Schoenen S, Mailliez A, Risbourg S
… +14 more, Decoupigny E, Vanseymortier M, Pasquesoone C, Le Saux O, Ray-Coquard I, Navarro AS, Bresson L, Thiebaut A, Antoni G, Bertrand N, Leblanc E, Narducci F, Le Deley MC, Martinez Gomez C
Int J Gynecol Cancer
· 2026 Apr · PMID 42140840
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BACKGROUND: Bilateral salpingo-oophorectomy is the gold-standard risk-reducing surgery for women at high risk of tubo-ovarian or primary peritoneal cancer. Fimbriectomy with delayed oophorectomy has emerged as a promisin...BACKGROUND: Bilateral salpingo-oophorectomy is the gold-standard risk-reducing surgery for women at high risk of tubo-ovarian or primary peritoneal cancer. Fimbriectomy with delayed oophorectomy has emerged as a promising alternative, potentially reducing tubo-ovarian cancer risk while minimizing the adverse effects of premature menopause. Larger cohorts and longer follow-up are required to confirm these findings. PRIMARY OBJECTIVES: To evaluate the effectiveness of the chosen care pathway in controlling the risk of advanced-stage tubo-ovarian carcinoma, and more specifically to determine whether prophylactic fimbriectomy with delayed oophorectomy is non-inferior to standard bilateral salpingo-oophorectomy in women at high risk and with germline mutations. STUDY HYPOTHESIS: Fimbriectomy with delayed oophorectomy is non-inferior to bilateral salpingo-oophorectomy in preventing oncological risk and reduces menopause-related health disorders. TRIAL DESIGN: This multi-center, non-randomized, pragmatic, preference-based controlled trial allows participants to choose their preventive surgical strategy between standard bilateral salpingo-oophorectomy (according to national guidelines) and fimbriectomy (considered from the age of 35, once childbearing is completed), followed by delayed oophorectomy at age 50 or at clinical menopause. Participants will undergo annual long-term follow-up until age 70. The association between the chosen care pathway and outcomes will be estimated using an inverse probability-weighted, cause-specific Cox model, with age as the time scale. MAJOR INCLUSION/EXCLUSION CRITERIA: This study will be proposed during oncogenetic counseling to pre-menopausal women aged 30 to 50 years with a documented pathogenic germline mutation (BRCA1, BRCA2, RAD51C, RAD51D, or PALB2). Exclusion criteria include prior bilateral oophorectomy or salpingectomy and a personal history of tubo-ovarian cancer. PRIMARY ENDPOINT: Advanced-stage tubo-ovarian or primary peritoneal carcinoma. SAMPLE SIZE: A total of 1100 patients is planned. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Recruitment will last 5 years (2026-2031). The first interim analysis is planned 6 to 8 years after study initiation (2032-2034). Final analysis is planned when all patients reach age 70 (around 2071). TRIAL REGISTRATION NUMBER: NCT06726330.
Sehouli J, Pietzner K, Zocholl D
… +9 more, Nguyen J, Leitner K, Eichbaum M, Goldmann J, Frühauf F, Van Gorp T, Estévez-García P, Katsaros D, Braicu EI
Int J Gynecol Cancer
· 2026 May · PMID 42140839
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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 polymera...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.
