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Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: Double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial 帕博西尼联合来曲唑治疗雌激素受体阳性晚期/复发性子宫内膜癌:双盲安慰剂对照随机II期ENGOT-EN3/PALEO试验
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.12.003
Mansoor R. Mirza , Line Bjørge , Frederik Marmé , René DePont Christensen , Marta Gil-Martin , Annika Auranen , Beyhan Ataseven , Maria Jesús Rubio , Vanda Salutari , Adam A. Luczak , Ingo B. Runnebaum , Andrés Redondo , Kristina Lindemann , Fabian Trillsch , M. Pilar Barretina Ginesta , Henrik Roed , Jean-Emmanuel Kurtz , Karen S. Petersson , Gitte-Bettina Nyvang , Jalid Sehouli

Purpose

The CDK4/6 inhibitor palbociclib inhibits cyclin A, which is overexpressed in endometrial cancer. Combining palbociclib with endocrine therapy improves efficacy in hormone receptor-positive breast cancer. We investigated palbociclib combined with endocrine therapy for estrogen receptor-positive advanced/recurrent endometrial cancer.

Patients and methods

This placebo-controlled double-blind, randomized phase II screening trial (NCT02730429) enrolled women with measurable/evaluable estrogen receptor-positive endometrioid endometrial cancer that was primary metastatic or had relapsed after ≥1 prior systemic therapy. Patients were randomized in a 1:1 ratio, stratified by number of prior chemotherapy lines, measurable versus evaluable non-measurable disease, and prior medroxyprogesterone/megestrol acetate treatment, to receive oral letrozole 2.5 mg on days 1–28 plus either oral palbociclib 125 mg or placebo on days 1–21, repeated every 28 days until disease progression or unacceptable toxicity. The primary end point was investigator-assessed progression-free survival (PFS).

Results

Among 77 patients randomized between February 16, 2017, and December 21, 2018, 73 were treated (36 with palbociclib–letrozole, 37 with placebo–letrozole). Median follow-up was 21.9 (95 % CI, 16.7 to 22.3) months. Median PFS was 8.3 (95 % CI, 4.6 to 11.2) versus 3.1 (95 % CI, 2.7 to 6.8) months, respectively. In a landmark analysis at 12 months the PFS hazard ratio was 0.57 (95 % CI, 0.32 to 0.99; P = .044). Grade ≥ 3 adverse events were more common with palbociclib–letrozole (67 %) than placebo–letrozole (30 %), most commonly neutropenia (44 % v 0 %, respectively).

Conclusion

These results support a potential role of the palbociclib–letrozole combination as treatment for hormone receptor-positive advanced/recurrent endometrial cancer. Based on these encouraging results, phase III evaluation of letrozole combined with a CDK4/6 inhibitor is planned.

Clinical trial information

NCT02730429
目的:CDK4/6抑制剂palbociclib抑制细胞周期蛋白A在子宫内膜癌中的过表达。帕博西尼联合内分泌治疗可提高激素受体阳性乳腺癌的疗效。我们研究了帕博西尼联合内分泌治疗雌激素受体阳性晚期/复发子宫内膜癌。患者和方法:这项安慰剂对照双盲、随机II期筛查试验(NCT02730429)招募了可测量/可评估的雌激素受体阳性子宫内膜样子宫内膜癌,原发转移或在既往系统性治疗≥1次后复发的女性。患者按1:1的比例随机分组,根据既往化疗线的数量、可测量的疾病与可评估的不可测量的疾病以及既往甲孕酮/醋酸甲地孕酮治疗进行分层,在第1-28天接受口服来曲唑2.5 mg,在第1-21天接受口服帕博西尼125 mg或安慰剂,每28天重复一次,直到疾病进展或不可接受的毒性。主要终点是研究者评估的无进展生存期(PFS)。结果:在2017年2月16日至2018年12月21日期间随机选取的77例患者中,有73例接受了治疗(36例使用帕博西利-来曲唑,37例使用安慰剂-来曲唑)。中位随访时间为21.9个月(95% CI, 16.7 - 22.3)。中位PFS分别为8.3个月(95% CI, 4.6 - 11.2)和3.1个月(95% CI, 2.7 - 6.8)。在12个月的里程碑式分析中,PFS风险比为0.57 (95% CI, 0.32至0.99;p = .044)。帕博西利-来曲唑组≥3级不良事件(67%)比安慰剂-来曲唑组(30%)更常见,最常见的是中性粒细胞减少症(分别为44%和0%)。结论:这些结果支持帕博西利-来曲唑联合治疗激素受体阳性晚期/复发子宫内膜癌的潜在作用。基于这些令人鼓舞的结果,来曲唑联合CDK4/6抑制剂的III期评估正在计划中。临床试验信息:NCT02730429。
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引用次数: 0
Implementation of enhanced recovery protocol did not increase rates of acute kidney injury in open gynecologic oncology surgery: A single-institution experience 实施强化恢复方案不会增加开放式妇科肿瘤手术中急性肾损伤的发生率:单一机构的经验。
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.12.005
Brandon P. Maddy , Kristin M. Tischer , Michaela E. McGree , Angela J. Fought , Sean C. Dowdy , Gretchen E. Glaser

Objective

To compare the incidence of acute kidney injury (AKI) among patients undergoing gynecologic surgery before and after implementing an Enhanced Recovery After Surgery (ERAS) pathway.

