International Journal of Gynecological Cancer最新文献

{"title":"Phase 2b, open-label, single-arm, multicenter pilot study of the efficacy, safety, and tolerability of dostarlimab in women with early-stage mismatch repair-deficient endometrioid endometrial adenocarcinoma.","authors":"Andreas Obermair, Val Gebski, Jeffrey Goh, Anna Kuchel, Alison Brand, Blossom Mak, Orla McNally, Eva Baxter, Thomas Jobling, Linda Mileshkin","doi":"10.1016/j.ijgc.2025.101644","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101644","url":null,"abstract":"<p><strong>Background: </strong>The standard treatment for endometrial cancer is hysterectomy with or without bilateral salpingo-oophorectomy; however, this may not be an optimal choice for women who have not completed childbearing or who are at a high risk of surgical complications. Conservative treatment with levonorgestrel intrauterine devices appear to be effective in patients with early-stage endometrial cancer; however, patients with mismatch repair-deficient (dMMR) tumors have a low likelihood of responding to levonorgestrel intrauterine devices.</p><p><strong>Primary objective: </strong>To assess the efficacy of dostarlimab, an active immune checkpoint inhibitor that targets the programmed cell death protein-1 receptor, in patients with early-stage dMMR endometrioid endometrial adenocarcinoma.</p><p><strong>Study hypothesis: </strong>Administration of 4 3-weekly cycles of 500 mg dostarlimab followed by a 3-week rest period and 3 6-weekly cycles of 1000 mg dostarlimab will be safe and efficacious in early-stage dMMR endometrial cancer patients.</p><p><strong>Trial design: </strong>Non-randomized, open-label, pilot, multicenter phase2b study designed to evaluate the efficacy and safety of dostarlimab in 10 women aged ≥18 years with a clinically confirmed diagnosis of early-stage and dMMR endometrioid endometrial adenocarcinoma.</p><p><strong>Major inclusion/exclusion criteria: </strong>Eligible patients must have histologically proven stage I, International Federation of Gynecology and Obstetrics grade 1 or 2 dMMR endometrioid endometrial adenocarcinoma and desire for fertility preservation. Exclusions include, but are not limited to, patients with other high-risk endometrial cancer cell types, a poor medical risk due to uncontrolled medical conditions, or those who experienced grade 3 or higher immune-related adverse events from prior immunotherapy.</p><p><strong>Primary endpoint(s): </strong>The primary endpoint is the number of participants achieving investigator-assessed pathological complete response within 6 months of treatment.</p><p><strong>Sample size: </strong>Ten (10) women ≥18 years of age will be enrolled.</p><p><strong>Estimated dates for completing accrual and presenting results: </strong>Accruals are expected to be completed by 2027, with the presentation of results by 2029.</p><p><strong>Trial registration: </strong>NCT06278857.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101644"},"PeriodicalIF":4.1,"publicationDate":"2025-01-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425327","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}

{"title":"Factors influencing surgeons' decision for diverting ileostomy and associated complications in ovarian cancer cytoreductive surgery.","authors":"Liat Hogen, Thirushi Siriwardena, Lina Salman, Marcus Q Bernardini, Sarah E Ferguson, Stephane Laframboise, Genevieve Bouchard-Fortier, Eshetu G Atenafu, Taymaa May","doi":"10.1016/j.ijgc.2025.101640","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101640","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to identify factors influencing the decision to perform diverting ileostomy during cytoreductive surgery with colon resection for advanced ovarian cancer and investigate the associated complications and survival outcomes.</p><p><strong>Methods: </strong>This was a retrospective cohort study of patients with advanced ovarian cancer who underwent cytoreductive surgery with colon resection and re-anastomosis between January 2010 and July 2020. Multivariate analysis was performed on the factors contributing to diverting ileostomy identified in the univariate analysis.