Assessment and Reporting of Perioperative Adverse Events and Complications in Patients Undergoing Inguinal Lymphadenectomy for Melanoma, Vulvar Cancer, and Penile Cancer: A Systematic Review and Meta-analysis.

BACKGROUND: Inguinal lymph node dissection (ILND) plays a crucial role in the oncological management of patients with melanoma, penile, and vulvar cancer. This study aims to systematically evaluate perioperative adverse events (AEs) in patients undergoing ILND and its reporting. METHODS: A systematic review was conducted according to PRISMA. PubMed, MEDLINE, Scopus, and Embase were queried to identify studies discussing perioperative AEs in patients with melanoma, penile, and vulvar cancer following ILND. RESULTS: Our search generated 3.469 publications, with 296 studies meeting the inclusion criteria. Details of 14.421 patients were analyzed. Of these studies, 58 (19.5%) described intraoperative AEs (iAEs) as an outcome of interest. Overall, 68 (2.9%) patients reported at least one iAE. Postoperative AEs were reported in 278 studies, combining data on 10.898 patients. Overall, 5.748 (52.7%) patients documented ≥1 postoperative AEs. The most reported ILND-related AEs were lymphatic AEs, with a total of 4.055 (38.8%) events. The pooled meta-analysis confirmed that high BMI (RR 1.09; p = 0.006), ≥1 comorbidities (RR 1.79; p = 0.01), and diabetes (RR 1.81; p = < 0.00001) are independent predictors for any AEs after ILND. When assessing the quality of the AEs reporting, we found 25% of studies reported at least 50% of the required criteria. CONCLUSION: ILND performed in melanoma, penile, and vulvar cancer patients is a morbid procedure. The quality of the AEs reporting is suboptimal. A more standardized AEs reporting system is needed to produce comparable data across studies for furthering the development of strategies to decrease AEs.

Epidemiology and significance of surgical margins in the management of HPV-associated vulvar precancers (H-SIL) - analysis of own data.

OBJECTIVE: Epidemiology and evaluation of the importance of surgical margins in the treatment of vulvar H-SIL - analysis of own data. MATERIAL AND METHODS: The prospective study included women dia-gnosed with HPV-associated vulvar epithelial neoplasia from 10/2016 to 1/2022. A total of 65 women were included. After surgical treatment, the women were distributed to groups according to surgical margins and were followed-up at regular intervals. RESULTS: Seventeen women (26%) dia-gnosed with HPV-associated vulvar intraepithelial neoplasia were under 49 years, whereas 48 women (74%) were older than 49 years. Recurrence rates of HPV-associated precancers were 12.3%, 1.5% and 3.1% in excisions with positive margins up to 1mm peripheral margins and 1-3mm peripheral margins, respectively. The risk of recurrence when the lesion reaches the margin is statistically significant, compared to a healthy margin of 1-3mm. CONCLUSION: Keeping the minimal healthy margin (1-3mm) seems to be an acceptable risk of recurrence of HPV-associated vulvar intraepithelial neoplasia with positive cosmetic effect and minimal risk of disturbing the psychosexual functions of women. Long-term regular follow-up is necessary.

Assessment of recurrence rate and risk factors of relapse in stage in IA vulvar carcinoma.

OBJECTIVE: To evaluate recurrence rates and risk factors of relapse in stage IA vulvar squamous cell carcinoma (VSCC) patients. MATERIAL AND METHODS: Population-based prospectively collected data on stage IA VSCC was retrieved through the Danish Gynecological Cancer Database (DGCD) during 2011-2017. A central pathology review was performed on tumors from women with recurrent disease. RESULTS: 62 women diagnosed and treated for stage IA VSCC were identified. Nine (14.5%) of the included cases relapsed within the observation period. The recurrences were in the vulva, groins or both in 5 (8.1%), 3 (4.8%) and 1 (1.6%) of the women, respectively. At central pathology review, including all recurrent cases (n = 9), 5 out of 21 reviewed patients were upstaged to stage IB due to depth of invasion >1 mm and two were downstaged to Carcinoma in situ. Two of the upstaged women developed an isolated groin recurrence and one an isolated vulvar relapse. After exclusion of the seven cases the overall recurrence rate decreased to 10.9% (n = 6). Among these cases (n = 55) resection margin <8 mm and tumor size were associated with cancer recurrence. CONCLUSION: Pathological assessment of stage IA VSCC (depth of invasion ≤1 mm) may be difficult. This may result in under-staging, which impact the choice of treatment and possibly the prognosis. This suggests a need for further clarification of the FIGO measurement and may require a more radical approach when it comes to treatment and groin exploration in stage IA VSCC. Resection margins <8 mm and tumor size were associated with relapse of the disease.