Methods

We conducted a retrospective review of medical records from Mayo Clinic during three time periods when ERAS was used, focusing on patients who underwent open gynecologic surgery. AKI was defined using Kidney Disease Improving Global Outcomes (KDIGO) criteria. We used inverse-probability of treatment weighting (IPTW) to adjust for baseline covariates between pre-ERAS (135 patients) and post-ERAS (486 patients) cohorts. Statistical comparisons were made using t-test, Wilcoxon rank-sum, chi-square or Fisher's exact test, and univariate logistic regression with odds ratio (OR) and 95 % confidence interval (CI).

Results

Pre-IPTW, the AKI incidence was similar between cohorts (10.4 % vs 8.4 %, p = 0.48), and the odds of AKI for post-ERAS patients compared to pre-ERAS was not significant (OR 0.80, 95 % CI 0.42–1.51). After IPTW-adjustment, the AKI incidence remained comparable (10.3 % vs 8.1 %, p = 0.41), with the odds ratio unchanged (OR 0.76, 95 % CI 0.40–1.45). AKI patients were older (mean 67.0 vs 62.4 years, p < 0.01), had higher ASA scores (61.8 % vs 45.2 %, p = 0.02), lower preoperative hemoglobin (median 10.8 vs 12.5 g/dL, p < 0.01), longer surgeries (median 331 vs 222 min, p < 0.01), greater intraoperative blood loss (median 800 vs 500 mL, p < 0.01), more transfusions (56.4 % vs 29.3 %, p < 0.01), and higher fluid volumes (median 5750 vs 4165 mL, p < 0.01).

Conclusion

The ERAS pathway did not significantly impact AKI incidence in gynecologic surgery patients. AKI remains associated with increased postoperative complications, highlighting the need for improved risk prediction and preventive strategies.
目的:比较实施ERAS (Enhanced Recovery after surgery)途径前后妇科手术患者急性肾损伤(AKI)的发生率。方法:我们对梅奥诊所使用ERAS的三个时期的医疗记录进行了回顾性分析,重点是接受开放式妇科手术的患者。AKI的定义采用肾脏疾病改善全球预后(KDIGO)标准。我们使用治疗加权逆概率(IPTW)来调整eras前(135例)和eras后(486例)队列之间的基线协变量。统计学比较采用t检验、Wilcoxon秩和检验、卡方检验或Fisher精确检验,采用优势比(or)和95%置信区间(CI)进行单因素logistic回归。结果:iptw前,各队列间AKI发生率相似(10.4% vs 8.4%, p = 0.48), eras后患者与eras前患者相比AKI的发生率无显著性差异(OR 0.80, 95% CI 0.42-1.51)。调整iptwt后,AKI发生率保持可比性(10.3% vs 8.1%, p = 0.41),优势比不变(OR 0.76, 95% CI 0.40-1.45)。AKI患者年龄较大(平均67.0岁vs 62.4岁)。结论:ERAS通路对妇科手术患者AKI发生率无显著影响。AKI仍然与术后并发症的增加有关,这突出了改进风险预测和预防策略的必要性。
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引用次数: 0
Gestational trophoblastic neoplasm: Patient outcomes and clinical pearls from a multidisciplinary referral center 妊娠滋养细胞肿瘤:一个多学科转诊中心的患者疗效和临床宝典。
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.12.009
Ying L. Liu , Aaron M. Praiss , Sarah Chiang , Kelly Devereaux , James Huang , Gabrielle Rizzuto , Duaa Al-Rawi , Britta Weigelt , Elizabeth Jewell , Nadeem R. Abu-Rustum , Carol Aghajanian

Objectives

To describe clinical outcomes and pearls for patients with gestational trophoblastic neoplasm (GTN).

Methods

Patients with GTN treated at a referral center from 1/2006 to 12/2022 were included. Clinical characteristics, World Health Organization risk score (low-risk 0–6, high-risk ≥7), and treatments/outcomes were evaluated using summary statistics, stratified by initial treatment at a referral center versus locally. Histologies included complete hydatidiform mole (CHM), partial hydatidiform mole (PHM), choriocarcinoma (CCA), placental site trophoblastic tumor (PSTT), and epithelioid trophoblastic tumor (ETT).

Results

Of 189 patients with GTN, 125 were treated initially at a referral center and 64 locally. Median age at diagnosis was 34 years (range, 17–70). Most patients were White (n = 132, 70 %); 80 patients had CHM, 26 PHM, 52 CCA, 11 PSTT, 19 ETT, and 1 ETT/CCA. For low-risk GTN, first-line treatment was primarily methotrexate, although some were cured with repeat dilation and curettage. For high-risk disease, first-line therapy consisted of multiagent chemotherapy regimens at a referral center (n = 18/18) compared to 7 of 15 patients with high-risk GTN treated with methotrexate at local institutions. Patients with low-risk and high-risk disease who received initial care at a tertiary referral institution had cure rates of 100 % (n = 87/87) and 89 % (n = 16/18), respectively, while patients with initial care locally had cure rates of 87 % (n = 33/37) and 47 % (n = 7/15), respectively.

