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Utilization and outcomes of fertility-sparing ovarian cystectomy for stage I malignant ovarian germ cell tumors 保留生育能力的卵巢膀胱切除术治疗I期卵巢恶性生殖细胞瘤的应用及疗效。
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-24 DOI: 10.1016/j.ygyno.2025.12.009
Delanie Ludmir , Yongmei Huang , Xiao Xu , Shayan Dioun , Alexander Buckley de Meritens , Thomas Randall , Tarah Pua , Caryn M. St. Clair , June Y. Hou , Koji Matsuo , Dawn L. Hershman , Jason D. Wright

Objective

Treatment for malignant ovarian germ cell tumors {MOGCTs) in women desiring fertility preservation is typically unilateral salpingo-oophorectomy (USO). While small studies have examined cystectomy for immature teratomas, larger-scale data are limited. We evaluated use and survival outcomes of cystectomy versus USO for stage I MOGCTs.

Methods

Using the National Cancer Database, we identified women aged 18–49 with stage I MOGCTs who underwent cystectomy or USO from 2004 to 2022. Log-linear regression identified factors associated with cystectomy. Propensity score inverse probability of treatment weighting (IPTW) for average treatment effect on the treated (IPTW-ATT) was applied to estimate the association of cystectomy versus USO with survival using weighted Cox proportional hazards models and Kaplan-Meier curves.

Results

Among 1345 patients, 1194 (88.8 %) underwent USO and 151 (11.2 %) cystectomy. Cystectomy use declined from 18.4 % (2004) to 9.4 % (2022) (P < 0.0001, APC = -5.5 %). Cystectomy was more common in mixed germ cell tumors and at community cancer programs. Patients who underwent cystectomy were less likely to receive lymphadenectomy (21.4 % vs. 35.3 %, SMD = 0.32), while adjuvant chemotherapy use was similar between groups. Adjusted 2-year survival was 99.7 % (USO) vs. 100.0 % (cystectomy), and 5-year survival was 98.7 % (USO) vs. 98.4 % (cystectomy). Adjusted hazard ratio for overall mortality was 0.70 (95 %CI: 0.21–2.33) for cystectomy versus USO. Stratified analyses by histology and age showed no survival differences.

Conclusion

Cystectomy use for stage I MOGCT has declined over time. Among patients who underwent cystectomy, estimated overall survival did not differ significantly from that expected of USO, including across histologic subtypes and age.
目的:对希望保留生育能力的女性恶性卵巢生殖细胞肿瘤(mogct)的治疗通常是单侧输卵管卵巢切除术(USO)。虽然小型研究已经检查了未成熟畸胎瘤的膀胱切除术,但大规模的数据有限。我们评估了I期mogct的膀胱切除术与USO的使用和生存结果。方法:使用国家癌症数据库,我们确定了从2004年到2022年接受膀胱切除术或USO的年龄在18-49岁的I期mogct女性。对数线性回归确定了与膀胱切除术相关的因素。使用加权Cox比例风险模型和Kaplan-Meier曲线,应用治疗加权倾向得分逆概率(IPTW)对被治疗者的平均治疗效果(IPTW- att)来估计膀胱切除术与USO与生存率的关系。结果:1345例患者中,1194例(88.8%)行USO, 151例(11.2%)行膀胱切除术。膀胱切除术的使用率从2004年的18.4%下降到2022年的9.4% (P结论:膀胱切除术在I期MOGCT中的使用率随着时间的推移而下降。在接受膀胱切除术的患者中,估计的总生存率与USO的预期生存率没有显着差异,包括组织学亚型和年龄。
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引用次数: 0
Prognostic value of perioperative circulating tumor DNA in endometrial cancer: systematic review & meta-analysis 子宫内膜癌围手术期循环肿瘤DNA的预后价值:系统回顾和荟萃分析
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-19 DOI: 10.1016/j.ygyno.2025.12.008
Amna Ahmed , Gagandeep Saini , Sarah E. Ferguson , Rouhi Fazelzad , Qixuan Li , Kathy Han , Trevor Pugh , Derek Wong , Raymond H. Kim , Anjelica Hodgson , Samuel Leung , Amy Jamieson , Jessica N. McAlpine , Kristina Lindemann , Franziska Siegenthaler , Soyoun Rachel Kim

Importance

Decisions regarding endometrial cancer (EC) adjuvant therapy can be challenging due to the need to balance the benefits of recurrence reduction with treatment toxicity. Circulating tumor DNA (ctDNA) has the potential to guide adjuvant therapy decisions by stratifying patients based on their risk of recurrence.

Objective

To determine the association between perioperative ctDNA positivity and survival outcomes in patients with EC.

Methods

An electronic search was performed in MEDLINE, Embase, Cochrane Central, Cochrane Database of Systematic Reviews, and Web of Science and included all articles up to July 23rd, 2025. Studies were included if they assessed patients with EC who had ctDNA assessment before and/or after surgery and reported on survival outcomes. Meta-analysis was done to explore the association between ctDNA levels and survival.

Main outcome and measures

The primary outcome was the association between ctDNA positivity pre- or post-operatively and progression-free survival (PFS).

