Gynecologic oncology最新文献

{"title":"Racial/ethnic disparities in time from diagnosis to surgical treatment for type I and type II endometrial carcinomas","authors":"Victoria E. Rodriguez ,&nbsp;Annie Ro ,&nbsp;Michael A. Hoyt ,&nbsp;Sora Park Tanjasiri ,&nbsp;Robert E. Bristow ,&nbsp;Alana M.W. LeBrón","doi":"10.1016/j.ygyno.2025.07.002","DOIUrl":"10.1016/j.ygyno.2025.07.002","url":null,"abstract":"<div><h3>Objective</h3><div>Timeliness of cancer care has been recognized as an indicator of quality of care for numerous cancer sites. Differences in endometrial cancer type may contribute to racial/ethnic disparities in treatment outcomes. This study examines racial/ethnic disparities in time to surgical treatment among type I and type II endometrial cancers.</div></div><div><h3>Methods</h3><div>We used data from 33,626 women with endometrial cancer in the California Cancer Registry between 2000 and 2019. Descriptive statistics, bivariate analyses, univariate logistic regression models, and multivariate logistic regression models stratified by endometrial cancer type (type I or type II) were performed.</div></div><div><h3>Results</h3><div>Surgical treatment delays were apparent in 35.3 % (<em>n</em> = 22,487) of type I and 34.6 % (<em>n</em> = 11,139) of type II endometrial cancers; treatment delays varied across racial/ethnic group. Among type I endometrial cancers, multivariable models indicate that American Indian/Alaska Native (odds ratio [OR] 1.47, 95 % CI 1.10–1.97, <em>p</em> &lt; 0.05), Black (OR 1.41, 95 % CI 1.23–1.62, <em>p</em> &lt; 0.001), Hispanic/Latina (OR 1.23, 95 % CI 1.15–1.33, p &lt; 0.001), and Asian or Pacific Islander (OR 1.12, 95 % CI 1.02–1.22, <em>p</em> &lt; 0.01) women had higher odds of experiencing treatment delays compared with White women. Among type II endometrial cancers, multivariable models indicate that Black (OR 1.36, 95 % CI 1.18–1.56, <em>p</em> &lt; 0.001) and Hispanic/Latina (OR 1.15, 95 % CI 1.03–1.28, <em>p</em> &lt; 0.05) women had higher odds of experiencing treatment delays compared with White women.</div></div><div><h3>Conclusions</h3><div>Targeted interventions are needed to address racial/ethnic disparities in time to surgical treatment for endometrial cancer to ensure equitable access to timely and appropriate cancer care.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 139-146"},"PeriodicalIF":4.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144581214","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":"Prognostic value of systemic inflammatory markers in predicting neoadjuvant platinum response and platinum resistance in advanced epithelial ovarian cancer: A peritoneal cancer index-based analysis","authors":"Onur Bektaş ,&nbsp;Kıvılcım Bektaş","doi":"10.1016/j.ygyno.2025.07.001","DOIUrl":"10.1016/j.ygyno.2025.07.001","url":null,"abstract":"<div><h3>Objective</h3><div>This study aimed to evaluate the prognostic value of pre-treatment systemic inflammatory indices in predicting the response to platinum-based neoadjuvant chemotherapy in patients with advanced ovarian cancer (AOC), as measured by the reduction rate of the Peritoneal Cancer Index (PCI). Additionally, the study sought to assess the predictive power of these markers in identifying patients likely to develop platinum resistance.</div></div><div><h3>Methods</h3><div>Systemic inflammatory markers including neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), monocyte-to-lymphocyte ratio (MLR) and systemic immune-inflammation index (SII) were recorded prior to treatment in patients diagnosed with FIGO stage IIIc-IV epithelial ovarian cancer who received neoadjuvant chemotherapy followed by interval debulking surgery. Correlations between these markers and post-treatment PCI reduction rates were analyzed. The predictive ability of these markers for platinum resistance was evaluated using receiver operating characteristic (ROC) curve analysis.