Conclusion

GTN is a rare gynecologic malignancy with high cure rates, particularly in low-risk disease. Treatment consolidation at a tertiary referral institution is critical for improved outcomes, particularly in those with high-risk disease or PSTT/ETT.
目的:描述妊娠滋养细胞肿瘤(GTN)患者的临床疗效和注意事项:描述妊娠滋养细胞肿瘤(GTN)患者的临床疗效和珠蛋白:纳入2006年1月1日至2022年12月12日在一家转诊中心接受治疗的GTN患者。临床特征、世界卫生组织风险评分(低风险0-6分,高风险≥7分)、治疗方法/结果均采用汇总统计法进行评估,并按最初在转诊中心治疗与在当地治疗进行分层。组织学包括完全水样痣(CHM)、部分水样痣(PHM)、绒毛膜癌(CCA)、胎盘部位滋养细胞肿瘤(PSTT)和上皮样滋养细胞肿瘤(ETT):在189名GTN患者中,125人在转诊中心接受了初步治疗,64人在当地接受了治疗。确诊时的中位年龄为34岁(17-70岁)。大多数患者为白人(n = 132,70%);80例患者患有CHM,26例患有PHM,52例患有CCA,11例患有PSTT,19例患有ETT,1例患有ETT/CCA。对于低风险的 GTN,一线治疗主要采用甲氨蝶呤,但也有一些患者通过重复扩张和刮宫术治愈。对于高危疾病,转诊中心的一线治疗包括多药化疗方案(n = 18/18),而在当地机构接受甲氨蝶呤治疗的 15 例高危 GTN 患者中,有 7 例接受了多药化疗。在三级转诊机构接受初始治疗的低危和高危患者的治愈率分别为100%(n=87/87)和89%(n=16/18),而在当地接受初始治疗的患者的治愈率分别为87%(n=33/37)和47%(n=7/15):结论:GTN是一种罕见的妇科恶性肿瘤,治愈率很高,尤其是在低风险疾病中。结论:GTN是一种罕见的妇科恶性肿瘤,治愈率很高,尤其是在低风险疾病中。在三级转诊机构进行巩固治疗对改善预后至关重要,尤其是对那些患有高风险疾病或PSTT/ETT的患者。
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引用次数: 0
Clinical trial screening in gynecologic oncology: Defining the need and identifying best practices 妇科肿瘤临床试验筛选:确定需求和确定最佳做法。
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.11.009
T. Castellano , O.D. Lara , C. McCormick , D. Chase , V. BaeJump , A.L. Jackson , J.T. Peppin , S. Ghamande , K.N. Moore , B. Pothuri , T.J. Herzog , T. Myers

Background

Evidence is limited in gynecologic cancers on best practices for clinical trial screening, but the risk of ineffective screening processes and subsequent under-enrollment introduces significant cost to patient, healthcare systems, and scientific advancement. Absence of a defined screening process makes determination of who and when to screen potential patients inconsistent allowing inefficiency and potential introduction of biases. This is especially germane as generative artificial intelligence (AI), and electronic health record (EHR) integration is applied to trial screening. Though often a requirement of cooperative groups such as the Cancer therapy Evaluation Program (CTEP), and/or the Commission on Cancer (CoC), there are no standard practice guidelines on best practices regarding screening and how best to track screening data.

