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PURPOSE The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN). METHODS GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences. RESULTS From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL ( P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.

Probability of survival of patients with vulvar cancer directly depends on the lymph node status. Surgery of lymph nodes can be performed as radical inguinofemoral lymphadenectomy or in cases with certain conditions as sentinel lymph node surgery. The aim of this study is to obtain an overview of the intervention-related morbidity and quality of life in patients with vulvar carcinoma after lymphadenectomy. Quality of life and morbidity was compared between patients who underwent radical inguinofemoral lymphadenectomy with those who underwent sentinel lymph node surgery. All recorded postoperative complications occur more frequently in the non-sentinel group, Significant difference was shown for the occurrence of lymphedema (p-value = 0.024) and sensitivity loss (p-value = 0.024). Recurrence of disease was more frequent in the non-sentinel group (38 % vs. 20 %, p = 0.621, n.s.) and satisfaction with groin surgery is slightly higher in the sentinel group (94 % vs. 89 %, p = 1.000, n.s.). We could demonstrate a significantly lower morbidity of sentinel lymphadenectomy compared to conventional inguinofemoral lymphadenectomy while maintaining the same oncological safety. The low morbidity of sentinel- lymphadenectomy does not seem to influence the postoperative quality of life significantly. However, recording of the individual burden of lymphadenectomy by questionnaires should be optimized.ZIEL: Die Überlebenswahrscheinlichkeit von Patientinnen mit Vulvakarzinom hängt direkt vom Lymphknotenstatus ab. Die Resektion der Lymphknoten kann als radikale inguinofemorale Lymphadenektomie oder bei Vorliegen bestimmter Voraussetzungen als Sentinel-Lymphadenektomie durchgeführt werden. Ziel dieser Studie ist es, einen Überblick über die interventionelle Morbidität und Lebensqualität bei Patientinnen mit Vulvakarzinom nach Lymphadenektomie zu erhalten. Lebensqualität und Morbidität wurden zwischen Patientinnen, bei denen eine radikale inguinofemorale Lymphadenektomie durchgeführt wurde, und Patientinnen, bei denen eine Sentinel-Lymphknotenchirurgie durchgeführt wurde, verglichen. Alle erfassten postoperativen Komplikationen traten in der Nicht-Sentinel-Gruppe häufiger auf, ein signifikanter Unterschied zeigte sich für das Auftreten von Lymphödemen (p = 0,024) und Sensibilitätsverlust (p = 0,024). Krankheitsrezidive traten in der Nicht-Sentinel-Gruppe häufiger auf (38 % vs. 20 %; p = 0,621, n.s.) und die Zufriedenheit mit dem Eingriff in der Leistenregion war in der Sentinel-Gruppe etwas höher (94 % vs. 89 %; p = 1,000, n.s.). Wir konnten eine signifikant geringere Morbidität der Sentinel-Lymphadenektomie im Vergleich zur konventionellen inguinofemoralen Lymphadenektomie bei gleichbleibender onkologischer Sicherheit nachweisen. Die niedrigere Morbidität bei der Sentinel-Lymphadenektomie hat keinen signifikanten Einfluss auf die postoperative Lebensqualität. Die Erfassung der individuellen Belastung durch die Lymphadenektomie mittels Fragebögen sollte jedoch optimiert werden.

The present article aims to highlight the importance of changes of personalized surgical treatment for vulvar cancer. Current international literature regarding surgical treatment of vulvar cancer was evaluated. This included several studies and systematic reviews. Radical surgery approach, such as en bloc resection, was the first therapeutic option and the standard care for many years, even if burdened with a high complication rate and frequently disfiguring. Taussing and Way introduced radical vulvectomy approach with en bloc bilateral inguinal-femoral lymphadenectomy; modified radical vulvectomy was developed, with a wide radical excision of the primary tumor. The role of inguinofemoral lymphadenectomy (mono or bilateral) changed in the years too, particularly with the advent of SLN biopsy as minimally invasive surgical approach for lymph node staging, in patients with unifocal cancer4 cm, without suspicious groin nodes. More personalized and conservative surgical approach, consisting of wide local or wide radical excisions, is necessary to reduce complications as lymphedema or sexual disfunction. The optimal surgical management of vulvar cancer needs to consider dimensions, staging, depth of invasion, presence of carcinoma at the surgical margins of resection and grading, with the goal of making the treatment as individualized as possible.

Introduction Despite the less frequent use of surgery in patients with vulvar cancer, the high rates of postoperative complications are still a matter of concern. The aim of the present study was to identify risk factors that influence postoperative complications rates in vulvar cancer and identify specific clinical parameters that may influence their incidence. Materials Patients who underwent curative-intent surgery for squamous cell carcinoma of the vulva from 2003 to 2018 were selected. All patient characteristics were analyzed as risk factors for the development of postoperative lymphocele, lymphedema, and wound dehiscence. The patients were followed up for 2 years postoperatively. Results The investigation comprised 121 patients, of whom 18.1% developed wound dehiscence, 17.7% a lymphocele, and 20.4% lymphedema. We found no significant evidence of an association between patient’s characteristics and postoperative complications. The depth of tumor invasion and the appearance of lymph-node metastasis were significantly associated with postoperative complications. Free resection margins of 5 mm or more were associated with a reduced risk of postoperative complications compared to resection margins less than 5 mm. No complications were encountered after sentinel node biopsy (SNB). Complication rates were associated with inguinofemoral lymphadenectomy, but not with the extent of lymphadenectomy. The development of a lymphocele or wound dehiscence may be correlated with the development of long-term lymphedema. Conclusion FIGO stage at diagnosis influences the risk of postoperative complications. The use of SNB minimized postoperative complications. Correlations between the free microscopic resection margin distance and the risk of postoperative wound dehiscence must be investigated further.