Results

Of 2862 articles reviewed, 11 met inclusion criteria, which led to reporting on 1298 patients. Pre-operative as well as post-operative ctDNA positivity was significantly associated with worse PFS (HR 3.69 [95 % confidence interval (CI), 2.58–5.26], HR 12.61 [95 % CI, 8.78–18.13] respectively), with no significant heterogeneity.

Conclusions and relevance

This systematic review and meta-analysis demonstrates that perioperative detection of ctDNA positivity is significantly associated with worse PFS and could serve as a valuable tool for EC prognostication and guidance for adjuvant therapy decision-making. Prospective studies that evaluate the role of ctDNA in EC are needed for this to be implemented in clinical practice.
关于子宫内膜癌(EC)辅助治疗的决定可能具有挑战性,因为需要平衡减少复发的益处和治疗毒性。循环肿瘤DNA (ctDNA)有可能根据复发风险对患者进行分层,从而指导辅助治疗决策。目的探讨EC患者围手术期ctDNA阳性与生存结局的关系。方法在MEDLINE、Embase、Cochrane Central、Cochrane Database of Systematic Reviews和Web of Science中检索2025年7月23日之前的所有论文。如果研究评估了术前和/或术后进行ctDNA评估并报告了生存结果的EC患者,则纳入研究。荟萃分析探讨ctDNA水平与生存率之间的关系。主要结局和测量主要结局是ctDNA阳性术前或术后与无进展生存期(PFS)之间的关系。结果在2862篇文献中,11篇符合纳入标准,共纳入1298例患者。术前和术后ctDNA阳性与较差的PFS显著相关(HR分别为3.69[95%可信区间(CI), 2.58-5.26], HR为12.61 [95% CI, 8.78-18.13]),且无显著异质性。本系统综述和荟萃分析表明,围手术期检测ctDNA阳性与较差的PFS显著相关,可作为EC预后和辅助治疗决策指导的有价值工具。评估ctDNA在EC中的作用的前瞻性研究需要在临床实践中实施。
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引用次数: 0
ASCO neoadjuvant chemotherapy in ovarian cancer guideline: A SGO endorsement ASCO卵巢癌新辅助化疗指南:SGO认可。
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-17 DOI: 10.1016/j.ygyno.2025.12.004
Jamie Lesnock , Stéphanie Gaillard , William P. Tew
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引用次数: 0
MLH1 promoter hypermethylated endometrial cancer survival outcomes: A systematic review and meta-analysis MLH1启动子高甲基化子宫内膜癌生存结果:系统回顾和荟萃分析
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-13 DOI: 10.1016/j.ygyno.2025.12.005
Justin Wei-Jia Lim , Leah Drost , Rouhi Fazelzad , Qixuan Li , Ella Huszti , Kathy Han , Anjelica Hodgson , Trevor J. Pugh , Sarah E. Ferguson , Soyoun Rachel Kim

Purpose

Mismatch repair deficient (MMRd) endometrial carcinomas (EC) constitute 30 % of ECs and emerging evidence suggests that MLH1 promoter hypermethylated (MLH1ph) tumours may be more aggressive than previously recognized. This study aimed to evaluate overall survival (OS) and progression-free survival (PFS) in MLH1ph ECs compared to non-MLH1ph MMRd ECs.

Design

A systematic review and meta-analysis was conducted following PRISMA guidelines. Five bibliographic databases and three clinical trial registries were searched from inception to January 10, 2025. Eligible studies included randomized/quasi-randomized clinical trials and prospective/retrospective cohort studies evaluating OS or PFS in MLH1ph ECs versus non-MLH1ph MMRd ECs. Data were extracted independently by two authors. Fixed-effect and random-effects meta-analyses estimated pooled HRs, and risk of bias was assessed using the Newcastle-Ottawa Scale.

Results

Of 15,659 studies identified, 11 cohort studies (2007–2023) from six countries included 3980 MMRd EC patients (3176 MLH1ph cases [80 %] and 804 non-MLH1ph MMRd cases [20 %]). Eight studies (n = 2524) were included in the OS meta-analysis and nine studies (n = 1968) in the PFS meta-analysis. Random-effects meta-analyses demonstrated significantly higher risk of (1) death (OS HR 1.34, 95 %CI 1.16–1.56) and (2) disease progression or death (PFS HR 1.33, 95 %CI 1.12–1.58) in MLH1ph ECs compared to non-MLH1ph MMRd ECs.