Ultrasound morphometric and cytologic preoperative assessment of inguinal lymph-node status in women with vulvar cancer: MorphoNode study.

OBJECTIVE: To assess the accuracy of preoperative ultrasound examination for predicting lymph-node (LN) status in patients with vulvar cancer. METHODS: This was a single-institution retrospective observational study of all women with a histological diagnosis of vulvar cancer triaged to inguinal surgery within 30 days following ultrasound evaluation between December 2010 and January 2016. For each groin examined, 15 morphological and dimensional sonographic parameters associated with suspicion for LN involvement were examined. A morphometric ultrasound pattern (MUP) was expressed for each groin, classifying the inguinal LN status into five groups (normal; reactive-but-negative; minimally suspicious/probably negative; moderately suspicious; and highly suspicious/positive) according to subjective judgment, followed by stratification as positive or negative for metastasis according to morphometric binomial assessment (MBA). In cases of positive MBA, fine-needle aspiration cytology was performed. Combining the information obtained from MUP and cytologic results, a binomial final overall assessment (FOA) was assigned for each groin. The final histology was considered as the reference standard. Comparison was performed between patients with negative and those with positive LNs on histology, and receiver-operating-characteristics curves were generated for statistically significant variables on univariate analysis, to evaluate their diagnostic ability to predict negative LN status. RESULTS: Of 144 patients included in the analysis, 87 had negative inguinal LNs and 57 had positive LNs on histology. A total of 256 groins were analyzed, of which 171 were negative and 85 showed at least one metastatic LN on histology. The following parameters showed the greatest accuracy, with the best balance between specificity and sensitivity, in predicting negative LN status: cortical (C) thickness of the dominant LN (cut-off, 2.5 mm; sensitivity, 90.0%; specificity, 77.9%); short-axis (S) length of the dominant LN (cut-off, 8.4 mm; sensitivity, 63.9%; specificity, 90.6%); C/medulla (M) thickness ratio of the dominant LN (cut-off, 1.2 mm; sensitivity, 70.4%; specificity, 91.5%), the combination of S length and C/M thickness ratio (sensitivity, 88.9%; specificity, 82.4%); and the FOA analysis (sensitivity, 85.9%; specificity, 84.2%). CONCLUSIONS: Preoperative ultrasound assessment, with or without the addition of cytology, has a high accuracy in assessing inguinal LN status in patients with vulvar cancer. In particular, the combination of two ultrasound parameters (S length and C/M thickness ratio) provided the greatest accuracy in discriminating between negative and positive LNs. Copyright © 2019 ISUOG. Published by John Wiley & Sons Ltd.

Groin sentinel node biopsy and 18F-FDG PET/CT-supported preoperative lymph node assessment in cN0 patients with vulvar cancer currently unfit for minimally invasive inguinal surgery: The GroSNaPET study.

OBJECTIVE: The study aims were: 1) to verify the role of sentinel node biopsy (SNB) in a subset of patients with clinical N0 (cN0) invasive vulvar cancer (VC) who were still candidates for radical inguinal surgery according to the current guidelines; 2) to investigate whether a preoperative 18F-FDG PET/CT (PET/CT) evaluation could improve the selection of node negative patients. METHODS: From July 2013 to July 2016, all patients with VC admitted to our Division were evaluated by standard imaging and clinical exam. Among the patients assessed as cN0 we enrolled those unsuitable for SNB, due to: T > 4 cm, multifocal tumors, complete tumor diagnostic excision, contralateral nodal involvement and local recurrence. A preoperative PET/CT was performed. For each patient surgery included SNB, performed using a combined technique (radiotracer plus blue dye), followed by standard inguino-femoral lymphadenectomy. The reference standard was histopathology. RESULTS: Forty-seven patients entered the study for a total of 73 groins. Histopathology revealed 12 metastatic SNs in 9 groins. No false negative SNs were found (NPV 100%). PET/CT showed a negative predictive value of 93%. CONCLUSIONS: Our data suggest that SNB is accurate and safe even in cN0 patients currently excluded from this procedure, providing that a careful preoperative selection is performed. PET/CT allows a reliable assessment of LN status and may be an effective support for the selection of patients who are safe candidates for SNB.

