To determine the incidence of clinical and subclinical venous thromboembolic events (VTE) in patients with locally advanced cervical cancer (LACC) treated with high-dose thromboprophylaxis during definitive chemoradiation and brachytherapy.
Methods
A prospective observational study was undertaken from August 2021 to December 2023 in patients with primary LACC treated with definitive chemoradiation in two Dutch tertiary hospitals. Patients received high-dose thromboprophylaxis during chemoradiation and brachytherapy. In week 4 or 5 of the overall treatment time, plasma D-dimer levels were determined, and all patients underwent venous ultrasound imaging of the legs to screen for deep vein thrombosis (DVT). If indicated, patients received a CT-angiography to screen for pulmonary embolism (PE).
Results
Among 89 included patients, cumulative incidence of clinical and subclinical (V)TE was 7.9 % (n = 7). DVT was found in two patients, PE in three patients, DVT and PE in one patient and one patient had an arterial thromboembolic event (ATE). Of these patients, three (3.4 %) had subclinical VTE, diagnosed during the screening before brachytherapy, and four (4.5 %) had clinical VTE of whom two developed VTE during chemoradiation, one during hospitalization for brachytherapy and one after completing treatment. Of the seven patients with VTE, two (28.6 %) were treated with hyperthermia. Adverse bleeding events after brachytherapy occurred in eight patients.
Conclusion
Routine thromboprophylaxis in patients with LACC leads to a relative low incidence of thromboembolic events during chemoradiation and brachytherapy. Further research should focus on identifying high risk factors leading to targeted screening and prevention of VTE in high risk patients.
{"title":"Thromboprophylaxis in patients with locally advanced cervical cancer treated with chemoradiation and brachytherapy","authors":"Lisa Leijtens , Jurgen Piek , An-Sofie Verrijssen , Dorien Rijkaart , Bastiaan Wortman , Ada Oele-Egelmeer , Alette Daniëls-Gooszen , Annemarie Thijs , Marten Nijziel , Sylvie Kolfschoten , Ruud Bekkers , Jeltsje Cnossen","doi":"10.1016/j.ygyno.2024.12.015","DOIUrl":"10.1016/j.ygyno.2024.12.015","url":null,"abstract":"<div><h3>Objective</h3><div>To determine the incidence of clinical and subclinical venous thromboembolic events (VTE) in patients with locally advanced cervical cancer (LACC) treated with high-dose thromboprophylaxis during definitive chemoradiation and brachytherapy.</div></div><div><h3>Methods</h3><div>A prospective observational study was undertaken from August 2021 to December 2023 in patients with primary LACC treated with definitive chemoradiation in two Dutch tertiary hospitals. Patients received high-dose thromboprophylaxis during chemoradiation and brachytherapy. In week 4 or 5 of the overall treatment time, plasma D-dimer levels were determined, and all patients underwent venous ultrasound imaging of the legs to screen for deep vein thrombosis (DVT). If indicated, patients received a CT-angiography to screen for pulmonary embolism (PE).</div></div><div><h3>Results</h3><div>Among 89 included patients, cumulative incidence of clinical and subclinical (V)TE was 7.9 % (<em>n</em> = 7). DVT was found in two patients, PE in three patients, DVT and PE in one patient and one patient had an arterial thromboembolic event (ATE). Of these patients, three (3.4 %) had subclinical VTE, diagnosed during the screening before brachytherapy, and four (4.5 %) had clinical VTE of whom two developed VTE during chemoradiation, one during hospitalization for brachytherapy and one after completing treatment. Of the seven patients with VTE, two (28.6 %) were treated with hyperthermia. Adverse bleeding events after brachytherapy occurred in eight patients.</div></div><div><h3>Conclusion</h3><div>Routine thromboprophylaxis in patients with LACC leads to a relative low incidence of thromboembolic events during chemoradiation and brachytherapy. Further research should focus on identifying high risk factors leading to targeted screening and prevention of VTE in high risk patients.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"193 ","pages":"Pages 41-48"},"PeriodicalIF":4.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142947785","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}
Pub Date : 2025-02-01DOI: 10.1016/j.ygyno.2024.12.014
Franziska Siegenthaler , Sara Imboden , Carol Büchi , Lucine Christe , Wiebke Solass , Flurina Saner , Claudia Rauh , Seline Hofer , Bettina Schlatter , Julian Wampfler , Stefan Mohr , Andrea Papadia , Maria Anokhina , Wolfgang Göring , Tilman T. Rau , Michael D. Mueller
Objective
Treatment approaches for endometrial cancer became more personalized in the last decade, mainly due to two key advancements - sentinel lymph node (SLN) mapping and molecular classification. However, their prognostic interaction remains relatively unexplored.