Int J Gynecol Cancer
· 2026 Jun · PMID 42140018
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We evaluated the prevalence, predictors, and survival impact of positive margins in localized invasive vulvar squamous cell carcinoma. Patients with localized invasive (pT1-T4, N0, M0) vulvar squamous cell carcinoma unde...We evaluated the prevalence, predictors, and survival impact of positive margins in localized invasive vulvar squamous cell carcinoma. Patients with localized invasive (pT1-T4, N0, M0) vulvar squamous cell carcinoma undergoing surgical excision were identified from the National Cancer Database (2004-2023). Margin status reflects the final pathologic assessment recorded as positive (microscopic or macroscopic residual tumor) or negative. Multivariable logistic regression was used to identify factors associated with positive margins. Overall survival was estimated using Kaplan-Meier and multivariable Cox models. Among 32,341 patients, 4,249 (13.1%) had positive margins. Factors independently associated with margin positivity included older age, later year of diagnosis, Black race, higher comorbidity burden, larger tumor size, higher grade, advanced T stage, treatment at non-academic centers, organ-sparing surgery. Positive margins were associated with worse overall survival (5-year: 59.6% vs 72.5%) and remained associated with increased mortality after adjustment for demographic, tumor, treatment, facility-related factors (aHR 1.30, 95% CI 1.23-1.37). Positive margins remain common in localized vulvar squamous cell carcinoma and are associated with worse overall survival, underscoring the need to optimize margin clearance, particularly in organ-sparing surgical approaches, while also considering other important factors such as tumor location, multifocality, re-excision, adjuvant therapy, and surgical expertise.
Leis LV, Vasconcellos JM, Gouveia MC
… +4 more, Melo MAZ, da Silva Neto AL, de Mattos JM, Scaranti M
Int J Gynecol Cancer
· 2026 Jun · PMID 42134101
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"From Congress to Clinic: Relevant Trials Presented at European Society of Gynaecological Oncology (ESGO) 2026" summarizes the most clinically relevant studies presented at the 27th Congress of European Society of Gynaec..."From Congress to Clinic: Relevant Trials Presented at European Society of Gynaecological Oncology (ESGO) 2026" summarizes the most clinically relevant studies presented at the 27th Congress of European Society of Gynaecological Oncology, held in Copenhagen, Denmark, from February 26 to 28, 2026. The meeting gathered more than 3000 attendees from over 100 countries and featured more than 100 international speakers, over 1200 abstracts, and more than 200 scientific lectures highlighting advances across gynecologic malignancies.Recent progress in gynecologic oncology continues to be driven by immunotherapy, targeted therapies, and biomarker-guided treatment strategies. At European Society of Gynaecological Oncology 2026, several presentations explored novel systemic therapies, innovative treatment combinations, and evolving maintenance approaches in ovarian, endometrial, cervical, and rare gynecologic cancers.This review highlights selected trials presented at the congress with the greatest potential to influence clinical practice and guide future research in gynecologic oncology.
Dzyubak O, Moshkovich M, Watts M
… +7 more, Tarafdar O, Wei-Jia Lim J, Maganti M, Han K, Hodgson A, Ferguson SE, Kim SR
Int J Gynecol Cancer
· 2026 Jun · PMID 42134100
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OBJECTIVE: This study investigates whether the specific molecular profile of endometrial cancer is associated with propensity for lymph node metastasis. METHODS: Patients undergoing primary surgery between 2015 and 2023...OBJECTIVE: This study investigates whether the specific molecular profile of endometrial cancer is associated with propensity for lymph node metastasis. METHODS: Patients undergoing primary surgery between 2015 and 2023 were reviewed. Clinicopathological, lymph node metastasis, recurrence, and survival patterns were compared between molecular sub-groups: no specific molecular profile, p53-abnormal, POLE-mutated, and mismatch repair-deficient, with a sub-group analysis of MLH1 promoter methylated and non-MLH1 promoter methylated mismatch repair-deficient cases. RESULTS: Of 537 patients, 239 (45%) were no specific molecular profile, 145 (27%) were p53-abnormal, 109 (20%) were MLH1 promoter methylated, 40 (7%) were non-MLH1 promoter methylated mismatch repair-deficient, and 4 (1%) were POLE-mutated. Lymph node assessment was done in 420 patients (78%), with lymph node metastases present in 92 (22%). There was no significant difference in lymph node metastasis between molecular groups (p =.080). However, MLH1 promoter methylated tumors had the highest incidence of lymphovascular space invasion (48%, p <.001) and microcystic, elongated, and fragmented pattern of invasion (17%, p <.001). The p53-abnormal sub-group had the highest median tumor volume (12.7 cm, 0.0-781.5, p =.013), followed by MLH1 promoter methylated (12.2 cm, 0.0-375.8). The median follow-up was 2.4 years (0.05-7.67). Two-year estimated progression-free survival was as follows: non-MLH1 promoter methylated mismatch repair-deficient (92.1%, 95% confidence interval 83.9% to 100%), no specific molecular profile (92.3%, 95% confidence interval 88.7% to 96.0%), MLH1 promoter methylated (83.1%, 95% confidence interval 76.0% to 90.8%), and p53-abnormal (75.0%, 95% confidence interval 67.9% to 82.9%) (p <.001). Two-year estimated overall survival was as follows: non-MLH1 promoter methylated mismatch repair-deficient (100%), no specific molecular profile (98.2%, 95% confidence interval 96.5 to 100.0), MLH1 promoter methylated (92.6%, 95% confidence interval 87.4% to 98.1%), and p53-abnormal (92.0%, 95% confidence interval 87.3% to 96.9%) (p <.001). CONCLUSIONS: Currently, there is not enough evidence to tailor lymph node staging according to molecular profile. Special attention should be paid to MLH1 promoter methylated tumors due to high-risk features and poor outcomes.
