Inguinofemoral Lymphadenectomy Research Articles

Update on the Sentinel Node Procedure in Vulvar Cancer.

Early-stage vulvar cancer is managed by a local excision of the primary tumor and, if indicated, a sentinel node (SN) biopsy to assess the need for further groin treatment. With the SN procedure, many patients can be treated less radically and will experience less complications and morbidity compared with an inguinofemoral lymphadenectomy (IFL). Still, the SN procedure can be further optimized. Different tracers for detecting the SN are being investigated, aiming to optimize detection rates and decrease the burden of the procedure and short-term complications. Until now, no standardized protocols exist for the pathologic workup of the SN, possibly leading to discrepancies in detection of metastases between institutes using different methods. New techniques, such as one-step nucleic amplification, seem to have potential in accurately detecting metastases in other cancers, but have not yet been investigated in vulvar squamous cell carcinoma (VSCC). Furthermore, several studies have investigated the possibility to broaden the indications for the SN procedure, such as its use in recurrent disease, larger tumors, or multifocal tumors. Although these studies show encouraging results, cohorts are small and further studies are needed. Prospective studies are currently investigating these subgroups. Lastly, several studies investigated optimization of groin treatment of patients with a metastatic SN. Inguinofemoral radiotherapy is a good alternative to IFL in patients with micrometastases in the SN, with comparable efficacy and less treatment-related morbidity. Reduction of the radicality of groin treatment is also possible in other ways, such as omitting contralateral IFL in patients with lateralized tumors and a unilateral metastatic SN. In conclusion, the SN procedure is an established procedure in early-stage VSCC, although optimization of the technique, pathologic workup, indications, and treatment in the setting of metastatic disease are the subject of ongoing research.

Advanced Squamous Cell Carcinoma of the Vulva in a 54 Year Old Postmenopausal Woman in the South- South Region of Nigeria- A Case Report

A case of a 54-year old post-menopausal Nigeria woman presenting with a huge fungating advanced squamous cell carcinoma of the vulva that measured 22.1cm x 12.3cm x 5.5cm. She presented to the gynaecological clinic of our facility following a referral from a private clinic in Benin City. At presentation, she had a 3-year history of progressive vulva swelling which later became ulcerated associated with itching and pains. At surgery, there was a huge vulva mass measuring 22.1 x12.3 x5.5cm and weighed 6.4kg. She had a radical vulvectomy with inguinofemoral lymphadenectomy and was discharged home on the seventh day post-operative day in a stable condition. Histopathological examination revealed advanced squamous cell carcinoma of the vulva. This is one very rare huge advanced vulva cancer in a postmenopausal women reported in our locality and managed in our institution.

Sentinel lymph node procedure in early-stage vulvar cancer: Correlation of lymphoscintigraphy with surgical outcome and groin recurrence

IntroductionIn early-stage vulvar squamous cell carcinoma (VSCC) a sentinel lymph node (SLN) procedure is regarded successful if at least one SLN is removed with minimal residual radioactivity. An inguinofemoral lymphadenectomy is considered if not all SLNs visualized on lymphoscintigraphy can be found, with subsequent increased morbidity. We correlated lymphoscintigraphy findings with surgical outcome and groin recurrence with focus on number of SLNs found. MethodsThis study concerns a retrospective cohort of 171 women treated for early-stage VSCC who underwent a SLN procedure between 2000 and 2020. The risk of groin recurrence was compared after either a successful or complete SLN procedure, i.e. removal of all SLNs that were visualized on lymphoscintigraphy. ResultsIn 13 (7.6%) groins of 171 patients SLN visualization on lymphoscintigraphy failed. In 230 of the 246 (93.5%) groins in which a SLN was visualized, at least one SLN was found during surgery. In 224 of the 246 (91.1%) groins the SLN procedure was regarded either successful (n = 14) or complete (n = 210). An isolated groin recurrence was documented in 5 out of 192 (2.6%, 95%-CI; 0.34 to 4.9) SLN-negative groins after a median follow-up of 47.0 months. All recurrences were noted in the complete SLN group (5/180 groins). The difference with the successful SLN group (0/12 groins) was not significant. ConclusionRisk of groin recurrence was 2.6% after SLN negative biopsy in early-stage VSCC. The risk appeared not increased if at least one SLN was found with minimal residual radioactivity, in case more SLNs were visualized on lymphoscintigraphy.

