI: 10.1002/14651858.CD010449.pub2 -
The Cochrane Database of Systematic... May 2011Despite changes in technique, morbidity after surgery for vulvar cancer is high and mainly related to the groin dissection. Primary radiotherapy to the groin is expected... (Comparative Study)
Comparative Study Review
BACKGROUND
Despite changes in technique, morbidity after surgery for vulvar cancer is high and mainly related to the groin dissection. Primary radiotherapy to the groin is expected to result in lower morbidity. However, studies on the efficacy of primary radiotherapy to the groin in terms of groin recurrences and survival show conflicting results.
OBJECTIVES
To determine whether the effectiveness and safety of primary radiotherapy to the inguinofemoral lymph nodes in early vulvar cancer is comparable with surgery.
SEARCH STRATEGY
We searched The Cochrane Gynaecological Cancer Group Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE and EMBASE from 1966 to July 2010.
SELECTION CRITERIA
We selected randomised clinical trials (RCTs) comparing inguinofemoral lymph node dissection and primary radiotherapy of the inguinofemoral lymph nodes for patients with early squamous cell cancer of the vulva.
DATA COLLECTION AND ANALYSIS
Two reviewers independently assessed study quality and extracted results. Primary outcome measures were the incidence of groin recurrences, patient survival and morbidity.
MAIN RESULTS
No new RCTs were identified by the updated search. Out of twelve identified papers only one met the selection criteria. From this one small RCT of 52 women, there was a trend towards increased groin recurrence rates (relative risk (RR) 10.21, 95% confidence interval (CI) 0.59 to 175.78), lower disease-specific survival rates (RR 3.70, 95% CI 0.87 to 15.80), less lymphoedema (RR 0.06, 95% CI 0.00 to 1.03) and fewer life-threatening cardiovascular complications (RR 0.08, 95% CI 0.00 to 1.45) in the radiotherapy group. Primary surgery was associated with a longer hospital stay than primary groin irradiation (RR 0.28, 95% CI 0.13 to 0.58).
AUTHORS' CONCLUSIONS
Primary radiotherapy to the groin results in less morbidity but may be associated with a higher risk of groin recurrence and decreased survival when compared with surgery. Due to the small numbers in this trial and criticisms regarding the depth of radiotherapy applied, corroboration of these findings by larger RCTs using a standardised radiotherapy method, is desirable. However, until better evidence is available, surgery should be considered the first choice treatment for the groin nodes in women with vulvar cancer. Individual patients not physically able to withstand surgery may be treated with primary radiotherapy.
Topics: Carcinoma, Squamous Cell; Female; Humans; Inguinal Canal; Lymph Nodes; Neoplasm Recurrence, Local; Neoplasm Staging; Randomized Controlled Trials as Topic; Vulvar Neoplasms
PubMed: 21563133
DOI: 10.1002/14651858.CD002224.pub2 -
The Cochrane Database of Systematic... Apr 2011Vulval cancer is a rare gynaecological cancer. There is no standard approach for treating locally advanced primary vulval cancer (FIGO stage III and IV). Combined... (Review)
Review
BACKGROUND
Vulval cancer is a rare gynaecological cancer. There is no standard approach for treating locally advanced primary vulval cancer (FIGO stage III and IV). Combined treatment modalities have been developed using radiotherapy, chemotherapy and surgery. The advantages and disadvantages of such treatment is not well evaluated.
OBJECTIVES
To evaluate the effectiveness and safety of neoadjuvant and primary chemoradiation for women with locally advanced primary vulval cancer compared to other primary modalities of treatment such as primary surgery or primary radiation.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2009, Issue 3), Cochrane Gynaecological Cancer Group Trials Register, MEDLINE and EMBASE (to July 2009). 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) or non-randomised studies that included multivariate analyses of chemoradiation in women with locally advanced, primary squamous cell carcinoma of the vulva.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias. An adjusted hazard ratio (HR) for overall survival was calculated for one non-randomised study and risk ratios (RRs) were used in an RCT to compare five-year death rates and adverse events in women who received neoadjuvant, primary chemoradiation or primary surgery. Adverse events were also reported more extensively in a further non-randomised study. All results were displayed in single study analyses.
MAIN RESULTS
One RCT and two non-randomised studies that allowed for multivariate analyses met the inclusion criteria and included a total of 141 women.One RCT found that neoadjuvant chemoradiation did not appear to offer longer survival compared to primary surgery in advanced vulval tumours (RR = 1.29, 95% confidence interval (CI) 0.87 to 1.91). There was also no statistically significant difference in survival between primary chemoradiation and primary surgery in a study that included 63 women (pooled adjusted HR= 1.09, 95% CI 0.37 to 3.17) and in another study that only included 12 eligible women and compared the same interventions (HR was non-informative when statistical adjustment was made).Adverse events were extensively reported in only one study, which found no statistically significant difference in risk of adverse events between primary chemoradiation and primary surgery due to the very small numbers in each group. In the RCT there was no observed statistically significant difference between neoadjuvant chemoradiation and primary surgery. Adverse events were not reported in the largest study of 63 women. Quality of life (QoL) was not reported in any of the included studies. All studies were at high risk of bias.