Background: Since the introduction of sentinel node biopsy (SLNB) in unifocal vulvar cancer (diameter of < 4cm) and unsuspicious groin lymph nodes, the morbidity rate of patients has significantly decreased globally. In contrast to SLNB, bilateral inguinofemoral lymphadenectomy (IFL) has been associated with increased risk of common morbidities. Current guidelines (NCCN, ESGO, RCOG, and German) recommend that in cases of unilaterally positive sentinel lymph node (SLN), bilateral IFL should be performed. However, two recent publications by Woelber et al. and Nica et al. contradict the current guideline, since a significant rate of positive non sentinel lymph nodes in IFL contralaterally was not observed (Woelber et al. 0% (p=0/28) and Nica et al. 5.3% (p=1/19)). Methods: A retrospective single-center analysis conducted in the University Hospital of Dusseldorf, evaluating vulvar cancer patients treated with SLNB from 2002 to 2018. Results: 22.2% of women (n=4/18) were found to have contralateral IFL groin metastasis after an initial diagnosis of unilateral SLN metastasis. The depth of tumor infiltrating cells correlated significantly and positively with the rate of incidence of groin metastasis (p=0.0038). Conclusion: Current guideline for bilateral IFL should remain as the standard management. Therefore, this depth may be taken into account as an indication for bilateral IFL. The management of VC and SLNB should be performed in a high volume center with an experienced team in marking SLN and performing the adequate surgical procedure. Well conducted counseling of the patients outlining advantages but also potential oncological risks of this technique especially concerning rate of groin recurrence is critical.

Objective We aimed to develop a less invasive inguinofemoral lymphadenectomy (IFL) approach for vulvar cancer based on the investigation of the anatomic distribution of sentinel and metastatic nodes. Methods Patients with vulvar cancer treated by surgery between 1995 and 2019 were retrospectively reviewed. A seven-field method was adopted to assign the anatomic locations for lymph nodes removed via IFL or sentinel node biopsy. Only patients with nodal metastasis or sentinel nodes were included. Results A total of 102 patients with eligible data were analyzed. Nodal metastasis was confirmed in 118 groins undergoing IFL; sentinel node detection succeeded in 46 groins. The medial-inguinal field had the highest rate of nodal metastasis involvement (59.3%, 70/118) and sentinel nodes present (73.9%, 34/46). The inferior-femoral field was involved only in one groin with quadruple-field metastases. The lateral-inguinal field was not involved in any groin. Neither the lateral-inguinal nor the inferior-femoral field presented sentinel nodes. Conclusion The lateral-inguinal and inferior-femoral fields of the groins have a low risk of developing nodal metastasis. Therefore, a modified IFL preserving these fields can be established to reduce surgical morbidity without sacrificing its therapeutic effect.

Objectives To determine the clinical significance and prognostic value of femoral lymph node metastasis (FLNM) in patients with International Federation of Gynecology and Obstetrics (FIGO) stage III vulvar carcinoma. Methods The medical records of patients with vulvar carcinoma who underwent inguinofemoral lymphadenectomy between 1990 and 2013 were retrospectively reviewed. Results Of 66 patients with stage III vulvar carcinoma, 42 had superficial lymph node metastasis (SLNM) only and 24 had FLNM. Significantly higher rates of extracapsular invasion (P = 0.008), multiple nodal metastasis (P = 0.042), and advanced FIGO substage (P = 0.026) as well as a larger tumor diameter (≥4 cm, P = 0.023) and greater depth of invasion (≥5 mm, P = 0.020) were observed among patients with FLNM compared to those with SLNM only. After a median follow-up of 46 months (range, 6–172 months), 35 patients experienced relapse and 30 died from disease. The 5-year cancer-specific survival (CSS) rates were 70.1% and 30.8% for patients with SLNM only and FLNM, respectively (P = 0.001). In multivariate analysis, only FLNM was found to be an independent risk factor for reduced recurrence-free survival (RFS) and CSS among patients with stage III vulvar cancer (hazard ratio [HR] = 2.277, P = 0.037 for RFS; HR = 2.360, P = 0.042 for CSS). When the FLNM cases were considered together as stage IIIC, significant differences emerged in the RFS (P = 0.002) and CSS (P = 0.004) among the re-divided FIGO substages. Conclusions FLNM represented an unfavorable status of node metastasis with a worse prognosis compared to that of SLNM alone, and this should be considered in a future FIGO staging system for vulvar cancer.

