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.

Validation of epithelial ovarian cancer and fallopian tube cancer and ovarian borderline tumor data in the Danish Gynecological Cancer Database.

OBJECTIVE: To validate the data on epithelial ovarian cancer, fallopian tube cancer and borderline ovarian tumors registered in the nationwide Danish Gynecological Cancer Database (DGCD) in 2005 and 2006. The DGCD is a multidisciplinary database that contains data for research and quality improvement. DESIGN: Comparative registry-based study supplemented with data from medical records. SETTING: Six hospitals in Denmark. PARTICIPANTS: Women registered with epithelial ovarian cancer, fallopian tube cancer and borderline ovarian tumor. MAIN OUTCOME MEASURE: Data completeness and strength of agreement. RESULTS: The estimated completeness of reporting to the DGCD was 94.2% and the strength of agreement between the variables in the DGCD and the medical file varied from moderate to very good. The important quality indicator 'complication' had the lowest strength of agreement. CONCLUSION: The validity of ovarian cancer data in the DGCD is sufficient for quality monitoring in gynecological oncology.

Danish Gynecological Cancer Database.

AIM OF DATABASE: The Danish Gynecological Cancer Database (DGCD) is a nationwide clinical cancer database and its aim is to monitor the treatment quality of Danish gynecological cancer patients, and to generate data for scientific purposes. DGCD also records detailed data on the diagnostic measures for gynecological cancer. STUDY POPULATION: DGCD was initiated January 1, 2005, and includes all patients treated at Danish hospitals for cancer of the ovaries, peritoneum, fallopian tubes, cervix, vulva, vagina, and uterus, including rare histological types. MAIN VARIABLES: DGCD data are organized within separate data forms as follows: clinical data, surgery, pathology, pre- and postoperative care, complications, follow-up visits, and final quality check. DGCD is linked with additional data from the Danish "Pathology Registry", the "National Patient Registry", and the "Cause of Death Registry" using the unique Danish personal identification number (CPR number). DESCRIPTIVE DATA: Data from DGCD and registers are available online in the Statistical Analysis Software portal. The DGCD forms cover almost all possible clinical variables used to describe gynecological cancer courses. The only limitation is the registration of oncological treatment data, which is incomplete for a large number of patients. CONCLUSION: The very complete collection of available data from more registries form one of the unique strengths of DGCD compared to many other clinical databases, and provides unique possibilities for validation and completeness of data. The success of the DGCD is illustrated through annual reports, high coverage, and several peer-reviewed DGCD-based publications.

Relevance of computerized tomography in the preoperative evaluation of patients with vulvar cancer: a prospective study.

BACKGROUND: The purpose of the study was to determine whether inclusion of computerized tomography (CT) in the prospective evaluation of vulvar cancer changed the surgical treatment strategy in terms of detection of lymph node metastases, tumor spread and comorbidity, and additionally to examine the logistical influence of adding further examinations prior to treating out-hospital patients referred from geographically distant areas. METHODS: During an 8 month period we conducted a prospective study of patients with newly diagnosed or recurrent vulvar cancer consecutively referred to Copenhagen University Hospital, Rigshospitalet. The patients underwent a gynecological examination, chest x-ray and a preoperative CT scanning of the chest, abdomen and pelvis. It was registered whether the radiological findings regarding the extent of the tumor, lymph node involvement, incidental findings and comorbidity changed the surgical treatment plan. Further, the logistical influence of the long referral distances was registered. RESULTS: Thirty patients with a median age of 69 years (range 44-93 years) were included in the study. CT did not significantly change the initial surgical treatment plan for the patients. CT did not reveal lymph node enlargement outside the inguinofemoral area and was inaccurate compared to the sentinal node examination of the local lymph nodes. CT diagnosed no cases with distant metastases from the primary malignancy, but two cases with a secondary malignant disease were found. CONCLUSIONS: CT scanning has no clinical impact as a routine screening examination prior to surgery. It may delay treatment, but can add important information when clinically indicated.

The psychosocial needs of gynaecological cancer survivors: A framework for the development of a complex intervention.

