Recurrent Vulvar Cancer Research Articles

Outcomes of groin recurrence in vulvar cancer after primary treatment with a sentinel lymph node procedure

Outcomes of groin recurrence in vulvar cancer after primary treatment with a sentinel lymph node procedure

Treatment of vulvar cancer recurrence with electrochemotherapy: a case-control study.

Electrochemotherapy (ECT) is a combined treatment method based on electroporation and simultaneous chemotherapy. In cases where radiotherapy has previously been used, surgery is often the only treatment option for vulvar cancer recurrence with potential resection of clitoris, vagina, urethra or anal sphincter. The unique advantage of ECT is its selectivity for cancer cells while sparing the surrounding healthy tissue. The aim of the study was to compare the ECT treatment of vulvar cancer recurrence for non-palliative purposes with surgical treatment. Eleven patients with single vulvar cancer recurrence were treated with ECT and followed up for 12 months. As a control group, 15 patients with single vulvar cancer recurrence were treated with wide local excision. The following data were collected, analyzed and compared: Age, body mass index, comorbidities, histological type, location and size of vulvar cancer recurrence, treatment history, details of procedures and hospital stay. The probability curves for local tumor control did not differ between the ECT group and the surgical group (p = 0.694). The mean hospital stay and the mean duration of procedure were statistically significantly shorter in the ECT group (p < 0.001). There were no statistically significant differences between the ECT and surgical groups in terms of mean body mass index, associated diseases, previous treatments, presence of lichen sclerosus, p16 status, gradus, anatomical site of the tumor, and type of anesthesia. In this case-control study, treatment of vulvar cancer recurrence with ECT for non-palliative purposes was comparable to surgical treatment in terms of effectiveness. The results need to be confirmed in larger randomized trials.

Pelvic Exenteration for Recurrent Vulvar Cancer: A Retrospective Study.

Pelvic exenteration (PE) is one of the most radical surgical approaches. In earlier times, PE was associated with high morbidity and mortality. Nowadays, due to improved selection of suitable patients, perioperative settings, and postoperative care, patients' outcomes have been optimized. To investigate patients' outcomes and identify possible influencing clinical and histopathological factors, we analysed 17 patients with recurrent vulvar cancer who underwent PE in our department between 2007 and 2022. The median age was 64.9 years, with a difference of 40 years between the youngest and the oldest patient (41 vs. 81 years). The mean overall survival time was 55.7 months; the longest survival time reached up to 164 months. The achievement of complete cytoreduction (p = 0.02), the indication for surgery (curative vs. palliative), and the presence of distant metastases (both p = 0.01) showed a significant impact on overall survival. The presence of lymphatic metastases (p = 0.11) seems to have an influence on overall survival (OS) time. Major complications appeared in 35% of the patients. Our results support the existing data for PE in cases of recurrent vulvar cancer; for a group of selected patients, PE is a treatment option with good overall survival times and acceptable morbidity.

Lymph node ratio as an indicator of nodal status in the assessment of survival and recurrence in vulvar cancer: A cohort study.