</p><p><strong>Results: </strong>Of the 134 patients, 60 (44.8%) underwent diverting ileostomies. The median follow-up was 35.75 months (range; 0.03-145.05) and the median age was 57 (range; 26-86). The anastomotic leakage rate was 3.7% (n = 5). On the univariate analysis, longer operative time (10 vs 6.4 hours), multiple bowel resections (>1 vs 1 hour), total colon resection length, pre-operative paracentesis, intraoperative ascites, and transfusion were associated with diverting ileostomy. In the multivariate analysis, longer operative time (OR 1.61, p < .0001) and total colon resection length (OR 1.06, p = .027) remained significant. Diverting ileostomy was associated with higher rates of intensive care unit admission (14.3% vs 2.8%, p = .001), dehydration (40% vs 9.5%, p < .0001), and acute kidney injury (16.4% vs 1.4%, p = .002). The median progression-free survival was similar (23.87 vs 21.24 months in non-diverted vs diverted ileostomy, p = .82).</p><p><strong>Conclusions: </strong>Longer operative time and total length of colon resection influenced the selection of diverting ileostomy. The patients selected for diversion underwent multiple bowel resections more frequently, received more transfusions, and developed intraoperative ascites. These findings suggest that surgeons favor diversion for more extensive procedures. Patients who underwent diverted ileostomy experienced more short-term complications, likely reflecting the surgical complexity. Progression-free survival remained similar between the 2 groups, with diverse patients experiencing stoma-related morbidity over time, mainly dehydration and acute kidney injury. A prospective model to predict anastomotic leak risk may reduce diverting ileostomy rates.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101640"},"PeriodicalIF":4.1,"publicationDate":"2025-01-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425314","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}

{"title":"Oral contraceptive use is associated with a reduction in the physical size of fallopian tube p53 signatures.","authors":"Evan Gibbard, Dawn R Cochrane, Ramlogan Sowamber, Jutta Huvila, Amanda S Nitschke, Kendall Greening, Christine Chow, Yimei Qin, Nissreen Mohammad, David Farnell, Wren S Lee, C Blake Gilks, Lien Hoang, Gillian E Hanley, David G Huntsman","doi":"10.1016/j.ijgc.2025.101635","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101635","url":null,"abstract":"<p><strong>Objective: </strong>Oral contraceptives reduce ovarian cancer risk, but the mechanism of risk reduction is not understood. We examined whether oral contraceptive pill (OCP) use influences p53 signatures, which are putative early fallopian tube precursors for high-grade serous ovarian carcinomas.</p><p><strong>Methods: </strong>For this retrospective cohort (n = 250) of subjects aged over 50 years who had fallopian tubes removed at the time of a benign gynecologic procedure, we used health records to identify 72 patients who used OCPs for at least 5 years and 178 subjects with no history of OCP use. Immunohistochemistry for p53 was performed on all fallopian tube sections, with 8 individuals removed for lack of identifiable tissue. p53 Signatures were identified and stratified based on size. Logistic regressions were run to estimate the association between OCP use and p53 lesion and lesion size.</p><p><strong>Results: </strong>There was no difference in the occurrence of p53 lesions with 20 of 70 of OCP users (28.6%) and 57 of 172 of those with no history of OCP use (33.1%). Subjects who used OCPs were more likely to have a small lesion (OR 1.98, 95% CI 1.03 to 3.83) and had decreased risk of having a medium/large lesion (OR 0.38, 95% CI 0.18 to 0.79). A total of 2 serous tubal intraepithelial lesions and 2 serous tubal intraepithelial carcinomas were identified in OCP-naive patients, whereas none were found in those with a history of OCP use.</p><p><strong>Conclusions: </strong>OCP exposure was associated with a shift toward smaller p53 lesion size but was not found to be associated with a difference in the number of p53 lesions between OCP-exposed and unexposed patients. Future research should examine whether OCP use reduces proliferation and clonal expansion of p53 signature lesions toward higher risk precursors and, eventually, cancer. There were no serous tubal intraepithelial lesions and serous tubal intraepithelial carcinomas in patients with OCP exposure.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"35 2","pages":"101635"},"PeriodicalIF":4.1,"publicationDate":"2025-01-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374105","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}

