Clinical Burden of Recurrent Disease in High-Risk Endometrial Cancer.

IF 3.2 Q2 ONCOLOGY
Kalé Kponee-Shovein, Vimalanand S Prabhu, Yan Song, Lei Chen, Mu Cheng, Yeran Li, Yezhou Sun, Annalise Hilts, Qi Hua, Jasmine Lichfield, Linda Duska
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引用次数: 0

Abstract

Introduction: Disease-free survival (DFS) is commonly a primary endpoint in clinical trials of investigational therapies for early stage and/or high-risk endometrial cancer and may be indicative of therapeutic benefit prior to maturity of overall survival (OS) data; however, its role as a predictor of OS in high-risk endometrial cancer is unknown. Therefore, this study estimates the individual-level correlation between DFS and OS and the association between recurrent disease and OS in patients with high-risk endometrial cancer receiving adjuvant chemotherapy.

Methods: Medicare beneficiaries with high-risk endometrial cancer who underwent surgery followed by adjuvant chemotherapy were identified from Surveillance, Epidemiology, and End Results data (2007-2019). OS and DFS from adjuvant chemotherapy initiation were estimated by Kaplan-Meier (KM) analyses; correlation was evaluated using Kendall's τ rank correlation. Multivariable Cox models were used to compare OS between recurrent and nonrecurrent patients at three landmark points and over the follow-up period.

Results: Among 771 patients, 250 (32.4%) experienced recurrence (median follow-up 3.6 years). Median OS was not reached (5-year OS 72.7%); median DFS was 7.9 years (5-year DFS 58.1%). A positive correlation between DFS and OS was observed [Kendall's τ = 0.83; 95% confidence interval (CI) 0.79‒0.86; p < 0.001]. Across landmark points, recurrent patients had 3.8-5.2-fold higher risk of mortality (all p < 0.001). During follow-up, patients with recurrence had a higher risk of mortality than those without (hazard ratio 7.9; 95% CI 5.7‒10.8; p < 0.001).

Conclusions: The findings of this study suggest that DFS may be a useful surrogate for OS in high-risk endometrial cancer, though validation in trial-level meta-analyses is needed, and highlight the substantial burden associated with recurrent disease, as evidenced by the four-fold to eight-fold higher risk of mortality across comparative assessments of OS. Effective novel therapies are needed to reduce the considerable burden of disease recurrence in this population.