Conclusions

MLH1ph ECs represent a higher-risk molecular subgroup with significantly poorer survival. Our findings support routine MLH1ph testing when MLH1/PMS2 protein loss is identified. Improved recognition of this subgroup is crucial for refining molecular risk stratification and will enable more personalized and effective oncologic management strategies based on tumour biology.
目的:匹配修复缺陷(MMRd)子宫内膜癌(EC)占ECs的30%,新出现的证据表明,MLH1启动子超甲基化(MLH1ph)肿瘤可能比以前认识到的更具侵袭性。该研究旨在评估MLH1ph ECs与非MLH1ph MMRd ECs的总生存期(OS)和无进展生存期(PFS)。DesignA系统评价和荟萃分析遵循PRISMA指南。检索了5个文献数据库和3个临床试验注册库,检索时间为成立至2025年1月10日。符合条件的研究包括随机/准随机临床试验和前瞻性/回顾性队列研究,评估MLH1ph型ECs与非MLH1ph型MMRd ECs的OS或PFS。数据由两位作者独立提取。固定效应和随机效应荟萃分析估计合并hr,并使用纽卡斯尔-渥太华量表评估偏倚风险。结果:在已确定的15659项研究中,来自6个国家的11项队列研究(2007-2023年)包括3980例MMRd EC患者(3176例MLH1ph病例[80%]和804例非MLH1ph MMRd病例[20%])。8项研究(n = 2524)被纳入OS荟萃分析,9项研究(n = 1968)被纳入PFS荟萃分析。随机效应荟萃分析显示,与非MLH1ph MMRd ECs相比,MLH1ph ECs的(1)死亡(OS HR 1.34, 95% CI 1.16-1.56)和(2)疾病进展或死亡(PFS HR 1.33, 95% CI 1.12-1.58)风险显著更高。结论smlh1ph ECs为高危分子亚群,生存期明显较差。当发现MLH1/PMS2蛋白丢失时,我们的研究结果支持常规MLH1ph检测。提高对这一亚群的认识对于完善分子风险分层至关重要,并将使基于肿瘤生物学的更个性化和有效的肿瘤管理策略成为可能。
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引用次数: 0
Updates in US Food and Drug Administration approvals for poly-ADP-ribose polymerase inhibitors in Ovarian Cancer: A society of gynecologic oncology clinical practice review 美国食品和药物管理局批准卵巢癌多adp核糖聚合酶抑制剂的最新进展:妇科肿瘤临床实践综述。
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-10 DOI: 10.1016/j.ygyno.2025.11.020
Christina Washington , Bhavana Pothuri , Karen Cadoo , Yvette Drew , Rachel Miller-Garcia , Deborah K. Armstrong , Roisin E. O'Cearbhaill
This Society of Gynecologic Oncology review synthesizes updated data from pivotal trials of poly-ADP-ribose polymerase inhibitors (PARPi) in ovarian cancer. Multiple phase III trials established PARPi as effective maintenance therapy, demonstrating substantial progression-free survival across biomarker-defined subgroups, particularly for patients with BRCA-mutated and homologous recombination-deficient (HRD) ovarian cancer. However, mature overall survival analyses and safety signals prompted the US Food and Drug Administration to narrow indications, while the broader indications were maintained by the European Medicines Agency. We review the current FDA approvals that now prioritize patients with BRCA-mutated and HRD ovarian cancers, underscoring the importance of biomarker stratification and careful patient selection. We discuss the evolving regulatory landscape and potential mechanisms of PARPi resistance.
这篇妇科肿瘤学会综述综合了卵巢癌中聚adp核糖聚合酶抑制剂(PARPi)关键试验的最新数据。多项III期试验证实PARPi是有效的维持疗法,在生物标志物定义的亚组中显示出显著的无进展生存期,特别是brca突变和同源重组缺陷(HRD)卵巢癌患者。然而,成熟的总体生存期分析和安全性信号促使美国食品和药物管理局(fda)缩小了适应症,而欧洲药品管理局(ema)维持了更广泛的适应症。我们回顾了目前FDA对brca突变和HRD卵巢癌患者的优先批准,强调了生物标志物分层和仔细选择患者的重要性。我们讨论了不断变化的调控环境和PARPi耐药的潜在机制。
{"title":"Updates in US Food and Drug Administration approvals for poly-ADP-ribose polymerase inhibitors in Ovarian Cancer: A society of gynecologic oncology clinical practice review","authors":"Christina Washington ,&nbsp;Bhavana Pothuri ,&nbsp;Karen Cadoo ,&nbsp;Yvette Drew ,&nbsp;Rachel Miller-Garcia ,&nbsp;Deborah K. Armstrong ,&nbsp;Roisin E. O'Cearbhaill","doi":"10.1016/j.ygyno.2025.11.020","DOIUrl":"10.1016/j.ygyno.2025.11.020","url":null,"abstract":"<div><div>This Society of Gynecologic Oncology review synthesizes updated data from pivotal trials of poly-ADP-ribose polymerase inhibitors (PARPi) in ovarian cancer. Multiple phase III trials established PARPi as effective maintenance therapy, demonstrating substantial progression-free survival across biomarker-defined subgroups, particularly for patients with <em>BRCA</em>-mutated and homologous recombination-deficient (HRD) ovarian cancer. However, mature overall survival analyses and safety signals prompted the US Food and Drug Administration to narrow indications, while the broader indications were maintained by the European Medicines Agency. We review the current FDA approvals that now prioritize patients with <em>BRCA</em>-mutated and HRD ovarian cancers, underscoring the importance of biomarker stratification and careful patient selection. We discuss the evolving regulatory landscape and potential mechanisms of PARPi resistance.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"204 ","pages":"Pages 218-227"},"PeriodicalIF":4.1,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145742210","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
Home-based treatment of low-risk gestational trophoblastic neoplasia with 8-day methotrexate/folinic acid 8天甲氨蝶呤/亚叶酸治疗低风险妊娠滋养细胞瘤的家庭治疗。
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-10 DOI: 10.1016/j.ygyno.2025.12.002
Izildinha Maesta , Valdete Aparecida Ribeiro Silva , Roberto Antonio Araújo Costa , Thays Herbst Carvalho , Mariza Branco-Silva , Antonio Braga , Kevin M. Elias , Ross S. Berkowitz , Neil S. Horowitz

Objective

To compare the effectiveness and safety of home-based versus hospital-based chemotherapy with 8-day methotrexate/folinic acid (MTX/FA) for low-risk gestational trophoblastic neoplasia (GTN).

