Preoperative predictors of inguinal lymph node metastases in vulvar cancer - A nationwide study.

BACKGROUND: A combination of tumour size, differentiation grade and location may identify a group of vulvar squamous cell cancer (VSCC) patients with a very low risk of inguinal lymph node metastasis. We aim to examine these findings in a large national cohort of VSCC patients. MATERIALS AND METHODS: Population based prospective data on VSCC patients treated with vulvectomy and primary groin surgery was obtained from the Danish Gynaecological Cancer Database. Univariate chi-square and multivariate logistic regression analysis were used. Statistical tests were 2-sided. P-values of <0.05 were considered statistically significant. RESULTS: In all, 388 VSCC patients were identified. Of these 264 (63.3%) were node negative and 121 (36.7%) node positive. Increasing tumour size (diameter ≤ 2 cm vs. > 2 to 4 cm), grade (1 vs. 2-3) and location of tumour to clitoris were all associated with a significantly increased risk of inguinal lymph node metastasis OR 2.81(95% CI 1.52-5.20), OR 3.19 (95% CI 1.77-5.74) and OR 2.74 (95% CI 1.56-5.20), respectively. Previous vulvar disease was not associated with lymph node metastasis. No lymph node metastasis was demonstrated in patients with grade 1 tumours, tumour size less than 2 cm and located outside the clitoris area (n = 51). CONCLUSIONS: VSCC patients with grade 1 tumours, ≤ 2 cm and without clitoral involvement have a very low risk of inguinal lymph node metastasis. These patients may be spared inguinal lymph node staging to decrease operating time and peri- and postoperative morbidity in the future. However, studies validating our findings are needed.

Recurrence and survival rates in node negative patients after sentinel node biopsy for early-stage vulva cancer - A nationwide study.

OBJECTIVE: The sentinel node (SN) procedure is adopted in selected patients with early-stage vulva cancer (VC) in Denmark. Due to the low incidence of VC, large population-based studies on the safety of SN outside multicenter clinical trials are lacking. The current study evaluated the risk of recurrence and survival in SN- negative VC patients. METHODS: Nationwide data was collected and registered prospectively in the Danish Gynecologic Cancer Database from January 2011 to July 2017. Patients with clinically stage IB-II unifocal vulva squamous cell carcinoma, tumor <4 cm and no clinically suspicious groin nodes or distant metastases, who underwent SN-procedure, were included. RESULTS: The SN-procedure was performed in 286 patients, of these 190 (66.4%) patients were SN-negative. Twenty-three of the 190 SN-negative patients (12.1%) had one or more recurrences during a median follow-up of 30 months (range 1-83). Four patients (2.1%) had an isolated groin recurrence identified from 5 to 17 months after primary surgery. Fourteen patients (7.4%) experienced a local recurrence in vulva, 1 patient (0.5%) had a recurrence in the vulva and the groin and 4 patients (2.1%) had distant recurrences. The 3-year overall (OS) and disease-specific survival (DSS) for SN-negative patients was 84% and 93%, respectively. The 3-year OS for patients with recurrent disease was 58%. CONCLUSIONS: This is the largest prospective nationwide study on SN-procedure in vulva cancer. The study confirms the safety of the SN-procedure in selected early-stage VC patients with a low isolated groin recurrence rate and a good DSS.

Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review.

OBJECTIVES: Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs. METHODS/MATERIALS: A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients. RESULTS: The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level. CONCLUSIONS: Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials.

Pelvic radiotherapy and sexual function in women.

BACKGROUND: During the past decade there has been considerable progress in developing new radiation methods for cancer treatment. Pelvic radiotherapy constitutes the primary or (neo) adjuvant treatment of many pelvic cancers e.g., locally advanced cervical and rectal cancer. There is an increasing focus on late effects and an increasing awareness that patient reported outcomes (PROs) i.e., patient assessment of physical, social, psychological, and sexual functioning provides the most valid information on the effects of cancer treatment. Following cure of cancer allow survivors focus on quality of life (QOL) issues; sexual functioning has proved to be one of the most important aspects of concern in long-term survivors. METHODS: An updated literature search in PubMed was performed on pelvic radiotherapy and female sexual functioning/dysfunction. Studies on gynaecological, urological and gastrointestinal cancers were included. The focus was on the period from 2010 to 2014, on studies using PROs, on potential randomized controlled trials (RCTs) where female sexual dysfunction (FSD) at least constituted a secondary outcome, and on studies reporting from modern radiotherapy modalities. RESULTS: The literature search revealed a few RCTs with FSD evaluated as a PRO and being a secondary outcome measure in endometrial and in rectal cancer patients. Very limited information could be extracted regarding FSD in bladder, vulva, and anal cancer patients. The literature before and after 2010 confirms that pelvic radiotherapy, independent on modality, increases the risk significantly for FSD both compared to data from age-matched healthy control women and compared to data on patients treated by surgery only. There was only very limited data available on modern radiotherapy modalities. These are awaited during the next five years. Several newer studies confirm that health care professionals are still reluctant to discuss treatment induced sexual dysfunction with patients. CONCLUSIONS: Pelvic radiotherapy has a persistent deteriorating effect on the vaginal mucosa impacting negatively on the sexual functioning in female cancer patients. Hopefully, modern radiotherapy modalities will cause less vaginal morbidity but results are awaited to confirm this assumption. Health care professionals are encouraged to address potential sexual dysfunction both before and after radiotherapy and to focus more on quality than on quantity.

Sexual functioning and vaginal changes after radical vaginal trachelectomy in early stage cervical cancer patients: a longitudinal study.

INTRODUCTION: Radical vaginal trachelectomy (RVT) offers low complication rate, good survival, and possibility for future childbearing for young women with early stage cervical cancer. However, the literature on quality of life (QOL) and sexual functioning in patients undergoing RVT is scarce. AIM: The aims of this study were to prospectively assess sexual function after RVT and to compare scores of sexual function in patients operated by RVT and radical abdominal hysterectomy (RAH) with those of age-matched control women from the general population. METHODS: Eighteen patients with early stage cervical cancer operated with RVT were prospectively included and assessed preoperatively, and 3, 6, and 12 months postoperatively using validated questionnaires. RAH patients were included consecutively and assessed once at 12 months postsurgery, while an age-matched control group of 30 healthy women was assessed once. MAIN OUTCOME MEASURE: Sexual dysfunction total score as measured by the Female Sexual Function Index (FSFI) was the main outcome measure. RESULTS: During the 12 months posttreatment, RVT patients tended to have persistent sexual dysfunction as measured by FSFI (mean overall score <26.55 at each assessment) and Female Sexual Distress Scale (mean overall score > 11). Sexual worry (P < 0.001) and lack of sexual desire (P = 0.038) were more frequently reported among patients in both treatment groups compared with control women. Sexual activity increased significantly during the observation time for the RVT group (P = 0.023) and reached that of healthy women. Global Health Status score improved over time for the RVT group but never reached that of healthy control women (P = 0.029). CONCLUSIONS: Our data suggest that patients treated with RVT for early stage cervical cancer experience persistent sexual dysfunction up to one year post surgery influencing negatively on their QOL.