International Journal of Gynecological Cancer最新文献

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Pragmatic gynecologic cancer clinical trials: statements and roadmap from the Gynecologic Cancer InterGroup Chicago Brainstorming Meeting. 实用的妇科癌症临床试验:来自妇科癌症小组芝加哥头脑风暴会议的声明和路线图。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-06-23 DOI: 10.1016/j.ijgc.2026.104827
Ainhoa Madariaga, Ana Veneziani, Michael Bookman, Nicholas Counsell, Austin Miller, John Andrews, Susana Banerjee, Adriana Chavez-Blanco, Noelle Cloven, Faiza Gaba, Elise Kohn, Alexandra Leary, Fabrice Lecuru, Yeh Chen Lee, Jung Yun Lee, Ying Liu, Kristina Lindemann, Shakuntala Malik, Christian Marth, Linda Mileshkin, Asima Mukhopadhyay, Alvina Nadeem, Remi Nout, J Alejandro Pérez-Fidalgo, Marie Plante, Sudha Sundar, Alicia Tone, Amit M Oza, Ros Glasspool, Helen MacKay
{"title":"Pragmatic gynecologic cancer clinical trials: statements and roadmap from the Gynecologic Cancer InterGroup Chicago Brainstorming Meeting.","authors":"Ainhoa Madariaga, Ana Veneziani, Michael Bookman, Nicholas Counsell, Austin Miller, John Andrews, Susana Banerjee, Adriana Chavez-Blanco, Noelle Cloven, Faiza Gaba, Elise Kohn, Alexandra Leary, Fabrice Lecuru, Yeh Chen Lee, Jung Yun Lee, Ying Liu, Kristina Lindemann, Shakuntala Malik, Christian Marth, Linda Mileshkin, Asima Mukhopadhyay, Alvina Nadeem, Remi Nout, J Alejandro Pérez-Fidalgo, Marie Plante, Sudha Sundar, Alicia Tone, Amit M Oza, Ros Glasspool, Helen MacKay","doi":"10.1016/j.ijgc.2026.104827","DOIUrl":"10.1016/j.ijgc.2026.104827","url":null,"abstract":"<p><p>Randomized controlled trials remain fundamental to evidence generation in oncology but are increasingly complex, costly, and often misaligned with real-world practice. Traditional explanatory trials, designed under ideal, controlled conditions, frequently enroll highly selected populations, limiting generalizability and underrepresenting key groups such as older adults, patients with comorbidities, and those from low- and middle-income countries. Pragmatic clinical trials offer an alternative by evaluating interventions under routine care conditions, with broader eligibility, simplified procedures, and patient-centered outcomes. To address these challenges, the Gynecologic Cancer InterGroup convened an international brainstorming meeting in May 2025 with multi-disciplinary experts, patients, and advocates to define priorities and develop a roadmap for pragmatic trials in gynecologic oncology. Key discussions emphasized embedding trial design within routine care, aligning eligibility criteria and procedures with standard practice, minimizing non-essential data collection, and prioritizing outcomes meaningful to patients, including quality of life. Innovative designs such as registry-based randomized trials, trials-within-cohorts, and cluster randomization were highlighted as feasible approaches to improve efficiency while preserving internal validity. Integration of patient-reported outcomes and real-world data was considered achievable when carefully streamlined. Major challenges identified included regulatory heterogeneity, consent complexity, data interoperability, and funding limitations, particularly in multi-national settings. Proposed solutions include simplified consent models, centralized ethics processes, hybrid funding strategies, and the responsible use of artificial intelligence to enhance patient identification, recruitment, and potential development of synthetic control arms. Patient engagement was recognized as essential to ensure relevance, feasibility, and equity. Incorporation of patient-reported outcomes was discussed as key to informing acceptance and tolerability. In summary, pragmatic trials within Gynecologic Cancer InterGroup represent a critical pathway to generate efficient, inclusive, and practice-changing evidence in gynecologic cancers across diverse health care settings.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"36 9","pages":"104827"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148584435","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Biomarkers guiding fertility-sparing treatment in endometrial cancer. 指导子宫内膜癌保留生育能力治疗的生物标志物。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-06-27 DOI: 10.1016/j.ijgc.2026.104839
