BackgroundAs part of its mission to improve the quality of care for women with gynecological cancers across Europe, the European Society of Gynaecological Oncology (ESGO) first published in 2017 evidence-based guidelines for the management of patients with vulvar cancer.ObjectiveTo update the ESGO guidelines based on the new evidence addressing the management of vulvar cancer and to cover new topics in order to provide comprehensive guidelines on all relevant issues of diagnosis and treatment of vulvar cancer.MethodsThe ESGO Council nominated an international development group comprised of practicing clinicians who provide care to vulvar cancer patients and have demonstrated leadership through their expertize in clinical care and research, national and international engagement and profile as well as dedication to the topics addressed to serve on the expert panel (18 experts across Europe). To ensure that the statements were evidence-based, new data identified from a systematic search were reviewed and critically appraised. In the absence of any clear scientific evidence, judgment was based on the professional experience and consensus of the international development group. Prior to publication, the guidelines were reviewed by 206 international practitioners in cancer care delivery and patient representatives.ResultsThe updated guidelines cover comprehensively diagnosis and referral, staging, pathology, pre-operative investigations, surgical management (local treatment, groin treatment, sentinel lymph node procedure, reconstructive surgery), (chemo)radiotherapy, systemic treatment, treatment of recurrent disease (vulvar, inguinal, pelvic, and distant recurrences), and follow-up. Management algorithms are also defined.

In this nationwide population-based cohort, the overall recurrence rate was 22.3%.• The 5-year cumulative incidence rate for isolated local recurrence was only 14.7%.• Median 4-year overall survival post local recurrence was poor, 37.4%.• Surgical groin staging was omitted in 23.7% of FIGO stages IB-II.• Omitting surgical groin staging in FIGO stages IB-II was significantly associated with poor survival.

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).