Background: Inguinofemoral lymphadenectomy (IFL) is part of the surgical treatment of different malignancies of the genital tract and/or the lower limb including vulvar carcinoma, penile carcinoma and melanoma. IFL is associated with morbidity in up to 85% of the patients. The aims of this MAMBO-IC study (Morbidity And Measurement of the Body) are to study the feasibility of using LigaSure for IFL and to assess the differences in the incidence of short-term complications using LigaSure versus conventional IFL randomized within each individual patient.Methods: In this multicenter randomized controlled trial (RCT), women diagnosed with squamous cell carcinoma of the vulva with an indication for bilateral IFL were included. It was randomly assigned for which groin the LigaSure was used; the other groin was treated with conventional IFL (sharp/diathermia). We estimated the incidence of >= 1 complication(s) per groin using logistic regression and compared this between the two surgical methods, adjusting for possible confounders.Results: We included 40 groins of 20 patients. The estimated incidence of >= 1 complication(s) was 29% after LigaSure versus 70% after conventional IFL (risk difference 41% (95% CI 19-62), p Conclusions: This RCT shows that LigaSure for IFL is feasible and associated with significantly less short-term surgical complications compared to conventional IFL. Further studies with a larger sample size are needed to validate our findings. ISRCTN15057626.

Objectives The International Society for the Study of Vulvovaginal Disease (ISSVD) Surgical Oncological Procedure Definitions Committee propose a consistent terminology based on well-defined and reproducible anatomic landmarks that can be used by all who are involved in care of patients with vulvar conditions. Materials and methods The fundamental principles behind the new terminology contained descriptions of the area extension and depth of the surgical procedure. Results Vulvar Surgical Topographic Anatomy LandmarksExtension. The internal border of the vulva is the hymenal ring. The genitocrural folds are the external lateral borders.The vertical line through the clitoris and the anus defines lateral portions of the vulva.The horizontal line from the upper border of the hymenal ring defines anterior and posterior portion of the vulva.Depth. The floor of the vulva is represented by the median perineal fascia or perineal membrane of the urogenital diaphragm.A. Vulvectomy1. Extension: partial/total vulvectomy. Removal of part/entire vulvar/perineal integument independent of the depth.2. Depth: superficial/deep. Removal of the most superficial layer/removal of the vulvar tissue to the superficial aponeurosis of the urogenital diaphragm and/or pubic periosteum.B. Inguinofemoral lymphadenectomy1. Superficial inguinofemoral lymphadenectomy. Removal of the nodes located beside the inguinal ligament and along the great saphenous vein.2. Deep femoral lymphadenectomy. Removal of the nodes below the cribriform lamina and medial to the femoral vein. Conclusions This terminology helps avoid confusion and promote better understanding and exchange of experiences among gynecologic oncologists involved in vulvar carcinoma care.

BackgroundIn squamous cell vulvar cancer, sentinel node biopsy is accepted as standard treatment in well-defined patient groups and has reduced surgical morbidity considerably. Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences.Primary objectiveThis study is primarily a pilot and feasibility trial, aiming to evaluate if the prerequisites concerning detection rate and negative predictive value are satisfactory before the implementation of a multinational trial.Study hypothesisSentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort.Trial designThis study is planned as a prospective, national, multicenter interventional trial. Participating patients will undergo a sentinel node biopsy in addition to an inguinofemoral lymphadenectomy.Inclusion and exclusion criteriaInclusion criteria: for women in group 1, a primary tumor ≥4 cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins.Primary endpointThe primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure.Sample sizeIn each of the four study arms, recruitment of 20–30 patients is planned.Estimated dates for completing recruitment and presenting resultsRecruitment will take place between November 2019 and October 2021. Results will be available in December 2021.Trial registrationThe trial is registered at “ClinicalTrials.gov” (ID: NCT04147780).

BACKGROUND Lymph node metastases represent the most important negative prognostic predictor in vulvar carcinoma. Therefore, an accurate preoperative assessment of suspicious lymph nodes would be fundamental for a personalized therapy. The aim of this article was to assess the reliability of ultrasound-guided fine-needle aspiration cytology (FNAC) in the preoperative assessment of nodal metastatic disease in 43 patients with vulvar cancer. METHODS In total, 43 FNAC specimens of clinicoradiologically suspicious lymph nodes with corresponding nodal resection specimens were collected from 2016 to 2018 at Catholic University Hospital in Rome. Cytohistologic correlation was performed. Patients were treated with wide local excision of the vulvar mass followed by bilateral inguinofemoral lymphadenectomy and radiotherapy if the tumor involved a lymph node or the vulvar margins. RESULTS Cytologic examination agreed with histology in 37 of 43 cases (86.04%). The authors observed a positive FNAC result in 14 of 20 histologically confirmed metastatic lymph nodes, 6 false-negative cases, and no false-positive results. The sensitivity and specificity of cytological examination were 76.92% and 100%, respectively. All patients with FNAC-positive results showed metastatic disease in other surgically resected inguinofemoral nodes. Eleven of 29 patients (37.9%) with FNAC-negative results also showed metastatic disease in subsequent lymphadenectomy specimens, but the extent of metastases was always