Andrej Cokan, Tibor A Zwimpfer, David Viveros-Carreño, Khayal Gasimli, Ilker Kahramanoglu, Houssein El Hajj, Martina Aida Angeles, Esra Bilir, Nicoló Bizzarri, Andrea Rosati, Zoia Razumova, Tanja Nikolova, Manuela Ludovisi, Maximilian Heinz Beck, Márton Keszthelyi, Maja Pakiž
{"title":"Biomarkers guiding fertility-sparing treatment in endometrial cancer.","authors":"Andrej Cokan, Tibor A Zwimpfer, David Viveros-Carreño, Khayal Gasimli, Ilker Kahramanoglu, Houssein El Hajj, Martina Aida Angeles, Esra Bilir, Nicoló Bizzarri, Andrea Rosati, Zoia Razumova, Tanja Nikolova, Manuela Ludovisi, Maximilian Heinz Beck, Márton Keszthelyi, Maja Pakiž","doi":"10.1016/j.ijgc.2026.104839","DOIUrl":"10.1016/j.ijgc.2026.104839","url":null,"abstract":"<p><p>Fertility-sparing treatment is an established option for reproductive-age women with early-stage endometrioid endometrial cancer or atypical endometrial hyperplasia. Despite high initial response rates with progestin-based therapy, predicting treatment response and recurrence remains challenging. This narrative review summarizes current evidence on prognostic and predictive biomarkers for conservative management. Progesterone receptor positivity is the most consistent favorable predictor of response, while POLE ultra-mutated tumors show excellent remission and low recurrence. Mismatch repair deficiency and p53 abnormalities are strong negative predictors, associated with poor response and higher relapse risk. PTEN loss and PIK3CA mutations may contribute to hormonal resistance, especially in combination. Ki-67 and L1 neuronal cell adhesion molecule provide additional prognostic value for recurrence risk. Elevated serum human epididymis protein 4 levels predict poor response to progestin-based therapy and represent the most promising non-invasive biomarker for patient selection and monitoring. Urine metabolomics is emerging as a complementary non-invasive tool. Magnetic resonance imaging-based radiomics and apparent diffusion coefficient histogram analysis show promise in predicting complete response and identifying resistance patterns before treatment. However, no single biomarker is sufficient for clinical decision-making. Future progress requires multi-modal strategies integrating molecular, serum, and imaging data, validated in prospective multi-center studies.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"36 9","pages":"104839"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148630455","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Surgical management and outcomes in localized vulvar basal cell carcinoma: a National Cancer Database Study. 局部外阴基底细胞癌的手术治疗和结果:一项国家癌症数据库研究。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-07-03 DOI: 10.1016/j.ijgc.2026.104849
Hue T T Tran, Duc V Le, Raslina Shrestha, Jamie N Bakkum-Gamez, Clark C Otley, Giang Huong Nguyen
{"title":"Surgical management and outcomes in localized vulvar basal cell carcinoma: a National Cancer Database Study.","authors":"Hue T T Tran, Duc V Le, Raslina Shrestha, Jamie N Bakkum-Gamez, Clark C Otley, Giang Huong Nguyen","doi":"10.1016/j.ijgc.2026.104849","DOIUrl":"10.1016/j.ijgc.2026.104849","url":null,"abstract":"<p><p>We evaluated factors associated with positive surgical margins and overall survival in localized vulvar basal cell carcinoma using the National Cancer Database (2004-2023). Patients with localized vulvar basal cell carcinoma undergoing surgical resection were included. Multi-variable logistic regression identified factors associated with positive margins. Overall survival was assessed using Kaplan-Meier estimates and multi-variable Cox regression. Among 2998 patients, 249 (8.3%) had positive margins. Older age (adjusted odds ratio [aOR] 1.022 per year, 95% confidence interval [CI] 1.008 to 1.035), tumor size >20 mm (aOR 2.451, 95% CI 1.169 to 5.139), basosquamous histology (aOR 1.873, 95% CI 1.071 to 3.275), and organ-sparing surgery (aOR 2.224, 95% CI 1.686 to 2.933) were independently associated with positive margins. Five-year overall survival was 81.79% after organ-sparing surgery, 82.75% after partial vulvectomy, and 73.30% after radical vulvectomy (log-rankp= .0013). In adjusted analyses, organ-sparing surgery was not associated with worse overall survival compared with partial vulvectomy, whereas radical vulvectomy was associated with worse survival (aHR 1.348; 95% CI 1.034 to 1.757). Organ-sparing surgery is associated with higher odds of positive margins but is not associated with worse overall survival in adjusted analyses compared with partial vulvectomy. These findings may help inform surgical decision-making in vulvar basal cell carcinoma.