Inguinal lymph node (LN) metastasis and particularly the number of metastatic lymph nodes (NMLN) represent a determinant prognostic factor in vulvar squamous cell carcinoma (VSCC). However, the NMLN may be related to the number of removed LNs. Therefore, the lymph node ratio (LNR) reflects not only the burden of LN involvement but also the quality and extent of lymphadenectomy. To investigate the value of the LNR and the count of LN on overall survival (OS) and recurrence-free survival (RFS). This study is a retrospective, longitudinal, institution-based study. This study included 192 patients treated for VSCC at the Salah Azaiez Institute between 1994 and 2022. Clinical, pathological, and evolutionary data were reported. Survival curves were generated by the Kaplan-Meier method, and predictive factors of outcome were analyzed using Cox proportional hazards models. Surgery consisted of a radical vulvectomy, hemivulvectomy, and pelvic exenteration in, respectively, 96.4%, 2.1%, and 1.6% of cases followed by adjuvant radiotherapy in 38.5% of cases. LN dissection was bilateral in 88.5% of cases. LNR = 0, LNR = 0-0.2, and LNR ⩾0.2 were recorded in, respectively, 64.7%, 22.1%, and 13.2% of cases. With a mean follow-up time of 35 ± 42.06 months, the 5-year OS was 52.5% and the 5-year RFS was 55.8%. On multivariate analysis, the independent prognostic factors of OS were the LNR (hazard ratio (HR) = 5.702; 95% confidence interval (CI) = 2.282-14.245; p < 0.0001), Federation of Gynecology and Obstetrics (FIGO) stage (HR = 2.089; 95% CI = 1.028-4.277; p = 0.042), and free margins (HR = 2.247; 95% CI = 1.215-4.155; p = 0.01). Recurrences were recorded in 37.5% of cases. Independent prognostic factors of RFS were the LNR (HR = 2.911; 95% CI = 1.468-5.779; p = 0.002), FIGO stage (HR = 1.835; 95% CI = 1.071-3.141; p = 0.027), and free margins (HR = 2.091; 95% CI = 1.286-3.999; p = 0.003). Surgical margin, FIGO stage, and LNR represent the independent prognostic factors of survival and LNR showed superior prognostic predictive accuracy compared with the revised 2021 FIGO staging system for predicting OS and RFS in VSCC.

Prevalence of prescribing topical corticosteroids to patients with lichen sclerosus following surgery for vulvar cancer: a survey among gynaecologic oncologists in The Netherlands

Background Vulvar lichen sclerosus (LS) is a chronic inflammatory dermatosis which can progress to precursor lesion differentiated vulvar intraepithelial neoplasia (dVIN) and vulvar squamous cell carcinoma (VSCC). The risk of developing recurrent vulvar cancer following LS-associated VSCC is high. Evidence suggests that treatment of LS with topical corticosteroids (TCS) can prevent progression to dVIN, VSCC and recurrences. However, current guidelines do not give any recommendation on the management of LS following surgery for VSCC. The aim of this study was to conduct a survey among all registered gynaecologic oncologists (GOs) in the Netherlands to evaluate the current management of LS patients without a history of VSCC (LSnoVSCC) and patients with LS following surgery for VSCC (LSVSCC). Methods An online survey was distributed to all registered GOs in the Netherlands. Primary outcome measures were the frequency, type and duration of TCS treatment prescribed for LSnoVSCC and LSVSCC patients, separately. As a secondary outcome measure, reasons for treating or not treating patients with LSnoVSCC and LSVSCC with TCS were analysed. Results Forty-four GOs completed the survey, resulting in a response rate of 75%. TCS were prescribed more often to patients with LSnoVSCC as compared to patients with LSVSCC (86% versus 52%, respectively, p < 0.001). If treatment was initiated, ultra-potent (class IV) TCS were most commonly prescribed for an indefinite period of time for both patient groups. The most reported reason for treating patients in both groups with TCS was symptoms, followed by clinical aspects of the lesion and prevention of progression to dVIN and VSCC. Conclusion The majority of GOs who participated in our study endorse the utilisation of long-term ultra-potent TCS therapy in both patients with LSnoVSCC and LSVSCC. Nevertheless, Dutch GOs are currently prescribing TCS more frequently to patients with LSnoVSCC than to patients with LSVSCC.

Vulvar cancer management and wrangling recurrent disease: A report from the society of gynecologic oncology journal club

The Society of Gynecologic Oncology (SGO) Journal Club webinar series is an open forum that invites national experts to discuss the literature pertaining to important topics in the management of gynecologic cancers. On August 14th, 2023, SGO hosted a journal club focused on the management of upfront and recurrent vulvar cancer. Our discussants included Dr. Brian M Slomovitz from Mount Sinai Medical Center in Miami Beach, Dr. Emi Yoshida from the University of California San Francisco Helen Diller Family Comprehensive Cancer Center, and Dr. Lilian Gien from the University of Toronto Sunnybrook Odette Cancer Center. During the discussion,we reviewed the progression of vulvar cancer surgery from en bloc resection of the vulva and groins, to partial radical vulvectomy and sentinel lymph nodes. We also reviewed the management of node positive vulvar cancer including published and accruing Groningen International Study on Sentinel Nodes in Vulvar Cancer (GROINSS) trials and other sentinel trials from the Gynecologic Oncology Group (GOG). Here we will also review the literature on the management of recurrent vulvar cancer, highlighting current treatment options and ongoing clinical trials. The following is a report of the journal club presentation.