Barretina-Ginesta MP, Redondo A, Cortés-Salgado A
… +6 more, Madariaga A, Pérez-Mies B, Sancho L, Valls-Masot L, Domínguez M, González-Martín A
Int J Gynecol Cancer
· 2026 Jun · PMID 42127859
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Ovarian cancer is one of the gynecologic malignancies with the highest mortality, largely due to diagnosis at advanced stages and high recurrence rates. Standard first-line treatment consists of platinum-based chemothera...Ovarian cancer is one of the gynecologic malignancies with the highest mortality, largely due to diagnosis at advanced stages and high recurrence rates. Standard first-line treatment consists of platinum-based chemotherapy followed by maintenance with poly (adenosine diphosphate-ribose) polymerase inhibitors and/or bevacizumab. Approximately 70% to 80% of patients with high-grade serous ovarian cancer respond to first-line platinum-based chemotherapy, while only a small proportion exhibit de novo platinum-resistant disease, a clinical scenario associated with poorer outcomes. Assessing platinum response during chemotherapy provides both prognostic and predictive information, functioning as a surrogate marker of genomic instability and informing subsequent therapeutic decisions. Although BRCA mutations and homologous recombination deficiency help identify tumors with increased vulnerability to platinum-induced DNA damage, these biomarkers only partially capture the underlying biological heterogeneity and do not fully guide therapeutic decision-making. Notably, a subset of homologous recombination-proficient tumors still achieves meaningful responses to platinum and poly (adenosine diphosphate-ribose) polymerase inhibitors, underscoring the need for complementary approaches to better characterize platinum sensitivity and refine therapeutic decision-making. This review summarizes the current evidence on methods used to assess response to platinum-based chemotherapy in first-line advanced ovarian cancer and discusses their clinical relevance. Radiological evaluation using Response Evaluation Criteria in Solid Tumors 1.1 remains the standard approach, while emerging imaging techniques aimed at quantifying changes in tumor volume and density may improve response assessment. Biochemical markers, including CA125 kinetics and the modeled CA125 ELIMination rate constant K, provide prognostic information and help identify platinum sensitivity. Pathologic assessment through the chemotherapy response score offers standardized evaluation of response to neoadjuvant chemotherapy. In addition, emerging molecular tools such as circulating tumor DNA and circulating tumor cells show promising results for improving response evaluation and detecting resistance mechanisms. A multi-factorial approach combining these molecular, radiological, biochemical, and pathologic parameters is critical to improve patient stratification and optimize individualized treatment strategies in clinical practice.