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"36 9","pages":"104849"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148712331","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Comprehensive cadaveric dissection of female pelvic neuroanatomy: the somatic system. 女性骨盆神经解剖:躯体系统。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-05-06 DOI: 10.1016/j.ijgc.2026.104742
Stefano Ferla, Diego Raimondo, Agnese Virgilio, Renato Seracchioli, Nucelio Lemos
{"title":"Comprehensive cadaveric dissection of female pelvic neuroanatomy: the somatic system.","authors":"Stefano Ferla, Diego Raimondo, Agnese Virgilio, Renato Seracchioli, Nucelio Lemos","doi":"10.1016/j.ijgc.2026.104742","DOIUrl":"10.1016/j.ijgc.2026.104742","url":null,"abstract":"<p><p>Deep infiltrating endometriosis and oncologic radical pelvic surgeries pose a significant risk of nerve damage. A thorough understanding of pelvic anatomy is essential for surgical precision and to avoid neurological complications or dysfunctions. Laparoscopic cadaveric dissections, with their magnification and bloodless dissection advantages, provide a safe and effective training method for mastering pelvic neuroanatomy and refining surgical skills.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"104742"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148005338","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Quality of life and patient-reported outcomes after non-surgical management of early-stage endometrial cancer and endometrial hyperplasia with atypia: a long-term follow-up of the feMMe phase II randomized clinical trial. 早期子宫内膜癌和异型性子宫内膜增生非手术治疗后的生活质量和患者报告的结果:feMMe II期随机临床试验的长期随访
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-06-11 DOI: 10.1016/j.ijgc.2026.104806
Katharina Steger, Eva Baxter, Ruqaiya Al Ramadhani, Monika Janda, Andreas Obermair
{"title":"Quality of life and patient-reported outcomes after non-surgical management of early-stage endometrial cancer and endometrial hyperplasia with atypia: a long-term follow-up of the feMMe phase II randomized clinical trial.","authors":"Katharina Steger, Eva Baxter, Ruqaiya Al Ramadhani, Monika Janda, Andreas Obermair","doi":"10.1016/j.ijgc.2026.104806","DOIUrl":"10.1016/j.ijgc.2026.104806","url":null,"abstract":"<p><strong>Objective: </strong>Non-surgical, fertility-sparing management using a levonorgestrel intra-uterine device is a de-escalation strategy for selected patients with early-stage endometrial adenocarcinoma or endometrial hyperplasia with atypia. Although the oncologic outcomes of the feMMe trial have been reported, long-term patient-reported outcomes remain insufficiently characterized. This study evaluated long-term quality of life, self-efficacy, social support, and patient-reported experiences following conservative management.</p><p><strong>Methods: </strong>The feMMe trial (open-label, randomized phase II study) includes three treatment arms: levonorgestrel intra-uterine device alone, levonorgestrel intra-uterine device plus weight loss, and levonorgestrel intra-uterine device plus metformin. Participants were contacted 15.8 to 130.2 months after trial entry. Quality of life was assessed using the Functional Assessment of Cancer Therapy-General questionnaire. Self-efficacy and social support regarding physical activity and diet were evaluated using the Self-Efficacy and Social Support questionnaire. Post-treatment experiences were collected using structured self-report items. Analyses were descriptive and included non-parametric group comparisons and correlation analyses.