Recurrence and survival after laparoscopy versus laparotomy without lymphadenectomy in early-stage endometrial cancer: Long-term outcomes of a randomised trial.

BACKGROUND: Laparoscopic hysterectomy is accepted worldwide as the standard treatment option for early-stage endometrial cancer. However, there are limited data on long-term survival, particularly when no lymphadenectomy is performed. We compared the survival outcomes of total laparoscopic hysterectomy (TLH) and total abdominal hysterectomy (TAH), both without lymphadenectomy, for early-stage endometrial cancer up to 5 years postoperatively. METHODS: Follow-up of a multi-centre, randomised controlled trial comparing TLH and TAH, without routine lymphadenectomy, for women with stage I endometrial cancer. Enrolment was between 2007 and 2009 by 2:1 randomisation to TLH or TAH. Outcomes were disease-free survival (DFS), overall survival (OS), disease-specific survival (DSS), and primary site of recurrence. Multivariable Cox regression analyses were adjusted for age, stage, grade, and radiotherapy with adjusted hazard ratios (aHR) and 95% confidence intervals (95%CI) reported. To test for significance, non-inferiority margins were defined. RESULTS: In total, 279 women underwent a surgical procedure, of whom 263 (94%) had follow-up data. For the TLH (n = 175) and TAH (n = 88) groups, DFS (90.3% vs 84.1%; aHR[recurrence], 0.69; 95%CI, 0.31-1.52), OS (89.2% vs 82.8%; aHR[death], 0.60; 95%CI, 0.30-1.19), and DSS (95.0% vs 89.8%; aHR[death], 0.62; 95%CI, 0.23-1.70) were reported at 5 years. At a 10% significance level, and with a non-inferiority margin of 0.20, the null hypothesis of inferiority was rejected for all three outcomes. There were no port-site or wound metastases, and local recurrence rates were comparable. CONCLUSION: Disease recurrence and 5-year survival rates were comparable between the TLH and TAH groups and comparable to studies with lymphadenectomy, supporting the widespread use of TLH without lymphadenectomy as the primary treatment for early-stage, low-grade endometrial cancer.

Feasibility of endometrial sampling by vaginal tampons in women with Lynch syndrome.

BACKGROUND: Endometrial sampling for the surveillance of women with Lynch syndrome is an invasive and painful procedure. The aim of this study was to evaluate the feasibility of a less invasive procedure of collecting vital cells by vaginal tampons. METHODS: This was a prospective feasibility study of women scheduled to undergo annual gynecological surveillance, including endometrial sampling. We included consecutive asymptomatic women with Lynch syndrome or first-degree relatives and asked them to insert a vaginal tampon 2-4 h before attending their outpatient appointment. Feasibility was evaluated by the following metrics: patient acceptance, pain intensity of each procedure (assessed by visual analog scale; range 0-10), and the presence of vital cells obtained by tampon-based or endometrial sampling methods. Two pathologists independently evaluated all samples. RESULTS: In total, 25 of 32 approached women completed the tampon-based procedure, with 23 of these subsequently undergoing invasive endometrial sampling. The median visual analog scale scores for tampon use and invasive endometrial sampling were 0 (range, 0-10) and 5.5 (range, 1-10) (p < 0.001). None of the tampon samples analyzed by cytology showed endometrial cells, but they did contain vital squamous cells and granulocytes. By contrast, 18 (78%) of the invasive endometrial samples contained enough endometrial tissue for analysis. No endometrial abnormalities were found by endometrial sampling. CONCLUSIONS: Tampon-based endometrial surveillance was a well-accepted and non-painful procedure, and although tampons contained vital cells, they did not provide endometrial cells. However, this study was limited to asymptomatic women with Lynch syndrome (no endometrial pathology), indicating that research is needed to evaluate whether the tampon method has any utility for endometrial surveillance in women with Lynch syndrome.

The clinical relevance of excisional margins after large loop excision of the transformation zone for the persistence of cervical dysplasia.

OBJECTIVE: A new guideline on population-screening cervical cytology was introduced to improve diagnosis and management of (pre-)malignant cervical lesions. Subsequently, more colposcopies and more large loop excision of the transformation zone (LLETZ) were performed. There is little information about the relevance of positive margins for cervical intraepithelial neoplasia (CIN) after LLETZ. This study assesses the clinical relevance of margins on the presence of CIN. METHODS: In this retrospective study, 567 women who had undergone LLETZ due to cervical dysplasia between January 2017 and December 2019 in Martini Hospital Groningen were included. The primary outcome was the persistence of cervical dysplasia (Pap ≥2) in relation to excisional margins. A χ2 test was performed and hazard ratios with 95% confident intervals (CIs) were reported. RESULTS: After median follow-up of 14 months, 9% (N = 28) with affected margins and 4% (N = 9) with clear margins had persistent cervical dysplasia (P = 0.044). Positive human papillomavirus (HPV) status was an independent risk factor (hazard ratio [HR] 8.97, 95% confidence interval [CI] 4.19-19.22). Women with affected margins and of older age were less prone to clear HPV (P < 0.001). CONCLUSION: Women treated with LLETZ for cervical dysplasia show favorable long-term outcomes, with low residual rate. High-risk HPV combined with excisional margin status and age appears to be an adequate risk stratification and individualized management might be based on these factors.

Patterns and frequency of recurrences of squamous cell carcinoma of the vulva.

OBJECTIVE: To analyze patterns and frequency of recurrences of squamous cell carcinoma (SCC) of the vulva after wide local excision (WLE) and superficial inguinal lymphadenectomy with separate incisions and to identify prognostic factors for the development of recurrences. METHODS: Between January 1985 and December 1999, all 125 consecutive patients with primary SCC of the vulva, treated with WLE and superficial inguinal lymphadenectomy, were retrospectively analyzed. Recurrences were registered by localization as: local, skin bridge, groin or distant. RESULTS: A local recurrence was diagnosed in 29 (23%) patients, 11 (9%) developed a groin and 4 (3%) a distant recurrence. No skin bridge recurrences were identified. The 5 years local relapse-free survival was 70%. After a first local recurrence, 72% of these patients developed a second local recurrence. Adjusted for other predictors, older age (>74 years) is an independent risk factor for local recurrences (HR: 2.38; 95%-C.I.: 1.08-5.23) and stage III/IV cancer for developing groin/distant recurrences (HR: 3.03; 95%-C.I.: 1.0-9.18). CONCLUSION: WLE and superficial inguinal lymphadenectomy with separate incisions result in a high groin recurrence rate in this study; superficial lymphadenectomy should be replaced by deep inguinofemoral lymphadenectomy. After a local recurrence, 72% of the patients developed a second local recurrence. These patients are at high risk and need a close follow-up.