Vulvar basal cell carcinoma: A case report and literature review

Basal cell carcinoma (BCC), is the most prevalent skin cancer with favorable prognosis, and lymphatic or hematogenous metastases are quite rare. Here we report an uncommon case of vulvar BCC. A 68-year-old woman with 5-year history of an asymptomatic lump on the right side of the vulva. The patient complained of progressive itching, pain, and color changes to brown for 3 months before visiting the clinic. Excisional biopsy revealed the lesion to be a BCC. After thorough negative metastasis work up the patient underwent a bilateral inguinofemoral lymphadenectomy and a wide local excision with a one-centimeter margin and final histology report confirmed the diagnosis of BCC. (HPV DNA and viral markers were negative, the bimanual exam was normal, both colposcopy and vaginoscopy were normal. There was no acetowhite lesion). To avoid delayed diagnosis, any persistent lesion even asymptomatic, in the vulvar region, especially when pigmented, irritating, or expanding in size, should be biopsied and investigated histologically, regardless of the patient's age. Any persistent lesion in the vulvar region, especially when pigmented, irritating, or expanding in size, should be biopsied and investigated histologically, regardless of the patient's age.

Neuroendocrine carcinoma of the vulva, a rare entity. Report of the first case in Venezuela.

Vulvar cancer represents 1% of cancers in women; vulvar neuroendocrine carcinoma is extremely rare, with less than 20 published cases. Its behavior is very aggressive, producing early local recurrences, lymph node and distant metastases. The case of a 60-year-old patient who consulted for a vulvar lesion of 6 months of evolution, with extension to the lower third of the urethra and vagina and left inguinal nodal plastron is described. The vulvar biopsy reported malignant round cell neoplasm and the immunohistochemistry result was compatible with neuroendocrine carcinoma. She received concurrent chemotherapy and radiotherapy, evidencing a complete response in the vulva and a partial response in the inguinal region.Later, bilateral inguinofemoral lymphadenectomy was performed. Neuroendocrine carcinoma of the vulva should be considered when managing malignant vulvar pathology, timely diagnosis requires histology and immunohistochemistry to establish an adequate prognosis and treatment.

Positive p16 Immunostaining Is an Independent Prognostic Variable for Disease-free Survival and Overall Survival in Patients With Squamous Cell Carcinoma of the Vulva Treated With Radical Surgery and Inguinofemoral Lymphadenectomy: An Italian Single Center Retrospective Study.

The expression of the cyclin-dependent kinase inhibitor p16 correlates with the presence of human papillomavirus. The purpose of this investigation was to assess the prognostic relevance of p16 expression in patients with vulvar squamous cell carcinoma (VSCC) treated with radical surgery followed by adjuvant (chemo) radiation in selected cases. Seventy-eight patients were analyzed retrospectively. Positive p16 immunostaining was detected in 19 (24.4%) patients. Five-year disease-free survival (DFS) and 5-year overall survival (OS) were better in p16-positive compared to p16-negative patients (83.9% versus 37.3% p=0.002 and 91.7% versus 57.6%, p=0.003, respectively). p16 expression retained prognostic relevance at multivariate analysis for both DFS and OS. p16 expression was detected in 24.4% of patients with VSCC and was found to be an independent prognostic variable for both DFS and OS.

The modified 5-item frailty index is a predictor of post-operative complications in vulvar cancer: a National Surgical Quality Improvement Program (NSQIP) analysis

ObjectiveTo determine whether frailty is associated with post-operative complications following surgery for vulvar cancer.MethodsThis retrospective study used a multi-institutional dataset from the National Surgical Quality Improvement Program (NSQIP) database (2014–2020)...

