Objective Ovarian cancer remains a significant global health concern. Contemporary therapeutics have led to an increased number of long-term survivors. This research investigates the unmet needs of long-term ovarian cancer survivors in Spain, focusing on persistent side effects, patient concerns, lifestyle changes, and ongoing challenges. Methods This is a multi-center, cross-sectional, observational study, assessing the results from the international North-Eastern German Society of Gynecological Oncology survey, Expression VI - Long-term survival with ovarian cancer in Spain. Participants were identified during follow-up visits at oncology departments. A structured questionnaire of 68 items, including demographic, clinical, psychosocial, and lifestyle domains, was completed anonymously in printed format, with implied consent through survey completion. Results A total of 250 long-term ovarian cancer survivors from Spain, defined as patients diagnosed of malignant ovarian cancer with a survival ≥8 years since diagnosis (median age at diagnosis 52 years; median survival time 11 years), completed the survey. A substantial number of participants continued to experience long-term side effects, including gastrointestinal (90%), dermatologic (91.6%), and neurologic symptoms, such as memory problems (15.1%) and concentration difficulties (10.8%). Nearly half of the survivors (47.3%) expressed concerns about nervousness, 43.6% reported ongoing pain, and 40% struggled with sleep disturbances. Lifestyle changes after cancer diagnostic were significant, with 56.5% of smoker participants quitting or reducing smoking and 41.6% adopting healthier diets. Finally, our results indicate that most participants received some form of follow-up, primarily through blood biomarker monitoring (87.0%) and imaging tests (73.0%). Conclusions This study highlights the persistent challenges among long-term ovarian cancer survivors in Spain, stressing the need for more comprehensive, tailored aftercare. These findings may be generalized to other regions, emphasizing the importance of addressing ongoing side effects and unmet care needs to improve survivors’ long-term quality of life. Enhanced follow-up care, patient support, and effective communication are essential components of this effort.
The ESGO-ESTRO-ESP guideline 2025 integrates the molecular classification into prognostic risk stratification and therapeutic decisions for patients with endometrial cancer (EC). In particular, a refined stratification of the molecular subgroup No-Specific-Molecular-Profile (NSMP) has been recently introduced to better reflect its pronounced prognostic heterogeneity. Retrospective analyses by Jamieson et al. and Vermij et al. demonstrate that histological tumor grade and immunohistochemical estrogen receptor expression represent independent prognostic factors within the NSMP subgroup, allowing for the identification of a large subgroup with an excellent prognosis and a small subgroup with a poor prognosis. Additional exploratory post hoc analyses suggest a potential differential benefit of adjuvant chemotherapy in ER-negative NSMP EC. However, these observations remain hypothesis-generating and lack prospective validation. In addition, the exact cut-off for ER-positivity remains unclear. The ESGO guideline defines prognostic risk groups according to the estimated 5-year risk of recurrence and derives recommendations for adjuvant therapy accordingly. Key randomized trials, including PORTEC-1, PORTEC-2, PORTEC-3, GOG-249 and GOG-258, are incorporated alongside molecular subgroups, whose biological characteristics increasingly inform treatment intensity. In contrast, the German S3 guideline adopts a more conservative methodological approach, incorporating molecular markers primarily as supportive information, particularly in the absence of prospective evidence guiding specific therapeutic decisions. With respect to surgical management in early-stage disease (Fédération Internationale de Gynécologie et d'Obstétrique [FIGO] I-II), both guidelines show substantial agreement, especially regarding the preference for minimally invasive surgery and the avoidance of unnecessary radicality. Differences mainly relate to the indication for sentinel lymph node staging. This statement aims to provide a balanced contextualization of these conceptual differences and to support an informed discussion of current international developments.
Background Standard therapy for advanced ovarian cancer consists of primary surgical debulking followed by 6 cycles of platinum-based chemotherapy and maintenance therapy with bevacizumab and/or poly-ADP ribose polymerase (PARP) inhibitors (PARPi). While homologous recombination deficiency (HRD)-positive patients derive meaningful benefit from PARPi maintenance; HRD-negative patients derive limited benefit, and the toxicity associated with 6 cycles of chemotherapy may negatively affect patients’ quality of life, raising the question whether reducing chemotherapy cycles could decrease morbidity without compromising efficacy. Primary Objective To compare recurrence-free survival and overall survival in patients with International Federation of Gynecology and Obstetrics stage III to IV, HRD-positive ovarian cancer who achieve complete debulking, treated with either 3 or 6 cycles of platinum-based chemotherapy, both followed by maintenance therapy with the PARP inhibitor niraparib. Study Hypothesis We hypothesize that recurrence-free survival in patients receiving 3 cycles of chemotherapy followed by niraparib is non-inferior (defined as a hazard ratio [HR] ≤1.3) to 6 cycles of chemotherapy followed by niraparib, as assessed by a multi-variable Cox regression model. Trial Design This is a multicenter, randomized, open-label Phase II non-inferiority study. Participants will be randomized 1:1 to either 3 (Arm A) or 6 (Arm B) cycles of platinum-based chemotherapy, both followed by niraparib maintenance for 3 years, at a starting dose of 200 mg once daily or 300 mg once daily depending on patient factors (eg, body weight, platelet count), after complete surgical debulking.The study is currently open for recruitment in all participating countries in Europe, further details can be found under at Clinicaltrials.gov ID: NCT05460000. Major Inclusion/Exclusion Criteria Eligible patients include women with International Federation of Gynecology and Obstetrics stage III to IV high-grade ovarian cancer, confirmed HRD positivity (including pathogenic BRCA mutations) after centralized testing, and no residual disease following primary tumor debulking. The HRD test will be conducted centrally using the validated North-Eastern-German Society of Gynaecologic Oncology-Genomic Instability Score Assay. Primary Endpoint The primary endpoint is recurrence-free survival. Main Secondary Endpoints Overall survival, Quality of life, Toxicity, detailed list under “outcomes.” Sample Size 640 patients. Estimated Dates for Completing Accrual and Presenting Results Accrual completion is expected in 2032, with results presentation anticipated in 2033. Trial Registration NCT05460000. Conclusions This trial aims to provide high-quality evidence on whether a reduced number of chemotherapy cycles in the era of niraparib maintenance for 3 years can safely maintain efficacy while minimizing treatment-related toxicity and improving patients’ quality of life.