Methods

Retrospective multiple-cohort study with patients receiving first-line MTX/FA for low-risk GTN at either the Botucatu Trophoblastic Disease Center-UNESP, Brazil (home-based treatment – 80 patients) or the New England Trophoblastic Disease Center, USA (hospital-based treatment - 61 patients), from 1995 to 2020. Follow-up was ≥12 months. Study variables were pre-treatment hCG, FIGO staging/risk score, sustained complete response, failure due to resistance/recurrence/toxicity, number of chemotherapy cycles, time to remission, and survival.

Results

There was no significant difference between treatment settings regarding pre-treatment hCG, GTN stage, sustained complete remission rate (home: 72.5 %, vs. hospital: 78.7 %, p = 0.52), resistance rate (home: 20 % vs. hospital: 15 %, p = 0.56), and rate of toxicity requiring a shift in single-agent chemotherapy (home: 3.5 % vs. hospital: 3.3 %, p = 1.00). The remission rate remained consistent after multivariate adjustment for age and FIGO risk score. However, there was a significant difference in median risk score (home: 2 vs. hospital: 1, p < 0.01) and median number of cycles (home: 3 cycles vs. hospital: 2 cycles; p < 0.01). Time to remission was 14 days longer with home treatment (home: 57 days vs. hospital: 41 days; p < 0.01). All patients survived.

Conclusion

Home- and hospital-based treatments showed similar sustained complete remission rate, with no change in frequency of toxicity-related failure and survival. Low-risk GTN treatment with 8-day-MTX/FA at home is feasible, produces outcomes similar to those observed in a hospital setting and offers a more flexible and patient-centered approach to care.
目的:比较8天甲氨蝶呤/亚叶酸(MTX/FA)家庭化疗与医院化疗治疗低危妊娠滋养细胞瘤(GTN)的有效性和安全性。方法:回顾性多队列研究,从1995年到2020年,在巴西Botucatu滋养细胞疾病中心(家庭治疗- 80例)或美国新英格兰滋养细胞疾病中心(医院治疗- 61例)接受一线MTX/FA治疗低风险GTN的患者。随访≥12个月。研究变量包括治疗前hCG、FIGO分期/风险评分、持续完全缓解、因耐药/复发/毒性而失败、化疗周期数、缓解时间和生存率。结果:在治疗前hCG、GTN分期、持续完全缓解率(家庭:72.5%,医院:78.7%,p = 0.52)、耐药率(家庭:20%,医院:15%,p = 0.56)和需要转移单药化疗的毒性率(家庭:3.5%,医院:3.3%,p = 1.00)等治疗环境之间无显著差异。在对年龄和FIGO风险评分进行多变量调整后,缓解率保持一致。然而,中位风险评分有显著差异(家庭:2对医院:1,p)。结论:家庭和医院为基础的治疗显示相似的持续完全缓解率,毒性相关失败和生存的频率没有变化。在家中使用8天甲氨喋呤/FA进行低风险GTN治疗是可行的,产生的结果与在医院环境中观察到的结果相似,并提供更灵活和以患者为中心的护理方法。
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引用次数: 0
Associations between obesity and outcomes in pembrolizumab-treated endometrial cancer 肥胖与派姆单抗治疗子宫内膜癌预后之间的关系
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-10 DOI: 10.1016/j.ygyno.2025.12.001
Bryanna Patterson , Nikita Sinha , Emily Broaddus , Sydney Stocks , William Zamboni , Benjamin B. Albright , Paola Gehrig , Victoria Bae-Jump , Olivia D. Lara

Background

To determine the association between obesity and pembrolizumab response in racially diverse cohort of patients with advanced and recurrent endometrial cancer (EC).

Methods

We conducted a retrospective review of patients with advanced or recurrent endometrial cancer receiving pembrolizumab. Baseline clinical, demographic and cancer characteristics were collected. Progression free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method and modeled via Cox regression. Covariate differences were assessed using the log-rank test.

Results

Among the 179 patients, the median age was 65 years (IQR, 58–71 yrs) and the mean BMI was 33 (SD, 8.5). The cohort consisted of 55 Black patents (31 %) and 112 White patients (63 %); 99 patients (55 %) were obese. Forty-six patients received pembrolizumab alone, and 133 received combination therapy. Higher BMI was associated with shorter PFS (BMI >40: HR 1.91, CI 1.13–3.21, p = 0.014 and BMI 30–40: HR 1.55, CI 1.02–2.35, p = 0.041). In MMR stratified analysis, obesity was associated with lower response rates among patients with MMRp tumors (23.4 %; BMI ≥30 vs 40.0 %; BMI <30), whereas response remained high across BMI categories in MMRd tumors. In the subgroup treated with pembrolizumab and Lenvatinib (n = 79), both White and Black obese experienced worse PFS compared to White non-obese patients (p = 0.021 and p = 0.035, respectively). No significant differences in OS were observed between obese and non-obese groups.