{"title":"Neuroendocrine cervical carcinomas: genomic insights, controversies in treatment strategies, and future directions: a NeCTuR study.","authors":"Gloria Salvo, Larissa A Meyer, Naomi R Gonzales, Michael Frumovitz, R Tyler Hillman","doi":"10.1016/j.ijgc.2025.101639","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101639","url":null,"abstract":"<p><p>Neuroendocrine cervical carcinomas are rare, aggressive tumors with a high risk of early metastasis and poor survival outcomes. Despite existing therapies, over half of patients experience recurrence or progression after primary treatment, and survival after recurrence remains limited. Survival rates have not significantly improved over the past several decades, underscoring an urgent need for better therapeutic options. The rarity of neuroendocrine cervical carcinoma has precluded randomized trials, leaving treatment strategies to be guided by small retrospective studies or adapted from protocols for small cell lung cancer. However, as we gain a deeper understanding of its unique origin, genomic landscape, and biological characteristics, it has become clear that neuroendocrine cervical carcinoma requires distinct management strategies. Key questions in managing neuroendocrine cervical carcinoma remain unanswered: does adjuvant radiation therapy improve outcomes for early-stage disease? Should neoadjuvant chemotherapy be considered for patients with bulky, localized tumors? Can immunotherapy improve outcomes when added to chemoradiation in locally advanced cases? Should immunotherapy be a standard option for recurrent disease? Addressing these questions requires a thorough understanding of the unique molecular and biological characteristics of neuroendocrine cervical carcinoma and its clinical behavior. This review aims to provide an updated summary of the molecular landscape of neuroendocrine cervical carcinoma, highlighting features that distinguish it from small cell lung cancer and align with other types of cervical cancer. We discuss current treatment approaches, identify gaps in knowledge, and examine paradigm-shifting clinical trials that have significantly impacted survival outcomes in cervical cancer and small cell lung cancer, translating these insights into potential strategies for neuroendocrine cervical carcinoma. By focusing on the unique aspects of neuroendocrine cervical carcinoma, this review emphasizes the need for specialized treatment strategies for this challenging disease.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"35 3","pages":"101639"},"PeriodicalIF":4.1,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143189124","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}

{"title":"Controversies in the Management of Mesonephric and Mesonephric-Like Adenocarcinomas of the Female Genital Tract.","authors":"Aaron Praiss, Kay Park, Simran Makker, Jeffrey Girshman, Carol Aghajanian, Rachel N Grisham","doi":"10.1016/j.ijgc.2025.101638","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101638","url":null,"abstract":"<p><p>Mesonephric and mesonephric-like adenocarcinomas of the gynecologic tract are a rare subset of gynecologic tumors that are frequently associated with the presence of somatic KRAS mutations. Owing to their rare nature and ability to arise in different gynecologic sites, pathologic diagnosis is often challenging and under-represented. Immunohistochemistry and routine use of next-generation sequencing has allowed these cases to be more readily identified; however, there is still a paucity of clinical outcomes data, and the efficacy of treatment paradigms remains largely unknown. Historically, mesonephric and mesonephric-like adenocarcinomas were considered to be less responsive to systemic treatment, but response rates to first-line platinum-doublet chemotherapy for metastatic disease may be higher than initially suspected. Recurrent disease is often distant and located in the lungs, suggesting an important role of surveillance chest imaging. Given that most of these tumors are associated with somatic mitogen-activated protein kinase pathway mutations, a currently open phase II trial is assessing the dual RAF/MEK clamp avutometinib in combination with the FAK inhibitor defactinib in patients with recurrent mesonephric and mesonephric-like adenocarcinomas. Continued multi-institutional prospective trials are necessary to elucidate additional treatment options for these rare tumors.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":"35 3","pages":"101638"},"PeriodicalIF":4.1,"publicationDate":"2025-01-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143364670","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}