Is There a Place for Brachytherapy in Vulvar Cancer? A Narrative Review

Vulvar cancer is a relatively rare neoplasm. The essential treatment is surgery for the primary tumour. However, postoperative recurrence rates are high, even in early-stage disease when tumour-free surgical margins are achieved or in the absence of associated risk factors (lymph node metastases, deep stromal invasion or invasion of the lymphatic vascular space). Radiotherapy plays an important role in the treatment of vulvar cancer. Adjuvant treatment after surgery as well as primary treatment of locally advanced vulvar cancer (LAVC) is composed of two key radiotherapy treatment scenarios, external beam radiation therapy (EBRT) either combined or not combined with brachytherapy (BT). In a recurrence setting, where surgery is not an option, BT alone or in combination with EBRT can be used. Compared to EBRT, BT has the radiobiological potential to improve dose to the target volume, minimise the dose to organs at risk, and facilitate hypofractionated-accelerated treatment. This narrative review presents recent data on the role of BT in the treatment of primary and/or recurrent vulvar cancer, including radiobiological, clinical, and therapeutic aspects.

High dose rate interstitial brachytherapy for locally advanced or recurrent vulvar cancer: Methods, prescription doses, toxicities, and outcomes at a single institution (1162)

High dose rate interstitial brachytherapy for locally advanced or recurrent vulvar cancer: Methods, prescription doses, toxicities, and outcomes at a single institution (1162)

Pelvic exenteration for vulvar cancer: Postoperative morbidity and oncologic outcome – A single center retrospective analysis

BackgroundPelvic exenteration may be the only curative treatment for some patients with primary advanced or recurrent vulvar cancer but is associated with high morbidity. This study evaluated the clinical outcome of patients treated at a centralized service in Norway. MethodologyThis retrospective study included patients treated with pelvic exenteration for primary locally advanced or recurrent vulvar cancer between 1996 and 2019 at Oslo University Hospital, Norway. Complications were coded according to the contracted Accordion classification. Relapse free survival (RFS), cancer specific survival (CSS) and overall survival (OS) were estimated with the Kaplan Meier method. ResultsThe 30 patients were followed for a median of 4.94 years (95%CI: 3.37-NR). Exenteration due to primary vulvar cancer was carried out in 16 (53%) patients, 14 (47%) had recurrent vulvar cancer. Free histopathological margins were achieved in 28 (93%) patients. The 90 days morbidity for grade 3 complications was 63%, predominantly wound/surgical flap infections, 7% had no complications. 90 days mortality was 3%. Five-year RFS was 26% (95% CI 8–48%), OS was 50% (95%CI: 29–69%) and CSS was 64% (95% CI 43–79%). There was no significant difference in survival between patients with primary vs recurrent disease. The 3-year CSS for patients with negative lymph nodes and positive lymph nodes was 70% (95% CI 47–84%) and 30% (95% CI 1–72%), respectively. ConclusionsAcceptable oncologic outcomes after pelvic exenteration for primary and recurrent vulvar cancer can be achieved if surgery is centralized. Careful patient selection is imperative due to significant postoperative morbidity and considerable risk of relapse.