</div></div><div><h3>Results</h3><div>Pre-treatment systemic inflammatory markers showed a statistically significant positive correlation with PCI reduction rate. Higher baseline values, particularly of SII, were associated with a greater PCI reduction, indicating a stronger response to chemotherapy. SII demonstrated the highest diagnostic accuracy for predicting platinum resistance, with an area under the curve (AUC) of 0.790. Optimal cut-off values for NLR (&gt;11.43) and SII (&gt;2223.15) were identified, showing good sensitivity and specificity for predicting resistance.</div></div><div><h3>Conclusion</h3><div>Systemic inflammatory indices, especially SII, appear to be valuable predictive and prognostic biomarkers in AOC. Their use in pre-treatment evaluation may help identify patients at risk of poor chemotherapy response and guide personalized treatment strategies, including the potential need for combination therapies such as bevacizumab.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 147-151"},"PeriodicalIF":4.5,"publicationDate":"2025-07-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144581215","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":"Surgical complexity and scope of procedures necessary after neoadjuvant chemotherapy for primary ovarian cancer","authors":"Chiara Ainio ,&nbsp;Marina Rosanu ,&nbsp;Lucia Ribero ,&nbsp;Giuseppe Caruso ,&nbsp;Luigi A. De Vitis ,&nbsp;Amanika Kumar ,&nbsp;Carrie L. Langstraat ,&nbsp;Michaela E. McGree ,&nbsp;Francesco Multinu ,&nbsp;Stuart A. Ostby ,&nbsp;Gabriella Schivardi ,&nbsp;Amanda L. Tapia ,&nbsp;Giovanni D. Aletti ,&nbsp;William A. Cliby","doi":"10.1016/j.ygyno.2025.06.024","DOIUrl":"10.1016/j.ygyno.2025.06.024","url":null,"abstract":"<div><h3>Objective</h3><div>The management of advanced ovarian cancer (AOC) has shifted, with neoadjuvant chemotherapy (NACT) followed by interval debulking surgery (IDS) surpassing primary debulking surgery (PDS) worldwide. This transition raises expectations for reduced need for high-complexity surgery at IDS. Our goal was to objectively evaluate surgical complexity required at IDS.</div></div><div><h3>Methods</h3><div>This retrospective cohort study included patients with stage IIIC-IVB AOC undergoing IDS or PDS between 2016 and 2021 at Mayo Clinic, Rochester, and the European Institute of Oncology, Milan. Surgical procedures were classified by anatomical location and deemed advanced if not routinely performed by gynecologic oncologists during standard staging procedures. Chi-squared tests were used to compare rates of advanced procedures between IDS and PDS.</div></div><div><h3>Results</h3><div>Of 1170 patients, 612 underwent NACT-IDS and 558 PDS. Advanced surgical procedures were performed in 51.5 % of IDS and 83 % of PDS cases. Upper abdominal procedures were necessary in 41.2 % of IDS and 71.1 % of PDS cases. Surgical complexity score was intermediate-to-high in 56.7 % of IDS and 88.45 % in PDS cases. CA-125 normalization post-NACT was not a specific predictor of low complexity surgery. Complete gross resection (CGR) was achieved in 61.6 % and 70.3 % of IDS and PDS cases, respectively.</div></div><div><h3>Conclusions</h3><div>Over half of IDS cases after NACT require advanced surgical procedures, including upper abdominal surgery. Given the prognostic significance of achieving CGR at IDS, efforts to maintain and expand specialized expertise is necessary, including advanced surgical training for gynecologic oncologists. Reliable predictors of complexity are urged for tailored surgical planning.