Conclusions

In this diverse cohort, obesity was associated with worse PFS in patients treated with pembrolizumab for EC. MMRp tumors in obese patients had lowest response rates among subgroups. Further studies with long term follow up are needed to elucidate the biological mechanisms linking obesity to immunotherapy outcomes.
背景:在不同种族的晚期和复发子宫内膜癌(EC)患者队列中,确定肥胖与派姆单抗反应之间的关系。方法:我们对接受派姆单抗治疗的晚期或复发子宫内膜癌患者进行了回顾性研究。收集基线临床、人口学和癌症特征。使用Kaplan-Meier方法估计无进展生存期(PFS)和总生存期(OS),并通过Cox回归建模。使用log-rank检验评估协变量差异。结果:179例患者中位年龄65岁(IQR, 58 ~ 71岁),平均BMI为33 (SD, 8.5)。该队列包括55名黑人患者(31%)和112名白人患者(63%);99例(55%)为肥胖。46例患者单独接受派姆单抗治疗,133例接受联合治疗。BMI越高,PFS越短(BMI bbb40: HR 1.91, CI 1.13-3.21, p = 0.014; BMI 30-40: HR 1.55, CI 1.02-2.35, p = 0.041)。在MMR分层分析中,肥胖与MMRp肿瘤患者较低的缓解率相关(23.4%;BMI≥30 vs 40.0%; BMI结论:在这个多样化的队列中,肥胖与接受派姆单抗治疗EC的患者较差的PFS相关。肥胖患者的MMRp肿瘤在亚组中反应率最低。需要进一步的长期随访研究来阐明肥胖与免疫治疗结果之间的生物学机制。
{"title":"Associations between obesity and outcomes in pembrolizumab-treated endometrial cancer","authors":"Bryanna Patterson ,&nbsp;Nikita Sinha ,&nbsp;Emily Broaddus ,&nbsp;Sydney Stocks ,&nbsp;William Zamboni ,&nbsp;Benjamin B. Albright ,&nbsp;Paola Gehrig ,&nbsp;Victoria Bae-Jump ,&nbsp;Olivia D. Lara","doi":"10.1016/j.ygyno.2025.12.001","DOIUrl":"10.1016/j.ygyno.2025.12.001","url":null,"abstract":"<div><h3>Background</h3><div>To determine the association between obesity and pembrolizumab response in racially diverse cohort of patients with advanced and recurrent endometrial cancer (EC).</div></div><div><h3>Methods</h3><div>We conducted a retrospective review of patients with advanced or recurrent endometrial cancer receiving pembrolizumab. Baseline clinical, demographic and cancer characteristics were collected. Progression free survival (PFS) and overall survival (OS) were estimated using the Kaplan–Meier method and modeled via Cox regression. Covariate differences were assessed using the log-rank test.</div></div><div><h3>Results</h3><div>Among the 179 patients, the median age was 65 years (IQR, 58–71 yrs) and the mean BMI was 33 (SD, 8.5). The cohort consisted of 55 Black patents (31 %) and 112 White patients (63 %); 99 patients (55 %) were obese. Forty-six patients received pembrolizumab alone, and 133 received combination therapy. Higher BMI was associated with shorter PFS (BMI &gt;40: HR 1.91, CI 1.13–3.21, <em>p</em> = 0.014 and BMI 30–40: HR 1.55, CI 1.02–2.35, <em>p</em> = 0.041). In MMR stratified analysis, obesity was associated with lower response rates among patients with MMRp tumors (23.4 %; BMI ≥30 vs 40.0 %; BMI &lt;30), whereas response remained high across BMI categories in MMRd tumors. In the subgroup treated with pembrolizumab and Lenvatinib (<em>n</em> = 79), both White and Black obese experienced worse PFS compared to White non-obese patients (<em>p</em> = 0.021 and <em>p</em> = 0.035, respectively). No significant differences in OS were observed between obese and non-obese groups.</div></div><div><h3>Conclusions</h3><div>In this diverse cohort, obesity was associated with worse PFS in patients treated with pembrolizumab for EC. MMRp tumors in obese patients had lowest response rates among subgroups. Further studies with long term follow up are needed to elucidate the biological mechanisms linking obesity to immunotherapy outcomes.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"204 ","pages":"Pages 228-234"},"PeriodicalIF":4.1,"publicationDate":"2025-12-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145742189","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
Evaluating the clinical utility and impact on healthcare utilization of serial troponin T monitoring in gynecologic cancer patients receiving immune checkpoint inhibitors – A single centre experience 评估接受免疫检查点抑制剂的妇科癌症患者连续肌钙蛋白T监测的临床效用和对医疗保健利用的影响-单中心经验
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-10 DOI: 10.1016/j.ygyno.2025.12.003
Italo Fernandes , Anjali Sachdeva , Farideh Tavangar , Matthew Lafreniere , Paul Yip , Teresa Petrella , Paaladinesh Thavendiranathan , Helen MacKay

Objectives

The primary objective of this study was to report on the clinical utility of serial troponin T (cTnT) monitoring in patients with gynecological cancers receiving immune checkpoint inhibitors (ICIs). Secondary objectives were to describe the experience of a single centre within a public healthcare system and to discuss the associated increase in healthcare utilization resulting from this intense monitoring strategy.