Safety and Feasibility of Vulvar Cancer Treatment with Electrochemotherapy

Electrochemotherapy is a local ablative therapy used for the treatment of various superficial and deep-seated tumors. Electrochemotherapy involves the application of electric pulses locally to tumors to destabilize cell membranes and facilitate the entry of cytotoxic drugs, thereby enhancing their cytotoxicity locally. The aim of our study is to investigate the safety and feasibility of electrochemotherapy in patients with vulvar cancer recurrence used for nonpalliative purposes. Ten patients with single local vulvar cancer recurrence were treated with intravenous bleomycin, followed by a local application of electric pulses (electrochemotherapy) to the tumor. Adverse events were determined using the National Cancer Institute’s Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The feasibility of treating vulvar cancer with electrochemotherapy was determined by an appropriate selection of electrodes based on the size and location of the tumor with safety margins included. Electrochemotherapy was feasible in all patients. No electrochemotherapy-related or other serious adverse events occurred. Our data suggest that electrochemotherapy is a feasible and safe technique for the treatment of vulvar cancer recurrence for nonpalliative purposes. Based on our results, electrochemotherapy might be a viable therapeutic tool for patients who would otherwise undergo surgery involving a mutilation of the external genitalia.

The distribution of HPV subtype in vulvar intraepithelial neoplasia and the association with recurrent VIN and vulva cancer in Taiwan.

e17635 Background: Vulvar intraepithelial neoplasia (VIN) is a precursor lesion of vulvar cancer. Human papillomavirus (HPV) is causative for part of VIN lesions. This retrospective study aimed to investigate HPV distribution in patients with vulvar intraepithelial neoplasia (VIN) and the factor associated with the recurrence of high-grade vulvar intraepithelial neoplasia (VIN2+), high-grade vaginal intraepithelial neoplasia (VAIN) , cervical intraepithelial neoplasia(CIN) or progression to vulvar cancer. Methods: We retrospectively analyzed patients who diagnosed as vulvar squamous intraepithelial lesions between 1990 and 2014 in our institution. All the diagnoses and classifications were confirmed by two pathologists in 2015 ISSVD terminology. HPV DNA was extracted from formalin-fixed and paraffin-embedded samples. SPF1/GP6+ polymerase chain reaction (PCR) followed by HPV Blot and E6 type-specific PCR were performed. Results: Ninety-eight VIN patients were included in our analysis. Ninety-three percent were positive for HPV and HPV16 (43.9%), HPV6 (11.38%), HPV11 (8.94%), and HPV58 (4.88%) were the most prevalent types. Patients with positive HPV were diagnosed younger than those with negative results (43.0 years vs. 61.1 years, P = 0.049). In 15 patients who with recurrent VIN (n = 11) or progression to vulvar cancer (n = 4), had positive HPV. All 4 patients who had progression to cancer were positive for HPV16 in their initial VINs. High risk type HPV infection, positive HPV16, and positive alpha-9 types are significant risk factors for recurrent VIN and progression to cancer. Conclusions: Positive HPV was detected in 92.8% of VINs and was related to younger age at diagnosis. HPV16 was the most prevalent type and was significantly related to recurrence/ progression. Other significant risk factors for recurrent VIN or progression to cancer were high-risk HPV and alpha-9 types. Closely monitor of those patients with risk factors was indicated for early detection and treatment of recurrent VIN and vulvar cancer.

SP-0009 The role of brachytherapy in the treatment of primary and recurrent vulvar cancer

SP-0009 The role of brachytherapy in the treatment of primary and recurrent vulvar cancer

SP-0010 The role of brachytherapy in the treatment of primary and recurrent vulvar cancer

SP-0010 The role of brachytherapy in the treatment of primary and recurrent vulvar cancer

Innovative approaches to the treatment of local recurrent vulvar cancer in patients with lichen sclerosus