</p><p><strong>Results: </strong>Forty-four participants completed long-term follow-up questionnaires. After a median follow-up of 63 months, overall quality of life was favorable; the mean (standard deviation) Functional Assessment of Cancer Therapy-General total score was 80.5 (16.4). Quality of life scores did not differ by treatment arm, baseline diagnosis, pathologic response, disease recurrence, or hysterectomy status. Self-efficacy for physical activity was more favorable among patients achieving pathologic complete response at trial completion (p =.002). Perceived social support for health-related behaviors was limited, with no significant correlations between self-efficacy and social support. A total of 32 (74.4%) of participants reported a positive treatment experience and 35 (85.4%) would recommend treatment with a levonorgestrel intra-uterine device.</p><p><strong>Conclusions: </strong>Long-term quality of life and patient-reported outcomes following non-surgical management of early-stage endometrial adenocarcinoma and endometrial hyperplasia with atypia are favorable and comparable across conservative treatment strategies. These findings contribute to the understanding of long-term patient-reported outcomes after conservative management and underscore the importance of integrating survivorship-focused outcomes into shared treatment decision-making.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"36 9","pages":"104806"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148404610","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The impact of BRCA status on the efficacy of paclitaxel monotherapy in recurrent ovarian cancer. BRCA状态对紫杉醇单药治疗复发性卵巢癌疗效的影响。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-03-11 DOI: 10.1016/j.ijgc.2026.104641
Giorgia Russo, Adriana Ionelia Apostol, Ilary Ruscito, Carolina Maria Sassu, Claudia Diella, Fabiana Salvati, Filippo Maria Capomacchia, Serena Maria Boccia, Laura Vertechy, Christian Marth, Anna Fagotti, Claudia Marchetti
{"title":"The impact of BRCA status on the efficacy of paclitaxel monotherapy in recurrent ovarian cancer.","authors":"Giorgia Russo, Adriana Ionelia Apostol, Ilary Ruscito, Carolina Maria Sassu, Claudia Diella, Fabiana Salvati, Filippo Maria Capomacchia, Serena Maria Boccia, Laura Vertechy, Christian Marth, Anna Fagotti, Claudia Marchetti","doi":"10.1016/j.ijgc.2026.104641","DOIUrl":"10.1016/j.ijgc.2026.104641","url":null,"abstract":"<p><strong>Objective: </strong>In BRCA-mutated (BRCAmut) patients, while sensitivity to platinum has been assessed, the efficacy of other chemotherapy drugs, such as paclitaxel, in the recurrent setting is less defined. To this purpose, a single-center retrospective study was designed to evaluate the effects of paclitaxel monotherapy in patients with platinum-resistant ovarian cancer based on BRCA status.</p><p><strong>Methods: </strong>We collected data on patients with recurrent high-grade epithelial ovarian cancer treated with paclitaxel monotherapy between November 2017 and October 2024. Only patients who received 2 to 4 previous lines of chemotherapy before paclitaxel were selected. BRCAmut patients were compared with BRCA wild-type (BRCAwt) patients. The primary outcome was the impact of paclitaxel monotherapy on overall survival in both groups separately. The secondary outcomes were progression-free survival, response rate, and toxicity profile.</p><p><strong>Results: </strong>Of 175 patients who received paclitaxel, 155 met the inclusion criteria: 50 (32.3%) BRCAmut and 105 (67.7%) BRCAwt patients. Median progression-free survival was 5 months (95% confidence interval [CI] 3.58 to 6.42) in the BRCAwt group compared with 4 months (95% CI 2.29 to 5.71) in the BRCAmut group (p = .013). In BRCAmut patients, median overall survival was 11 months (95% CI 8.28 to 13.72) compared with 18 months for the BRCAwt group (95% CI 16.04 to 19.96) (p < .001). In the 93 patients who had previously received poly (ADP-ribose) polymerase (PARP) inhibitors, overall survival remained significantly longer in BRCAwt patients (p = .004), but not progression-free survival (p > .05).</p><p><strong>Conclusions: </strong>Treatment with paclitaxel monotherapy seems to be less effective in patients with recurrent platinum-resistant BRCAmut ovarian cancer compared with the BRCAwt population. Further clinical studies are needed to confirm these data and investigate potential mechanisms of paclitaxel resistance in BRCAmut carriers.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"104641"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147633367","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