PURPOSE: To develop and pilot test an intervention targeting the women's psychosocial needs during the follow-up period after surgical treatment for gynaecological cancer. METHODS: The project consisted of four phases. Phase 1 involved development of an intervention on the basis of meetings with key healthcare professionals, a literature review and six semi-structured interviews with women who attended the existing follow-up program. The Guided Self-Determination (GSD) method developed in diabetes care was identified as an appropriate framework for the intervention. GSD consists of reflection sheets for patients and advanced professional communication skills. The GSD method was adapted to women in a follow-up program after gynaecologic cancer treatment (GSD-GYN-C). Phase 2 involved primary pilot testing of the intervention and the findings were used to modify the intervention in phase 3. This modification involved the development of additional reflection sheets and a fidelity assessment tool. A systematic training program was arranged for the GSD-GYN-C-nurses. Phase 4 involved secondary pilot testing where nurses and women confirmed the applicability of GSD-GYN-C and final adjustments were made. Selected measurements were tested for sensitivity during pilot testing. Data from phase 2 and 4 were also used to select the primary outcome and calculate power for a future randomized clinical trial (RCT). RESULTS: Pilot testing supported our hypothesis that GSD-GYN-C may be transferable and useful to survivors of gynaecological cancer. CONCLUSION: GSD-GYN-C was developed and validated and is now ready for evaluation in an RCT.

Late urologic morbidity in 177 consecutive patients after radiotherapy for cervical carcinoma: a longitudinal study.

PURPOSE: To provide longitudinal data on urologic morbidity after radiotherapy and brachytherapy for cervical carcinoma. METHODS AND MATERIALS: Five-year longitudinal urologic morbidity data were recorded from 177 consecutive patients of median age 59 years (range: 22-86 years) with cervical carcinoma receiving radiotherapy with curative intent at the Copenhagen University Hospital, Denmark. FIGO stages (%) were as follows: Stage I (15), Stage II (30), Stage III (54), and Stage IV (1). Late morbidity was calculated as cumulative incidence based on actuarial estimates. RESULTS: The 5-year cumulative incidence based on actuarial estimates of urologic morbidity Grades 1 + 2 + 3, Grades 2 + 3, and Grade 3 were 62%, 32%, and 5%, respectively. Frequencies of urologic morbidity in the 54 recurrence-free survivors at the end of follow-up indicated some reversibility in the case of Grades 1 and 2 morbidity. CONCLUSION: With the longitudinal design used in the present study, a rate of mild and moderate morbidity higher than that found in most of the previously reported literature was observed, giving cause for concern and underlining the importance of further longitudinal studies on this subject, specifically studies that relate to the background urologic morbidity in the female population, as well as to the fact that urologic morbidity might regress.

Evaluation of urologic morbidity after radiotherapy for cervical carcinoma by urodynamic examinations and patient voiding schemes: a prospective study.

PURPOSE: To assess urologic morbidity in a 5-year period by urodynamic examinations and patient voiding schemes after radiotherapy and brachytherapy for cervical carcinoma. METHODS AND MATERIALS: Thirty-six consecutive patients designated to receive radiotherapy with curative intent entered the study on urodynamic changes after radiotherapy for cervical carcinoma. Patients in the study had urodynamic examinations performed on admission and 3, 9, 18, 24, 30, 36, 48, and 60 months after radiotherapy. In addition, the patients were instructed to record 24-h voiding schemes before each consultation. Each voiding scheme contained information about exact time of voiding and amount voided, as well as time of involuntary voiding, if present. RESULTS: No changes were observed in the urodynamic parameters: volume of residual urine, maximum bladder capacity, maximum flow rate, or volume of first bladder sensation. Detrusor instability and frequent small voiding did develop in 15%-20% of patients during follow-up. Incontinence after therapy was, however, a rare observation. CONCLUSION: In a prospective design combining urodynamic examinations and patient voiding schemes, and with modern application techniques, presence of minor urologic morbidity was found to be much more rare than previously reported. Nevertheless, detrusor instability and frequent small voiding did develop in 15%-20% of patients during follow-up. Future studies should be concerned about possible bias from urologic morbidity unrelated to therapy.

Longitudinal study of sexual function and vaginal changes after radiotherapy for cervical cancer.