Development of manuscript

The authors provided a review of current clinical trial screening practices and the effect on enrollment and trial activation across a variety of disease and practice sites. Established clinical trial screening practices and evidence supporting emerging strategies were reviewed and reported. Due to lack of published literature in gynecologic oncology, authors sought to survey the members of current rostered GOG sites to provide perspectives on clinical trial screening practices. Survey results showed a variety of screening practices. Most respondents participate in some type of manual screening process, where approximately 13 % also report incorporating AI or EHR integration. Over half (60 %) of sites track screening data to use for feasibility when opening new trials. The rapid increase in generative AI, EHR integration, and site agnostic screening initiatives could provide a significant opportunity to improve screening efficiency, translating to improved enrollment, but limitations and barriers remain.
背景:妇科癌症临床试验筛查最佳实践的证据有限,但筛查过程无效和随后入组不足的风险给患者、医疗系统和科学进步带来了巨大的成本。由于缺乏明确的筛查过程,确定谁和何时筛查潜在患者的决定不一致,从而导致效率低下和潜在的偏见。当生成式人工智能(AI)和电子健康记录(EHR)集成应用于试验筛选时,这一点尤为重要。虽然癌症治疗评估项目(CTEP)和/或癌症委员会(CoC)等合作组织经常要求,但关于筛查的最佳实践以及如何最好地跟踪筛查数据,没有标准的实践指南。手稿的发展:作者提供了当前临床试验筛选实践的回顾,以及对各种疾病和实践地点的入组和试验激活的影响。对已建立的临床试验筛选做法和支持新战略的证据进行了审查和报告。由于缺乏已发表的妇科肿瘤学文献,作者试图调查目前登记的GOG站点的成员,以提供临床试验筛选实践的观点。调查结果显示了多种筛选方法。大多数受访者都参与了某种类型的人工筛选过程,其中约13%的受访者还报告整合了人工智能或电子病历。超过一半(60%)的站点跟踪筛选数据,以便在开展新试验时用于可行性。生成式人工智能、EHR集成和地点不确定筛查举措的快速增长可以为提高筛查效率提供重要机会,转化为提高入学率,但限制和障碍仍然存在。
{"title":"Clinical trial screening in gynecologic oncology: Defining the need and identifying best practices","authors":"T. Castellano ,&nbsp;O.D. Lara ,&nbsp;C. McCormick ,&nbsp;D. Chase ,&nbsp;V. BaeJump ,&nbsp;A.L. Jackson ,&nbsp;J.T. Peppin ,&nbsp;S. Ghamande ,&nbsp;K.N. Moore ,&nbsp;B. Pothuri ,&nbsp;T.J. Herzog ,&nbsp;T. Myers","doi":"10.1016/j.ygyno.2024.11.009","DOIUrl":"10.1016/j.ygyno.2024.11.009","url":null,"abstract":"<div><h3>Background</h3><div>Evidence is limited in gynecologic cancers on best practices for clinical trial screening, but the risk of ineffective screening processes and subsequent under-enrollment introduces significant cost to patient, healthcare systems, and scientific advancement. Absence of a defined screening process makes determination of who and when to screen potential patients inconsistent allowing inefficiency and potential introduction of biases. This is especially germane as generative artificial intelligence (AI), and electronic health record (EHR) integration is applied to trial screening. Though often a requirement of cooperative groups such as the Cancer therapy Evaluation Program (CTEP), and/or the Commission on Cancer (CoC), there are no standard practice guidelines on best practices regarding screening and how best to track screening data.</div></div><div><h3>Development of manuscript</h3><div>The authors provided a review of current clinical trial screening practices and the effect on enrollment and trial activation across a variety of disease and practice sites. Established clinical trial screening practices and evidence supporting emerging strategies were reviewed and reported. Due to lack of published literature in gynecologic oncology, authors sought to survey the members of current rostered GOG sites to provide perspectives on clinical trial screening practices. Survey results showed a variety of screening practices. Most respondents participate in some type of manual screening process, where approximately 13 % also report incorporating AI or EHR integration. Over half (60 %) of sites track screening data to use for feasibility when opening new trials. The rapid increase in generative AI, EHR integration, and site agnostic screening initiatives could provide a significant opportunity to improve screening efficiency, translating to improved enrollment, but limitations and barriers remain.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 111-119"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142791690","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
Prognostic value of circulating tumor DNA at diagnosis and its early decrease after one cycle of neoadjuvant chemotherapy for patients with advanced epithelial ovarian cancer. An ancillary analysis of the CHIVA phase II GINECO trial 晚期上皮性卵巢癌患者诊断时循环肿瘤 DNA 的预后价值及其在一个新辅助化疗周期后的早期下降。CHIVA二期GINECO试验的辅助分析。
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.12.004
Henri Azaïs , Camille Brochard , Valérie Taly , Louise Benoit , Gwenaël Ferron , Isabelle Ray-Coquard , Benoit You , Sophie Abadie-Lacourtoisie , Coriolan Lebreton , Laurence Venat , Christophe Louvet , Laure Favier , Cyriac Blonz , Nadine Dohollou , Emmanuelle Malaurie , Coraline Dubot , Jean-Emmanuel Kurtz , Eric Pujade-Lauraine , Etienne Rouleau , Alexandra Leary , Pierre Laurent-Puig

Objective

To evaluate the prognostic impact of circulating tumor DNA (ctDNA) detection at diagnosis (T0) and its early decrease after one cycle (T1) of neoadjuvant chemotherapy (NACT) in patients with advanced epithelial ovarian cancer (EOC) included in the CHIVA trial (NCT01583322).

Methods

Blood samples were collected at T0 and before each administration of NACT. Circulating tumor DNA detection was performed by next-generation sequencing. Multivariate analysis was performed. A p-value of 0.05 was considered significant. Progression-free survival (PFS) and overall survival (OS) were compared between groups defined by ctDNA kinetic profile. Cox survival model was used to search variables associated with PFS and OS. Kaplan-Mayer curve was used to graphically express the differences in PFS and OS. A log-rank test compared the two curves.

Results

188 patients were included. Blood samples were available for 168 patients at T0 and for 160 patients at T0 and T1 to assess ctDNA ratio kinetics. At T0, 107 patients (63.7 %) had detectable ctDNA. At T1, 137 (85.6 %) patients had negative ctDNA or a decrease of more than 80 %. There was a significant benefit in either PFS (p = 0.0017) or OS (p = 0.0036) in favor of early decrease of ctDNA ratio. A favorable decrease was associated with a greater likelihood of being able to perform CRS (OR: 3.94 (CI95 % 1.45–10.70), p = 0.0074).