Methods
This retrospective cohort study included patients with endometrial cancer, who underwent surgical treatment including SLN mapping at the Bern University Hospital, Switzerland. Ultrastaging of the SLNs and a molecular analysis on the primary tumor was performed.
Results
The study cohort included 206 patients, of which 197 tumor samples underwent molecular classification. 11.2 % were classified as POLEmut, 25.9 % as MMRd, 46.2 % as NSMP, and 16.8 % as p53abn. Overall, 834 SLN were removed. SLN macrometastasis were most prevalent in patients with p53abn tumors (24.2 %), followed by MMRd (13.7 %), NSMP (5.5 %), and POLEmut (0 %) tumors (p = .006). Mean follow-up time was 70.9 months. SLN macrometastasis was significantly associated with a higher risk of recurrence in the entire study cohort (p > .001) and the NSMP subgroup (p > .001). In the MMRd subgroup, SLN macrometastasis remained a significant predictor of recurrence (p = .030) and disease-specific death (p = .047) in multivariate Cox regression analysis. For patients with p53abn endometrial cancer, there was no association between SLN macrometastasis and risk of recurrence (p = .618) or disease specific death (p = .798).
Conclusions
SLN macrometastasis is an independent predictor of recurrence and disease-specific death in patients with MMRd endometrial cancer. In the subgroup of p53abn endometrial cancers, SLN macrometastasis did not have an added impact on oncological outcome.
{"title":"Added prognostic value of sentinel lymph node mapping in endometrial cancer to molecular subgroups","authors":"Franziska Siegenthaler , Sara Imboden , Carol Büchi , Lucine Christe , Wiebke Solass , Flurina Saner , Claudia Rauh , Seline Hofer , Bettina Schlatter , Julian Wampfler , Stefan Mohr , Andrea Papadia , Maria Anokhina , Wolfgang Göring , Tilman T. Rau , Michael D. Mueller","doi":"10.1016/j.ygyno.2024.12.014","DOIUrl":"10.1016/j.ygyno.2024.12.014","url":null,"abstract":"<div><h3>Objective</h3><div>Treatment approaches for endometrial cancer became more personalized in the last decade, mainly due to two key advancements - sentinel lymph node (SLN) mapping and molecular classification. However, their prognostic interaction remains relatively unexplored.</div></div><div><h3>Methods</h3><div>This retrospective cohort study included patients with endometrial cancer, who underwent surgical treatment including SLN mapping at the Bern University Hospital, Switzerland. Ultrastaging of the SLNs and a molecular analysis on the primary tumor was performed.</div></div><div><h3>Results</h3><div>The study cohort included 206 patients, of which 197 tumor samples underwent molecular classification. 11.2 % were classified as <em>POLE</em>mut, 25.9 % as MMRd, 46.2 % as NSMP, and 16.8 % as p53abn. Overall, 834 SLN were removed. SLN macrometastasis were most prevalent in patients with p53abn tumors (24.2 %), followed by MMRd (13.7 %), NSMP (5.5 %), and <em>POLE</em>mut (0 %) tumors (<em>p</em> = .006). Mean follow-up time was 70.9 months. SLN macrometastasis was significantly associated with a higher risk of recurrence in the entire study cohort (<em>p</em> > .001) and the NSMP subgroup (p > .001). In the MMRd subgroup, SLN macrometastasis remained a significant predictor of recurrence (<em>p</em> = .030) and disease-specific death (<em>p</em> = .047) in multivariate Cox regression analysis. For patients with p53abn endometrial cancer, there was no association between SLN macrometastasis and risk of recurrence (<em>p</em> = .618) or disease specific death (<em>p</em> = .798).