Methods

We conducted a retrospective cohort study of all patients with endometrial, cervical, and vaginal cancers treated with ICIs at Sunnybrook Health Sciences Centre, Toronto, Canada, until June 2024. Serial cTnT was measured at baseline and prior to each cycle. Comprehensive clinical data was collected. Associations between cTnT elevation and outcomes were analyzed.

Results

Sixty-eight patients were included: 41 (60.3 %) with endometrial, 25 (36.8 %) with cervical, and 2 (2.9 %) with vaginal cancer. At baseline, 37.9 % had elevated cTnT. During therapy, 63.2 % experienced at least one troponin elevation above the upper normal limit. Troponin increases were associated with age, hypertension, and other immune-related adverse events, but not with overall survival. Two patients (2.9 %) developed confirmed ICI-induced myocarditis. In total, over 1400 cTnT assays were performed, leading to multiple downstream investigations and treatment delays without consistent clinical benefit.

Conclusions

Serial cTnT monitoring frequently identified biomarker elevations but was not associated with outcomes in gynecologic cancer patients receiving ICIs. Despite a 63.2 % rate of elevated troponin, ICI-induced myocarditis occurred in 2.9 %. These findings suggest the need for evidence-based guidelines that balance early toxicity detection with safety, treatment continuity, and resource stewardship.
目的:本研究的主要目的是报告连续肌钙蛋白T (cTnT)监测在接受免疫检查点抑制剂(ICIs)治疗的妇科癌症患者中的临床应用。次要目的是描述在公共医疗保健系统内单一中心的经验,并讨论这种强化监测策略导致的医疗保健利用率的相关增加。方法:我们对加拿大多伦多Sunnybrook健康科学中心接受ICIs治疗的所有子宫内膜癌、宫颈癌和阴道癌患者进行了一项回顾性队列研究,研究持续至2024年6月。在基线和每个周期之前测量连续cTnT。收集了全面的临床资料。分析cTnT升高与预后之间的关系。结果:68例患者:子宫内膜癌41例(60.3%),宫颈癌25例(36.8%),阴道癌2例(2.9%)。基线时,37.9%的患者cTnT升高。在治疗期间,63.2%的患者至少有一次肌钙蛋白高于正常上限。肌钙蛋白升高与年龄、高血压和其他免疫相关不良事件相关,但与总生存率无关。2例患者(2.9%)确诊为ici引起的心肌炎。总共进行了1400多次cTnT检测,导致多次下游调查和治疗延误,没有一致的临床效益。结论:连续cTnT监测经常发现生物标志物升高,但与接受ICIs的妇科癌症患者的预后无关。尽管肌钙蛋白升高率为63.2%,但ici诱导的心肌炎发生率为2.9%。这些发现表明,有必要制定以证据为基础的指南,以平衡早期毒性检测与安全性、治疗连续性和资源管理。
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引用次数: 0
Comparative outcomes of nab-paclitaxel and paclitaxel in platinum-resistant ovarian cancer (COMPASS) nab-紫杉醇与紫杉醇治疗铂耐药卵巢癌(COMPASS)的比较结果
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-05 DOI: 10.1016/j.ygyno.2025.11.022
Mark S. Shahin , Raina Mathur , Anju Parthan , Prakirthi Yerram , Amanda Kesner-Hays , Rachel Myers , Iulia Cristina Tudor , Darin Dobler , Adrian M. Jubb , Robert L. Coleman

Objective

To compare the real-world effectiveness and safety of monotherapy nab-paclitaxel and paclitaxel in patients with platinum-resistant ovarian cancer (PROC).

Methods

COMPASS is a retrospective, observational study using deidentified patient data from the longitudinal US Flatiron Health Research Database in patients with PROC who received monotherapy nab-paclitaxel or paclitaxel. Real-world progression-free survival (rwPFS), overall survival (OS), and prespecified real-world adverse events (rwAEs) were assessed. Cohorts were weighted by the inverse probability of treatment (IPTW) approach.

Results

Of the 225 patients included, 67 received nab-paclitaxel and 158 received paclitaxel monotherapy. Most patients were > 65 years old with an Eastern Cooperative Oncology Group performance status of 0–1 and were treated in the community setting. rwPFS and OS were comparable across cohorts (rwPFS: unadjusted hazard ratio [HR],1.11; 95 % CI, 0.82–1.49; IPTW-adjusted HR, 1.03; 95 % CI, 0.66–1.63; OS: unadjusted HR, 0.95; 95 % CI, 0.69–1.3; IPTW-adjusted HR, 1.11; 95 % CI, 0.79–1.56). A sensitivity analysis using doubly robust IPTW showed consistent results. Incidence rates of anemia, diarrhea, fatigue, infusion-related reactions, nausea/vomiting, peripheral neuropathy, and thrombocytopenia were lower with nab-paclitaxel than with paclitaxel, while those of neutropenia, febrile neutropenia, and leukopenia were higher. The frequency of peripheral neuropathy in the nab-paclitaxel cohort (14 %) was half that of the paclitaxel cohort (28 %). The observed trends in rwAEs persisted when adjusted for duration of exposure.