Aims The depth of invasion is an important prognostic factor for patients with vulvar squamous cell carcinoma (SCC). The threshold of 1 mm distinguishes between FIGO stages IA and >= IB disease and guides the need for groin surgery. Therefore, high interobserver agreement is crucial. The conventional and the alternative method are described to measure the depth of invasion. The aims of this study were to assess interobserver agreement for classifying the depth of invasion using both methods and to identify pitfalls. Methods and results Fifty slides of vulvar SCC with a depth of invasion approximately 1 mm were selected, digitally scanned and independently assessed by 10 pathologists working in a referral or oncology centre and four pathologists in training. The depth of invasion was measured using both the conventional and alternative method in each slide and categorised into 1 mm. The percentage of agreement and Light's kappa for multi-rater agreement were calculated, and 95% confidence intervals were calculated by bootstrapping (1000 runs). The agreement using the conventional method was moderate (kappa = 0.57, 95% confidence interval = 0.45-0.68). The percentage of agreement among the participating pathologists using the conventional method was 85.0% versus 89.4% using the alternative method. Six pitfalls were identified: disagreement concerning which invasive nest is deepest, recognition of invasive growth and where it starts, curved surface, carcinoma situated on the edge of the tissue block, ulceration and different measurement methods. Conclusions Pathologists reached only moderate agreement in determining the depth of invasion in vulvar SCC, without a notable difference between the two measurement methods.

To evaluate the effect of a collagen-fibrin sealant patch (TachoSil®) in preventing postoperative complications after inguinofemoral lymphadenectomy for vulvar cancer. Double-blind randomized-controlled trial on consecutive patients undergoing bilateral inguinofemoral lymphadenectomy for vulvar cancer. Intraoperatively, inguinofemoral areas were randomized: one was treated with TachoSil®, while the contralateral had standard closure without collagen-fibrin sealant patch. Surgical outcomes, amount of drainage volume, duration of drain placement, and any postoperative complication (vulvar wound dehiscence, inguinal wound dehiscence, cellulitis, lymphangitis, lymphoceles, and hematoma) were recorded. Leg measurements were taken preoperatively and during postoperative follow-up until 6 months to evaluate lymphedema. A total of 19 patients were enrolled and 38 inguinofemoral dissections were performed. There was no significant difference between the investigational and control arm in the amount of drainage volume (p = 0.976), and duration of drain placement (p = 0.793). The postoperative complications, excluding lymphedema, were 10/19 (53%) in investigational arm and 9/19 (47%) in control arm (p = 0.74). At the end of follow-up, the prevalence of grade 1 lymphedema was 44.4% and 50% in investigational and control arm, respectively (p = 0.744); grade 2 and 3 lymphedema had a prevalence of 33.3% in both arms (p = 1). Application of TachoSil® does not seem to improve postoperative lymphorrhagia nor to reduce the incidence of postoperative complications in patients undergoing inguinofemoral lymphadenectomy for vulvar cancer. Considering this point, it would be useful to identify additional strategies in inguinofemoral dissection for the prevention of these complications.

Objective To determine the efficacy of the addition of an ultrasound of the groins in routine follow up of women with vulvar squamous cell carcinoma (SCC) after a negative sentinel lymph node (SLN). Design Prospective single‐centre study. Setting A tertiary expert oncology centre for the treatment of vulvar cancer. Population All women with vulvar SCC with a negative SLN, treated between 2006 and 2014. Methods We prospectively collected data of 139 women with vulvar SCC treated with an SLN procedure. We analysed data of 76 patients with a negative SLN. Three‐monthly follow‐up visits consisted of physical examination combined with an ultrasound of the groins by a radiologist. Main outcome measures The diagnostic value of ultrasound in the follow up of women with vulvar SCC with a negative SLN during the first 2 years after treatment. Results During a routine visit, two asymptomatic isolated groin recurrences were detected. Both patients were treated by inguinofemoral lymphadenectomy and adjuvant radiotherapy and are alive without evidence of disease 39 and 120 months after diagnosis. In total, 348 ultrasounds and 29 fine‐needle aspiration were performed. The sensitivity of ultrasound to detect a groin metastasis was 100% (95% CI 16–100%), and specificity was 92% (95% CI 89–95%). Conclusions Routine follow up including ultrasound of the groin led to early detection of asymptomatic isolated groin recurrences. Further research is necessary to determine the exact role of ultrasound in the follow up of patients with vulvar SCC with a negative SLN. Tweetable abstract Routine follow up including ultrasound of the groin led to early detection of asymptomatic isolated groin recurrences., Tweetable abstract Routine follow up including ultrasound of the groin led to early detection of asymptomatic isolated groin recurrences.

Inguinofemoral lymphadenectomy (IFL) is included in the standard surgical management of early-stage vulval cancer (VC) but is often accompanied by surgical complications. Efforts have been made to limit the postoperative morbidity by adopting more conservative IFL techniques without compromising the surgical outcomes. Saphenous vein (SV) preservation during IFL for VC appears to reduce the incidence of postoperative complications including lymphedema. To ascertain the efficacy of SV preservation, we aimed to revisit the impact of SV preservation on short-term per groin complications by updating on a previous meta-analysis to further guide current clinical practice.A systematic literature review was conducted to identify studies that reported postoperative complications following IFL with SV preservation and controls (SV ligation during IFL) in VC patients. We included articles in English language and avoided date restrictions. Direct-comparison meta-analysis was performed between the use of SV preservation and SV ligation for the short-term outcomes of lymphedema, cellulitis, and wound dehiscence/breakdown. Fixed- and random-effects models were fitted to calculate the odds ratios (ORs) and 95% confidence intervals (CIs).Five studies were included in the final analysis. Direct-comparison per-groin meta-analysis between SV preservation and SV ligation significantly decreased the odds for developing lymphedema (OR, 0.363; 95% CI, 0.228-0.578; P0.001), cellulitis (OR, 0.481; 95% CI, 0.28-0.825; P = 0.008), and wound dehiscence/breakdown (OR, 0.296; 95% CI, 0.191-0.458; P0.001). When SV sparing was clearly the sole intervention, lymphedema was the only complication in which the positive effect of SV sparing is exerted (OR, 0.28; 95% CI, 0.149-0.526; P0.001).This per groin meta-analysis updates on the current evidence suggesting the SV sparing improves postoperative outcomes following IFL in VC patients. Where sentinel biopsy is not indicated, this risk-reducing strategy should be considered in selected VC patients undergoing IFL until a multicenter randomized controlled trial becomes available.