</div></div><div><h3>Conclusions</h3><div>SLN macrometastasis is an independent predictor of recurrence and disease-specific death in patients with MMRd endometrial cancer. In the subgroup of p53abn endometrial cancers, SLN macrometastasis did not have an added impact on oncological outcome.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"193 ","pages":"Pages 12-19"},"PeriodicalIF":4.5,"publicationDate":"2025-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143136724","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}
Pub Date : 2025-01-01DOI: 10.1016/j.ygyno.2024.11.010
Rebecca A. Previs , Kyle C. Strickland , Zachary Wallen , Heidi Ko , Michelle Green , Maureen Cooper , Elizabeth Lyon , Michael Biorn , Jennifer Armetta , Rennie Quarles , Catherine H. Watson , Kari Ring , Jonathan L. Klein , Brian Caveney , Eric A. Severson , Shakti Ramkissoon
Background
Epithelial ovarian cancer (EOC) remains a significant challenge in gynecologic oncology, particularly in the context of platinum-resistant disease. Mirvetuximab soravtansine (MIRV), was approved after trials revealed favorable response and survival outcomes. MIRV targets folate receptor alpha (FRα), a cell-surface receptor that is overexpressed in EOC and has been associated with aggressive disease phenotypes.
Methods
This retrospective study analyzed 425 patient samples tested for FRα using the VENTANA® FOLR1 RxDx immunohistochemical assay. The patient cohort included cases with high grade serous carcinoma predominantly, tested across various anatomical sites. Statistical analysis examined the correlation between FRα positivity and clinical parameters such as tumor site and histology.
Results
FRα was highly expressed in 36.3 % of the cases, with a significant association between FRα positivity and high grade serous ovarian histology. Tumor samples from the ovary, fallopian tube, adnexa, and dominant pelvic masses showed higher FRα positivity compared to metastatic sites (positive rates of 44.4 % vs 32.5 %, p = 0.02), highlighting the potential influence of tumor origin on expression of FRα. Time between sample collection and testing did not impact FRα expression, with sample testing spread over a median of 19.5 months post-collection. Eight patients had more than one specimen tested, of which 3 (37.5 %) had discordant results when a subsequent specimen was tested.
Conclusion
Our results highlight a need for standardized protocols for FRα testing to ensure accurate biomarker evaluation across varied clinical settings. The heterogeneity in FRα expression, influenced by tumor histology and anatomical origin, warrant further investigation to optimize therapeutic outcomes.
Prior presentation
Preliminary findings from this study were previously presented in poster format at the Society of Gynecologic Oncology 2024 Annual Metting. We confirm that the submission complies with the journal requirements.
