Anxiety and depression among women with newly diagnosed vulvar cancer - A nationwide longitudinal study.

INTRODUCTION: Our objective was to investigate the trajectories of anxiety, depression, emotional and social functioning in women with newly diagnosed vulvar cancer from the time of diagnosis to 12 months after treatment. A further aim was to identify risk factors for high levels of anxiety. MATERIAL AND METHODS: PROVE (PROspective Vulvar Cancer Evaluation) is a nationwide longitudinal cohort study investigating quality of life in women with newly diagnosed vulvar cancer by the following validated patient-reported outcome measures at diagnosis, and 3 and 12 months after treatment: The Hospital Anxiety and Depression Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Vulvar module VU34. Mean scores, changes over time and associations were analyzed by generalized estimated equations and log-linear regression models, adjusted for possible confounders. RESULTS: Between 2019 and 2021, 105 (69%) women completed the questionnaires at all three time points. At diagnosis, 42% of the women reported elevated anxiety levels, decreasing significantly to 30% during the first 12 months. Insomnia, persisting vulvar symptoms and high information needs were significantly associated with a high level of anxiety (relative risk [RR] 2.1, 95% CI 1.2-3.7 for insomnia; RR 2.8, 95% CI 1.7-4.6 for vulvar symptoms, RR 2.7, 95% CI 1.5-4.9 for information needs). We found a trend towards a higher level of anxiety in younger women (<65 years: RR 1.5, 95% CI 1.0-2.5). Participants reported a low and stable prevalence of depression (14%) and high social functioning throughout the study period. CONCLUSIONS: Women with newly diagnosed vulvar cancer report a high level of anxiety at diagnosis. Despite a significant improvement, anxiety remains widely prevalent during the first year of follow-up. Targeting insomnia, vulvar symptoms and unmet needs may decrease anxiety during surveillance.

Time to extend the indication for sentinel node biopsy in vulvar cancer? Results from a prospective nationwide Swedish study.

OBJECTIVE: To assess detection rates and negative predictive values of sentinel node biopsy in vulvar squamous cell carcinoma with tumors ≥4 cm, multifocal tumors, and in locally recurrent disease. METHODS: Between December 2019 and December 2022, patients with vulvar squamous cell carcinoma with tumors ≥4 cm (group 1), multifocal tumors (group 2), or a first local recurrence without or with previous groin treatment (groups 3 and 4, respectively) were included in a prospective, nationwide multicenter interventional pilot study. The participants underwent a sentinel node biopsy followed by inguinofemoral lymph node dissection. Detection rates, negative predictive values, the proportion of micrometastases, and isolated tumor cells were determined separately for each group. RESULTS: In all, 64 women were included, 36 women in group 1 (56%), and 17 women in group 2 (27%). Due to the small number and heterogeneity of the 11 women in groups 3 and 4, they were excluded from further analyses. In groups 1 and 2, 25 women (47%) were diagnosed with node-positive disease, and in 16 women (64%) only in the sentinel nodes. The detection rates varied between 94.1-100% per patient and 84.1-85.3% per groin. No false-negative sentinel nodes were identified, giving a negative predictive value of 100% for group 1 (95% CI 91.2% to 100%) and for group 2 (95% CI 83.9% to 100%). Of the node-positive patients, 32% had micrometastasis or isolated tumor cells only. One third of the metastases were detected by ultrastaging. In 27% of the non-mapping groins, metastases were found in the lymphadenectomy specimen, and in 75% the metastases showed extranodal growth. CONCLUSION: In this small cohort of patients, we provide further data that may widen the indication of the sentinel node technique to women with tumors ≥4 cm and multifocal tumors. TRIAL REGISTRATION NUMBER: NCT04147780.

European Society of Gynaecological Oncology Guidelines for the Management of Patients with Vulvar Cancer - Update 2023.

BACKGROUND: As 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. OBJECTIVE: To 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. METHODS: The 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. RESULTS: The 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.

Vaginal reconstruction using a gluteal transposition flap after abdominoperineal excision for anorectal malignancy.

The purpose of this study is to present and evaluate a surgical method using gluteal flap for combined perineal and vaginal reconstruction after abdominoperineal excision (APE) with partial vaginectomy for anorectal malignancy. The method is a two-centre study of consecutive patients undergoing APE including partial vaginectomy for anorectal tumours, with immediate combined perineal and vaginal reconstruction using gluteal flaps. Follow-up data were retrieved via retrospective review of medical records, questionnaires and gynaecological examinations. Some 34 patients fulfilled the inclusion criteria. At the time of follow-up, 14 (78%) of the 18 patients alive responded to questionnaires. Seven (50%) of the survey responders agreed to undergo gynaecological examination. Major flap-specific complications (Clavien-Dindo > 2) were observed in 3 (9%) patients. Among survey responders, 11 (79%) had been sexually active preoperatively of which five (45%) resumed sexual activity postoperatively and three (27%) resumed vaginal intercourse. These three patients had all implemented an active vaginal health promotion strategy postoperatively. Perineo-vaginal reconstruction using gluteal flap after extended APE for anorectal malignancy is feasible. Although comparable to other methods of reconstruction, the rate of perineo-vaginal complications is high and post-operative sexual dysfunction is substantial. Postoperative strategies for vaginal health promotion may improve sexual function after vaginal reconstruction.

Patterns of recurrence and survival in vulvar cancer: A nationwide population-based study.

OBJECTIVE: To examine the patterns of recurrence and how these patterns are associated with survival in vulvar squamous cell carcinoma. We also explored the survival impact of surgical groin staging (SGS). METHODS: Nationwide population-based study including women diagnosed with vulvar squamous cell carcinoma between 2012 and 2015 and registered in the Swedish Quality Registry for Gynecologic Cancer. Cumulative incidence rates (CIR), recurrence-free (RFS) and overall survival (OS) were calculated by Kaplan Meier estimates. The impact of SGS on RFS and OS was analyzed by proportional hazards models. RESULTS: 489 eligible women were included. Median follow-up time was 64 months. The overall recurrence rate was 22.3%. Site of recurrence: local in 61.0%, groin in 30.0%, distant in 9.0%. The CIR for local recurrences increased with time (5.9% at 2-years, 14.7% at 5-years) while the rate of groin and distant recurrences was nearly steady (5.5% to 6.3% and 1.5% to 1.7%, respectively). Median 2-year and 4-year OS post-recurrence was 57.8% and 37.4% for local, 17.2%, 10.3% for groin and 0% for distant recurrences, respectively. SGS was omitted in 23.7% of surgically treated women with FIGO stages IB-II and significantly associated with worse RFS (Hazard ratio, HR, 1.9; 95%CI, 1.0-3.5; p = 0.04) and OS (HR 2.0; 95%CI, 1.1-3.8; p = 0.04) after adjustment for age, FIGO stage, tumor size, resection margins and performance status. CONCLUSION: The cumulative incidence of isolated vulvar recurrence was low but for those affected the prognosis was poor. Surgical groin staging is a crucial part of primary treatment and should not be omitted.

Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden.

BACKGROUND: In 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 OBJECTIVE: This 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 HYPOTHESIS: Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. TRIAL DESIGN: This 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 CRITERIA: Inclusion 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 ENDPOINT: The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure. SAMPLE SIZE: In each of the four study arms, recruitment of 20-30 patients is planned. ESTIMATED DATES FOR COMPLETING RECRUITMENT AND PRESENTING RESULTS: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021. TRIAL REGISTRATION: The trial is registered at "ClinicalTrials.gov" (ID: NCT04147780).