Conclusions

Early decrease of ctDNA ratio can provide prognostic information early in the management of patients, allowing a more accurate information to patients and an early preparation for CRS (prehabilitation).
目的评估CHIVA试验(NCT01583322)中晚期上皮性卵巢癌(EOC)患者在诊断时(T0)检测到的循环肿瘤DNA(ctDNA)及其在新辅助化疗(NACT)一个周期(T1)后的早期下降对预后的影响:方法:在T0和每次使用NACT前采集血液样本。方法:在T0和每次服用NACT前采集血液样本,通过新一代测序技术检测循环肿瘤DNA。进行多变量分析。P值为0.05为显著。比较了ctDNA动力学特征所定义的组间无进展生存期(PFS)和总生存期(OS)。采用 Cox 生存模型搜索与无进展生存期和总生存期相关的变量。Kaplan-Mayer曲线用于表示PFS和OS的差异。通过对数秩检验比较两条曲线:共纳入 188 名患者。168名患者在T0时获得血样,160名患者在T0和T1时获得血样,以评估ctDNA比值动力学。T0时,107名患者(63.7%)可检测到ctDNA。在 T1,137 名患者(85.6%)的 ctDNA 为阴性或下降超过 80%。早期降低ctDNA比率对患者的PFS(p = 0.0017)或OS(p = 0.0036)均有明显益处。降低ctDNA比值与更有可能进行CRS相关(OR:3.94(CI95 % 1.45-10.70),p = 0.0074):ctDNA比值的早期下降可在患者治疗的早期提供预后信息,从而为患者提供更准确的信息,并为CRS(康复前)做好早期准备。
{"title":"Prognostic value of circulating tumor DNA at diagnosis and its early decrease after one cycle of neoadjuvant chemotherapy for patients with advanced epithelial ovarian cancer. An ancillary analysis of the CHIVA phase II GINECO trial","authors":"Henri Azaïs ,&nbsp;Camille Brochard ,&nbsp;Valérie Taly ,&nbsp;Louise Benoit ,&nbsp;Gwenaël Ferron ,&nbsp;Isabelle Ray-Coquard ,&nbsp;Benoit You ,&nbsp;Sophie Abadie-Lacourtoisie ,&nbsp;Coriolan Lebreton ,&nbsp;Laurence Venat ,&nbsp;Christophe Louvet ,&nbsp;Laure Favier ,&nbsp;Cyriac Blonz ,&nbsp;Nadine Dohollou ,&nbsp;Emmanuelle Malaurie ,&nbsp;Coraline Dubot ,&nbsp;Jean-Emmanuel Kurtz ,&nbsp;Eric Pujade-Lauraine ,&nbsp;Etienne Rouleau ,&nbsp;Alexandra Leary ,&nbsp;Pierre Laurent-Puig","doi":"10.1016/j.ygyno.2024.12.004","DOIUrl":"10.1016/j.ygyno.2024.12.004","url":null,"abstract":"<div><h3>Objective</h3><div>To evaluate the prognostic impact of circulating tumor DNA (ctDNA) detection at diagnosis (T0) and its early decrease after one cycle (T1) of neoadjuvant chemotherapy (NACT) in patients with advanced epithelial ovarian cancer (EOC) included in the CHIVA trial (<span><span>NCT01583322</span><svg><path></path></svg></span>).</div></div><div><h3>Methods</h3><div>Blood samples were collected at T0 and before each administration of NACT. Circulating tumor DNA detection was performed by next-generation sequencing. Multivariate analysis was performed. A <em>p</em>-value of 0.05 was considered significant. Progression-free survival (PFS) and overall survival (OS) were compared between groups defined by ctDNA kinetic profile. Cox survival model was used to search variables associated with PFS and OS. Kaplan-Mayer curve was used to graphically express the differences in PFS and OS. A log-rank test compared the two curves.</div></div><div><h3>Results</h3><div>188 patients were included. Blood samples were available for 168 patients at T0 and for 160 patients at T0 and T1 to assess ctDNA ratio kinetics. At T0, 107 patients (63.7 %) had detectable ctDNA. At T1, 137 (85.6 %) patients had negative ctDNA or a decrease of more than 80 %. There was a significant benefit in either PFS (<em>p</em> = 0.0017) or OS (<em>p</em> = 0.0036) in favor of early decrease of ctDNA ratio. A favorable decrease was associated with a greater likelihood of being able to perform CRS (OR: 3.94 (CI95 % 1.45–10.70), <em>p</em> = 0.0074).</div></div><div><h3>Conclusions</h3><div>Early decrease of ctDNA ratio can provide prognostic information early in the management of patients, allowing a more accurate information to patients and an early preparation for CRS (prehabilitation).</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 145-154"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821970","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Less is more: The benefits of reduced follow-up in gynecologic cancers 少即是多:减少妇科癌症随访的好处。
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.12.008
Julien A.M. Vos , M. Caroline Vos , Luc R.C.W. van Lonkhuijzen , Lonneke V. van de Poll-Franse , Nicole P.M. Ezendam
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引用次数: 0
Living in a food desert in Louisiana and its effects on gynecologic cancer outcomes 生活在路易斯安那州的食物沙漠及其对妇科癌症结果的影响。
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.12.001
Tina Nguyen MS , Yong Yi PhD , Shawna Morron PA-C , Devin Brittain RD LDN , Ryan Yates RD LDN , Tara Castellano MD , Amelia Jernigan MD , Xiao-Cheng Wu MD MPH , Navya Nair MD MPH

Objective

Food insecurity is becoming recognized as an important measure of public health. Louisiana has a poorer health index and a higher food insecurity rate than the national average. This study aims to investigate how living in a food desert affects the stage at diagnosis and 5-year overall survival in patients with gynecologic cancers.