Conclusions

Nab-paclitaxel demonstrated comparable effectiveness to paclitaxel with a lower rate of peripheral neuropathy, suggesting that nab-paclitaxel is an effective treatment option and a relevant comparator for clinical trials of patients with PROC.
目的比较nab-紫杉醇与紫杉醇单药治疗铂耐药卵巢癌(PROC)的实际疗效和安全性。compass是一项回顾性观察性研究,使用来自纵向美国Flatiron健康研究数据库的未确定患者数据,研究对象是接受单药nab-紫杉醇或紫杉醇治疗的PROC患者。评估真实世界无进展生存期(rwPFS)、总生存期(OS)和预先指定的真实世界不良事件(rwAEs)。采用治疗逆概率法(IPTW)对队列进行加权。结果225例患者中,67例接受nab-紫杉醇治疗,158例接受紫杉醇单药治疗。大多数患者年龄65岁,东部肿瘤合作组成绩0-1,在社区环境中接受治疗。rwPFS和OS在各队列间具有可比性(rwPFS:未校正风险比[HR],1.11; 95% CI, 0.82-1.49; iptw校正风险比,1.03;95% CI, 0.66-1.63; OS:未校正风险比,0.95;95% CI, 0.69-1.3; iptw校正风险比,1.11;95% CI, 0.79-1.56)。使用双鲁棒IPTW的敏感性分析显示出一致的结果。nab-紫杉醇组的贫血、腹泻、疲劳、输液相关反应、恶心/呕吐、周围神经病变和血小板减少的发生率低于紫杉醇组,而中性粒细胞减少、发热性中性粒细胞减少和白细胞减少的发生率高于紫杉醇组。nab-紫杉醇组周围神经病变的发生率(14%)是紫杉醇组的一半(28%)。根据暴露时间调整后,观察到的rwae趋势仍然存在。结论nab-紫杉醇与紫杉醇疗效相当,且周围神经病变发生率较低,提示nab-紫杉醇是PROC患者临床试验的有效治疗选择和相关比较物。
{"title":"Comparative outcomes of nab-paclitaxel and paclitaxel in platinum-resistant ovarian cancer (COMPASS)","authors":"Mark S. Shahin ,&nbsp;Raina Mathur ,&nbsp;Anju Parthan ,&nbsp;Prakirthi Yerram ,&nbsp;Amanda Kesner-Hays ,&nbsp;Rachel Myers ,&nbsp;Iulia Cristina Tudor ,&nbsp;Darin Dobler ,&nbsp;Adrian M. Jubb ,&nbsp;Robert L. Coleman","doi":"10.1016/j.ygyno.2025.11.022","DOIUrl":"10.1016/j.ygyno.2025.11.022","url":null,"abstract":"<div><h3>Objective</h3><div>To compare the real-world effectiveness and safety of monotherapy nab-paclitaxel and paclitaxel in patients with platinum-resistant ovarian cancer (PROC).</div></div><div><h3>Methods</h3><div>COMPASS is a retrospective, observational study using deidentified patient data from the longitudinal US Flatiron Health Research Database in patients with PROC who received monotherapy nab-paclitaxel or paclitaxel. Real-world progression-free survival (rwPFS), overall survival (OS), and prespecified real-world adverse events (rwAEs) were assessed. Cohorts were weighted by the inverse probability of treatment (IPTW) approach.</div></div><div><h3>Results</h3><div>Of the 225 patients included, 67 received nab-paclitaxel and 158 received paclitaxel monotherapy. Most patients were &gt; 65 years old with an Eastern Cooperative Oncology Group performance status of 0–1 and were treated in the community setting. rwPFS and OS were comparable across cohorts (rwPFS: unadjusted hazard ratio [HR],1.11; 95 % CI, 0.82–1.49; IPTW-adjusted HR, 1.03; 95 % CI, 0.66–1.63; OS: unadjusted HR, 0.95; 95 % CI, 0.69–1.3; IPTW-adjusted HR, 1.11; 95 % CI, 0.79–1.56). A sensitivity analysis using doubly robust IPTW showed consistent results. Incidence rates of anemia, diarrhea, fatigue, infusion-related reactions, nausea/vomiting, peripheral neuropathy, and thrombocytopenia were lower with nab-paclitaxel than with paclitaxel, while those of neutropenia, febrile neutropenia, and leukopenia were higher. The frequency of peripheral neuropathy in the nab-paclitaxel cohort (14 %) was half that of the paclitaxel cohort (28 %). The observed trends in rwAEs persisted when adjusted for duration of exposure.</div></div><div><h3>Conclusions</h3><div>Nab-paclitaxel demonstrated comparable effectiveness to paclitaxel with a lower rate of peripheral neuropathy, suggesting that nab-paclitaxel is an effective treatment option and a relevant comparator for clinical trials of patients with PROC.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"204 ","pages":"Pages 202-209"},"PeriodicalIF":4.1,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145690379","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
Machine-learning survival models for predicting time to recurrence in epithelial ovarian cancer 预测上皮性卵巢癌复发时间的机器学习生存模型
IF 4.1 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-12-05 DOI: 10.1016/j.ygyno.2025.11.021
John Nakayama , Michael McGaughey , Grace Pindzola , Eirwen Miller , Thomas Krivak , Christopher Morse , Sarah Crafton , Alyssa Wield , Jeffrey Toole , Tiffany Summerscales

Objective

To evaluate the effectiveness of machine learning survival models to predict time to recurrence using information from patient medical records known at the completion of frontline chemotherapy.