INTRODUCTION The aim of this study was to compare oncological outcomes and morbidity in patients with early-stage vulvar cancer with negative sentinel lymph node (SLN) biopsy vs negative inguinofemoral lymphadenectomy (IFL). MATERIAL AND METHODS Study with retrospectively collected data in patients with squamous cell vulvar carcinomas ≤ 4 cm without suspected inguinofemoral lymph node metastases. Only patients with negative nodes after histopathology procedure were followed. Patients who underwent only SLN were compared with patients who underwent IFL ± SLN to compare recurrences, survival rates and morbidity. RESULTS Ninety-three patients were eligible for follow up: 42 with negative SLN and 51 with negative IFL ± SLN. The median follow-up period was 60.4 months (range 6.7-160.7). The rate of isolated first groin recurrence was 4.8% in patients with negative SLN and 2.0% in patients with negative IFL ± SLN (P = 0.587) and the rates of first isolated local recurrence were 28.6% and 31.4%, respectively (P = 0.823). Only 1 patient (2.4%) in the group of negative SLN had distant recurrence. The disease-specific survival rate at 5 years was 83.3% in the negative SLN group and 92.2% in the negative IFL ± SLN group (P = 0.214). We observed a higher rate of wound breakdown and infection after IFL than SLN biopsy (17.6% vs 10.6%; P = 0.020) and lymphedema (33.3% vs 0%; P

Inguinal lymph node (LN) metastasis is a crucial prognostic factor in vulva carcinoma. The aim of this study was to determine the prognostic value of the number of resected LNs in patients with vulvar carcinoma on recurrence rates. This retrospective study includes patients with vulvar squamous cell carcinoma who underwent inguinofemoral lymphadenectomy (IFL) between 1998 and 2011. Dissected groins were stratified by the number of removed lymph nodes (

Background: We aimed to determine the frequency of early and late complications following groin surgery for vulvar cancer and analyze possible risk factors. Materials and Methods: This retrospective cohort study included 99 women who underwent for vulvar cancer. The early (≤1 month) complications were wound infection, breakdown and lymphocyst and late (>1 month) complications were lower limb lymphedema, incontinence and erysipelas. The risk factors for developing each of the complications were analyzed with regression analysis. Results: In the entire cohort, 29 (29.3%) women experienced early and 12 (12.1%) had late complications. Wound complications including infection and breakdown were the leading early complications (23.2%). In the multivariate analysis, both obesity (body mass index ≥30 kg/m2 ) and advanced age (≥65 years) were found as independent predictive factors for early complications. Obese women of advanced age had 6.32 times more risk of experiencing any of the early complications, when compared to non-obese and young women (55.6% vs 8.7%). The most common late complication was lower limb lymphedema (10.1%) that was more frequently seen in young women. However, neither age nor lymph node count were significantly associated with the occurrence of lower limb lymphedema. Conclusions: More than 40% of the women suffered from postoperative complications after inguinofemoral lymphadenectomy in the current study. While advanced age and obesity were the significant predictors for any of the early complications, there was no identified risk factor for lower limb lymphedema.

Two prospective, multicenter clinical trials have demonstrated the feasibility and reproducibility of sentinel lymph node (SLN) biopsy as part of the standard management of early-stage vulvar carcinoma. On the basis of the results of these trials, many gynecologic oncologists have incorporated SLN biopsy for vulvar cancer into their practice. Studies have further shown that SLN biopsy is associated with better quality of life than full lymphadenectomy, is more cost-effective than full lymphadenectomy, and improved pathologic evaluation. A large observational study is currently evaluating the outcomes of patients with early-stage vulvar cancer according to the results of their SLN biopsy and the approach to their care; this study may confirm that full inguinofemoral lymphadenectomy is no longer necessary in most patients with this disease. Here, we review the published data supporting SLN biopsy as part of the standard of care for women with early-stage vulvar cancer and discuss future considerations for the management of this disease. (C) 2015 Elsevier Inc. All rights reserved.