Matsuo K, Luhar R, Lee MW
… +5 more, Friedman EL, Erfani H, Lim AE, Ouzounian AJ, Roman LD
Int J Gynecol Cancer
· 2026 Jun · PMID 42127858
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This cohort study included 157 patients with isolated serous tubal intraepithelial carcinoma and compared with 330 patients with stage IA high-grade serous fallopian tubal carcinoma identified in the Commission-on-Cancer...This cohort study included 157 patients with isolated serous tubal intraepithelial carcinoma and compared with 330 patients with stage IA high-grade serous fallopian tubal carcinoma identified in the Commission-on-Cancer's National Cancer Database from 2011 to 2017. Patients with isolated serous tubal intraepithelial carcinoma were younger, more likely to be non-Hispanic White, and had more recent diagnosis than those with stage IA high-grade serous fallopian tubal carcinoma. With a median follow-up of 7.2 years, the 7-year overall survival rate of patients with isolated serous tubal intraepithelial carcinoma exceeded 90%, which was higher than stage IA high-grade serous fallopian tubal carcinoma (93.2% vs 87.6%, adjusted-hazard ratio 0.30, 95% confidence interval 0.14 to 0.65). The majority of patients with isolated serous tubal intraepithelial carcinoma did not undergo lymph node evaluation and did not receive chemotherapy (82.2%). The 7-year overall survival rate of these patients remained higher than 90% (92.6%). In conclusion, these data suggest that isolated serous tubal intraepithelial carcinoma and stage IA high-grade serous fallopian tubal carcinoma have distinct clinical characteristics and survival. Although limited in sample size, favorable long-term survival without lymph node evaluation and chemotherapy for patients with isolated serous tubal intraepithelial carcinoma found in this study requires further validation and evaluation.
Zomerdijk N, Janda M, Mulcahy E
… +2 more, Baxter E, Roberts N
Int J Gynecol Cancer
· 2026 Jun · PMID 42114343
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OBJECTIVE: We aimed to synthesize evidence from qualitative studies on women's experiences of diagnosis and treatment decision-making for early-stage endometrial cancer, and to identify implications for clinical practice...OBJECTIVE: We aimed to synthesize evidence from qualitative studies on women's experiences of diagnosis and treatment decision-making for early-stage endometrial cancer, and to identify implications for clinical practice and future research. METHODS: A systematic review was conducted using Cochrane-Campbell guidance. Searches included CINAHL, EMBASE, and PubMed bibliographic databases. A meta-synthesis of 17 qualitative studies was undertaken using a thematic approach to integrate findings on women's needs, preferences, and priorities throughout the diagnostic and treatment journey. RESULTS: Three overarching themes were identified: (1) Conditions that prepare or hinder women's ability to engage in decisions at diagnosis, shaped by symptom interpretation, stigma, and emotional shock; (2) Processes that facilitate informed decisions during treatment discussions, highlighting the central role of timely information, clear explanations, and clinician engagement; and (3) Women's understanding of their decisions and regaining control, reflecting short- and long-term impacts of treatment decision-making. CONCLUSIONS: Findings demonstrate that decision-making unfolds across time rather than at a single clinical encounter. Timely information, and accessible lifestyle and peer support are needed to strengthen decision-making and well-being. Future research should develop strategies to enhance receptivity information that can support decisions for treatment planning, and prioritize underrepresented populations, who experience disproportionally higher endometrial cancer mortality and lower treatment completion rates.