From genetic testing to prevention: an integrated clinical pathway for hereditary risk assessment in tubo-ovarian cancer. 从基因检测到预防:输卵管卵巢癌遗传风险评估的综合临床途径。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-08-03 DOI: 10.1016/j.ijgc.2026.104898
David Viveros-Carreño, Nathalia Mora-Soto, Isabel Beshar, Nuria Agustí, Lucía Martínez-Cruz, Andreina Fernandes, Alessandro Buda, Alejandro Rauh-Hain, René Pareja
{"title":"From genetic testing to prevention: an integrated clinical pathway for hereditary risk assessment in tubo-ovarian cancer.","authors":"David Viveros-Carreño, Nathalia Mora-Soto, Isabel Beshar, Nuria Agustí, Lucía Martínez-Cruz, Andreina Fernandes, Alessandro Buda, Alejandro Rauh-Hain, René Pareja","doi":"10.1016/j.ijgc.2026.104898","DOIUrl":"10.1016/j.ijgc.2026.104898","url":null,"abstract":"<p><p>Hereditary tubo-ovarian cancer risk assessment has evolved from a BRCA1/2-centered consultation to an integrated prevention pathway that begins at diagnosis and extends to unaffected relatives. Germline testing is now justified for patients with epithelial tubo-ovarian cancer because actionable pathogenic variants are common enough that family-history-only referral misses many carriers. The central clinical challenge is no longer whether testing matters, but whether testing is interpreted and implemented in a way that prevents cancer. BRCA1 and BRCA2 remain the highest-impact tubo-ovarian cancer predisposition genes, but Lynch syndrome genes, BRIP1, RAD51C, RAD51D, PALB2, and selected rare histology-directed syndromes require distinct counseling. Gene-specific penetrance, age-specific risk, family history, comorbidities, reproductive plans, and menopause consequences should shape the timing of risk-reducing surgery. Tumor testing improves therapeutic selection and can identify possible hereditary variants, but tumor-only testing does not replace germline testing when hereditary evaluation is indicated. Cascade testing should be measured and resourced as part of tubo-ovarian cancer care rather than treated as a passive family responsibility. Mainstream testing, traceback programs, and navigation-supported cascade testing offer pragmatic implementation models, but access gaps remain. For gynecologic oncology clinicians, modern hereditary risk assessment should be understood as a multi-disciplinary prevention intervention: testing is the entry point, not the endpoint. This narrative review synthesizes gene-specific counseling, tumor-germline interpretation, and implementation strategies into a clinically oriented pathway from diagnosis to prevention for patients and relatives.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"36 9","pages":"104898"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148792899","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
FIGO/IGCS Statement on the efficacy of topical treatments for high-risk human papillomavirus in preventing CIN 3+ lesions. FIGO/IGCS关于局部治疗高危人乳头瘤病毒预防CIN 3+病变疗效的声明。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 DOI: 10.1016/j.ijgc.2026.104946
René Pareja, Fernando Heredia, Emmanuel Sánchez-Díaz, Mauricio A Cuello, Silvia de Sanjosé, José Jerónimo, Suzanne M Garland, Marta Del Pino, Angélica Fletcher, Aureli Torné, Gabriel Levin, Lisa Flowers, Munachiso Iheme Ndukwe, Lina María Trujillo, Sarikapan Wilailak, Neerja Bhatla, Christina Fotopoulou, Barbara Schmalfeldt, Gloria Inés Sánchez, Maria Kyrgiou, Patrick Petignat, Nadeem Abu-Rustum
{"title":"FIGO/IGCS Statement on the efficacy of topical treatments for high-risk human papillomavirus in preventing CIN 3+ lesions.","authors":"René Pareja, Fernando Heredia, Emmanuel Sánchez-Díaz, Mauricio A Cuello, Silvia de Sanjosé, José Jerónimo, Suzanne M Garland, Marta Del Pino, Angélica Fletcher, Aureli Torné, Gabriel Levin, Lisa Flowers, Munachiso Iheme Ndukwe, Lina María Trujillo, Sarikapan Wilailak, Neerja Bhatla, Christina Fotopoulou, Barbara Schmalfeldt, Gloria Inés Sánchez, Maria Kyrgiou, Patrick Petignat, Nadeem Abu-Rustum","doi":"10.1016/j.ijgc.2026.104946","DOIUrl":"10.1016/j.ijgc.2026.104946","url":null,"abstract":"<p><p>Cervical cancer is caused by persistent high-risk human papillomavirus (HR-HPV) infection and remains a major global health burden despite available preventive strategies. Most HR-HPV infections and associated low-grade squamous intraepithelial