A Prospective Assessment of Surgical Risk Factors in 114 Gluteal Fold Flap Reconstructions After Oncological Vulvoperineal Resection.

BACKGROUND AND AIM: To date, clinically relevant selection criteria have not been established for the use of the gluteal fold flap after oncological vulvoperineal resection. We prospectively assessed the surgical risk factors of this reconstructive technique in a large series. METHODOLOGY: From April of 2000 through December of 2015, 114 gluteal fold flaps were used for vulvoperineal reconstruction after excision of (pre)malignant skin disorders in 75 women. The possible influence of 10 patient-related and 6 procedure-related risk factors on flap-related postoperative complications was statistically analyzed. RESULTS: We observed a major complication in 13 flaps (11%) and a minor complication in 19 flaps (17%). Previous radiotherapy (P = 0.01) was associated with significantly more complications, and a rotation flap design rather than VY advancement (P = 0.02) was associated with major complications. Recurrent disease, multifocal tumor localization, incomplete removal of tumor, and bilateral flap procedure were found to be clinically relevant risk factors, but not significantly so. The same applied to recurrence of disease during postoperative follow-up. CONCLUSIONS: We identified surgical risk factors for gluteal fold flap use after oncological vulvoperineal resection. These observations may potentially allow for more favorable future surgical outcomes by adaption of selection of patients or procedure.

Utilization and Outcomes of Sentinel Lymph Node Biopsy for Vulvar Cancer.

OBJECTIVE: To examine the use and predictors of sentinel node biopsy in women with vulvar cancer. METHODS: The Perspective database, an all-payer database that collects data from more than 500 hospitals, was used to perform a retrospective cohort study of women with vulvar cancer who underwent vulvectomy and lymph node assessment from 2006 to 2015. Multivariable models were used to determine factors associated with sentinel node biopsy. Length of stay and cost were compared between women who underwent sentinel node biopsy and lymphadenectomy. RESULTS: Among 2,273 women, sentinel node biopsy was utilized in 618 (27.2%) and 1,655 (72.8%) underwent inguinofemoral lymphadenectomy. Performance of sentinel node biopsy increased from 17.0% (95% confidence interval [CI] 12.0-22.0%) in 2006 to 39.1% (95% CI 27.1-51.0%) in 2015. In a multivariable model, women treated more recently were more likely to have undergone sentinel node biopsy, whereas women with more comorbidities and those treated at rural hospitals were less likely to have undergone the procedure. The median length of stay was shorter for those undergoing sentinel node biopsy (median 2 days, interquartile range 1-3) compared with women who underwent inguinofemoral lymphadenectomy (median 3 days, interquartile range 2-4). The cost of sentinel node biopsy was $7,599 (interquartile range $5,739-9,922) compared with $8,095 (interquartile range $5,917-11,281) for lymphadenectomy. CONCLUSION: The use of sentinel node biopsy for vulvar cancer has more than doubled since 2006. Sentinel lymph node biopsy is associated with a shorter hospital stay and decreased cost compared with inguinofemoral lymphadenectomy.

Lymphatic mapping and sentinel lymph node dissection compared to complete lymphadenectomy in the management of early-stage vulvar cancer: A cost-utility analysis.