Lavie M, Michaan N, Joubran J
… +4 more, Baruch Y, Grisaru D, Cohen A, Laskov I
Int J Gynecol Cancer
· 2026 Jun · PMID 42107280
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OBJECTIVE: Enhanced Recovery After Surgery pathways have improved post-operative outcomes in gynecologic oncology, yet recovery trajectories vary widely. Objective measures of post-operative mobilization, such as daily s...OBJECTIVE: Enhanced Recovery After Surgery pathways have improved post-operative outcomes in gynecologic oncology, yet recovery trajectories vary widely. Objective measures of post-operative mobilization, such as daily step count, may serve as reliable indicators of functional recovery, but their impact remains unclear. This study evaluated the relationship between peri-operative step counts and post-operative outcomes while accounting for established clinical and surgical recovery factors. METHODS: A prospective cohort study of patients undergoing gynecologic cancer surgery at a single tertiary, university-affiliated center. Participants wore smartwatches to record daily step counts before and after surgery. Demographic, clinical, and surgical data were collected, along with post-operative recovery parameters including pain, narcotic use, duration of urinary catheterization and abdominal drainage, and peri-operative hemoglobin decline. Primary outcomes were hospital length of stay and re-admission rates. Multivariable Poisson generalized estimating equation models were applied to evaluate associations while adjusting for potential confounders. RESULTS: Seventy-seven women were included. Longer length of stay correlated with older age, greater hemoglobin decline, higher narcotic use, and prolonged urinary catheterization (all p < .01). Higher pre-operative and post-operative daily step counts were significantly associated with shorter length of stay (r = -0.356 and r = -0.318, respectively, both p < .001). Re-admission was associated with catheterization duration, delayed oral intake, and surgical complexity, but not with step counts. After adjusting for models, higher post[operative step counts remained an independent predictor of shorter length of stay (β = -5.12 × 10, p = .008), with a diminishing effect over later post-operative days. CONCLUSION: Early-onset mobilization evaluated by post-operative step counts is independently associated with shorter hospitalization, confirming activity as a robust, modifiable predictor of recovery. Smartwatch-based step monitoring offers accurate, objective mobility assessment, supporting its integration into peri-operative Enhanced Recovery After Surgery pathways to optimize recovery and guide targeted rehabilitation strategies.
Chen Z, Zeng Y, Luo L
… +11 more, Li J, Zheng L, Xie Y, Xiao J, Zhang L, Zhang Q, Sun Y, Sun X, Sui L, Tao X, Cong Q
Int J Gynecol Cancer
· 2026 Jun · PMID 42102630
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OBJECTIVE: Cervical cancer remains a leading cause of gynecologic cancer-related mortality worldwide, with human papillomavirus (HPV) testing being a key screening tool. However, current guidelines often categorize high-...OBJECTIVE: Cervical cancer remains a leading cause of gynecologic cancer-related mortality worldwide, with human papillomavirus (HPV) testing being a key screening tool. However, current guidelines often categorize high-risk HPV types broadly, overlooking their varying oncogenic potentials. This study aimed to develop and validate a machine learning model to predict cervical intra-epithelial neoplasia grade (CIN) 2 or worse (CIN2+) using HPV genotyping, cytology results, and patient age. METHODS: A retrospective analysis was conducted using data from 52,063 patients (61,022 clinical records) from the Obstetrics and Gynecology Hospital of Fudan University, Shanghai, collected between October 2017 and June 2023. Clinical data included HPV genotyping, cytology results, and histopathologic diagnoses. Six machine learning algorithms (logistic regression, decision tree, random forest, Support Vector Machine-Radial Basis Function, XGBoost, and CatBoost) were compared, with performance evaluated using area under the curve, accuracy, sensitivity, and F1 score. The optimal model was validated using a temporal cohort from Obstetrics and Gynecology Hospital of Fudan University and external cohorts from Xiamen Maternal and Child Health Hospital and Jinan Maternal and Child Health Hospital. RESULTS: Among the models, CatBoost achieved the highest area under the curve (0.917) in internal validation, with an accuracy of 86% and sensitivity of 78% for CIN2+. External validation confirmed robust performance: 89% accuracy (Obstetrics and Gynecology Hospital of Fudan University), and 78% (Xiamen Maternal and Child Health Hospital), and 80% (Jinan Maternal and Child Health Hospital). Simulation analysis indicated that the AI (Artificial Intelligence)-guided strategy could reduce colposcopy referrals by 14.3%, whereas maintaining 96.8% sensitivity and an exceptional negative predictive value of 99.18%. A user-friendly tool (www.cervixcare.cn) was developed to provide individualized CIN2+ risk scores based on input variables. CONCLUSIONS: This multi-center-validated model enables precise risk stratification by accounting for HPV genotype-specific pathogenicity, improving clinical decision-making for cervical cancer screening and management.