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 133-138"},"PeriodicalIF":4.5,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144570813","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":"Fit4Surgery: A pilot randomized controlled trial to assess the feasibility of prehabilitation prior to debulking surgery for ovarian cancer","authors":"Jason N. Silberman ,&nbsp;Annella Benjamin ,&nbsp;Payton Solk ,&nbsp;Daniela Matei ,&nbsp;Raanan Alter ,&nbsp;Emily Hinchcliff ,&nbsp;Dario Roque ,&nbsp;Jenna Marcus ,&nbsp;Edward Tanner ,&nbsp;June M. McKoy ,&nbsp;Ann Marie Flores ,&nbsp;Masha Kocherginsky ,&nbsp;Siobhan Phillips ,&nbsp;Emma Barber","doi":"10.1016/j.ygyno.2025.06.020","DOIUrl":"10.1016/j.ygyno.2025.06.020","url":null,"abstract":"<div><h3>Objectives</h3><div>To assess the feasibility of enrolling women with ovarian cancer in a randomized controlled trial (RCT) of a home-based, patient-tailored physical activity prehabilitation program (Fit4Surgery, F4S) and assess adherence while estimating effects on patient-reported outcomes (PROs), frailty, and physical function.</div></div><div><h3>Methods</h3><div>Thirty patients aged ≥60 with ovarian cancer, scheduled for neoadjuvant chemotherapy and surgery, were randomized 2:1 to Fit4Surgery or educational control. The intervention group received a Fitbit, access to the F4S app, and weekly coaching calls. Controls received educational calls and access to the Cancer.Net app. The primary outcome was feasibility, defined as &gt;80 % evaluability and adherence. Daily steps and PROs were compared using paired <em>t</em>-tests or Wilcoxon rank sum tests.</div></div><div><h3>Results</h3><div>Of 74 patients approached, 32 consented and 30 were randomized. Average age was 69.7 years (range 60–81). Ninety percent of patients completed both baseline and pre-surgical assessments. Patients wore their FitBit on 94 % of days, attended 97 % of coaching calls, and engaged with the F4S app on 80 % of days. Patients reached personal step goals on 49 % of days, while 77.8 % of patients increased their daily steps over the intervention, with an average increase of 1804 steps per day (37 % increase, <em>p</em> = 0.01). Patient-reported physical function (<em>p</em> = 0.09) and frailty-related metrics, including energy levels (p = 0.01) and weekly walks (<em>p</em> = 0.02) improved in the F4S group, while no differences were detected in surgical outcomes.</div></div><div><h3>Conclusions</h3><div>Fit4Surgery was feasible with high engagement and adherence. Patients demonstrated increased daily step count and positive trends in PROs, frailty, and physical function.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 116-123"},"PeriodicalIF":4.5,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144563634","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":"Low-dose lenvatinib plus toripalimab for patients with platinum-resistant recurrent ovarian cancer: preliminary results from a multicenter, phase II trial (NCT06241105)","authors":"Hao Su ,&nbsp;Xiao Shang ,&nbsp;Hongruo Liu ,&nbsp;Mingle Tian ,&nbsp;Yang Yu ,&nbsp;Yanhua Xu ,&nbsp;Kui Jiang ,&nbsp;Fengzhi Feng","doi":"10.1016/j.ygyno.2025.06.023","DOIUrl":"10.1016/j.ygyno.2025.06.023","url":null,"abstract":"<div><h3>Objective</h3><div>Platinum-resistant ovarian cancer (PROC) remains a therapeutic challenge. While immune checkpoint inhibitor plus lenvatinib demonstrates potential efficacy in ovarian cancer, the standard 20 mg lenvatinib dosage causes significant adverse events leading to treatment disruption. We present preliminary results of a multicenter, single-arm phase II trial evaluating low-dose lenvatinib plus toripalimab for recurrent PROC.</div></div><div><h3>Methods</h3><div>Patients with recurrent PROC received low-dose lenvatinib (8 or 12 mg daily) and toripalimab (240 mg, every three weeks). Primary endpoint was progression-free survival (PFS). Second endpoints included objective response rate (ORR), duration of response (DOR), disease control rate (DCR), overall survival (OS), and safety.</div></div><div><h3>Results</h3><div>Thirty-three patients were enrolled at preliminary analysis. 