AUTHORS' CONCLUSIONS
Women with advanced vulval tumours showed no significant difference in overall survival or treatment-related adverse events when chemoradiation (primary or neoadjuvant) was compared with primary surgery.The retrospective studies had a high risk of bias as the entry criteria for primary chemoradiation was based on inoperability or tumour requiring exenteration.The radiochemotherapy regimens varied widely. There was no data on QoL.There is no standard terminology for 'operable and inoperable vulval cancer', and for 'primary and neoadjuvant chemoradiation'. Stratification according to unresectability of the primary tumour and/or lymph nodes is needed, for good quality comparison.
Topics: Carcinoma, Squamous Cell; Female; Humans; Neoadjuvant Therapy; Vulvar Neoplasms
PubMed: 21491387
DOI: 10.1002/14651858.CD003752.pub3 -
The Cochrane Database of Systematic... Jan 2011Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin. This uncommon chronic skin condition of the vulva is associated with a high risk... (Review)
Review
BACKGROUND
Vulval intraepithelial neoplasia (VIN) is a pre-malignant condition of the vulval skin. This uncommon chronic skin condition of the vulva is associated with a high risk of recurrence and the potential to progress to vulval cancer. The condition is complicated by its' multicentric and multifocal nature. The incidence of this condition appears to be rising particularly in the younger age group.There is a lack of consensus on the optimal surgical treatment method. However, the rationale for surgical treatment of VIN has been to treat symptoms and exclude underlying malignancy with the continued aim of preservation of vulval anatomy and function. Repeated treatments affect local cosmesis and cause psychosexual morbidity thus impacting on the patients' quality of life.
OBJECTIVES
To evaluate the effectiveness and safety of surgical interventions for high grade VIN.
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Issue 3, 2010, Cochrane Gynaecological Cancer Group Trials Register, 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 compared surgical interventions, in adult women diagnosed with high grade vulval intraepithelial neoplasia.
DATA COLLECTION AND ANALYSIS
Two review authors independently abstracted data and assessed risk of bias.
MAIN RESULTS
We found only one RCT which included 30 women that met our inclusion criteria and this trial reported data on carbon dioxide laser (CO(2) laser) versus ultrasonic surgical aspiration (USA).There was no statistically significant difference in the risk of disease recurrence after one year follow-up, pain, presence of scarring, dysuria or burning, adhesions, infection, abnormal discharge and eschar between women who received CO(2) laser and those who received USA. The trial lacked statistical power due to the small number of women in each group and the low number of observed events, but was at low risk of bias.
AUTHORS' CONCLUSIONS
The included trial lacked statistical power due to the small number of women in each group and the low number of observed events. Therefore in the absence of reliable evidence regarding the effectiveness and safety of the two surgical techniques for the management of vulval intraepithelial neoplasia precludes any definitive guidance or recommendations for clinical practice.
Topics: Adult; Carcinoma in Situ; Female; Humans; Lasers, Gas; Precancerous Conditions; Randomized Controlled Trials as Topic; Suction; Ultrasonic Therapy; Vulvar Neoplasms
PubMed: 21249698
DOI: 10.1002/14651858.CD007928.pub2 -
The Cochrane Database of Systematic... Apr 2009Psychosexual dysfunction (sexual difficulties not directly due to physical factors) is known to be a common complication of treatment for gynaecological cancer. It has a... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Psychosexual dysfunction (sexual difficulties not directly due to physical factors) is known to be a common complication of treatment for gynaecological cancer. It has a considerable impact on quality of life (QoL) for the increasing number of women who are survivors of gynaecological cancer.
OBJECTIVES
To determine the effectiveness of interventions for psychosexual dysfunction in women who have been treated for gynaecological malignancy (cancer of uterine cervix, uterine corpus, ovary, vulva).
SEARCH STRATEGY
We searched the Cochrane Central Register of Controlled Trials (CENTRAL, up to October 2008), MEDLINE (1950 to October 2008), EMBASE (1982 to October 2008), CINAHL (1980 to October 2008) and PsycINFO (1806 to October 2008). We hand searched reference lists from eligible trials.
SELECTION CRITERIA
We selected all randomized controlled trials (RCTs) of a medical or psychological intervention to prevent or treat psychosexual dysfunction in adult women previously treated for gynaecological cancer.
DATA COLLECTION AND ANALYSIS
We selected five studies for inclusion in this review and analysed any outcome data relating to resumption of sexual intercourse, DSM-IV diagnoses or validated scales of sexual functioning. Sensitivity analysis was performed where possible.