{"title":"Third International Arabic Women's Cancer Days and sixth Gynecologic Cancer InterGroup - Cervix Cancer Research Network symposium 2024 in Morocco.","authors":"Xezal Derin, Esra Bilir, Sara Nasser, Adil Elghanmi, Alison Brand, Remi Nout, Adriana Chávez-Blanco, Katherine Bennett, David Tan, Jalid Sehouli","doi":"10.1016/j.ijgc.2025.101632","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101632","url":null,"abstract":"","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101632"},"PeriodicalIF":4.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425355","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}

{"title":"Two possible entities of endometriosis-associated ovarian cancer: correlated or incidental?","authors":"Francesco Mezzapesa, Giulia Dondi, Camelia Alexandra Coada, Antonio De Leo, Francesca De Terlizzi, Lidia Strigari, Stella Di Costanzo, Gloria Ravegnini, Miriam Santoro, Dario de Biase, Lucia Genovesi, Pierandrea De Iaco, Anna Myriam Perrone","doi":"10.1016/j.ijgc.2025.101634","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101634","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Objective: &lt;/strong&gt;This study aimed to describe 2 types of endometriosis-associated ovarian cancer: those with transitional elements (atypical endometriosis and borderline tumors) termed endometriosis-correlated or incidental benign endometriosis vs ovarian cancer cases not associated with endometriosis.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This was a prospective, observational, monocentric study conducted from November 2021 to December 2023. Patients with ovarian cancer eligible for surgery were enrolled and classified into endometriosis-correlated ovarian carcinoma, endometriosis-incidental ovarian carcinoma, or ovarian carcinoma without endometriosis groups based on the presence or not of endometriosis and transitional lesions. Clinical, sonographic, surgical and pathological data and progression-free survival were recorded. Logistic regression models for accurate patient classification were developed from pre-surgical variables.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results: &lt;/strong&gt;Of the 170 patients included, 83 (48.82%) had ovarian carcinoma without endometriosis, 39 (22.94%) had endometriosis-incidental ovarian carcinoma, and 48 (28.24%) had endometriosis-correlated ovarian carcinoma. Patients with endometriosis-incidental ovarian carcinoma and endometriosis-correlated ovarian carcinoma were diagnosed at younger ages (p = .002) and had lower post-menopausal rates than patients with ovarian carcinoma without endometriosis (p = .011). Patients with endometriosis-correlated ovarian carcinoma had fewer pregnancies (p &lt; .001) and higher CA-19.9 levels (p = .002) presented with unilateral and multilocular solid lesions than patients with ovarian carcinoma without endometriosis (p &lt; .001). Patients with endometriosis-incidental ovarian carcinoma showed intermediate lesion morphology. Endometriosis-correlated ovarian carcinoma was mostly diagnosed at early Federation of Gynecology and Obstetrics stages (range; I-II) compared with endometriosis-incidental ovarian carcinoma and ovarian carcinoma without endometriosis (p &lt; .001), had less extensive disease (p &lt; .001), and a higher likelihood of complete cytoreduction (p = .035). Endometriosis-correlated ovarian carcinoma was more likely to include clear cell, endometrioid, and mesonephric-like adenocarcinomas, whereas serous histotype predominated in the other groups (p &lt; .001). Logistic regression models accurately identified patients with endometriosis-correlated ovarian carcinoma vs patients with endometriosis-incidental ovarian carcinoma (area under the curve [AUC] = 0.926) and ovarian carcinoma without endometriosis (AUC = 0.968) but could not reliably differentiate endometriosis-incidental ovarian carcinoma from ovarian carcinoma without endometriosis (AUC = 0.668). The 2-year progression-free survival rates were 91% in endometriosis-incidental ovarian carcinoma, 80% in endometriosis-correlated ovarian carcinoma, and 59% in ovarian carcinoma without endometriosis (p = .024).&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions: &lt;/stro","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101634"},"PeriodicalIF":4.1,"publicationDate":"2025-01-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425372","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}