AimThe aim of this study was to evaluate if the lymph node count from inguinofemoral lymphadenectomy impacted the risk of isolated groin recurrence in patients with node-negative squamous cell vulvar cancer.Materials and MethodsThis is a retrospective cohort study of women with squamous cell vulvar cancer (stage IB–II according to the 2009 Revised International Federation of Gynecology and Obstetrics staging system) who underwent primary radical vulvar surgery and groin lymphadenectomy between January 2005 and December 2014. Patients' sociodemographic characteristics, the disease characteristics, the number of nodes removed from each groin, and the oncologic outcome were evaluated. A cutoff value of at least 6 nodes removed from each groin was used to define the adequacy of inguinofemoral dissection.ResultsSeventy-six patients, fulfilling the study inclusion criteria, were considered. The mean number of nodes removed (bilaterally) was 14.5 (±5.3, SD), with a range of 2 to 29 nodes. Thirty-three women (43.4%) had less than 6 nodes removed from each groin. In the whole study cohort, 4 cases of isolated groin recurrence (5.3%) were detected, and all these recurrences developed in patients with less than 6 nodes removed. Considering the demographic, clinical, and histopathological characteristics potentially related to the risk of groin recurrence, only the number of nodes removed showed a significant correlation.ConclusionsWomen treated for vulvar cancer in which less than 6 nodes are removed from each groin are at higher risk of groin recurrence.

ObjectiveThe aim of this study was to prospectively monitor the patients’ quality of life (QoL) after vulvar cancer surgery.DesignThe design was prospective clinical study.SettingThe study was set in the Department of Obstetrics and Gynecology, 2nd Medical Faculty of the Charles University and University Hospital Motol, Prague, Czech Republic.MethodsA group of 36 patients underwent vulvar cancer surgery: 24 patients were subject to inguinofemoral lymphadenectomy (RAD) and 12 to sentinel lymph node biopsy. To evaluate QoL, the European Organisation for Research and Treatment of Cancer, QoL questionnaires (QLQ-C30 and QLQ-CX24) were administered to patients before and 6 and 12 months after surgery.ResultsIn patients with vulvar cancer after inguinofemoral lymphadenectomy, increased fatigue and impaired lymphedema were observed. In the group of patients after sentinel lymph node biopsy, none of the QoL variables worsened postoperatively. Comparing both groups 12 months after surgery, the RAD group had significantly worse outcomes in body image and cognitive functioning than the sentinel lymph node biopsy group.Patients in the RAD group, who received adjuvant radiotherapy (n = 13), had worse QoL in symptom experience (P < 0.05) at 6 and 12 months after the surgery than patients without radiotherapy (n = 11).ConclusionsLess radical surgery showed objectively better QoL results.

ObjectiveSentinel lymph node biopsy has been widely adopted in the surgical management of women with early-stage vulvar cancer, but many patients require inguinofemoral lymphadenectomy (IFL). Following IFL, many surgeons drain the groin to prevent lymphocyst formation despite a lack of evidence to support this practice. Our objective was to investigate whether groin drains after IFL are associated with reduced postoperative morbidity in women undergoing surgery for vulvar cancer.MethodsA retrospective cohort study of women diagnosed as having primary vulvar cancer who underwent vulvectomy/radical local excision and unilateral or bilateral IFL was conducted. Cases were ascertained from the weekly outcome reports of a statewide tertiary gynecologic oncology tumor board. Data including postoperative outcomes were abstracted from medical records. Patients were stratified into 1 of 2 groups according to whether a groin drain had been used.ResultsSeventy-one patients were included. Inguinal drains were used in 48 patients (67.6%) and 23 patients (32.4%) did not have their groin wound(s) drained. The most common postoperative complications recorded were wound infection (59.2%), groin lymphocyst (32.4%), and cellulitis (25.4%). The mean length of hospital admission was 11.5 days (2–40 days). Compared with patients in whom inguinal drains were placed, those in the “no drain” group had a significantly lower incidence of postoperative groin cellulitis (8.7% vs 25.4% P = 0.039). No significant differences were observed between patients in the “drain” and “no drain” groups in lymphocyst formation, wound infection, return to the operating room, duration of hospital stay, readmission post-discharge, and lower-limb lymphedema.ConclusionsIn this study of patients undergoing inguinofemoral dissection for primary vulvar cancer, postoperative cellulitis occurred less frequently in patients without an inguinal drain. The incidence of other postoperative complications was no different whether or not a groin drain was used. Prospective studies may be warranted.

Lymph node metastasis has been shown to represent the most significant prognostic factor in vulvar carcinoma. Because only 25% to 35% of patients with early stage disease have lymph node metastases, a significant 65% to 75% possibly do not benefit from elective inguinofemoral lymphadenectomy considering the related morbidities of wound infection, breakdown, and lower limb lymphedema. This review article aims to present and summarize the evidence available with regard to sentinel lymph node (SLN)-guided management of vulvar carcinoma.A literature search was performed in MEDLINE resources using the subject headings "vulvar neoplasms," "sentinel lymph node," "sentinel lymph node biopsy," and "lymphatic metastasis." This search returned 886 articles that were published through January 2017. Prospective studies investigating sentinel node identification techniques and their impact on vulvar cancer management and prognosis were considered. Case reports were excluded from the review.Technetium-99-m-labeled nanocolloid with or without blue dye and more recently indocyanine green fluorescence have been the main techniques used for SLN identification in vulvar carcinoma. Radioisotope and near-infrared techniques have been shown to be superior to blue dye particularly with midline lesions that drain bilaterally or that drain directly to a deep pelvic node. Patients with a small unifocal primary tumor (4 cm) and no obvious preoperative metastasis have been shown to have low groin recurrence rates and excellent disease-specific survival rates with minimal treatment-related morbidity when undergoing SLN biopsy-guided management.Sentinel lymph node biopsy-guided management seems to be safe when restricted to International Federation of Gynecology and Obstetrics IB to II cases where tumors are unifocal, less than 4 cm in size, and when there is no evidence of lymph node metastasis on clinical/radiological assessment. This reduces operative morbidity in this cohort of patients.