Methods

Data on genital cancers diagnosed between 2015 and 2019 among Louisiana women aged 20 years and older were from the Louisiana Tumor Registry. The food desert data was based on the USDA Food Access Research Atlas (FARA). The covariates included in this study were race, age, insurance status, BMI, tobacco use, and Charlson Comorbidity Index. Univariate, multivariable logistic regression and Cox proportional hazard regression models were employed.

Results

Food insecurity is independently associated with diagnoses at an advanced stage in patients with cervical and uterine cancer (OR = 1.41 [1.01, 1.96] and 1.28 [1.04, 1.58], respectively) after adjusting for covariates. This association was not observed in patients with ovarian cancer (OR = 0.94 [0.64, 1.39]). In evaluating overall survival at 5 years after initial diagnosis, patients living in a food desert have higher mortality rates across cervical, uterine, and ovarian cancers in the univariate analysis (OR = 1.27 [1.01, 1.60], 1.27 [1.07, 1.49], and 1.34 [1.10, 1.65], respectively); however, this significance is diminished in the multivariate analyses.

Conclusions

Food insecurity affects gynecologic cancer morbidity and can offer an important point of intervention to increase cancer prevention initiatives and improve resources for underserved populations.
目的:人们逐渐认识到,粮食不安全是衡量公共健康的一个重要指标。与全国平均水平相比,路易斯安那州的健康指数较低,食品不安全率较高。本研究旨在探讨生活在食物沙漠中如何影响妇科癌症患者的诊断分期和5年总生存率:路易斯安那州 20 岁及以上女性在 2015 年至 2019 年期间确诊的生殖器癌症数据来自路易斯安那州肿瘤登记处。食物沙漠数据基于美国农业部食物获取研究图集(FARA)。本研究中的协变量包括种族、年龄、保险状况、体重指数、吸烟情况和 Charlson 生病指数。研究采用了单变量、多变量逻辑回归和考克斯比例危险回归模型:结果:经协变量调整后,粮食不安全与宫颈癌和子宫癌患者的晚期诊断有独立关联(OR = 1.41 [1.01, 1.96] 和 1.28 [1.04, 1.58])。在卵巢癌患者中未观察到这种关联(OR = 0.94 [0.64, 1.39])。在评估初次确诊后 5 年的总生存率时,在单变量分析中,生活在食物沙漠中的宫颈癌、子宫癌和卵巢癌患者的死亡率较高(OR = 1.27 [1.01,1.60],1.27 [1.07,1.49] 和 1.34 [1.10,1.65]);然而,在多变量分析中,这种显著性降低了:结论:粮食不安全会影响妇科癌症的发病率,可以作为一个重要的干预点,增加癌症预防措施并改善服务不足人群的资源。
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引用次数: 0
Clinical trials are not the solution to inequities in cancer care
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2025.01.004
David I. Shalowitz , Franklin G. Miller
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引用次数: 0
Association between genomic instability score and progression-free/overall survival in patients with newly diagnosed non-BRCA1/2 ovarian cancer 新诊断的非brca1 /2卵巢癌患者的基因组不稳定性评分与无进展/总生存期之间的关系
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2025-01-01 DOI: 10.1016/j.ygyno.2024.11.011
Stephen Graves , Mackenzie W. Sullivan , Anusha Adkoli , Qin Zhou , Alexia Iasonos , Pier Selenica , Carol Aghajanian , Ying L. Liu , William Tew , Yukio Sonoda , Lora H. Ellenson , Dennis Chi , Roisin E. O'Cearbhaill , Britta Weigelt , Rachel N. Grisham

Objective

We sought to describe the association between genomic instability score (GIS) and progression-free survival (PFS) and overall survival (OS) in patients with newly diagnosed, non-BRCA1/2 ovarian cancer.

Methods

Homologous recombinant deficiency (HRD) status was based on a cutoff of ≥42 GIS; patients <42 were categorized with homologous recombination proficiency (HRP). We collected type and duration of maintenance therapy, among other variables, and built a multivariate model with landmark analysis at 6 months from baseline and applied it for time-dependent variables.

Results

Increasing GIS as a continuous variable was associated with improved PFS and OS in our cohort. Overall, median PFS was significantly longer in patients with HRD ovarian cancer (35.4 months, 25.4–NE) than in those with HRP disease (14.9 months, 13.1–16.2; p < 0.001). Median OS was 36.2 months (32.4–NE) for HRP and not reached for HRD (p = 0.002). Notably, in patients with HRP ovarian cancer, we observed a shorter median PFS in those who received a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi) than in those who did not (12.7 months for HRP with PARPi vs 15.2 months for HRP without PARPi).