OBJECTIVE: Sentinel lymph node biopsy (SLNB) is an acceptable method of evaluating groin lymph nodes in women with vulvar cancer. The purpose of this study is to assess the cost and effectiveness of SLNB compared to universal inguinofemoral lymphadenectomy (LND) for vulvar cancer. METHODS: A modified Markov decision model was generated to compare two surgical approaches for newly diagnosed, early-stage vulvar cancer: (1) radical vulvectomy+LND and (2) radical vulvectomy+SLNB. Published data were used to estimate survival outcomes, probability of positive lymph nodes and lymphedema. Costs of surgery and radiation and lymphedema therapies were estimated from published data. Lymphedema's effect on quality of life (QOL) was extrapolated from other disease sites and assigned a utility score of 0.84. Multiple sensitivity analyses were performed. RESULTS: SLNB was less costly ($13,449 versus $14,261) and more effective (4.16 quality-adjusted life years (QALYs) versus 4.00 QALYs) than LND. The model was sensitive to the impact of lymphedema on QOL. Unless the impact of lymphedema on QOL was minimal (utility score>0.975) SLNB dominated LND. Variations in the rate of positive SLNB and probability of lymphedema over clinically reasonable ranges did not alter the results. CONCLUSIONS: SLNB is a cost-effective strategy for the treatment of newly diagnosed vulvar cancer, mainly due to the impact of lymphedema on QOL.

Cost-effectiveness analysis of sentinel lymph node biopsy in the treatment of early-stage vulvar cancer.

OBJECTIVE: The objective of this study was to determine the costs and outcomes of inguinal-femoral lymph node dissection (IF-LND) versus sentinel lymph node biopsy (SLNB) for the management of early-stage vulvar cancer. METHODS: A cost-effectiveness model compared 2 different strategies for the management of early-stage vulvar cancer: (1) vulvectomy and SLNB and (2) vulvectomy and IF-LND. Probabilities of inguinal-femoral node metastases and recurrence rates associated with each strategy were estimated from published data. Actual payer costs of surgery and radiation therapy were obtained using 2012 CPT codes and Medicare payment information. Rates and costs of postoperative complications including lymphedema, lymphocyst formation, and infection were estimated and included in a separate model. Cost-effectiveness ratios were determined for each strategy. Sensitivity analyses were performed to evaluate pertinent uncertainties in the models. RESULTS: For the estimated 3000 women diagnosed annually with early-stage vulvar cancer in the United States, the annual cost of the SLNB strategy is $65.2 million compared with $76.8 million for the IF-LND strategy. Three-year inguinal-femoral recurrence-free survival was similar between groups (96.9% vs 97.3%). This translates into a lower cost-effectiveness ratio for the SLNB strategy ($22,416), compared with the IF-LND strategy ($26,344). When adding complication costs to the model, cost-effectiveness ratios further favor the SLNB strategy ($23,711 vs $31,198). Sensitivity analysis revealed that the SLNB strategy remained cost-effective until the recurrence rate after a negative sentinel lymph node approaches 9%. CONCLUSIONS: Sentinel lymph node biopsy is the most cost-effective strategy for the management of patients with early-stage vulvar cancer due to lower treatment costs and lower costs due to complications.

Sentinel lymph node biopsy in vulvar cancer: a health technology assessment for the canadian health care context.

OBJECTIVES: Inguinofemoral lymphadenectomy for vulvar cancer is associated with a high incidence of groin wound complications and lymphedema. Sentinel lymph node biopsy (SLNB) is a morbidity-reducing alternative to lymphadenectomy. The objective of this health technology assessment was to determine the clinical effectiveness, cost-effectiveness, and organizational feasibility of SLNB in the Canadian health care system. METHODS: A review of the English-language literature published from January 1992 to October 2011 was performed across five databases and six grey-literature sources. Predetermined eligibility criteria were used to select studies, and results in the clinical, economic, and organizational domains were summarized. Included studies were evaluated for methodologic quality using the Newcastle-Ottawa Scale. RESULTS: Of 825 reports identified, 88 observational studies met the eligibility criteria. Overall study quality was poor, with a median Newcastle-Ottawa Scale score of 2 out of 9 stars. Across all studies, the detection rate of the sentinel lymph node was 82.2% per groin and the false-negative rate was 6.3%. The groin recurrence rate after negative SLNB was 3.6% compared with 4.3% after negative lymphadenectomy, and complications were reduced after SLNB. No economic evaluations were identified comparing SLNB to lymphadenectomy. Safe implementation of SLNB requires appropriate patient selection, detection technique, and attention to the learning curve. CONCLUSIONS: Although study quality is poor, the available data suggest implementation of SLNB may be safe and feasible in Canadian centres with adequate procedural volumes, assuming that implementation includes careful patient selection, careful technique, and ongoing quality assessment. Cost-effectiveness has yet to be determined.