{"title":"Addition of chemotherapy to radiation is associated with improved survival in older patients with cervical cancer: a Surveillance, Epidemiology, and End Results database analysis.","authors":"Kittinun Leetanaporn, Jitti Hanprasertpong","doi":"10.1016/j.ijgc.2025.101633","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101633","url":null,"abstract":"<p><strong>Objective: </strong>We evaluated the effectiveness of chemoradiation compared with radiotherapy alone in older patients with cervical cancer and determined the age sub-group wherein chemotherapy loses its significance using the Surveillance, Epidemiology, and End Results database.</p><p><strong>Methods: </strong>Women aged ≥65 years with cervical cancer who received definitive radiotherapy or chemoradiation were identified on the basis of the 2000-2019 Surveillance, Epidemiology, and End Results data. Overall and cancer-specific survival were compared in treatment groups, with survival prognostic factors assessed using multivariate analysis. Exploratory sub-group analyses at 5-year age increments determined the age threshold at which chemotherapy benefits became non-significant, with a multivariate p value ≥ .05 indicating reduced impact on overall and cancer-specific survival.</p><p><strong>Results: </strong>A total of 1832 patients were included in the study. Of these, 563 patients received radiotherapy, and 1269 patients received chemoradiation. The median age of the cohort was 74 years (Q1-Q3, 69.00-80.00). The 5-year overall and cancer-specific survival rates were 40.52% and 53.47%, respectively. In the multivariate analysis, chemotherapy significantly improved both overall (HR 0.47, p < .001) and cancer-specific (HR 0.57, p < .001) survival. For cancer-specific survival, the chemotherapy benefits progressively decreased with age, remaining significant until the age of >75 years (HR 0.63, p < .001) and decreasing after the age of 80 years (HR 0.79, p = .12). However, for overall survival, the chemotherapy benefit was observed in all age groups, except for patients aged >85 years (HR 0.72, p = 0.14).</p><p><strong>Conclusions: </strong>Chemotherapy was beneficial for women aged ≥65 years with cervical cancer who underwent radiotherapy. However, in patients aged >80 years, chemotherapy had no significant impact on cancer-specific survival.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101633"},"PeriodicalIF":4.1,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425257","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}

{"title":"Trends and comparisons of palliative care utilization for patients with metastatic gynecologic malignancy.","authors":"Matthew W Lee, Intira Sriprasert, Peter G Phung, Christian Pino, Sabrina M Woll, Andrew Vallejo, Katelyn B Furey, Laila I Muderspach, Lynda D Roman, Jason D Wright, Koji Matsuo","doi":"10.1016/j.ijgc.2025.101631","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101631","url":null,"abstract":"<p><strong>Objective: </strong>To assess the use of non-curative interventions and palliative pain management for patients with advanced gynecologic malignancy in the United States.</p><p><strong>Methods: </strong>This retrospective cohort study queried the Commission-on-Cancer's National Cancer Database. The study population was 2,098,291 patients with stage IV malignancies from 2004 to 2020, including 5 gynecologic malignancies (uterine cervix, uterine corpus, tubo-ovary, vulva, and vagina) and 7 non-gynecologic malignancies (lung, pancreas, colorectum, breast, kidney, liver, and bladder), stratified by gender. Utilization rates and temporal trends of non-curative interventions (systemic therapy, surgery, radiotherapy) and palliative pain management in the first course of intervention were evaluated across the malignancy types.