Methods

Five survival models – Penalized Cox Proportional Hazards (PenCoxPH), Random Survival Forest (RSF), Gradient Boosted Survival Analysis (GBSA), DeepSurv, and FastCPH — were trained on medical record data and used to predict time to recurrence. The models were trained on both the full set of patients and high-stage (III and IV) patients only. They were trained on the full-length (total time to recurrence) data as well as short-horizon (restricted to 15 months) recurrence data to increase prediction accuracy for the first year following completion of frontline chemotherapy. Feature hazard ratios for the PenCoxPH model were evaluated.

Results

GBSA received the highest performance scores when predicting full-length time to recurrence, while the DeepSurv and RSF models did best on predictions for short-horizon recurrence. GBSA achieved CD-AUC (cumulative/dynamic AUC) measures above 0.8 at 2 and 3 years. Stage I, HRD Negative, NACT and a rise in CA125 over the course of frontline chemotherapy were significant predictors of recurrence. PenCoxPH and FastCPH achieved a 6-month CD-AUC of 0.74 the high-stage, high-grade serous cohort for full-horizon recurrence.

Conclusion

Machine learning survival models can predict time to recurrence with sufficient accuracy to be clinically useful. While confirmatory studies are needed to validate these findings, providers could potentially use this information to tailor treatment strategies in maintenance therapy and select patients for clinical trial enrollment.
目的利用一线化疗结束时已知的患者病历信息,评估机器学习生存模型预测复发时间的有效性。方法5种生存模型——惩罚Cox比例风险(pencox Proportional Hazards,简称pencox)、随机生存森林(Random survival Forest,简称RSF)、梯度增强生存分析(Gradient boosting survival Analysis,简称GBSA)、DeepSurv和FastCPH——在病历数据上进行训练,并用于预测复发时间。这些模型既适用于全部患者,也适用于高分期(III期和IV期)患者。他们接受了全长(总复发时间)数据和短期(限制在15个月)复发数据的培训,以提高一线化疗完成后第一年的预测准确性。评估PenCoxPH模型的特征风险比。结果gbsa模型在预测复发的全程时间方面得分最高,而DeepSurv和RSF模型在预测短期复发方面得分最高。GBSA在2年和3年的CD-AUC(累积/动态AUC)指标均高于0.8。I期、HRD阴性、NACT和CA125在一线化疗过程中的升高是复发的重要预测因素。PenCoxPH和FastCPH在高分期、高级别浆液性复发患者中,6个月的CD-AUC为0.74。结论机器学习生存模型能够准确预测复发时间,具有一定的临床应用价值。虽然需要验证性研究来验证这些发现,但提供者可能会利用这些信息来定制维持治疗的治疗策略,并选择临床试验的患者。
{"title":"Machine-learning survival models for predicting time to recurrence in epithelial ovarian cancer","authors":"John Nakayama ,&nbsp;Michael McGaughey ,&nbsp;Grace Pindzola ,&nbsp;Eirwen Miller ,&nbsp;Thomas Krivak ,&nbsp;Christopher Morse ,&nbsp;Sarah Crafton ,&nbsp;Alyssa Wield ,&nbsp;Jeffrey Toole ,&nbsp;Tiffany Summerscales","doi":"10.1016/j.ygyno.2025.11.021","DOIUrl":"10.1016/j.ygyno.2025.11.021","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the effectiveness of machine learning survival models to predict time to recurrence using information from patient medical records known at the completion of frontline chemotherapy.</div></div><div><h3>Methods</h3><div>Five survival models – Penalized Cox Proportional Hazards (PenCoxPH), Random Survival Forest (RSF), Gradient Boosted Survival Analysis (GBSA), DeepSurv, and FastCPH — were trained on medical record data and used to predict time to recurrence. The models were trained on both the full set of patients and high-stage (III and IV) patients only. They were trained on the full-length (total time to recurrence) data as well as short-horizon (restricted to 15 months) recurrence data to increase prediction accuracy for the first year following completion of frontline chemotherapy. Feature hazard ratios for the PenCoxPH model were evaluated.</div></div><div><h3>Results</h3><div>GBSA received the highest performance scores when predicting full-length time to recurrence, while the DeepSurv and RSF models did best on predictions for short-horizon recurrence. GBSA achieved CD-AUC (cumulative/dynamic AUC) measures above 0.8 at 2 and 3 years. Stage I, HRD Negative, NACT and a rise in CA125 over the course of frontline chemotherapy were significant predictors of recurrence. PenCoxPH and FastCPH achieved a 6-month CD-AUC of 0.74 the high-stage, high-grade serous cohort for full-horizon recurrence.</div></div><div><h3>Conclusion</h3><div>Machine learning survival models can predict time to recurrence with sufficient accuracy to be clinically useful. While confirmatory studies are needed to validate these findings, providers could potentially use this information to tailor treatment strategies in maintenance therapy and select patients for clinical trial enrollment.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"204 ","pages":"Pages 184-193"},"PeriodicalIF":4.1,"publicationDate":"2025-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145690380","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
期刊
Gynecologic oncology
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