Background:The purpose of this study was to determine the accuracy of sentinel lymph node (SLN) biopsy with technetium 99 (99mTc) and/or blue dye-enhanced lymphoscintigraphy in vulval cancer.Methods:Sensitive searches of databases were performed upto October 2013. Studies with at least 75% of women with FIGO stage IB or II vulval cancer evaluating SLN biopsy with 99mTc, blue dye or both with reference standard of inguinofemoral lymphadenectomy (IFL) or clinical follow-up were included. Meta-analyses were performed using Meta-Disc version 1.4.Results:Of the 2950 references, 29 studies (1779 women) were included; most of them evaluated 99mTc combined with blue dye. Of these, 24 studies reported results for SLN followed by IFL, and 5 reported clinical follow-up only for SLN negatives. Pooling of all studies was inappropriate because of heterogeneity. Mean SLN detection rates were 94.0% for 99mTc, 68.7% for blue dye and 97.7% for both. SLN biopsy had pooled sensitivity of 95% (95% CI 92-98%) with negative predictive value (NPV) of 97.9% in studies using 99mTc/blue dye, ultrastaging and immunohistochemistry with IFL as reference. Pooled sensitivity for SLN with clinical follow-up for SLN-negatives was 91% (85-95%) with NPV 95.6%. Patients undergoing SLN biopsy experienced less morbidity than those undergoing IFL.Conclusions:Sentinel lymph node biopsy using 99mTC, blue dye and ultrastaging with immunohistochemistry is highly accurate when restricted to carefully selected patients, within a rigorous protocol, with close follow-up and where sufficient numbers for learning curve optimisation exist. Patients must make an informed choice between the slightly higher groin recurrence rates of SLN biopsy vs the greater morbidity of IFL. © 2014 Cancer Research UK. Funded by Health technology assessment, National Institute of Health Research, United Kingdom – project number 09/112/03

Background: This study examines the cost-effectiveness of sentinel lymph node biopsy, a potentially less morbid procedure, compared with inguinofemoral lymphadenectomy (IFL) among women with stage I and stage II vulval squamous cell carcinoma. Methods: A model-based economic evaluation was undertaken based on clinical evidence from a systematic review of published sources. A decision tree model was developed with the structure being informed by clinical input, taking the perspective of the health-care provider. Results: For overall survival for 2 years, IFL was found to be the most cost-effective option and dominated all other strategies, being the least costly and most effective. For morbidity-free related outcomes for 2 years, sentinel lymph node (SLN) biopsy with 99mTc and blue dye and haematoxylin & eosin (H&E) histopathology, with ultrastaging and immunohistochemistry reserved for those that test negative following H&E is likely to be the most effective approach. Conclusion: SLN biopsy using 99mTc and blue dye with ultrastaging may be considered the most cost-effective strategy based on the outcome of survival free of morbidity for 2 years. The findings here also indicate that using blue dye and H&E for the identification of the SLN and the identification of metastasis, respectively, are not sensitive enough to be used on their own.

Item does not contain fulltext OBJECTIVE: Inguinofemoral lymphadenectomy for patients with vulvar squamous cell carcinoma is associated with a high incidence of postoperative wound complications, which may be influenced by inguinal drain management. The aim of this nationwide prospective study (MAMBO: Morbidity And Measurement of the BOdy) was to assess the feasibility and the incidence of complications after volume-controlled versus short drainage. METHODS: The MAMBO study consisted of two observational studies in all eight oncology centers in the Netherlands, conducted between 2012 and 2016. In the first study, the drain was removed when the production was

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.

Objective Women with locally advanced vulvar carcinoma have an excellent chance of a cure by undergoing a radical vulvectomy with an “en bloc” inguinofemoral lymphadenectomy, but the morbidity associated this surgical approach is substantial. To achieve an outcome comparable with the traditional radical method in terms of oncologic safety, and an improved post-operative quality of life, we modified the classic triple-incision technique and suggested it as an alternative for these patients. The aim of this study was to report this new technique. Study design Between January 2004 and November 2009, 24 patients with clinical stage T2 (≥4 cm) or T3 invasive vulvar cancer underwent surgical treatment with our modified triple incision technique. Their clinical and surgical complications and follow-up data were retrospectively reviewed. Results The post-surgical complications were as follows: lymphoedema in 45.8%, wound breakdown in 20.8% and cellulitis in 8.3%. After a median follow-up of 35.5 months, three (12.5%) patients developed a recurrence in the skin bridge (2/24, 8.3%) or lungs (1/24, 4.2%). All patients suffering from skin bridge recurrences were salvaged by local re-resection. Four (16.7%) cases of death were noted: three (12.5%) patients died of non-cancer-related diseases and one (4.2%) died from a multifocal pulmonary metastasis; no evidence of vulvar or groin disease was observed at these patients’ last follow-up. Conclusion The modified triple-incision technique described in this preliminary study appears to be safe, feasible and tolerable for patients with a locally advanced vulvar cancer, and offers an acceptable morbidity.