Background. In recent years, there has been an increase in the incidence of vulvar precancer (lichen sclerosus), as well as vulvar cancer. Since this disorder is rare, treatment planning and therapy itself are often suboptimal, which results in a high recurrence rate. Treatment of patients with local recurrence is even more difficult. Improper therapy often leads to fatal outcomes.Aim. To develop an innovative therapeutic approach to local recurrent vulvar cancer that includes combination (intraarterial and systemic) chemotherapy and surgery.Materials and methods. This pilot study included two patients with a second episode of local recurrent vulvar cancer. The first patient was denied special treatment, whereas the second one was offered abdominoperineal resection of the rectum. At the first stage, the patients received combination chemotherapy; at the second stage, they had combination reconstructive surgeries.Results. Combination chemotherapy was highly effective as demonstrated by the reduction of the recurrent tumor to a resectable size. Combination and reconstructive surgeries allowed us to preform radical treatment and preserve functions of the adjacent organs.Conclusion. Combination treatment was highly effective in patients with local recurrent vulvar cancer, when the tumor was located near the urethra, vagina, and anus or invaded them. Combination chemotherapy ensured good tumor regression, while surgery gave hopes for a favorable outcome.

GSOR18 Presentation Time: 11:55 AM: Obesity and Skin D2cc Predict for Radiation Necrosis After Interstitial Brachytherapy Boost in Locally Advanced Vulvar Cancer

<h3>Background</h3> Interstitial brachytherapy (ISBT) has been increasingly utilized in treating locally advanced as well as locally recurrent vulvar cancer. However, the risk of BT-associated grade 3 or 4 skin necrosis is largely underreported, owing to the rarity of the disease. The purpose of this investigation was to evaluate therapeutic benefit of BT boost and risk of necrosis in a relatively large subset of patients with locally advanced vulvar cancer. <h3>Methods</h3> Patients with vulvar cancer treated with radiation therapy at Upstate Medical University between January 1, 2014 and July 1, 2021 were retrospectively analyzed. Demographics, oncologic history, external beam and BT dosimetry details, clinical outcomes, and CTCAE graded skin toxicities were evaluated and compared across individuals receiving external beam radiation (EBRT) only versus EBRT+brachytherapy (EBRT+BT). <h3>Results</h3> Of the 33 patients with vulvar cancer included, the median age of the cohort was 65.5 years; 97% were non-Hispanic Caucasian. Median follow-up was 31.1 months (2 patients were lost to follow-up and 11 patients were deceased at the time of analysis). The majority of patients had FIGO stage III and IV disease (24/33, 73%); however, stage IV was more frequent among patients treated with EBRT+BT (9/15, 60%; p=0.03). A total of 6 patients were being treated for recurrent disease and 27 with definitive intent. In this cohort, 15 patients received only EBRT and 18 received EBRT+BT. There was a greater proportion of patients with history of smoking in the EBRT+BT group (87% vs. 56%, p=0.05); and the percentage of active smokers was numerically greater in the EBRT+BT group (54% vs. 20%, p=0.09). The median dose of EBRT alone was 6120 cGy (4500-7000 cGy) and the median dose of EBRT for patients receiving BT was 5040 cGy (4500-6750 cGy). Median BT prescription was 2500 cGy over 5 fractions twice daily (1600-3000 cGy). Overall (n=31), there were 6 cases of grade 3 (19%) and 7 of grade 4 (23%) radiation-related skin toxicity including ulceration and/or necrosis. Grade 4 toxicities were exclusively cited among patients treated with BT (7/7, 100%, p=0.014). There were 10 (33%) cases of necrosis: 3 in the EBRT group and 7 in the EBRT+BT group (50%, p=0.07). The odds of developing necrosis were greater among women treated with BT, OR=4.3, CI (0.85-22.23). Obese patients (BMI ≥ 30 kg/m2) had 15 times the odds of developing necrosis from BT as compared to non-obese patients, OR=15.0, 95% CI (1.03-218.3). The risk of BT-related necrosis was even greater in obese smokers, OR=20.0, (1.4-282.5). Patients with grade 4 skin necrosis had a mean skin D2cc of 139%, whereas those with grade 1 or 2 toxicity had a mean D2cc of 79.8% (p=0.001). Overall response to treatment, either partial or complete, appeared to be greater in the BT group (92% vs. 81%, p=0.14). Clinically, a greater proportion of patients receiving BT achieved complete response (77% vs. 65%, p=0.312). Complete responders had a significantly lower BMI (30.3 kg/m²) than non-responders (36.2 kg/m²) and partial responders (37.2 kg/m²) (p=0.05). <h3>Conclusion</h3> ISBT for locally advanced vulvar cancer appears to provide an improvement in overall response to therapy. Toxicity appears greatest in obese patients who are active smokers. Additionally, skin D2cc greater than 130% of prescribed dose appears to correlate with increased risk of grade 4 skin necrosis. These clinical and dosimetric factors should be taken into account when utilizing ISBT for vulvar cancer.