[Vulvar cancer: survey of surgical practice in France. Do expert centers need?]. / Cancer de la vulve: enquête de pratique de la prise en charge chirurgicale en France. Faut-il se diriger vers des centres de références ?

OBJECTIVE: Vulvar cancer is rare. In France, surgical management of this cancer is codified by national guidelines. The aim of this survey was to evaluate its surgical management regards to the French guidelines. MATERIALS AND METHODS: Six hundred questionnaires were given to surgeons during two French congress in 2009. They focused on the surgeon (age, sex, occupation, center of work, practice of vulvar surgery, number of cancers treated individually and in the center), and the disease (initial work-up, surgical management and adjuvant therapy). Three case reports were also proposed, related to vulvar cancer management. RESULTS: Seventeen percent of surgeons (n=102) answered the questionnaire. Only half of them (52.9%) managed vulvar cancer. Of them, 83.2% reported treated less than five cancers per year; 87.4% of centers treated less than 10 vulvar cancers per year. Only 8.7% of surgeons respected the guidelines for the three case reports. The compliance rate was 80.5% for case A; 63.7% for case B and 22.5% for case C. No difference in answers' conformity to the guidelines was found according to age of surgeons, experience, workplace, number of cancers treated per year and centers. CONCLUSION: Despite some limits of our study, it appears that vulvar cancer management is often not conform to the French guidelines raising concerns on their insufficient diffusion and creation of expert centers.

Patterns of care in the initial management of women with vulvar cancers in Ontario.

BACKGROUND: To facilitate the planning of future resources for cancer services in Ontario, Cancer Care Ontario commissioned an evaluation of operative services delivered for vulvar cancer. METHODS: Women with an incident diagnosis of vulvar malignancy were identified from 1, April 2003 to 31 March, 2004 using the Ontario Cancer Registry. Record linkages were created to other provincial health databases such as the Ontario Health Insurance Plan. RESULTS: Vulvar cancers affected 148 women. Disease specific rates of cancer were higher in rural areas and in women in the lower income quintiles. No surgery occurred in 17.6% of women. Use of surgery did not appear to vary by urban/rural residence or LHIN. Ontario's 17 gynecologic oncologists performed 75% of the surgeries. Groin lymphadenectomy rate was 52.8%. Surgery was performed in the LHIN of residence for 41% of women. All women were assessed by CXR. CT scan of the abdomen and pelvis occurred in 77%. MRIs were done infrequently. Radiation consults were preformed in half of the women with vulvar cancer but treatment was only delivered in half of those seen. Medical oncologists saw about 10% of women with gynecologic cancers. CONCLUSIONS: There appear to be variations in incidence rates of vulvar cancer with disease being more frequent in rural areas. Subspecialty care from gynecologic oncologists was provided to 75% of women. Rates of lymphadenectomy as part of a surgical attempt occurred in 52.8% of women. These data would be enhanced with further information such as comorbidity, treatment intent (palliative/curative), histology, grade and stage.

Assessment of the sentinel lymph node in patients with invasive squamous carcinoma of the vulva.

OBJECTIVE: This study aims to evaluate the feasibility and diagnostic validity of the sentinel lymph node technique in detecting inguinal lymph node metastases in patients with invasive squamous cancer of the vulva. DESIGN: Retrospective analysis of the in-house tumor registry. SETTING: Dr. Horst Schmidt Klinik, a tertiary gynecologic oncology unit in Wiesbaden, Germany, June 2000-May 2008. POPULATION: All consecutive operated patients with primary envisaged diagnosis were included. METHODS: The sentinel node identification technique was performed and patients were informed accordingly. Patients who consented and were found eligible underwent preoperative lymphscintigraphy on the day before surgery. MAIN OUTCOME MEASURES: Sentinel node detection in specimen from sentinel lymph node biopsy and from full lymphadenectomy (LNE); sentinel lymph node biopsy as a sole surgical groin procedure in patients with histological negative sentinel node; benefit with respect to side effects for sentinel lymph node biopsy compared to full LNE; complication rates; and recurrences of vulvar cancer. RESULTS: In all, 46 of 59 patients with vulvar malignancy underwent inguinofemoral LNE, sentinel lymph node biopsy (SLB) of the groin followed by LNE, or SLB alone. Most patients had been diagnosed in the early stages of the disease. Since no false positive or false negative results were recorded, the sensitivity, specificity, positive predictive value and negative predictive value of the sentinel lymph node were 100%. However, in 6%, a sentinel lymph node could not be detected intraoperatively indicating a feasibility of 94%. CONCLUSION: The implementation of sentinel lymph node technique for groin staging in squamous cell vulvar cancer seems to provide a feasible and safe technique in tertiary gynecologic oncology.