lesions (LSIL) regress spontaneously, yet increasing commercial promotion of topical therapies targeting HPV clearance has emerged in clinical practice. This FIGO/International Gynecologic Cancer Society (IGCS) Position Statement critically appraises the available evidence on topical treatments for HR-HPV infection and LSIL, and provides evidence-based recommendations for clinical practice and future research. No randomized controlled trial has been adequately designed or powered to evaluate the effect of topical therapies on the prevention of histologically confirmed high-grade squamous intraepithelial lesions (HSIL/CIN3+). Available studies are characterized by small sample sizes, short follow-up periods, heterogeneous populations, inadequate comparators, and reliance on surrogate endpoints of uncertain clinical relevance, including cytological regression, HPV nondetection, and immunohistochemical markers such as p16/Ki-67. Published meta-analyses reporting statistically significant improvements in virological and cytological surrogates are limited by substantial heterogeneity, publication bias, and follow-up periods under 1 year. Product-specific appraisal of Coriolus versicolor-based and silicon dioxide/selenite-based vaginal gels reveal additional methodological concerns, including retrospective trial registration, industry funding, and misinterpretation of findings consistent with the spin phenomenon. In the absence of high-quality evidence demonstrating clinically meaningful benefit, FIGO and IGCS do not endorse the routine clinical use of any currently available topical agent for HR-HPV infection or LSIL. Evidence-based surveillance remains the standard of care. Future research should prioritize rigorous trial design with histologically confirmed HSIL/CIN3+ as the primary endpoint, adequate follow-up of at least 3 years, and appropriate comparators. Clinical management should center on informed shared decision-making and evidence-based counseling, rather than on interventions lacking proven clinical benefit.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"104946"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148874045","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Cadonilimab for recurrent small cell neuroendocrine carcinoma of the cervix: a phase 2 study. 卡多尼单抗治疗复发性宫颈小细胞神经内分泌癌:2期研究。
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-07-06 DOI: 10.1016/j.ijgc.2026.104860
Helen D Clark, Michael Frumovitz, Kelly M Rangel, Zhouxuan Li, Ying Yuan, Shannon N Westin, Amir A Jazaeri, Larissa A Meyer, Travis T Sims
{"title":"Cadonilimab for recurrent small cell neuroendocrine carcinoma of the cervix: a phase 2 study.","authors":"Helen D Clark, Michael Frumovitz, Kelly M Rangel, Zhouxuan Li, Ying Yuan, Shannon N Westin, Amir A Jazaeri, Larissa A Meyer, Travis T Sims","doi":"10.1016/j.ijgc.2026.104860","DOIUrl":"10.1016/j.ijgc.2026.104860","url":null,"abstract":"<p><strong>Objective: </strong>Small cell neuroendocrine carcinoma is a rare, aggressive histologic sub-type of cervical cancer. Although a standard frontline regimen exists, no standard highly active agent is available for recurrent disease. Single-agent anti-programmed cell death 1 therapy has also failed to demonstrate efficacy in this population; however, dual immune checkpoint blockade of programmed cell death 1 and cytotoxic T-lymphocyte-associated protein 4 has shown promising activity in high-grade neuroendocrine neoplasms. Data specific to recurrent small cell neuroendocrine cervical cancer remain sparse. We examined the safety and efficacy of cadonilimab, a bispecific antibody targeting programmed cell death 1 and cytotoxic T-lymphocyte-associated protein 4, in recurrent or metastatic small cell neuroendocrine cervical cancer.</p><p><strong>Methods: </strong>This was a phase 2, open-label, single-arm study of cadonilimab monotherapy in patients with recurrent or metastatic high-grade small cell neuroendocrine cervical cancer. Eligible patients received 6 mg/kg of cadonilimab on days 1 and 15 of each 28-day treatment cycle for up to 24 months. The primary objective was to estimate the 6-month progression-free survival probability using Kaplan-Meier analysis. Progression-free survival was defined as the time from treatment initiation to disease progression or death from any cause.