PURPOSE: To investigate the longitudinal course of self-reported sexual function and vaginal changes in patients disease free after radiotherapy (RT) for locally advanced, recurrent, or persistent cervical cancer. MATERIALS AND METHODS: A total of 118 patients referred for RT were included. The patients were assessed, using a validated self-assessment questionnaire, at the termination of RT and 1, 3, 6, 12, 18, and 24 months later. The results were compared with an age-matched control group from the general population. RESULTS: Persistent sexual dysfunction and adverse vaginal changes were reported throughout the 2 years after RT, with small changes over time: approximately 85% had low or no sexual interest, 35% had moderate to severe lack of lubrication, 55% had mild to severe dyspareunia, and 30% were dissatisfied with their sexual life. A reduced vaginal dimension was reported by 50% of the patients, and 45% were never, or only occasionally, able to complete sexual intercourse. Despite sexual dysfunction and vaginal adverse effects, 63% of those sexually active before having cancer remained sexually active after treatment, although with a considerably decreased frequency. CONCLUSIONS: Patients who are disease free after RT for locally advanced, recurrent, or persistent cervical cancer are at high risk of experiencing persistent sexual and vaginal problems compromising their sexual activity and satisfaction.

Validation of a questionnaire for self-assessment of sexual function and vaginal changes after gynaecological cancer.

The Sexual function-Vaginal changes Questionnaire (SVQ), was developed to investigate sexual and vaginal problems in gynaecological cancer patients. The instrument consists of 20 core items, measuring sexual interest, lubrication, orgasm, dyspareunia, vaginal dimensions, intimacy, sexual problems of partner, sexual activity, sexual satisfaction, and body image. Seven additional items assessing current levels of sexual and vaginal problems compared to pre-diagnosis are intended to be used only once in longitudinal studies. The SVQ was validated in two ways: first, the comprehensibility of each item was investigated through combined quantitative and qualitative assessment of patient-observer agreement in 75 gynaecological cancer patients, second, multitrait analyses and principal component analyses were applied to responses from 257 patients with cervical cancer to investigate the scale properties. The level of agreement between the patients' and the observer's ratings was high (median overall agreement 0.84, range 0.46-1.00; median kappa: 0.80, range 0.52-1.00). From the 10 items applicable to all patients, three scales were hypothesized: intimacy, sexual interest and global sexual satisfaction. For sexually active respondents an additional two scales were hypothesized: vaginal changes and sexual functioning. The psychometric analyses confirmed these scales. The internal consistency of the scales ranged 0.76-0.83 (Cronbach's alpha). The study supports the validity and reliability of the SVQ.

Early-stage cervical carcinoma, radical hysterectomy, and sexual function. A longitudinal study.

BACKGROUND: Limited knowledge exists concerning the impact of radical hysterectomy (RH) alone on the sexual function of patients with early-stage cervical carcinoma. The authors investigated the longitudinal course of self-reported sexual function after RH. METHODS: The current study was comprised of 173 patients with lymph node-negative, early-stage cervical carcinoma who had undergone RH and pelvic lymphadenectomy. They were assessed prospectively using a validated self-assessment questionnaire 5 weeks and 3 months, 6 months, 12 months, 18 months, and 24 months after RH. Results were compared with an age-matched control group from the general population. RESULTS: Compared with control women, patients experienced severe orgasmic problems and uncomfortable sexual intercourse due to a reduced vaginal size during the first 6 months after RH, severe dyspareunia during the first 3 months, and sexual dissatisfaction during the 5 weeks after RH. A persistent lack of sexual interest and lubrication were reported throughout the first 2 years after RH. Long-term lack of sexual interest and insufficient vaginal lubrication were confirmed by the patient's self-reported changes 12 months after RH compared with before the cancer diagnosis and by a pre-post comparison within patients. However, most of the patients who were sexually active before their cancer diagnosis were sexually active again 12 months after surgery (91%), although with a decrease in sexual frequency reported. CONCLUSIONS: RH had a persistent and negative impact on patients' sexual interest and vaginal lubrication whereas the majority of other sexual and vaginal problems disappeared over time. Sexual and vaginal problems in the short-term and long-term after RH should be discussed with the patient before and after surgery.