Recommendations for the treatment of vulvar cancer in settings with limited resources: Report from the International Gynecological Cancer Society consensus meeting

IntroductionDue to scant literature and the absence of high-level evidence, the treatment of vulvar cancer is even more challenging in countries facing limited resources, where direct application of international guidelines is difficult. Recommendations from a panel of experts convened to address some of these challenges were developed.MethodsThe panel met in Rio de Janeiro in September 2019 during the International Gynecological Cancer Society congress and was composed of specialists from countries in Africa, Asia, Eastern Europe, Latin America, and the Middle East. The panel addressed 62 questions and provided recommendations for the management of early, locally advanced, recurrent, and/or metastatic vulvar cancer. Consensus was defined as at least 75% of the voting members selecting a particular recommendation, whereas a majority vote was considered when one option garnered between 50.0% and 74.9% of votes. Resource limitation was defined as any issues limiting access to qualified surgeons, contemporary imaging or radiation-oncology techniques, antineoplastic drugs, or funding for the provision of contemporary medical care.ResultsConsensus was reached for nine of 62 (14.5%) questions presented to the panel, whereas a majority vote was reached for 29 (46.7%) additional questions. For the remaining questions, there was considerable heterogeneity in the recommendations.ConclusionThe development of guidelines focusing on areas of the world facing more severe resource limitations may improve medical practice and patient care.

MRI in the Evaluation of Locally Advanced Vulvar Cancer Treated with Chemoradiotherapy and Vulvar Cancer Recurrence: The 2021 Revision of FIGO Classification and the Need for Multidisciplinary Management.

Simple SummaryVulvar cancer is a rare gynecologic tumor (representing 4% of all gynecologic malignancies). We review the role of MRI in patients with locally advanced vulvar cancer (LAVC), highlighting the findings that influence clinical management. We also present the MRI findings of local recurrence according to its type and location.Magnetic resonance imaging (MRI) plays an essential role in the management of patients with locally advanced vulvar cancer (LAVC), who frequently benefit from a multidisciplinary approach. Accordingly, chemoradiotherapy (CRT) with radical or neoadjuvant intent seems to provide a better quality of life and less morbidity than extensive surgery alone. In this overview, we discuss the role of MRI in the post-CRT assessment of LAVC, emphasizing the evaluation of primary tumor response. In order to assess treatment response and select candidates for post-CRT local excision, the MRI findings are described according to signal intensity, restricted diffusion, enhancement, and invasion of adjacent organs. We also focus on the role of MRI in detecting vulvar cancer recurrence. It occurs in 30–50% of patients within two years after initial treatment, the majority appearing near the original resection margins or in ipsilateral inguinal or pelvic lymph nodes. Finally, we describe early and delayed complications of CRT, such as cellulitis, urethritis, vulvar edema, bone changes, myositis, and fistulization. By describing the role of MRI in assessing LAVC response to CRT and detecting recurrence, we hope to provide suitable indications for a personalized approach.