{"title":"Analysis of real world FRα testing in ovarian, fallopian tube, and primary peritoneal cancers","authors":"Rebecca A. Previs , Kyle C. Strickland , Zachary Wallen , Heidi Ko , Michelle Green , Maureen Cooper , Elizabeth Lyon , Michael Biorn , Jennifer Armetta , Rennie Quarles , Catherine H. Watson , Kari Ring , Jonathan L. Klein , Brian Caveney , Eric A. Severson , Shakti Ramkissoon","doi":"10.1016/j.ygyno.2024.11.010","DOIUrl":"10.1016/j.ygyno.2024.11.010","url":null,"abstract":"<div><h3>Background</h3><div>Epithelial ovarian cancer (EOC) remains a significant challenge in gynecologic oncology, particularly in the context of platinum-resistant disease. Mirvetuximab soravtansine (MIRV), was approved after trials revealed favorable response and survival outcomes. MIRV targets folate receptor alpha (FRα), a cell-surface receptor that is overexpressed in EOC and has been associated with aggressive disease phenotypes.</div></div><div><h3>Methods</h3><div>This retrospective study analyzed 425 patient samples tested for FRα using the VENTANA® FOLR1 RxDx immunohistochemical assay. The patient cohort included cases with high grade serous carcinoma predominantly, tested across various anatomical sites. Statistical analysis examined the correlation between FRα positivity and clinical parameters such as tumor site and histology.</div></div><div><h3>Results</h3><div>FRα was highly expressed in 36.3 % of the cases, with a significant association between FRα positivity and high grade serous ovarian histology. Tumor samples from the ovary, fallopian tube, adnexa, and dominant pelvic masses showed higher FRα positivity compared to metastatic sites (positive rates of 44.4 % vs 32.5 %, <em>p</em> = 0.02), highlighting the potential influence of tumor origin on expression of FRα. Time between sample collection and testing did not impact FRα expression, with sample testing spread over a median of 19.5 months post-collection. Eight patients had more than one specimen tested, of which 3 (37.5 %) had discordant results when a subsequent specimen was tested.</div></div><div><h3>Conclusion</h3><div>Our results highlight a need for standardized protocols for FRα testing to ensure accurate biomarker evaluation across varied clinical settings. The heterogeneity in FRα expression, influenced by tumor histology and anatomical origin, warrant further investigation to optimize therapeutic outcomes.</div></div><div><h3>Prior presentation</h3><div>Preliminary findings from this study were previously presented in poster format at the Society of Gynecologic Oncology 2024 Annual Metting. We confirm that the submission complies with the journal requirements.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 102-110"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142779995","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}
Exercise therapy is a potentially beneficial treatment option for chemotherapy-induced peripheral neuropathy (CIPN). However, there is a lack of consensus on the management of CIPN in patients with ovarian cancer. The purpose of this scoping review was to evaluate the evidence on the effectiveness of exercise therapy in patients with ovarian cancer and explore key physical fitness parameters.
Methods
A systematic electronic search was conducted using the MEDLINE, CINAHL, Web of Science, PEDro, and ClinicalTrials.gov databases. Two independent reviewers summarized the features and data from the literature regarding the effectiveness of exercise therapy for CIPN and the association between CIPN and physical fitness parameters.
Results
Ten articles involving 3402 participants were reviewed. The study design included one randomized controlled trial, one single-arm trial, one prospective cohort study, five retrospective cohort studies, and two cross-sectional studies. The mean patient age was >60 years in three studies and 50–60 years in six studies. The mean body mass index was >25.0 kg/m2 in six studies and not stated in four studies. In six references, patients received platinum and taxane-based chemotherapy. The effectiveness of an exercise therapy program for CIPN was reported in a randomized controlled trial. Two cross-sectional studies highlighted the association between daily physical inactivity and CIPN; two retrospective cohort studies showed an association between low skeletal muscle density and CIPN; one article demonstrated an association between physical dysfunction and CIPN.
Conclusion
This scoping review indicates that although evidence is lacking, exercise intervention programs for CIPN in patients with ovarian cancer have potential benefits, especially when focused on daily physical activity, skeletal muscle density, and physical function.