Genital lesions complicating female genital cutting in infancy: a hospital-based study in south-east Nigeria.

BACKGROUND: Despite the global outcry against female genital cutting (FGC), the practice continues in many African communities. The morbidity of this practice on the girl child deserves more attention. OBJECTIVE: To determine the genital lesions complicating childhood FGC and the underlying factors that sustain this practice among the Igbos in south-east Nigeria. METHODS: Prospective evaluation of girls with genital complications of FGC between January 2003 and June 2005 at the Federal Medical Centre, Owerri, south-east Nigeria. The girls' mothers were interviewed at presentation and subsequent visits to determine their perception and attitudes towards FGC. RESULTS: The average age at presentation was 3.5 years (range 1-5) and the genital cutting procedures were performed 8-90 days after birth. The procedure was undertaken by traditional practitioners in 14 (66.7%) girls and by nurses in 7 (33.3%) girls. Twelve girls (57.1%) had type I genital cutting and nine (42.9%) type II. Inclusion clitoral dermoid cyst and labial fusion were the complications in 13 (61.9%) and eight (38.1%), respectively. Treatment involved complete excision of the cysts and operative division of the labial fusion. Post-operative complications were wound infection (5) and labial adhesion (2). With duration of admission ranging from 3 to 5 days, the average cost of managing each child was $120. Of the girls' mothers, 15 (71.4%) had been educated to secondary level and 17 (80.1%) were aware of the campaign against FGC. Regrettably, all the mothers had genital cutting themselves during childhood and 13 (61.9%) stated that they would like to perpetuate the practice for socio-cultural reasons. Despite this, they all volunteered that FGC is enforced by the child's paternal relations. CONCLUSION: Childhood FGC contributes to appreciable morbidity among girls, a large proportion of whom are not managed in a hospital setting. The cost of managing these complications can be enormous, especially in low-resource settings. Girl child education to tertiary level and the involvement of traditional rulers and local decision-makers in the campaign against FGC might help to eradicate the practice.

Vulvar cancer patients' quality of life: a qualitative assessment.

To develop a vulvar cancer-specific quality of life (QOL) subscale to accompany the Functional Assessment of Cancer-General (FACT-G) questionnaire, semistructured interviews were performed with 15 patients treated for vulvar cancer (FIGO stage 0-3). All but one patient, who received chemoradiotherapy, were treated by radical vulvectomy and six patients received a groin lymph node dissection. Patients experienced reductions in several aspects of QOL including emotional functioning, physical functioning, social functioning, sexuality, and body image. Six patients suffered from lymphedema of the legs with a mean severity of 3.5 on a 10-point scale. Four patients reported pruritus (severity rating 8.5). Seven patients expressed a need for more information about the illness and treatment. Only four patients returned to employment after treatment, and all of these patients reported work-related problems. Reductions in sexual functioning were a major concern for five patients, all younger than 65 years. Other topics were groin discomfort after removal of the lymph nodes and disturbance by odor from the vulva. Results of this study revealed vulvar cancer-specific reductions in QOL for inclusion in the newly developed vulvar cancer-specific subscale.

Cost-effectiveness and quality of life of granulocyte-colony stimulating factor (filgrastim) after radical vulvectomy and bilateral inguino-femoral lymphadenectomy: results of a randomized clinical trial.