Video endoscopic inguinofemoral lymphadenectomy in penile cancer

Background. Dissection of inguinal lymph nodes is an important method of treatment of invasive and locally advanced penile cancer. Unfortunately, the procedure is associated with very high complication rate exceeding 50 %.Aim. To perform retrospective comparative analysis of oncological outcomes, intraoperative and early postoperative complications of open and endoscopic inguinofemoral lymphadenectomy in treatment of patients with penile cancer.Materials and methods. Treatment outcomes of 64 patients with penile cancer who underwent open or video endoscopic lymphadenectomy were analyzed. Primary and secondary surgical treatment outcomes were evaluated.Results. Open inguinofemoral lymphadenectomy was performed in 54 patients, video endoscopic in 10. Analysis of primary surgical results showed a significant (3-fold) reduction of the duration of lymphorrhea and the duration of hospitalization (2-fold) in patients of the video endoscopic lymphadenectomy group. There was no difference in the number of removed lymph nodes in the two types of surgeries. Average operative time for video endoscopic lymphadenectomy was 15–20 % longer than operative time of open intervention. Analysis of safety indicators showed that during open surgery, the frequency of wound infection was 24 %, skin flap necrosis – 55.5 %, wound dehiscence – 52 %, lymphedema – 15 %. No such complications were observed in lateral video endoscopic inguinofemoral lymphadenectomy.Conclusion. Video endoscopic inguinofemoral lymphadenectomy has significant advantages compared to open method in terms of reduction of the rate of surgical complications and duration of hospitalization.

A comparison of ICG-NIR with blue dye and technetium for the detection of sentinel lymph nodes in vulvar cancer.

The sentinel lymph node (SLN) procedure for vulva cancer is a safe alternative to a radical inguino-femoral lymphadenectomy (IFLN) for small unifocal tumours. SLN evaluation through biopsy and ultra-staging has helped gynaecological oncology surgeons improve operative morbidity with no cost to oncologic safety. Established techniques for groin SLN detection and excision in vulvar cancer use 99mTc-nanocolloid radiotracer and blue dye (BD) for identification of the SLN. Indocyanine green (ICG)-near infrared (ICG-NIR) techniques for SLN mapping have proven utility in other gynaecological cancer sites and is gaining interest as a technique for SLN mapping in vulvar cancer METHODS: Fifty consecutive patients with unifocal vulvar squamous cell cancers of <40mm lateral diameter and with depth of invasion > 1mm underwent SLN mapping and excision using a combination of 99mTc-nanocolloid, BD and ICG. SLN detection results were recorded on a per-patient and per-groin basis. The success rates SLN for detection by individual tracer substance or combinations of tracer were determined by presence of one or more tracer, detectable in the SLN specimen. 92% of patients had a successful SLN procedure. The per-groin detection rate was 84%. All successfully mapped SLN were identified with the combination of ICG-NIR and 99mTc-nanocolloid compared to 69% with BD 99mTc-nanocolloid. Success rates for the SLN procedure were not dependent on prior excision of the primary lesion or operator experience. Incorporation of ICG-NIR into standard SLN mapping protocols may allow for the abandonment of routine use of BD and its poor side effect profile.

Groin Surveillance by Serial Ultrasonography Rather Than Sentinel Node Biopsy or Inguinofemoral Lymphadenectomy for Patients with Vulvar Cancer: A Pilot Study.

A pilot study was conducted to determine whether 3-monthly groin ultrasonography could eliminate groin dissection after a negative bilateral groin ultrasound in three groups of patients: (i) Those with a unifocal stage 1B squamous cell carcinoma of up to 20 mm in diameter. (ii) Those with an ipsilateral squamous cell carcinoma of any size which extended to within 1 cm either side of the midline. These patients underwent ipsilateral inguinofemoral lymphadenectomy and ultrasonic surveillance of the contralateral groin. (iii) Patients with multifocal invasive lesions with the largest individual focus 20 mm or less in diameter. Three additional patients were added because they either refused groin dissection or were considered unfit for surgery. All ultrasonically positive nodes were confirmed histologically. Thirty-two patients were entered, and no patients were lost to follow-up. Forty-three groins were followed. With a median follow-up of 37 months, three positive nodes (9.4%) were detected. One patient died of her recurrence (3.1%), and 39 groins (90.7%) were preserved. The overall sensitivity of ultrasonic surveillance was 100% (95% CI: 44-100%), with a specificity of 97% (95% CI: 83-99%) and a negative predictive value of 100% (95% CI: 88-100%). This pilot justifies a larger study on serial ultrasonography in lieu of groin dissection in selected patients with vulvar cancer.

Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: GROningen INternational Study on Sentinel nodes in Vulvar cancer III (GROINSS-V III/NRG-GY024)

BackgroundStandard treatment of early-stage vulvar cancer is a radical, wide, local excision of the primary tumor and a sentinel lymph node (SLN) procedure for the groins. An inguinofemoral lymphadenectomy is...

Vulvar cancer in young woman—case report

Vulvar cancer is rare with incidence of 45,240 new cases globally which account for 4% of all genitourinary tract neoplasma. It is considered as a postmenopausal disease, however incidence age has decreased over the years because of high prevalence of persistent high-risk human papillomavirus (hrHPV) infection. Vulvar cancer diagnosis in young women is challenging. Prompt and adequate diagnosis, and treatment can ensure the life quality. A 23 years old patient was admitted to Department of Operative Gynecology for treating malignant vulvar neoplasma. She was reffered to our clinic for electrocauterization after being diagnosed of condylomata accuminata. Physical examination revealed vulva atrophy with smooth discolored skin patches on both sides. A 2 cm exophytic lesion was noted ~10 mm from clitoris on right labia majora. Multifocal biopsy was performed for suspect finding which proved invasive vulvar squamous keratinizing cancer. Positron emission tomography-computed tomography (PET/CT) scan showed individual lymph nodes on right inguinofemoral region which were moderately metabolically active. Wide excision of cancer was performed with unilateral inguinofemoral lymphadenectomy. Macroscopic evaluation of entire specimen depicted 2.4 × 2.2 × 0.5 cm HPV associated invasive vulvar squamous keratinizing cancer, vulvar high grade squamous intraepithelial lesion (vHSIL) or usual type vulvar intraepithelial neoplasia (uVIN3) and lichen sclerosus. Healthcare professionals in primary care centers should be adequately trained, aware of and familiar with vulvar malignancies in younger women despite their rarity. Early diagnosis can improve outcomes in vulvar cancer via reducing morbidity and mortality. The individualized surgical treatment is the preferred strategy for patients at present.

Inguinofemoral sentinel lymph node biopsy by scar injection in vulvar cancer: an assessment of feasibility and long-term outcomes

BackgroundPerforming inguinofemoral sentinel lymph node biopsy for vulvar cancer following a previous vulvar excision, often referred to as ‘scar injection’, is debated.ObjectiveTo assess the feasibility of sentinel lymph node biopsy...

Unilateral inguinofemoral lymphadenectomy in patients with early-stage vulvar squamous cell carcinoma and a unilateral metastatic sentinel lymph node is safe

ObjectiveOptimal management of the contralateral groin in patients with early-stage vulvar squamous cell carcinoma (VSCC) and a metastatic unilateral inguinal sentinel lymph node (SN) is unclear. We analyzed patients who participated in GROINSS-V I or II to determine whether treatment of the contralateral groin can safely be omitted in patients with a unilateral metastatic SN. MethodsWe selected the patients with a unilateral metastatic SN from the GROINSS-V I and II databases. We determined the incidence of contralateral additional non-SN metastases in patients with unilateral SN-metastasis who underwent bilateral inguinofemoral lymphadenectomy (IFL). In those who underwent only ipsilateral groin treatment or no further treatment, we determined the incidence of contralateral groin recurrences during follow-up. ResultsOf 1912 patients with early-stage VSCC, 366 had a unilateral metastatic SN. Subsequently, 244 had an IFL or no treatment of the contralateral groin. In seven patients (7/244; 2.9% [95% CI: 1.4%-5.8%]) disease was diagnosed in the contralateral groin: five had contralateral non-SN metastasis at IFL and two developed an isolated contralateral groin recurrence after no further treatment. Five of them had a primary tumor ≥30 mm. Bilateral radiotherapy was administered in 122 patients, of whom one (1/122; 0.8% [95% CI: 0.1%–4.5%]) had a contralateral groin recurrence. ConclusionThe risk of contralateral lymph node metastases in patients with early-stage VSCC and a unilateral metastatic SN is low. It appears safe to limit groin treatment to unilateral IFL or inguinofemoral radiotherapy in these cases.