背景与目的：运动疗法是化疗诱导的周围神经病变（CIPN）的一种潜在有益的治疗选择。然而，对于卵巢癌患者CIPN的处理缺乏共识。本综述的目的是评估运动疗法对卵巢癌患者有效性的证据，并探讨关键的身体健康参数。方法：使用MEDLINE、CINAHL、Web of Science、PEDro和ClinicalTrials.gov数据库进行系统的电子检索。两位独立审稿人总结了运动疗法治疗CIPN有效性的文献特征和数据，以及CIPN与身体健康参数之间的关系。结果：共纳入文献10篇，3402名受试者。研究设计包括1项随机对照试验、1项单臂试验、1项前瞻性队列研究、5项回顾性队列研究和2项横断面研究。3项研究的患者平均年龄为60岁，6项研究的患者平均年龄为50-60岁。6项研究的平均体重指数为25.0 kg/m2, 4项研究没有说明。在6篇文献中，患者接受了铂和紫杉烷为基础的化疗。一项随机对照试验报告了运动治疗方案对CIPN的有效性。两项横断面研究强调了日常缺乏运动与CIPN之间的关联；两项回顾性队列研究显示低骨骼肌密度与CIPN之间存在关联；一篇文章证明了身体功能障碍与CIPN之间的联系。结论：本综述表明，尽管缺乏证据，但运动干预方案对卵巢癌患者CIPN有潜在的益处，特别是当关注日常体力活动、骨骼肌密度和身体功能时。
{"title":"Effectiveness of exercise therapy on chemotherapy-induced peripheral neuropathy in patients with ovarian cancer: A scoping review","authors":"Masanori Konuma , Tomohiro Ikeda , Tomohiro Mitoma , Shinsuke Shirakawa , Jota Maki , Yoshimi Katayama , Masanori Hamada , Shoji Nagao , Toshifumi Ozaki","doi":"10.1016/j.ygyno.2024.12.007","DOIUrl":"10.1016/j.ygyno.2024.12.007","url":null,"abstract":"<div><h3>Background & aims</h3><div>Exercise therapy is a potentially beneficial treatment option for chemotherapy-induced peripheral neuropathy (CIPN). However, there is a lack of consensus on the management of CIPN in patients with ovarian cancer. The purpose of this scoping review was to evaluate the evidence on the effectiveness of exercise therapy in patients with ovarian cancer and explore key physical fitness parameters.</div></div><div><h3>Methods</h3><div>A systematic electronic search was conducted using the MEDLINE, CINAHL, Web of Science, PEDro, and <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> databases. Two independent reviewers summarized the features and data from the literature regarding the effectiveness of exercise therapy for CIPN and the association between CIPN and physical fitness parameters.</div></div><div><h3>Results</h3><div>Ten articles involving 3402 participants were reviewed. The study design included one randomized controlled trial, one single-arm trial, one prospective cohort study, five retrospective cohort studies, and two cross-sectional studies. The mean patient age was >60 years in three studies and 50–60 years in six studies. The mean body mass index was >25.0 kg/m<sup>2</sup> in six studies and not stated in four studies. In six references, patients received platinum and taxane-based chemotherapy. The effectiveness of an exercise therapy program for CIPN was reported in a randomized controlled trial. Two cross-sectional studies highlighted the association between daily physical inactivity and CIPN; two retrospective cohort studies showed an association between low skeletal muscle density and CIPN; one article demonstrated an association between physical dysfunction and CIPN.</div></div><div><h3>Conclusion</h3><div>This scoping review indicates that although evidence is lacking, exercise intervention programs for CIPN in patients with ovarian cancer have potential benefits, especially when focused on daily physical activity, skeletal muscle density, and physical function.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 155-162"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821946","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}
Pub Date : 2025-01-01DOI: 10.1016/j.ygyno.2024.12.002
Féline O. Voss , Guus Fons , Annette H. Bruggink , Hans H.B. Wenzel , Johannes Berkhof , Marc van Beurden , Maaike C.G. Bleeker
Objective
To systematically explore vulvar pathology diagnosed prior to vulvar squamous cell carcinoma (VSCC), as well as the association with tumor characteristics, stage and survival outcome, with the aim of improving vulvar cancer prevention strategies.