Kaplan–Meier estimates of PFS stratified on Giscar HRD status among inconclusive status of MGMC (n = 43).
MGMC and GIScar scores among concordant and discordant HRD classification on the clinical collection (n = 469)
Real-world data on treatment patterns and outcomes in recurrent or metastatic cervical cancer (r/mCC) are lacking. This first national quality assurance initiative was a retrospective analysis of patients with r/mCC diagnosed between 2018 and 2022, who were identified from medical records of 31 gynecologic cancer centers in Germany. Patient demographic and clinical characteristics, treatment patterns, and clinical outcomes were assessed descriptively. Progression-free (PFS) and overall survival (OS) were calculated using Kaplan-Meier analysis. A total of 503 eligible patients (median age 55 years) were analyzed for r/mCC. 276/503 patients (55%) received first-line (1L) chemotherapy (platinum combination: 247/276; 79%) followed by targeted antibody therapy with bevacizumab (177/247; 72%), immunotherapy (19/247; 8%), or both combined (50/247; 20%). 111/503 (22%) received chemotherapy only (platinum combination: 64/111; 58%, platinum mono: 35/111; 31%, or platinum-free: 12/111; 11%), and 110/503 (22%) did not receive any systemic treatment (the remaining 6/503 patients received immunotherapy only). For these subgroups after a median follow-up of 16 months, the PFS was 12 months (95% CI 11–14), 8.8 months (95% CI 7.1–11), and 3 months (95% CI 2.3–4.8), and OS was 25 months (95% CI 21–31), 17 months (95% CI 14–22), and 3.6 months (95% CI 2.8–5.3), respectively. 176/283 (62%) patients who developed progressive disease (PD) were treated with second-line (2L) therapy. Only half of the patients with r/mCC were treated 1L with platinum-combination therapy including antibody therapy according to national guidelines. Moreover, 22% at initial diagnosis and 38% of patients at PD were not treated with systemic therapy at all. This might reflect poor general performance status, patients’ preference, and/or lack of effective therapies especially in 2L treatment.
AbstractPurpose :Tamoxifen undergoes Patients and Methods :We conducted a prospective, interventional, three group randomized trial including 235 patients with hormone receptor–positive breast cancer who received standard tamoxifen therapy (20 mg/day). Patients were stratified by CYP2D6 genotype (n = 78), defining poor, intermediate, and normal metabolizers, or by baseline (Z)-endoxifen plasma concentration (n = 78), defining ≤n = 79) received placebo regardless of metabolizer phenotype. The primary endpoint was the number of patients with (Z)-endoxifen levels >32 nmol/L after 6 weeks of treatment. Adverse events were continuously monitored. Results: A higher proportion of patients in both intervention groups achieved target concentrations >32 nmol/L compared with control (P < 0.0001). At 3 mg (Z)-endoxifen supplementation, 92.3% of CYP2D6 poor metabolizer patients and all patients with baseline (Z)-endoxifen ≤15 nmol/L achieved the target concentration. At 1.5 mg (Z)-endoxifen supplementation, 88% of CYP2D6 intermediate metabolizer patients and 95% of patients with 15 to 25 nmol/L baseline (Z)-endoxifen levels achieved the target concentration. Similar proportions of patients receiving (Z)-endoxifen (6/80, 7.5%) or placebo (8/155, 5.2%) experienced grade 3 adverse events. Conclusions: Adding low-dose (Z)-endoxifen to standard tamoxifen is safe and provides a new approach to personalized antiestrogen treatment for patients with low endoxifen plasma levels.
Suppl Fig. S1: Concentration time course of tamoxifen, N-desmentyl tamoxifen, (Z)-4-hydroxy tamoxifen, and (Z)-endoxifen