91 % were platinum-resistant, and 9 % were platinum-refractory, with a median of 3 prior therapy lines (range 1–12). Median (95 % CI) PFS and OS were 5.0 months (3.8–6.2) and 13.3 months (12.4–14.2), respectively. Patients with CA125 decrease ≥50 % after the first cycle had longer PFS (7.9 vs 3.7 months). The ORR was 27 % (95 % CI 13 %–46 %) and DCR was 54 % (95 % CI 36 %–72 %). Median DOR was 4.4 months (range 2.1- ≥ 17.4). Treatment-related adverse events occurred in 97 % of patients (39 % grade 3; no grade 4–5). Four (12 %) patients required lenvatinib dose reduction, with treatment interruption and discontinuation rates of 42 % and 12 %, respectively. Patients who underwent platinum rechallenge following progression on trial treatment appeared to regain platinum sensitivity.</div></div><div><h3>Conclusions</h3><div>Low-dose lenvatinib plus toripalimab demonstrated encouraging efficacy and tolerability in patients with heavily pretreated, recurrent PROC. Completed accrual is needed to confirm these results.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 124-132"},"PeriodicalIF":4.5,"publicationDate":"2025-07-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144556638","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":"Delays, fragmentation, and desire for alternatives: A qualitative study of the patient experience through diagnosis and treatment of endometrial cancer","authors":"Bria Johnson ,&nbsp;Arianna Milicia ,&nbsp;Jennifer Hicks ,&nbsp;Ebony Hoskins ,&nbsp;Lucile Adams-Campbell ,&nbsp;Charlotte Gamble","doi":"10.1016/j.ygyno.2025.06.013","DOIUrl":"10.1016/j.ygyno.2025.06.013","url":null,"abstract":"<div><h3>Background</h3><div>Black patients in the United States have twice the mortality rate from endometrial cancer as their White peers. Washington D.C. has the highest endometrial cancer mortality rate in the nation. The study objective was to assess barriers and facilitators of care in the context of Black patients' experiences during diagnosis, referral, and management of endometrial cancer in Washington D.C.</div></div><div><h3>Methods</h3><div>Black patients with an endometrial cancer diagnosis who had completed surgery and adjuvant chemotherapy and/or radiation therapy were recruited over a 16-month period. Hour-long semi-structured interviews were conducted, recorded and transcribed. Qualitative analysis of the transcripts was performed and themes distilled from patient experience.</div></div><div><h3>Results</h3><div>There were 22 patient transcripts that were included in the qualitative analysis. Three core themes related to barriers included: delays to accessing care, fragmentation in the delivery of healthcare, and desire for alternatives to standard of care hysterectomy. Three core themes related to facilitators included: positive role of nurse navigators, streamlined referral process, thorough counseling from surgeon.</div></div><div><h3>Conclusion</h3><div>Barriers and facilitators to care impact the experience of Black patients undergoing care for endometrial cancer, which may contribute to disparities in outcomes. Future research can leverage patient-identified facilitators to address inequities in endometrial cancer outcomes.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 103-107"},"PeriodicalIF":4.5,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144549507","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":"What are we worth? An SGO analysis of compensation structures that measure and value work in academic gynecologic oncology practices","authors":"Margaret I. Liang ,&nbsp;Emeline M. Aviki ,&nbsp;Rinki Agarwal ,&nbsp;Jhalak Dholakia ,&nbsp;Gwendolyn P. Quinn ,&nbsp;Ronald D. Alvarez ,&nbsp;Emily M. Ko ,&nbsp;Leslie R. Boyd","doi":"10.1016/j.ygyno.2025.06.018","DOIUrl":"10.1016/j.ygyno.2025.06.018","url":null,"abstract":"<div><h3>Objective</h3><div>To obtain perspectives about existing compensation structures in gynecologic oncology, including common challenges and successful strategies within diverse systems.</div></div><div><h3>Methods</h3><div>Electronic mail was used to recruit OB/GYN department chairs and directors of cancer centers who were gynecologic oncologists and responsible for administering compensation structures at their institution. Using a semi-structured guide, three interviewers conducted 30-min qualitative interviews, which were recorded and transcribed. Two coders used the constant comparative method to summarize key themes.