Methods
VSCC diagnosed between 2005 and 2019 were identified from a population-based cohort provided by the Dutch Nationwide Pathology Databank. Pathology reports were reviewed to identify vulvar pathology diagnosed before primary VSCC. Data on treatment, tumor stage and survival were collected from the Netherlands Cancer Registry. Prior vulvar pathology was correlated to tumor characteristics and stage. Cox's proportional hazards model was used to assess the impact of clinicopathological variables on survival.
Results
A total of 1036 VSCC patients were identified, of whom most (73 %) had no prior biopsy-confirmed vulvar pathology. High-grade squamous intraepithelial lesion (HSIL) and differentiated vulvar intraepithelial neoplasia (dVIN) were diagnosed prior to VSCC in only 8 % and 2 % of cancer patients, respectively, while adjacent HSIL and adjacent dVIN were reported in 35 % and 22 % of surgical VSCC resection specimens, respectively. The remaining 17 % had a benign vulvar pathology diagnosis prior to cancer. Patients showed advanced staged tumors in 15 % and 9 % of patients with prior HSIL and dVIN, respectively, as compared to 32 % in patients without prior vulvar pathology (p < 0.001). There was no independent association between prior vulvar pathology and survival outcomes.
Conclusion
The vast majority of VSCC patients were not preceded by a pre-malignant lesion or other benign vulvar pathology, although such lesions were frequently identified adjacent to VSCC in resection specimens. Patients without prior vulvar pathology showed more advanced-stage tumors, which may contribute to less favorable outcomes.
{"title":"Prevalence and impact of vulvar lesions diagnosed prior to vulvar squamous cell carcinoma: A population-based cohort study","authors":"Féline O. Voss , Guus Fons , Annette H. Bruggink , Hans H.B. Wenzel , Johannes Berkhof , Marc van Beurden , Maaike C.G. Bleeker","doi":"10.1016/j.ygyno.2024.12.002","DOIUrl":"10.1016/j.ygyno.2024.12.002","url":null,"abstract":"<div><h3>Objective</h3><div>To systematically explore vulvar pathology diagnosed prior to vulvar squamous cell carcinoma (VSCC), as well as the association with tumor characteristics, stage and survival outcome, with the aim of improving vulvar cancer prevention strategies.</div></div><div><h3>Methods</h3><div>VSCC diagnosed between 2005 and 2019 were identified from a population-based cohort provided by the Dutch Nationwide Pathology Databank. Pathology reports were reviewed to identify vulvar pathology diagnosed before primary VSCC. Data on treatment, tumor stage and survival were collected from the Netherlands Cancer Registry. Prior vulvar pathology was correlated to tumor characteristics and stage. Cox's proportional hazards model was used to assess the impact of clinicopathological variables on survival.</div></div><div><h3>Results</h3><div>A total of 1036 VSCC patients were identified, of whom most (73 %) had no prior biopsy-confirmed vulvar pathology. High-grade squamous intraepithelial lesion (HSIL) and differentiated vulvar intraepithelial neoplasia (dVIN) were diagnosed prior to VSCC in only 8 % and 2 % of cancer patients, respectively, while adjacent HSIL and adjacent dVIN were reported in 35 % and 22 % of surgical VSCC resection specimens, respectively. The remaining 17 % had a benign vulvar pathology diagnosis prior to cancer. Patients showed advanced staged tumors in 15 % and 9 % of patients with prior HSIL and dVIN, respectively, as compared to 32 % in patients without prior vulvar pathology (<em>p</em> < 0.001). There was no independent association between prior vulvar pathology and survival outcomes.</div></div><div><h3>Conclusion</h3><div>The vast majority of VSCC patients were not preceded by a pre-malignant lesion or other benign vulvar pathology, although such lesions were frequently identified adjacent to VSCC in resection specimens. Patients without prior vulvar pathology showed more advanced-stage tumors, which may contribute to less favorable outcomes.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 163-170"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142821953","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}
Pub Date : 2025-01-01DOI: 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.