Management of Early-Stage Vulvar Cancer.

Simple SummaryVulvar cancer is a rare gynecological malignancy that affects mainly postmenopausal women. Recently, however, an alarming increase in the rates among young women has been observed due to human papillomavirus infection. The standard treatment for vulvar cancer is surgery with or without radiotherapy as adjuvant treatment. In recent decades, sentinel lymph node biopsy has been included as part of the surgical treatment. Thus, our objective was to review and discuss the advances found in the literature about early-stage vulvar cancer. For this, we searched PubMed for publications in the English language. Relevant articles, such as the GROINS-V studies, and the GOG protocols, are presented in this review exhibiting the evolution of early-stage vulvar cancer treatment and the decrease in surgical morbidity rates.Vulvar cancer is a rare gynecological malignancy since it represents 4% of all cancers of the female genital tract. The most common histological type is squamous cell carcinoma (90%). This type can be classified into two clinicopathological subtypes according to the etiology. The first subtype is associated with persistent human papillomavirus infection and is usually diagnosed in younger women. The second subtype is associated with lichen sclerosus condition, and in most cases is diagnosed in postmenopausal women. Currently, an increase in first subtype cases has been observed, which raised the concern about associated mortality and treatment morbidity among young women. Vulvar cancer treatment depends on histopathology grade and staging, but surgery with or without radiotherapy as adjuvant treatment is considered the gold standard. In recent decades, sentinel lymph node biopsy has been incorporated as part of the treatment. Therefore, we sought to review and discuss the advances documented in the literature about vulvar cancer focusing on the treatment of early-stage disease. Relevant articles, such as the GROINS-V studies and the GOG protocols, are presented in this review. Additionally, we discuss key points such as the evolution of treatment from invasive surgery with high morbidity, to more conservative approaches without compromising oncologic safety; the role of sentinel lymph node mapping in the initial staging, since it reduces the complications caused by inguinofemoral lymphadenectomy; the recurrences rates, since local recurrence is common and curable, however, groin-associated, or distant recurrences have a poor prognosis; and, finally, the long-term follow-up that is essential for all patients.

Tumor stage-specific trends of sentinel lymph node biopsy for vulvar melanoma (406)

<b>Objectives:</b> Vulvar melanoma is a rare and understudied malignancy. Due to its poor prognosis, management has included vulvectomy and complete bilateral inguinofemoral lymphadenectomy. The Standard of care for cutaneous melanomas is to perform sentinel lymph node (SLN) biopsy during excision of intermediate thickness lesions. Lymph node dissection in the inguinofemoral region can result in significant morbidity; thus, the utilization of SLN biopsy for vulvar melanoma is under active investigation. The Standard of care regarding SLN biopsy for vulvar melanoma is not yet determined due to limited prospective data. The objective of this study was to examine the trends and outcomes related to SLN biopsy for vulvar melanoma in the United States according to the local tumor stage. <b>Methods:</b> This population-based retrospective cohort study utilized the National Cancer Institute's Surveillance, Epidemiology, and End Result program from 2004 to 2018. The study population included women with non-metastatic T1-4 stage vulvar melanoma who underwent vulvectomy and had data regarding the method of nodal evaluation. The exposure assignment was based on nodal evaluation: lymphadenectomy, SLN biopsy, or no surgical nodal evaluation. The main outcome was <i>(i)</i> temporal trends of lymphadenectomy or SLN biopsy based on T stage, assessed with a three-year time increment and the Cochrane-Armitage trend test, and <i>(ii)</i> overall survival related to SLN biopsy assessed with inverse probability of treatment weighting propensity score. <b>Results:</b> A total of 729 women with T1-4 vulvar melanoma were examined for analysis. For T1 disease (<i>n</i>=215), the utilization of SLN biopsy significantly increased from 16.7% to 38.9% (<i>p</i>=0.002) over time. For T2 disease (<i>n</i>=156) and T3 disease (<i>n</i>=120), the frequency of SLN biopsy was unchanged during the study period (T2 disease, 22.6% to 26.6%, <i>p</i>=0.279; and T3 disease, 27.3% to 37.0%, <i>p</i>=0.812). For T4 disease (<i>n</i>=238), there was a statistically significant increase in the number of women receiving SLN biopsy from 21.2% to 32.9% (<i>p</i>=0.042) during the study period. Across the four disease groups, the SLN biopsy and LND groups had comparable overall survival in the weighted models (all <i>p</i>>0.05). <b>Conclusions:</b> This large sample size, population-based study found an upward trend in performance of SLN biopsy in both T1 and T4 vulvar melanoma in the past decade in the United States. In T2 and T3 vulvar melanoma, SLN biopsy did not increase. While SLN biopsy is standard in T2-3 cutaneous melanoma, it appears to be less utilized in these tumor stages of vulvar melanoma. Given the significant morbidity associated with inguinal lymph node dissection, further research is warranted on whether these trends have truly resulted in decreased perioperative morbidity.