</div></div><div><h3>Results</h3><div>Response rate was 65 %, resulting in 17 interviewees. Participants were a third women and in their current position for a median of 7 years. The most prominent theme was the tension of balancing reimbursement for revenue-generating clinical activities with non-clinical work in research and education. Chair discretionary funds were useful to offset unfunded responsibilities. Broad clinical productivity measures were used: from more traditional work Relative Value Units (wRVUs) to measures that captured downstream impact, such as number of new patients or surgeries. Even in institutions with centralized funds flow systems, disparities were frequently noted for the monetary value assigned per wRVU. Academic scorecards were described as a method to ascribe value for academic work, often for bonus incentives. Another common stressor unique to gynecologic oncology was low reimbursement for chemotherapy-related services compared to surgery. Provision of regular productivity reports was common, but full transparency was controversial.</div></div><div><h3>Conclusions</h3><div>Our inquiry demonstrates that our academic leaders are unable to use compensation to fully support areas they deem important.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 108-115"},"PeriodicalIF":4.5,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144549511","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":"Relax - It’s evidence-based: The role of hypnosis in managing post-operative symptoms","authors":"Stacy D'Andre ,&nbsp;Debbie L. Fuehrer","doi":"10.1016/j.ygyno.2025.06.019","DOIUrl":"10.1016/j.ygyno.2025.06.019","url":null,"abstract":"","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"198 ","pages":"Pages A1-A3"},"PeriodicalIF":4.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144581143","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 phase 2 trial of niraparib plus bevacizumab maintenance therapy following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer: final analysis and overall survival results from OVARIO","authors":"Melissa M. Hardesty ,&nbsp;Thomas C. Krivak ,&nbsp;Gail S. Wright ,&nbsp;Erika Hamilton ,&nbsp;Evelyn L. Fleming ,&nbsp;Jimmy Belotte ,&nbsp;Shelby Gorman ,&nbsp;Natalie Compton ,&nbsp;Aine Clements ,&nbsp;Heidi J. Gray ,&nbsp;Gottfried E. Konecny ,&nbsp;Richard G. Moore ,&nbsp;Debra L. Richardson","doi":"10.1016/j.ygyno.2025.06.014","DOIUrl":"10.1016/j.ygyno.2025.06.014","url":null,"abstract":"<div><h3>Objective</h3><div>To report long-term outcomes from the OVARIO trial of niraparib plus bevacizumab maintenance following first-line platinum-based chemotherapy with bevacizumab in advanced ovarian cancer.</div></div><div><h3>Methods</h3><div>The phase 2, single-arm, open-label trial enrolled adult patients with stage IIIB–IV epithelial ovarian, fallopian tube, or primary peritoneal cancer (<span><span>NCT03326193</span><svg><path></path></svg></span>). Patients were required to have attempted debulking surgery and have a complete or partial response or no evidence of disease following first-line, platinum-based chemotherapy with ≥3 cycles of bevacizumab. The primary endpoint was 18-month progression-free survival (PFS) rate, per RECIST. Secondary endpoints included PFS, overall survival (OS), safety, and health-related quality of life (HRQOL) as assessed by the Functional Assessment of Cancer Therapy–Ovarian Symptoms Index (FOSI). Final analysis cutoff date, August 12, 2024.