Alvaro Tejerizo

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.

Step-by-step total pelviperitonectomy with modified posterior pelvic exenteration

SUROVA study: global real-world treatment strategies and mortality risk prediction in advanced ovarian cancer

This study aimed to compare 5-year overall survival between primary debulking surgery and neoadjuvant chemotherapy followed by interval surgery in patients with stage IIIB to IVB epithelial ovarian cancer, using global real-world data. Secondary objectives included evaluation of progression-free survival and the influence of race, post-operative complications, and residual disease. SUROVA is a retrospective, international cohort study involving patients treated between 2018 and 2019 across 174 centers in 55 countries. Patients underwent primary surgery or received neoadjuvant chemotherapy followed by interval surgery, per institutional protocols. Propensity score matching was based on 7 baseline variables: age, race, Eastern Cooperative Oncology Group performance status at diagnosis, CA125 level at diagnosis, FIGO (International Federation of Gynecology and Obstetrics) stage IV disease, presence of ascites, and final tumor grade. Cox regression models with time-dependent effects and interaction terms were applied. A clinical risk calculator was developed and internally validated. A total of 3286 patients had a mean age of 60.0 years (SD 12); 2978 (90.6%) had high-grade serous carcinoma, and 795 (24.7%) presented with FIGO stage IV disease. A total of 1666 patients (50.7%) underwent primary cytoreductive surgery, and 1620 (49.3%) received neoadjuvant chemotherapy. The median follow-up duration was 43.8 months (interquartile range; 22.6-59.3). After propensity score matching (n=1524), overall survival was similar between groups (67.2 vs 65.0 months; HR 1.002, 95% CI 0.85 to 1.18, p=.98). Outcomes differed by ethnicity, residual disease, and post-operative complications. Post-operative complications (28%) significantly worsened survival (66 vs 46 months; HR 1.5, 95% CI 1.2 to 1.9, p<.001), especially among patients undergoing primary surgery (73 vs 46 months; HR 1.85, 95% CI 1.43 to 2.37, p<.001). The most favorable outcomes were observed among patients with primary surgery, complete resection, and no complications, with median overall survival not reached (HR 1.25, 95% CI 1.12 to 1.40, p<.001). Although overall survival was similar between groups, treatment effects differed by ethnicity, residual disease, and complications. Post-operative complications were associated with significantly worse survival, particularly among patients undergoing primary surgery, while the best outcomes were achieved in those who had primary surgery with complete resection and no complications.

Oncological outcomes of intraperitoneal chemotherapy in advanced ovarian cancer: BRCA mutation role

The knowledge of BRCA status offers a chance to evaluate the role of the intraperitoneal route in patients selected by biomolecular profiles after primary cytoreduction surgery in advanced ovarian cancer. We performed a retrospective, multicenter study to assess oncological outcomes depending on adjuvant treatment (intraperitoneal [IP] vs intravenous [IV]) and BRCA status (BRCA1/2 mutated vs. BRCA wild type [WT]). The primary endpoint was to determine progression-free survival. The secondary objectives were overall survival and toxicity. A total of 288 women from eight centers were included: 177 in the IP arm and 111 in the IV arm, grouped into four arms according to BRCA1/2 status. Significantly better PFS was observed in BRCA1/2-mutated patients with IP chemotherapy (HR: 0.35; 95% CI, 0.16-0.75, p = 0.007), which was not present in BRCA1/2-mutated patients with IV chemotherapy (HR: 0.65; 95% CI, 0.37-1.12, p = 0.14). Significantly better OS was also observed in IP chemotherapy (HR: 0.17; 95% CI, 0.06-043, p < 0.0001), but was not present in IV chemotherapy in relation with BRCA mutation (HR: 0.52; 95% CI, 0.22-1.27, p = 0.15). For BRCA WT patients, worse survival was observed regardless of the adjuvant route used. The IP route was more toxic compared to the IV route, but toxicity was equivalent at the long-term follow-up. This retrospective study suggests that BRCA status can help to offer an individualized, systematic treatment after optimal primary surgery for advanced ovarian cancer, but is limited by the small sample size. Prospective trials are essential to confirm these results.

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.