BackgroundLower-limb lymphedema is one of the most disabling adverse effects of vulvar cancer surgery. Multifrequency Bioelectrical Impedance Analysis (MFBIA) is a modern noninvasive method to detect lymphedema. The first aim of this study was to prospectively determine the prevalence of secondary lower-limb lymphedema after surgical treatment for vulvar cancer using objective methods, circumference measurements and MFBIA technique. The second aim was to compare quality of life (QoL) before and 6 months after vulvar surgery.MethodsTwenty-nine patients underwent vulvar cancer surgery in our study: 17 underwent inguinofemoral lymphadenectomy (RAD), and 12 underwent sentinel lymph node biopsy (CONS). Patients were examined before and 6 months after vulvar surgery by measuring the circumference of the lower limbs and with MFBIA. A control group of 27 healthy women was also measured. To evaluate QoL, the European Organisation for Research and Treatment of Cancer (EORTC) QoL questionnaires (QLQ-C30 and QLQ-CX24) were administered to patients before and 6 months after surgery.ResultsUsing circumference measurement, 9 lymphedemas (31%) were diagnosed: 3 (25%) in the CONS and 6 (37.5%) in the RAD group (P= 0.69). After vulvar surgery, patients in the RAD group reported more fatigue and worsening of physical and role functioning. When comparing both groups, the RAD group had significantly worse parameters in social functioning, fatigue, and dyspnea.ConclusionsLower radicality in inguinofemoral lymphadenectomy shows a trend toward lower morbidity and significantly improves QoL. Multifrequency Bioelectrical Impedance Analysis was tested in these patients as a noninvasive, objective method for lymphedema detection. Detection of lymphedema based on subjective evaluations proved to have an unsatisfactory sensitivity. Less radical surgery showed objectively better results in QoL.

Introduction Restricting inguinofemoral lymphadenectomy to patients with malignant nodes would reduce treatment-related morbidity in vulval cancer patients. A prospective study was conducted to determine the diagnostic accuracy of the Sentinel Lymph Node (SLN) procedure in vulval cancer patients referred following either diagnostic or excision biopsy. Methods Patients with clinical stage I and II squamous cell carcinoma of the vulva underwent SLN identification with peri-scar/lesional injection of 99m Technetium-labelled nanocolloid (pre-operative lymphoscintigraphy and intra-operative use of a hand-held probe) and intra-operative blue dye. Radical excision of the vulval tumour or scar and formal inguinofemoral lymphadenectomy was then performed as necessary. SLN were processed separately and further examined at multiple levels to exclude micrometastases (H&E/cytokeratin staining) if negative on routine analysis. Clinical follow-up was carried out to identify and treat recurrences or treatment-related morbidity. Results Thirty-two women took part. Fifteen were referred following excision biopsy and seventeen following diagnostic biopsy of their primary vulval tumour. One or more SLN was successfully detected intra-operatively in 31 patients (97%) and 45 groins. An SLN could not be identified intra-operatively in one case (re-excision of scar). On average, more SLN were identified in patients with their primary vulval lesion in situ compared with those whose tumour had previously been excised (2.6 vs. 1.8, p = 0.03). Midline tumours were more likely (15/17) than lateral tumours (1/15) to have bilateral SLN identified pre-operatively. Two patients with midline tumours previously excised had unilateral SLN. Seven patients (23%) and ten groins had inguinofemoral lymph node metastases. The SLN procedure correctly identified inguinofemoral metastases in six patients (nine groins). In one case (midline tumour, re-excision of scar) the sentinel node was positive on one side but false negative on the other. Conclusions The SLN procedure may be used to identify malignant groins in selected patients with vulval cancer. The extent to which previous vulval surgery might influence the accuracy of the SLN procedure deserves further investigation.

Objective: To assess the value of preoperative lymphoscintigraphy, and to evaluate the validity and feasibility of the sentinel node (SN) procedure in vulvar carcinoma. Study design: Retrospective clinical and histopathological review of 77 patients with invasive squamous cell carcinoma in vulva who were treated at Karolinska University Hospital Stockholm, Sweden, from 2000 to 2007. The patients underwent SN mapping preoperatively with radioactive tracer and blue dye (n = 60) or only blue dye (n = 17). The SN was removed separately followed by complete inguinofemoral lymphadenectomy. Results: The relation between SNs detected on the scintigram and those found during surgery showed good agreement using weighted kappa. The detection rate of SN was 98% for radioisotope plus blue dye, and 94% for blue dye alone. Two cases of false negative SN (false negative rate 2.7%) were found, both with large midline tumors. Conclusion: Preoperative scintigram is a valuable help to identify and localize the SNs and gives the best estimate of the accurate number but cannot determine if unilateral or bilateral groins should be explored in cases of midline tumors. Our results are in favor of using radioisotope and blue dye to identify the SNs. This study support previous reports that the method is not recommended for tumors larger than 40 mm to optimize detection of SN and minimize the false negative detection rate.

Contains fulltext : 89256.pdf (Publisher’s version ) (Closed access) BACKGROUND: Currently, all patients with vulvar cancer with a positive sentinel node undergo inguinofemoral lymphadenectomy, irrespective of the size of sentinel-node metastases. Our study aimed to assess the association between size of sentinel-node metastasis and risk of metastases in non-sentinel nodes, and risk of disease-specific survival in early stage vulvar cancer. METHODS: In the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V), sentinel-node detection was done in patients with T1-T2 (