Conclusions

Our results demonstrate that in newly diagnosed advanced non-BRCA1/2 ovarian cancer, GIS as a continuous variable is associated with longer PFS and OS. In patients with HRP ovarian cancer, PARPi treatment may be associated with shorter PFS, which warrants further evaluation.
目的我们试图描述新诊断的非 BRCA1/2 卵巢癌患者的基因组不稳定性评分(GIS)与无进展生存期(PFS)和总生存期(OS)之间的关系:在我们的队列中,GIS作为连续变量的增加与PFS和OS的改善有关。总体而言,HRD 卵巢癌患者的中位生存期(35.4 个月,25.4-NE)明显长于 HRP 患者(14.9 个月,13.1-16.2;P我们的研究结果表明,在新诊断的晚期非 BRCA1/2 卵巢癌患者中,GIS 作为一个连续变量与较长的 PFS 和 OS 相关。在 HRP 卵巢癌患者中,PARPi 治疗可能与较短的 PFS 相关,这值得进一步评估。
{"title":"Association between genomic instability score and progression-free/overall survival in patients with newly diagnosed non-BRCA1/2 ovarian cancer","authors":"Stephen Graves ,&nbsp;Mackenzie W. Sullivan ,&nbsp;Anusha Adkoli ,&nbsp;Qin Zhou ,&nbsp;Alexia Iasonos ,&nbsp;Pier Selenica ,&nbsp;Carol Aghajanian ,&nbsp;Ying L. Liu ,&nbsp;William Tew ,&nbsp;Yukio Sonoda ,&nbsp;Lora H. Ellenson ,&nbsp;Dennis Chi ,&nbsp;Roisin E. O'Cearbhaill ,&nbsp;Britta Weigelt ,&nbsp;Rachel N. Grisham","doi":"10.1016/j.ygyno.2024.11.011","DOIUrl":"10.1016/j.ygyno.2024.11.011","url":null,"abstract":"<div><h3>Objective</h3><div>We sought to describe the association between genomic instability score (GIS) and progression-free survival (PFS) and overall survival (OS) in patients with newly diagnosed, non<em>-BRCA1/2</em> ovarian cancer.</div></div><div><h3>Methods</h3><div>Homologous recombinant deficiency (HRD) status was based on a cutoff of ≥42 GIS; patients &lt;42 were categorized with homologous recombination proficiency (HRP). We collected type and duration of maintenance therapy, among other variables, and built a multivariate model with landmark analysis at 6 months from baseline and applied it for time-dependent variables.</div></div><div><h3>Results</h3><div>Increasing GIS as a continuous variable was associated with improved PFS and OS in our cohort. Overall, median PFS was significantly longer in patients with HRD ovarian cancer (35.4 months, 25.4–NE) than in those with HRP disease (14.9 months, 13.1–16.2; <em>p</em> &lt; 0.001). Median OS was 36.2 months (32.4–NE) for HRP and not reached for HRD (<em>p</em> = 0.002). Notably, in patients with HRP ovarian cancer, we observed a shorter median PFS in those who received a poly (adenosine diphosphate-ribose) polymerase inhibitor (PARPi) than in those who did not (12.7 months for HRP with PARPi vs 15.2 months for HRP without PARPi).</div></div><div><h3>Conclusions</h3><div>Our results demonstrate that in newly diagnosed advanced non-<em>BRCA1/2</em> ovarian cancer, GIS as a continuous variable is associated with longer PFS and OS. In patients with HRP ovarian cancer, PARPi treatment may be associated with shorter PFS, which warrants further evaluation.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 120-127"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142794647","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
Less is more? Comparison between genomic profiling and immunohistochemistry-based models in endometrial cancer molecular classification: A multicenter, retrospective, propensity-matched survival analysis. 少即是多?在子宫内膜癌分子分类中比较基因组剖析和免疫组化模型:多中心、回顾性、倾向匹配生存分析。
IF 4.5 2区 医学 Q1 OBSTETRICS & GYNECOLOGY Pub Date : 2024-12-01 Epub Date: 2024-10-18 DOI: 10.1016/j.ygyno.2024.10.010
Emanuele Perrone, Ilaria Capasso, Diana Giannarelli, Rita Trozzi, Luigi Congedo, Elisa Ervas, Vincenzo Tarantino, Giovanni Esposito, Luca Palmieri, Arianna Guaita, Anne-Sophie van Rompuy, Giulia Scaglione, Gian Franco Zannoni, Giovanni Scambia, Frédéric Amant, Francesco Fanfani

Background: Genomic profiling-based model (GP-M) is the gold-standard for endometrial cancer (EC) molecular classification, but several issues related to the availability of genomic sequencing in low-income settings remain and health disparities in the management are increasing. This study aims to investigate the non-inferiority of the immunohistochemistry-alone model in classifying ECs compared to the standard genomic profiling-based model in terms of oncologic outcomes.

