Blanca Gil-Ibañez

European training requirements for gynecological oncology: the European Society of Gynaecological Oncology Curriculum

A multimodal intervention program to improve sexual health and self-perceived quality of life in patients treated for cervical cancer: a randomized prospective study (PROVIDENCE trial)

Patients with cervical cancer treatment experience an impairment of sexual function and quality of life. This issue is usually underreported and undertreated, and evidence-based interventions are lacking. Prevention of sexual dysfunction is a crucial pillar in improving the quality of life of these patients. The primary objective of this trial is to evaluate the impact of a multimodal intervention, encompassing prevention of vaginal dysfunction and patient education, on sexual function and quality of life in cervical cancer survivors utilizing patient-reported outcome measurements. Multi-institutional, randomized clinical trial where patients will be randomized 1:2 at diagnosis of initial or locally advanced cervical cancer to control arm or intervention arm. After treatment, control arm patients will undergo standard follow-up by their referring physician. The multimodal intervention for patients in the intervention group includes application of vaginal estrogens plus hyaluronic-acid cream along with use of vaginal vibrator, systematic evaluation of the need of systemic hormone replacement therapy and treatment if needed, and access to online content about sexuality, nutrition, sports and lifestyle habits. Through 4 appointments (at diagnosis, 1, 6, and 12 months after treatment), sexual health, vaginal trophism and self-perceived quality of life of patients in both arms will be assessed with validated questionnaires as female sexual function index (FSFI), European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire 30, and Cx-24, Cervantes Scale, vaginal health index and vaginal thickness assessed by ultrasound. The major inclusion criteria will be patients aged ≥18 years with the International Federation of Gynecology and Obstetrics stage I-III cervical cancer treated with surgery and/or radiotherapy. The primary endpoint will be FSFI score 12 months after treatment, which will be compared between groups. Uni- and multivariate analysis will be performed to identify factors influencing sexual function recovery after treatment. The sample size will be of 120 eligible patients, who will be randomized to detect an improvement of 5.2 points in FSFI score. Complete accrual is estimated in March 2026. To date, the present study has no external funding. ClinicalTrials.gov Identifier: NCT06031493.

Vaginal fertility-sparing surgery and laparoscopic sentinel lymph node detection in early cervical cancer. Retrospective study with 15 years of follow-up

The aim of this study was to evaluate the oncological outcomes of vaginal fertility-sparing surgery plus laparoscopic sentinel lymph node biopsy in patients with early cervical cancer over a 15-years period. From March 2005 to April 2018, 38 patients diagnosed with early stage cervical cancer underwent vaginal fertility-sparing surgery at the Hospital Clínic, Barcelona, Spain. Patients with FIGO stage IA1 with lymphovascular space invasion and stage IA2 underwent simple trachelectomy and patients with stage IB1 underwent radical vaginal trachelectomy. All cases underwent laparoscopic sentinel lymph node biopsy. In the first 19 cases, laparoscopic bilateral pelvic lymphadenectomy was completed immediately after sentinel lymph node biopsy. Clinical and oncological follow-up data were collected. The median age at diagnosis was 33.5 years (range 22-44). Simple trachelectomy was performed in seven cases (18.4%) and vaginal radical trachelectomy in 31 (81.6%). Nineteen patients were exclusively treated with laparoscopic sentinel lymph node biopsy and 19 with sentinel lymph node biopsy plus laparoscopic bilateral pelvic lymphadenectomy. There were no significant differences between the two lymph node assessment groups regarding histology and tumour size. The median follow-up was 73 months (range 1-160 months). There were 4 recurrences (3 patients with IB1 and 1 with IA2). Two occurred in the sentinel lymph node biopsy group and 2 in the sentinel lymph node biopsy plus laparoscopic bilateral pelvic lymphadenectomy group. All the recurrences were diagnosed in patients with adenocarcinoma and in 3 patients without lymphovascular space invasion. Vaginal fertility-sparing surgery combined with laparoscopic sentinel lymph node biopsy seems to be a safe oncological procedure in selected patients with early stage cervical cancer. Further studies are needed to clarify the role of sentinel lymph node biopsy in fertility- sparing surgery in cervical cancer. Adenocarcinoma histology seems to be an important risk factor for recurrence.

Prognostic factors in young women with epithelial ovarian cancer: the Young Ovarian Cancer-Care (YOC-Care) study

To determine oncological outcomes and to identify prognostic factors in women aged <45 years with epithelial ovarian cancer. A multicenter retrospective study was performed of patients treated for epithelial ovarian cancer aged <45 years between January 2010 and December 2019. A total of 998 patients with epithelial ovarian cancer from 55 different institutions in Spain were collected. The median age of the study population was 40.8 years (range 35.6-43.4). The grouped International Federation of Gynecology and Obstetrics (FIGO) stage distribution was 508 (50.9%) patients in initial stages (I and II) and 490 (49.1%) with advanced stages (III and IV). Three hundred and twenty-five (32.6%) patients presented with recurrent disease after a median follow-up of 33.1 months (range 16.1-66.4). The type of staging surgery (incomplete vs complete), type of initial treatment modality (primary cytoreduction vs interval surgery), and amount of residual disease were all significantly associated with overall survival. Tumor rupture was noted in 288 (27.9%) cases, but it was not associated with oncologic outcomes (p=0.11 for overall survival). In the multivariate analysis, the response based on radiological findings (HR 3.24, 95% CI 2.14 to 4.91 for partial response; HR 6.93, 95% CI 4.79 to 10.04 for progression), neoadjuvant chemotherapy (HR 1.42, 95% CI 1.04 to 1.94), and FIGO stage (HR 1.68, 95% CI 1.40 to 2.02) were identified as independent prognostic factors associated with worse oncologic outcomes (p<0.001). The partial and progression radiology-based response after chemotherapy, neoadjuvant chemotherapy, and advanced FIGO stage are independent prognostic factors associated with worse oncological outcomes in women aged <45 years with epithelial ovarian cancer.

A Multimodal Intervention Program to Improve Sexual Health and Self-perceived Quality of Life in Patients Treated for Cervical Cancer (PROVIDENCE)

The PROVIDENCE Trial aims to explore the improvement of sexual health and self-perceived health related quality of life (measured by Patient Reported Outcome Measures) through a multimodal intervention that includes patient education on healthy habits and the prevention of vaginal dysfunction using vaginal moisturizers and topical estrogens. To achieve this, a randomized design is proposed to assess sexual health and quality of life in patients treated for cervical cancer who undergo this intervention compared to those who receive standard care.