</p><p><strong>Results: </strong>Among 9 patients who initiated treatment, 8 were evaluable for efficacy. One patient remained progression-free at 6 months (probability 0.125, 95% confidence interval 0.02 to 0.78). The median progression-free survival for the efficacy cohort was 2.19 months (95% confidence interval 1.84 to not available). The objective response rate was 0% (95% confidence interval 0% to 37%). Two patients experienced stable disease lasting 9.4 and 16.2 weeks, resulting in a disease control rate of 25% (2/8; 95% confidence interval 3% to 65%). One patient (1/9, 11%) experienced grade 3 fatigue. No grade 4 or 5 adverse events occurred.</p><p><strong>Conclusions: </strong>Cadonilimab monotherapy for recurrent or metastatic small cell neuroendocrine cervical cancer was safe; however, no objective responses were observed.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"36 9","pages":"104860"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148591037","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Management of medically inoperable low-grade endometrial cancer: patterns of care and outcomes with radiation, brachytherapy, and hormonal therapy. 医学上不能手术的低级别子宫内膜癌的治疗:放疗、近距离放疗和激素治疗的护理模式和结果
IF 5.4 2区 医学
International Journal of Gynecological Cancer Pub Date : 2026-09-01 Epub Date: 2026-01-20 DOI: 10.1016/j.ijgc.2026.104496
Kevin Tam, Leslie D Peralta, Glenn P Boyles, Meredith A Newton, Kimberly Dessources, Shivani Sud, Olivia D Lara, Benjamin B Albright
{"title":"Management of medically inoperable low-grade endometrial cancer: patterns of care and outcomes with radiation, brachytherapy, and hormonal therapy.","authors":"Kevin Tam, Leslie D Peralta, Glenn P Boyles, Meredith A Newton, Kimberly Dessources, Shivani Sud, Olivia D Lara, Benjamin B Albright","doi":"10.1016/j.ijgc.2026.104496","DOIUrl":"10.1016/j.ijgc.2026.104496","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to explore treatment patterns and outcomes for medically inoperable patients with stage I low-grade endometrial cancer undergoing primary non-surgical treatment with radiation or hormonal therapy.</p><p><strong>Methods: </strong>From the 2004-2021 National Cancer Database files, we identified patients aged > 50 years with clinical stage I grade 1 to 2 endometrioid endometrial adenocarcinoma undergoing primary radiation or hormonal therapy without surgery. We described trends and explored factors associated with treatment choice with logistic regression and survival with Kaplan-Meier curves and Cox regression.</p><p><strong>Results: </strong>Among 3842 patients, 70.6% were treated with radiation, 34.9% with hormonal therapy, and 5.6% with both. Among those undergoing radiation, 45.0% received brachytherapy. Comparing 2004-2008 with 2017-2021, the use of hormonal therapy increased (16.4% to 45.8%), whereas radiation declined (86.4% to 61.2%). Patients with grade 2 tumors had higher odds of receiving radiation. Otherwise, the use of hormonal therapy and brachytherapy were strongly associated with facility characteristics (region, academic affiliation, volume). Patients treated with radiation had longer median overall survival versus hormonal therapy alone (53.8 vs 46.6 months; p = .004), with the survival longest in patients receiving brachytherapy (median 66.2 months). After adjustment, hormonal therapy was associated with increased hazard of death (hazard ratio [HR] 1.27, 95% confidence interval [CI] 1.15 to 1.41), with a greater estimated hazard for grade 2 (HR 1.47, 95% CI 1.21 to 1.81) versus grade 1 disease (HR 1.22, 95% CI 1.09 to 1.38). Similar hazards were identified comparing treatment lacking brachytherapy versus those with brachytherapy (HR 1.37, 95% CI 1.24 to 1.51).</p><p><strong>Conclusions: </strong>Despite limited data on comparative efficacy, the use of hormonal therapy is increasing over time, with treatment choice strongly associated with facility type, region, and volume. Patients undergoing radiation, particularly, brachytherapy, had longer survival.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"104496"},"PeriodicalIF":5.4,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146776349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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