</div></div><div><h3>Results</h3><div>The median duration of follow-up was 65.7 months. Among evaluable patients (<em>N</em> = 105), PFS results were consistent with the primary analysis. Median OS (95% CI) was 61.1 months (44.9 months–not evaluable [NE]; 52.4% maturity) in the overall population, NE (58.2 months–NE) in the homologous recombination-deficient, 38.7 months (21.9–63.8 months) in the homologous recombination-proficient, and 39.8 months (21.7 months–NE) in the homologous recombination status not determined subgroups. Most patients (73.3%) received subsequent anticancer therapy; 30.5% received subsequent PARP inhibitor therapy. No new safety signals were identified; safety remained consistent with the primary analysis. Per FOSI, HRQOL was not negatively affected.</div></div><div><h3>Conclusion</h3><div>In OVARIO, median OS was 61.1 months in the overall population. Safety was consistent with known safety profiles of niraparib and bevacizumab as monotherapies.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 96-102"},"PeriodicalIF":4.5,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144523807","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":"Patient-reported outcomes from the phase 3, randomized, double-blind, placebo-controlled ENGOT-cx11/GOG-3047/KEYNOTE-A18 study of pembrolizumab plus concurrent chemoradiotherapy in participants with high-risk locally advanced cervical cancer","authors":"Leslie Randall ,&nbsp;Yang Xiang ,&nbsp;Takashi Matsumoto ,&nbsp;Diana Giannarelli ,&nbsp;Dency Pilar Milla ,&nbsp;Karla Alejandra Lopez ,&nbsp;Alejandro Acevedo ,&nbsp;Julia Vizkeleti ,&nbsp;Ritu Salani ,&nbsp;Angelica Nogueira-Rodrigues ,&nbsp;Fernando Contreras Mejia ,&nbsp;Jacob Korach ,&nbsp;Hüseyin Akilli ,&nbsp;Jung-Yun Lee ,&nbsp;Valeriya Vladimirovna Saevets ,&nbsp;Vanessa Samouelian ,&nbsp;Jalid Sehouli ,&nbsp;Ekkasit Tharavichikul ,&nbsp;Vladyslav Sukhin ,&nbsp;Nicoletta Colombo ,&nbsp;Domenica Lorusso","doi":"10.1016/j.ygyno.2025.06.003","DOIUrl":"10.1016/j.ygyno.2025.06.003","url":null,"abstract":"<div><h3>Objective</h3><div>In ENGOT-cx11/GOG-3047/KEYNOTE-A18 (<span><span>NCT04221945</span><svg><path></path></svg></span>), pembrolizumab (vs placebo) + concurrent chemoradiotherapy (CCRT) followed by pembrolizumab (vs placebo) significantly improved progression-free survival and overall survival in participants with newly diagnosed, high-risk locally advanced cervical cancer (LACC). We report patient-reported outcomes (PROs) from the study.</div></div><div><h3>Methods</h3><div>Participants (≥18 years) with high-risk LACC (FIGO 2014 stage IB2–IIB with node-positive disease or stage III–IVA) were randomized 1:1 to 5 cycles of pembrolizumab 200 mg or placebo Q3W plus CCRT, followed by 15 cycles of pembrolizumab 400 mg or placebo Q6W. CCRT was 5 cycles (optional 6th dose) of cisplatin 40 mg/m² Q1W plus external beam radiotherapy followed by brachytherapy. Secondary PRO endpoints included EORTC QLQ-C30 GHS/QoL and physical functioning subscales and EORTC QLQ-CX24 symptom experience scale; EQ-5D-5L visual analogue scale (VAS) was an exploratory endpoint. No alpha was assigned to the PRO analyses.</div></div><div><h3>Results</h3><div>1008 (95.1 %) of 1060 randomized participants were included in the PRO full analysis set population. No meaningful between-group differences were observed for any of the prespecified PRO instruments. Between-group differences (95 % CIs) in least-squares mean score changes from baseline to week 36 (primary time point) were 0.57 (−2.34 to 3.49) for QLQ-C30 GHS/QoL, 0.64 (−1.54 to 2.82) for QLQ-C30 physical functioning, 0.54 (−1.02 to 2.09) for QLQ-CX24 symptom experience, and −0.55 (−2.97 to 1.86) for EQ-5D-5L VAS. Empirical mean score changes over time and the proportions of participants whose scores improved, remained stable, or deteriorated over time were similar between treatment arms.</div></div><div><h3>Conclusions</h3><div>Pembrolizumab+CCRT did not negatively impact participants' health-related quality of life.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"199 ","pages":"Pages 88-95"},"PeriodicalIF":4.5,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144517515","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}