Gluteal Fold V-Y Advancement Flap for Genital Reconstruction following Radical Vulvectomy with Bilateral Inguinofemoral Lymphadenectomy in Vulvar Cancer: A Case Report

Background: Vulvar cancer is a rare malignancy representing about 4% of all genital cancers in women. Historically, the gold standard for treatment of squamous cell carcinoma of the vulva was en bloc radical vulvectomy with bilateral inguinofemoral lymphadenectomy. For the reconstruction the options are primary closure, skin grafts, or local and distant flaps. In this case we used the gluteal fold fasciocutaneous V-Y advancement flap that is sensate and thin with a reliable blood supply, can be advanced easily, and can be performed in a single-stage procedure. Care Report: We present a clinical case of an 82- year old female patient who had an exophytic vulvar lesion, which grew progressively with the histopathologic diagnosis of invasive vulvar squamous cell carcinoma. It was decided to perform radical vulvectomy with right unilateral lymphadenectomy and reconstruction with Gluteal Fold V-Y Advancement Flap. During the post-surgical period it recurred with wound dehiscence and finally skin necrosis developed in the area of the left thigh. Surgical debridement, escharectomy, harvesting and application of skin graft, and closure of the femoral hernia with omentum patch were performed with no associated complications. Follow-up was carried out during the next 3 months after surgery. She presented adequate evolution of the flap and left thigh area. Conclusions: The Gluteal Fold V-Y Advancement Flap is an excellent option for the reconstruction of the vulvovaginoperineal area after a radical vulvectomy. It provides us with a good prognosis and quality of life for the patient. Article Details Issue

Gluteal Fold V-Y Advancement Flap for Genital Reconstruction following Radical Vulvectomy with Bilateral Inguinofemoral Lymphadenectomy in Vulvar Cancer: A Case Report

Gluteal Fold V-Y Advancement Flap for Genital Reconstruction following Radical Vulvectomy with Bilateral Inguinofemoral Lymphadenectomy in Vulvar Cancer: A Case Report

Sentinel lymph node biopsy utilization in early-stage vulvar cancer: A National Cancer Database Study.