Nüks gelişen vulvar skuamöz hücreli kanser hastalarında prognostik faktörler ve nüksün toplam sağ kalıma etkisi

Amaç: Nüks gelişmiş olan vulvar kanser hastalarında birçok faktörün etkisi araştırılmıştır. Çalışmamızda nüks gelişen ve gelişmeyen skuamöz hücreli vulvar kanserli hastalarda klinik ve patolojik faktörlerin karşılaştırılması ve nüksün toplam sağ kalıma olan etkisini araştırmayı hedefledik. Gereç ve Yöntem: İzmir Tepecik Eğitim ve Araştırma Hastanesi Jinekolojik Onkoloji Kliniği’nde 1995 - 2018 yılları arasında opere olmuş ve takipleri hastanemizde olan vulvar kanserli hastaların dosyaları retrospektif olarak tarandı. Hastalar nüks gelişmiş ve gelişmemiş olarak iki gruba ayrıldı. Yaş, evre, tümör boyutu, tümörün orta hat durumu, tümörün lokalizasyonu, yapılan operasyon, cerrahi sınır, tümörün invazyon derinliği, metastatik lenf nodu varlığı, adjuvan tedavi değişkenleri açısından gruplar karşılaştırıldı ve nüksün sağ kalıma olan etkisi araştırıldı. Bulgular: Yaş, evre, tümör boyutu, tümörün orta hat durumu, tümörün lokalizasyonu, yapılan operasyon, cerrahi sınır, tümörün invazyon derinliği, metastatik lenf nodu varlığı, adjuvan tedavi gibi değişkenler vulvar kanserli hastalarda nüks gelişimi açısından istatiksel olarak anlamlı bulunmadı. Nüks ile toplam sağ kalım arasında da bir korelasyon bulunmadı. Sonuç: Literatürde belirtilen birçok prognostik faktör çalışmamızda nüks açısından anlamlı bulunmamış olup, toplam sağ kalım açısından da nüks olan ve olmayan grup arasında bir fark saptanmamıştır.

Trans-inguinal pelvic lymphadenectomy in vulvar cancer patients: TRIPLE pilot study

ObjectiveThe goal of this study was to assess the feasibility and safety of a retrograde extraperitoneal trans-inguinal novel approach to pelvic lymphadenectomy in vulvar cancer patients. The secondary objectives were...

Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma: a\xa0proposed protocol for a multicentre observational study

BackgroundStandard groin treatment in recurrent vulvar cancer consists of uni- or bilateral inguinofemoral lymphadenectomy (IFL), whereas in the primary setting women with selected unifocal tumours will undergo a sentinel lymph node (SLN) procedure. The SLN procedure results in fewer short and long-term sequelae compared to IFL, but some concerns must first be considered. Lymph drainage of the vulvar region can be affected by a previous surgery, which might reduce the number of detectable SLN nodes (feasibility) but increase the chance of encountering aberrant lymph drainage patterns such as bilateral SLNs in lateral tumours or SLNs at unexpected locations. Therefore, the SLN procedure potentially carries a higher risk of groin recurrence if a tumour positive node is not retrieved, but may also improve outcomes for women with aberrant drainage patterns. Since the relative benefits and drawbacks of the SLN procedure are still unclear we will investigate the safety of the SLN procedure in women with a first recurrent vulvar cancer. In a simultaneously started registration study we prospectively gather information on women with a first recurrence of vulvar cancer ineligible for the SLN procedure.MethodIn this prospective multicentre observational study all women with a first recurrence of vulvar cancer will be asked to consent to the collection of information on their diagnostics, treatment and outcome, and to complete quality of life and lymph oedema questionnaires. Women with unifocal tumours smaller than 4 cm and unsuspicious groin nodes will be offered the SLN procedure, with follow-up every 3 months together with imaging at 6 and 12 months when the SLN is tumour negative. The primary outcome is groin recurrence within 2 years of initial surgery. A total of 150 women with negative SLNs will be required to demonstrate safety, a stopping rule will apply and an extensive statistical analysis has been designed.DiscussionShould the SLN procedure prove feasible and safe in recurrent vulvar cancer, it will be available for implementation in clinics worldwide. The inclusion of women ineligible for the SLN procedure in the current prospective study will help to bridge knowledge gaps and define future research questions.Trial registrationMedical Ethical Committee approval number NL70149.078.19 (trial protocol version 2.0, date March 2nd, 2020). Affiliation: Erasmus Medical Centre. Dutch trial register NL8467. Date of registration 19.03.2020.