OBJECTIVE: To examine the effect of filgrastim on the incidence of wound infection, quality of life and costs after a radical vulvectomy and bilateral inguino-femoral lymphadenectomy. STUDY DESIGN: In a prospective, randomized clinical trial 40 patients were treated with either filgrastim or placebo for 9 consecutive days starting at the day before surgery. Data on wound healing was scored up to 56 days postoperatively. Quality of life was measured and cost data were collected. Statistical analyses used were the Mann-Whitney test and the Student's t-test. RESULTS: The clinical results showed no differences in wound infection between both groups. The average score on the EuroQol showed that patients felt worst in the week after surgery. Treatment costs were higher in the filgrastim group versus the placebo group. CONCLUSION: Filgrastim does not improve wound healing after radical vulvectomy, does not improve quality of life and is not cost-effective. However, the postoperative stay after radical vulvectomy is relatively long due to wound healing problems and has a major impact on the patient's quality of life.

The assessment and surgical management of early-stage vulvar cancer.

The treatment of early vulvar cancer has undergone a major paradigm shift from a radical surgical approach to tissue-sparing surgery and preservation of sexual function. Stage I and II tumours represent two-thirds of the cases, and 5-year survival rates reach 80-90%. These tumours, with clinically negative nodes, do not require metastatic work-up, and the patients are submitted to surgery. Stage IA tumours, with a depth of stromal invasion of less than 1 mm, have a very low risk of lymph node (LN) involvement (<1%) and are treated by radical (wide) local excision without the need for lymphadenectomy. The remaining patients with stage I or II disease undergo radical (wide) local excision of the vulvar lesion, accompanied by some sort of inguinal lymphadenectomy. Evaluation of the lymph nodes using sentinel node mapping appears promising and is extensively reviewed. It should probably include serial sectioning and immunohistochemistry to detect micrometastases, although their true clinical importance remains to be determined. Molecular detection methods that reveal cancer cells in sites not detectable by routine histology have been introduced to evaluate sentinel lymph nodes and may eventually become part of the routine metastatic work-up.

The prevention and management of treatment related morbidity in vulval cancer.

The traditional and the most common management of primary vulval cancer is radical surgery of the vulva and radical groin lymphadenectomy (unilateral or bilateral). Adjuvant radiotherapy is used in poor prognosis cases. Rare vulval cancers, locally advanced cancers and recurrent vulval cancers often are treated with a combination of surgery, radiation therapy and chemotherapy. The treatments, while often curative, are associated with considerable morbidity, which, until recently, has not been well publicized or quantified. Increasingly, younger patients are presenting with extensive and often multi-focal pre-invasive disease and with vulval cancer. Long-term post-treatment physical, sexual and psychological morbidity is of major concern. There is more onus on clinicians to provide less radical but equally curative treatment, while also reducing morbidity. There is also the need to provide treatment and treatment modification based on supporting evidence. For a rare disease such as vulval cancer it is more difficult to generate data and to conduct trials on treatment modifications. Although surgical modifications have been made, the morbidity of radical surgery for vulval cancer is considerable. The prevention and management of treatment-related morbidity will continue to challenge the gynaecological oncology team.

Vulvar carcinoma. The price of less radical surgery.

BACKGROUND: The objective of this study was to determine whether modifications in the treatment of patients with vulvar carcinoma influence the rates of recurrence and survival. METHODS: Between 1982 and 1997, 253 patients with T1 and T2 invasive squamous cell carcinoma of the vulva were treated by essentially the same team of gynecologic oncologists, and 168 patients (Group I) underwent radical vulvectomy with en bloc inguinofemoral lymphadenectomy. Standard therapy was changed in 1993, and 85 patients (Group II) underwent wide local excision with inguinofemoral lymphadenectomy through separate incisions. The rates of recurrence and survival were compared between both groups. RESULTS: In Group II, the overall recurrence rate (33.3%) within 4 years was increased compared with Group I (19.9%; P = 0.03). In Group II, 5 of 79 patients (6.3%) developed fatal groin or skin bridge recurrences compared with 2 of 159 patients (1.3%) in Group I (P = 0.029); this did not result in a difference in overall survival. In Group II, 40 of 79 patients had tumor free margins measuring 8 mm, resulting in no local recurrences (P = 0.002). CONCLUSIONS: The current study showed that fatal recurrences in either the groin or the skin bridge were more frequent after wide local excision and inguinofemoral lymphadenectomy through separate incisions; however, probably due to lack of power, this did not result in shorter survival. In 40 of 79 patients, the histologic margins measured