Methods: All preoperative uterine-confined ECs undergoing surgical staging were retrospectively included. Patients classified by IHC-M were stratified into: MMR-proficient (MMRp), p53 wild type (p53wt) and estrogen receptor (ER) positive, 2) MMRp, p53wt and ER-negative, 3) MMRd, and 4) p53abn. A case-control comparison was performed between the IHC-M and GP-M cohorts. Then, a propensity-matched analysis was performed: ECs classified by IHC-M were matched in a 3:1 ratio with patients classified by GP-M.

Results: 1587 patients with EC were included. The Kaplan-Meier survival curves for disease-free survival and overall survival demonstrated that the two models performed similarly in risk-stratifying the study population (p < 0.0001). Moreover, the AUC-ROC showed overlapping results: 0.77 (0.66-0.87) for IHC-M and 0.72 (0.63-0.81) for GP-M, indicating that both models were able to successfully identify patients at high-risk and low-risk of disease recurrence/progression.

Conclusion: The IHC-M showed overlapping classification performance compared to the GP-M in terms of oncologic outcomes. This study may lay the basis to further investigate the real-life clinical impact of POLE sequencing in molecular classification and the potential stand-alone prognostic role of ER status for further allocation of EC patients into risk classes.

背景:基于基因组图谱的模型(GP-M)是子宫内膜癌(EC)分子分类的黄金标准,但在低收入环境中,与基因组测序可用性相关的几个问题依然存在,而且管理中的健康差异正在增加。本研究旨在探讨免疫组化单独模式与基于基因组图谱的标准模式相比,在对子宫内膜癌进行分类时在肿瘤治疗效果方面的非劣效性:方法:回顾性纳入所有术前接受手术分期的子宫内膜癌患者。根据 IHC-M 对患者进行分层:MMRp、p53野生型(p53wt)和雌激素受体(ER)阳性;2)MMRp、p53wt和ER阴性;3)MMRd;4)p53abn。IHC-M和GP-M队列之间进行了病例对照比较。然后,进行倾向匹配分析:根据IHC-M分类的EC患者与根据GP-M分类的患者按3:1的比例进行匹配:结果:共纳入1587名EC患者。无病生存期和总生存期的 Kaplan-Meier 生存曲线显示,这两种模型在对研究人群进行风险分级时表现相似(p 结论:IHC-M 与 GP-M 的分级结果存在重叠:与 GP-M 相比,IHC-M 在肿瘤结果方面显示出重叠的分类性能。本研究可为进一步研究 POLE 测序在分子分级中的实际临床影响,以及ER 状态在进一步将 EC 患者划分为不同风险等级时的潜在独立预后作用奠定基础。
{"title":"Less is more? Comparison between genomic profiling and immunohistochemistry-based models in endometrial cancer molecular classification: A multicenter, retrospective, propensity-matched survival analysis.","authors":"Emanuele Perrone, Ilaria Capasso, Diana Giannarelli, Rita Trozzi, Luigi Congedo, Elisa Ervas, Vincenzo Tarantino, Giovanni Esposito, Luca Palmieri, Arianna Guaita, Anne-Sophie van Rompuy, Giulia Scaglione, Gian Franco Zannoni, Giovanni Scambia, Frédéric Amant, Francesco Fanfani","doi":"10.1016/j.ygyno.2024.10.010","DOIUrl":"10.1016/j.ygyno.2024.10.010","url":null,"abstract":"<p><strong>Background: </strong>Genomic profiling-based model (GP-M) is the gold-standard for endometrial cancer (EC) molecular classification, but several issues related to the availability of genomic sequencing in low-income settings remain and health disparities in the management are increasing. This study aims to investigate the non-inferiority of the immunohistochemistry-alone model in classifying ECs compared to the standard genomic profiling-based model in terms of oncologic outcomes.</p><p><strong>Methods: </strong>All preoperative uterine-confined ECs undergoing surgical staging were retrospectively included. Patients classified by IHC-M were stratified into: MMR-proficient (MMRp), p53 wild type (p53wt) and estrogen receptor (ER) positive, 2) MMRp, p53wt and ER-negative, 3) MMRd, and 4) p53abn. A case-control comparison was performed between the IHC-M and GP-M cohorts. Then, a propensity-matched analysis was performed: ECs classified by IHC-M were matched in a 3:1 ratio with patients classified by GP-M.</p><p><strong>Results: </strong>1587 patients with EC were included. The Kaplan-Meier survival curves for disease-free survival and overall survival demonstrated that the two models performed similarly in risk-stratifying the study population (p < 0.0001). Moreover, the AUC-ROC showed overlapping results: 0.77 (0.66-0.87) for IHC-M and 0.72 (0.63-0.81) for GP-M, indicating that both models were able to successfully identify patients at high-risk and low-risk of disease recurrence/progression.</p><p><strong>Conclusion: </strong>The IHC-M showed overlapping classification performance compared to the GP-M in terms of oncologic outcomes. This study may lay the basis to further investigate the real-life clinical impact of POLE sequencing in molecular classification and the potential stand-alone prognostic role of ER status for further allocation of EC patients into risk classes.</p>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"191 ","pages":"150-157"},"PeriodicalIF":4.5,"publicationDate":"2024-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142463325","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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Gynecologic oncology
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