e17536 Background: Since 2012, sentinel lymph node biopsy (SLNB) has been considered equivalent in terms of survival to standard inguinofemoral lymphadenectomy (IFLD) in patients with early-stage vulvar cancer. Moreover, SLNB is associated with lower rates of postoperative short-term and long-term morbidity. However, uptake of SLNB has been limited and little information exists about factors associated with access to SLNB in vulvar cancer. Methods: Between 2012-2018, women with stage IB vulvar squamous cell carcinoma were identified using the National Cancer Database. Patient, facility, and disease characteristics were compared between patients who underwent SLNB versus IFLD. Multivariable logistic regression analyses, adjusted for patient, facility, and disease characteristics were used to evaluate factors associated with SLNB. Kaplan-Meier survival analysis using log rank test and Cox regression was performed. Results: Of the 3,454 patients, 1,094 (31.6%) did not undergo lymph node evaluation (LNE) and 2,360 (68.3%) underwent LNE, with 1,668 (82.0%) undergoing IFLD and 692 (29.3%) SLNB. On multivariable analysis, patients diagnosed between 2015-2018 were more likely to undergo SLNB than patients diagnosed 2012-2014 (OR 1.86, 95% CI 1.50-2.31). Patients residing in zip codes with the highest proportion of high school graduates were more likely to undergo SLNB than those residing in regions with lower levels of education (OR 2.00, 95% CI 1.28-3.13). Midwestern patients were less likely to undergo SLNB than those in the Northeast (OR 0.70, 95% CI 0.50-0.96). Hospital volume was significantly associated with SLNB rates, with low-volume hospitals defined as those performing 0-8 vulvectomies/year, moderate-volume performing 8-16, and high-volume performing 16-45. Moderate (OR 1.58, 95%CI 1.18-2.09) and high (OR 2.12, 95% CI 1.56-2.88) volume hospitals were associated with higher rates of SLNB compared to low-volume hospitals. Patients with tumors &gt; 3cm in size were less likely to undergo SLNB than those &lt; 1cm in size (OR 0.69, 95% CI 0.50-0.94). After controlling for patient and tumor characteristics, there was no difference in overall survival (OS) between patients who underwent SLNB and those who underwent IFLD with negative nodes (HR 0.90, 95% CI 0.70-1.15). Similarly, there was no difference in OS between patients who underwent SLNB (with or without subsequent IFLD) and those who underwent IFLD alone with positive nodes (HR 0.99, 95% CI 0.60-1.61). Conclusions: Utilization of SLNB in early-stage vulvar cancer continues to increase over time but significant variation in its use exists at the patient, hospital, and regional level. The lack of survival difference between the two procedures suggests overtreatment in the 71% of node-negative women who underwent IFLD. Further work is needed to de-escalate care that has previously been associated with worse postoperative outcomes in this population.

Trial in progress: Phase II activity trial of high-dose radiation and chemosensitization in patients with macrometastatic lymph node spread after sentinel node biopsy in vulvar cancer: Groningen International Study on Sentinel Nodes in Vulvar Cancer III (GROINSS-V III/NRG-GY024).

TPS5624 Background: Early stage invasive squamous cell carcinoma of the vulva is treated by radical excision of the primary tumor combined with a sentinel node (SN) procedure for the groins. GROINSS-VI and GOG-173 demonstrated that if there is no metastasis to the SN, then standard of care is observation. GROINSS-VII/GOG-270 demonstrated that micrometastatic disease (&lt;2mm) to the SN requires standard radiotherapy (50 Gy) without the need for an inguinofemoral lymphadenectomy (IFL). This study also found that patients with macrometastasis ( &gt; 2mm) required IFL in order to have an acceptably low groin recurrence rate. However, IFL is associated with significant morbidity such as lymphedema, wound healing issues, and recurrent infections. It is hypothesized that for those with macrometastasis ( &gt; 2 mm) in the SN, the efficacy of treatment can be increased by giving a higher dose of radiotherapy along with chemosensitization. Methods: This is an international multicenter single-arm phase II prospective clinical trial. The primary objective is to investigate the safety of replacing IFL by chemoradiation in early-stage vulvar cancer patients with a macrometastasis ( &gt; 2mm) and/or extracapsular extension in the SN. The primary endpoint is the groin recurrence rate in the first two years after primary treatment. Secondary endpoints are short and long-term morbidity associated with the SN procedure and chemoradiation and quality of life as measured by EORTC-QLQc30. Patients with invasive ( &gt; 1mm) squamous cell carcinoma of the vulva, stage T1, tumor size &lt; 4 cm diameter and no suspicious lymph nodes by imaging of the groins will proceed with SN detection. Institutions enrolling patients must demonstrate prior surgical experience with SN detection with the submission of at least 10 successfully completed cases in vulvar cancer. Patients with SN metastases &gt; 2mm and/or with extracapsular extension or those with &gt; 1 SN with micrometastases will be eligible for this study. Treatment will consist of chemoradiation with a dose of 56 Gy to the groin combined with weekly cisplatin 40 mg/m2 IV on days 1, 8, 15, 21 and 29 of radiotherapy. One hundred and fifty-seven patients in Europe, United States and Canada will be enrolled. The study includes continuous monitoring of groin recurrences with stopping rules. Results of this trial may be practice changing and eliminate the need for IFL in all women with clinically early stage vulvar cancer. The study is currently open for enrollment. Clinical trial information: NCT05076942.