</p><p><strong>Results: </strong>In 19 gender-stratified malignancy groups, the median rate of non-curative interventions and palliative pain management use rate was 18.3%. All the gynecologic malignancies ranked below the median, including the 3 lowest groups (12.6%, 10.5%, and 7.8% for uterine corpus, vulva, and tubo-ovary, respectively). Non-curative interventions and palliative pain management use increased significantly in non-gynecologic malignancies, whereas utilization remained unchanged over several years for most gynecologic malignancies, including uterine cervix (19.8% to 20.1% for 2012-2020, p-trend = .744), uterine corpus (12.0% to 13.4% for 2013-2020, p-trend = .072), and tubo-ovary (8.3% to 9.2% for 2011-2020, p-trend = .311). Compared with non-gynecologic malignancies, patients with gynecologic malignancy were less likely to receive non-curative systemic therapy by 48% to 80% (all 5 types), non-curative surgery by 15% to 61% (all but vagina), non-curative radiotherapy by 37% to 95% (uterus, tubo-ovary, vulva), and palliative pain management by 18% to 45% (all 5 types) (all, adjusted-p < .05).</p><p><strong>Conclusions: </strong>In this cohort study, the initial utilization of non-curative interventions and palliative pain management has been unchanged for patients with advanced gynecologic malignancy, and fewer patients receive palliative care than those with non-gynecologic malignancy, including palliative pain management. Possible under-utilization of palliative care services for patients with advanced gynecologic malignancy call for attention and further investigation.</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101631"},"PeriodicalIF":4.1,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143449006","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}

{"title":"A randomized, multicenter, open-label phase III trial of cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in platinum-resistant recurrent ovarian cancer: a rationale and study design of the KOV-HIPEC-02 trial.","authors":"Ji Hyun Kim, Eunyoung Park, Sang-Yoon Park, Myong Cheol Lim","doi":"10.1016/j.ijgc.2025.101630","DOIUrl":"https://doi.org/10.1016/j.ijgc.2025.101630","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to identify the survival benefits of hyperthermic intraperitoneal chemotherapy (HIPEC) after cytoreductive surgery for platinum-resistant recurrent ovarian cancer.</p><p><strong>Primary objectives: </strong>The primary objective is to evaluate the efficacy of cytoreductive surgery and HIPEC on progression-free survival in platinum-resistant recurrent ovarian cancer.</p><p><strong>Study hypothesis: </strong>The implementation of cytoreductive surgery and HIPEC combined with doxorubicin and mitomycin C may extend progression-free survival with manageable safety in patients with platinum-resistant recurrent ovarian cancer.</p><p><strong>Trial design: </strong>This trial (KOV-HIPEC-02) is a multicenter, open-label, 1:1 randomized, phase III trial that enrolled 140 patients with platinum-resistant recurrent ovarian cancer. The patients will receive or will not receive cytoreductive surgery and HIPEC with doxorubicin 35 mg/m² and mitomycin 15 mg/m². Enrolled patients will receive non-platinum compound systemic chemotherapy until disease progression.</p><p><strong>Major inclusion/exclusion criteria: </strong>Patients with recurrent epithelial ovarian, fallopian tube, and primary peritoneal cancer, who demonstrate resistance or refractory to platinum-based chemotherapy, are eligible for this trial. Patients exhibiting resectable intraperitoneal disease, as determined by clinical history, recent imaging findings, and laparoscopic assessment, will be enrolled. Furthermore, they must have an Eastern Cooperative Oncology Group Performance Status of 0 to 2, a life expectancy of at least 3 months, adequate organ function, and must provide informed consent to participate in the study.</p><p><strong>Primary endpoint: </strong>Progression-free survival defined as the time from random assignment in a clinical trial to disease progression or death from any cause.</p><p><strong>Sample size: </strong>Assuming that the enrollment period is 3 years and the follow-up period is 2 years, 140 patients will be randomized in this study design (70 patients in the HIPEC group and 70 patients in the control group).</p><p><strong>Estimated dates for completing accrual and presenting results: </strong>The expected date of interim analysis of primary end point is early 2025, and the patient enrollment is expected to be completed in 2025.</p><p><strong>Trial registration: </strong>The trial is registered at ClinicalTrials.gov (NCT05316181).</p>","PeriodicalId":14097,"journal":{"name":"International Journal of Gynecological Cancer","volume":" ","pages":"101630"},"PeriodicalIF":4.1,"publicationDate":"2025-01-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425240","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}