{"title":"Palbociclib plus letrozole in estrogen receptor-positive advanced/recurrent endometrial cancer: Double-blind placebo-controlled randomized phase II ENGOT-EN3/PALEO trial","authors":"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","doi":"10.1016/j.ygyno.2024.12.003","DOIUrl":"10.1016/j.ygyno.2024.12.003","url":null,"abstract":"<div><h3>Purpose</h3><div>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.</div></div><div><h3>Patients and methods</h3><div>This placebo-controlled double-blind, randomized phase II screening trial (<span><span>NCT02730429</span><svg><path></path></svg></span>) 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).</div></div><div><h3>Results</h3><div>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; <em>P</em> = .044). Grade ≥ 3 adverse events were more common with palbociclib–letrozole (67 %) than placebo–letrozole (30 %), most commonly neutropenia (44 % <em>v</em> 0 %, respectively).</div></div><div><h3>Conclusion</h3><div>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.</div></div><div><h3>Clinical trial information</h3><div><span><span>NCT02730429</span><svg><path></path></svg></span></div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 128-136"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142806824","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}
Pub Date : 2025-01-01DOI: 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。
{"title":"Implementation of enhanced recovery protocol did not increase rates of acute kidney injury in open gynecologic oncology surgery: A single-institution experience","authors":"Brandon P. Maddy , Kristin M. Tischer , Michaela E. McGree , Angela J. Fought , Sean C. Dowdy , Gretchen E. Glaser","doi":"10.1016/j.ygyno.2024.12.005","DOIUrl":"10.1016/j.ygyno.2024.12.005","url":null,"abstract":"<div><h3>Objective</h3><div>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.</div></div><div><h3>Methods</h3><div>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 <em>t</em>-test, Wilcoxon rank-sum, chi-square or Fisher's exact test, and univariate logistic regression with odds ratio (OR) and 95 % confidence interval (CI).</div></div><div><h3>Results</h3><div>Pre-IPTW, the AKI incidence was similar between cohorts (10.4 % vs 8.4 %, <em>p</em> = 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 %, <em>p</em> = 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, <em>p</em> < 0.01), had higher ASA scores (61.8 % vs 45.2 %, <em>p</em> = 0.02), lower preoperative hemoglobin (median 10.8 vs 12.5 g/dL, <em>p</em> < 0.01), longer surgeries (median 331 vs 222 min, <em>p</em> < 0.01), greater intraoperative blood loss (median 800 vs 500 mL, <em>p</em> < 0.01), more transfusions (56.4 % vs 29.3 %, p < 0.01), and higher fluid volumes (median 5750 vs 4165 mL, p < 0.01).</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 181-188"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142864026","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}
Pub Date : 2025-01-01DOI: 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.
{"title":"Gestational trophoblastic neoplasm: Patient outcomes and clinical pearls from a multidisciplinary referral center","authors":"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","doi":"10.1016/j.ygyno.2024.12.009","DOIUrl":"10.1016/j.ygyno.2024.12.009","url":null,"abstract":"<div><h3>Objectives</h3><div>To describe clinical outcomes and pearls for patients with gestational trophoblastic neoplasm (GTN).</div></div><div><h3>Methods</h3><div>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).</div></div><div><h3>Results</h3><div>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 (<em>n</em> = 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 (<em>n</em> = 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 % (<em>n</em> = 87/87) and 89 % (<em>n</em> = 16/18), respectively, while patients with initial care locally had cure rates of 87 % (<em>n</em> = 33/37) and 47 % (<em>n</em> = 7/15), respectively.</div></div><div><h3>Conclusion</h3><div>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.</div></div>","PeriodicalId":12853,"journal":{"name":"Gynecologic oncology","volume":"192 ","pages":"Pages 171-177"},"PeriodicalIF":4.5,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142823964","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}
Pub Date : 2025-01-01DOI: 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.
{"title":"Clinical trial screening in gynecologic oncology: Defining the need and identifying best practices","authors":"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","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}
Pub Date : 2025-01-01DOI: 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).
{"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 , 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","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}
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