MAIN RESULTS
The review included data from 5 studies, comprising a total of 413 patients, examining 5 different interventions. One trial suggested a short-term benefit for the use of vaginal Dienoestrol in women after pelvic radiotherapy (NNT = 4). Another trial suggested a short-term benefit for one regime of low dose-rate brachytherapy over another but this modality is not in widespread use. Studies of a Clinical Nurse Specialist intervention, Psychoeducational Group Therapy and a Couple-Coping intervention, did not show any significant benefit. All the studies were of poor methodological quality.
AUTHORS' CONCLUSIONS
There is no convincing evidence to support the use of any interventions for psychosexual dysfunction in women treated for gynaecological cancer. There is a need for more studies of high methodological quality.
Topics: Brachytherapy; Estrogens; Female; Genital Neoplasms, Female; Humans; Patient Education as Topic; Psychotherapy; Randomized Controlled Trials as Topic; Sexual Dysfunctions, Psychological
PubMed: 19370605
DOI: 10.1002/14651858.CD004708.pub2 -
Pain Research & Management 2008Within the past three decades, increased attention has been placed on the study of vulvodynia -- an unexplained chronic vulvular discomfort felt without any related... (Review)
Review
BACKGROUND
Within the past three decades, increased attention has been placed on the study of vulvodynia -- an unexplained chronic vulvular discomfort felt without any related pathology. In addition to its physical implications, vulvodynia has a psychosocial dimension.
OBJECTIVE
The purpose of the current article is to present a review of the literature on the psychoemotional reality of women with vulvodynia.
METHOD
A systematic literature review was conducted in the main social sciences databases, such as Dissertation Abstracts, Current Contents and PsycINFO.
RESULTS
Although some discrepancies were found in study results, the review of the literature revealed that women with vulvodynia are often confronted with identity and psychological difficulties, which are, in turn, influenced by social standards regarding sexuality and femininity. To cope with these difficulties, women develop different strategies to decrease the stress related to pain and enhance their psychological well-being.
CONCLUSION
The psychological and relational difficulties experienced by women with vulvodynia are not only due to the physical pain but also to the meaning they attribute to it, often influenced by social expectations related to heterosexuality and femininity. Hence, it is important to assist these women by increasing their knowledge on the psychosocial aspects of their experience while taking into account influences from the social context.
Topics: Adaptation, Psychological; Emotions; Female; Humans; Pain; Pain Management; Self Concept; Vaginal Diseases; Vulva
PubMed: 18592063
DOI: 10.1155/2008/801019 -
The Cochrane Database of Systematic... 2000Radical surgery has been standard treatment for patients with early vulvar cancer since mid century. Survival figures are excellent, but complication rates are high.... (Review)
Review
BACKGROUND
Radical surgery has been standard treatment for patients with early vulvar cancer since mid century. Survival figures are excellent, but complication rates are high. Over the last two decades, surgical treatment has become more individualised in order to decrease complications in patients with limited disease.
OBJECTIVES
To determine whether the effectiveness and safety of individualised treatment is comparable with that of more extensive (non-individualised) surgery.
SEARCH STRATEGY
The cirteria set by the Cochrane Gynaecological Cancer Group were used. We searched Medline and Embase (last search on 16 November 1999) We used our own publication archives, based on a prospective handsearch of six leading relevant journalswhich was started in December 1986. Reference lists of identified studies, gynaecological cancer handbooks and conference abstracts were also used.
SELECTION CRITERIA
Types of study: RCT's, case control and observational studies on the effectiveness of surgical treatment of vulvar cancer.
TYPES OF PARTICIPANTS
patients with cT1N0M0 squamous cell carcinoma of the vulva. Types of interventions: local surgical treatment as well as regional lymph node dissection. Types of outcome measurements: overall, disease specific and disease free survival; treatment complications; quality of life issues.
DATA COLLECTION AND ANALYSIS
The two reviewers independently assessed study quality and extracted data.
MAIN RESULTS
Only two studies with a total of 94 participants were included in the review. Both were observational studies. None of the other eleven considered studies met the minimum criteria as set by the Cochrane Collaboration. From these two studies, it can be concluded that: 1. radical local excision is as safe as a radical vulvectomy; 2. An ipsilateral lymph node dissection is safe in patients with a well lateralised tumour, and 3. A superficial groin node dissection is not as safe as a full femoro-inguinal groin node dissection. The fourth question we intended to answer is of great clinical importance: is the triple incision technique as safe as an en bloc dissection? This question could only be answered by using some of the unselected studies. From these studies, the triple incision technique appears to be as safe as the en bloc technique.
REVIEWER'S CONCLUSIONS
The available evidence regarding surgical treatment of early vulvar cancer is generally of poor quality. From the evidence with sufficient quality we conclude that radical local excision, ipsilateral lymph node dissection in lateral tumors and triple incision technique are safe treatment options for early vulvar cancer. However, superficial groin node dissection results in an excess of groin recurrences compared to a full femoro-inguinal groin node dissection.
Topics: Carcinoma, Squamous Cell; Female; Humans; Vulvar Neoplasms
PubMed: 10796849
DOI: 10.1002/14651858.CD002036