高危子宫内膜癌复发疾病的临床负担。
无病生存期(DFS)通常是早期和/或高风险子宫内膜癌研究性治疗临床试验的主要终点,可能是总生存期(OS)数据成熟之前的治疗获益指标;然而,其在高危子宫内膜癌中作为OS预测因子的作用尚不清楚。因此,本研究估计高危子宫内膜癌辅助化疗患者DFS与OS的个体水平相关性,以及复发性疾病与OS的相关性。方法:从监测、流行病学和最终结果数据(2007-2019)中确定接受手术后辅助化疗的高危子宫内膜癌医疗保险受益人。通过Kaplan-Meier (KM)分析估计辅助化疗起始的OS和DFS;使用肯德尔τ秩相关评估相关性。多变量Cox模型用于比较复发和非复发患者在三个里程碑点和随访期间的OS。结果:771例患者中,250例(32.4%)复发(中位随访3.6年)。中位OS未达到(5年OS 72.7%);中位DFS为7.9年(5年DFS为58.1%)。DFS与OS呈正相关[Kendall’s τ = 0.83;95%置信区间(CI) 0.79 ~ 0.86;结论:本研究的结果表明,DFS可能是高风险子宫内膜癌OS的有用替代方法,尽管需要在试验水平的荟萃分析中进行验证,并强调了与复发性疾病相关的实质性负担,在OS的比较评估中,死亡率风险高出4至8倍。需要有效的新疗法来减轻这一人群疾病复发的负担。
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来源期刊
CiteScore
3.40
自引率
0.00%
发文量
31
审稿时长
6 weeks
期刊介绍: Now indexed in PubMed Aims and Scope Oncology and Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality pre-clinical, clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Oncology and Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research. Rapid Publication The journal’s rapid publication timelines aim for a peer review decision within 2 weeks of submission. If an article is accepted it will be published online 3-4 weeks from acceptance. These rapid timelines are achieved through the combination of a dedicated in-house editorial team, who closely manage article workflow, and an extensive Editorial and Advisory Board who assist with rapid peer review. This allows the journal to support the rapid dissemination of research, whilst still providing robust peer review. Combined with the journal’s open access model this allows for the rapid and efficient communication of the latest research and reviews, allowing the advancement of clinical therapies. Personal Service The journal’s dedicated in-house editorial team offer a personal “concierge service” meaning that authors will always have a personal point of contact able to update them on the status of their manuscript. The editorial team check all manuscripts to ensure that articles conform to the most recent COPE, GPP and ICMJE publishing guidelines. This supports the publication of ethically sound and transparent research. We also encourage pre-submission enquiries and are always happy to provide a confidential assessment of manuscripts. Digital features and plain language summaries Oncology and Therapy offers a range of additional features designed to increase the visibility, readership and educational value of the journal’s content. Each article is accompanied by key summary points, giving a time-efficient overview of the content to a wide readership. Articles may be accompanied by plain language summaries to assist readers who have some knowledge of, but not in-depth expertise in, the area to understand the scientific content and overall implications of the article. The journal also provides the option to include various types of digital features including animated abstracts, video abstracts, slide decks, audio slides, instructional videos, infographics, podcasts and animations. All additional features are peer reviewed to the same high standard as the article itself. If you consider that your paper would benefit from the inclusion of a digital feature, please let us know. Our editorial team are able to create high-quality slide decks and infographics in-house, and video abstracts through our partner Research Square, and would be happy to assist in any way we can. For further information about digital features, please contact the journal editor (see ‘Contact the Journal’ for email address), and see the ‘Guidelines for digital features and plain language summaries’ document under ‘Submission guidelines’. Preprints We encourage posting of preprints of primary research manuscripts on preprint servers, authors'' or institutional websites, and open communications between researchers whether on community preprint servers or preprint commenting platforms. Posting of preprints is not considered prior publication and will not jeopardize consideration in our journals. Please see here for further information on preprint sharing: https://www.springer.com/gp/authors-editors/journal-author/journal-author-helpdesk/submission/1302#c16721550 Peer Review Process Upon submission, manuscripts are assessed by the editorial team to ensure they fit within the aims and scope of the journal and are also checked for plagiarism. All suitable submissions are then subject to a comprehensive single-blind peer review. Reviewers are selected based on their relevant expertise and publication history in the subject area. The journal has an extensive pool of editorial and advisory board members who have been selected to assist with peer review based on the afore-mentioned criteria. At least two extensive reviews are required to make the editorial decision, with the exception of some article types such as Commentaries, Editorials and Letters which are generally reviewed by one member of the Editorial Board. Where reviewer recommendations are conflicted, the editorial board will be contacted for further advice and a presiding decision. Manuscripts are then either accepted, rejected or authors are required to make major or minor revisions (both reviewer comments and editorial comments may need to be addressed). Once a revised manuscript is re-submitted, it is assessed along with the responses to reviewer comments and if it has been adequately revised it will be accepted for publication. Accepted manuscripts are then copyedited and typeset by the production team before online publication. Appeals against decisions following peer review are considered on a case by case basis and should be sent to the journal editor. Copyright Oncology and Therapy''s content is published open access under the Creative Commons Attribution-Noncommercial License, which allows users to read, copy, distribute, and make derivative works for non-commercial purposes from the material, as long as the author of the original work is cited. The author assigns the exclusive right to any commercial use of the article to Springer. For more information about the Creative Commons Attribution-Noncommercial License, click here: http://creativecommons.org/licenses/by-nc/4.0 Publication Fees Upon acceptance of an article, authors will be required to pay the mandatory Rapid Service Fee of £3650/€4500/$5100. The journal will consider fee discounts for developing countries and this is decided on a case by case basis. Open Access All articles published by Oncology and Therapy are published open access Contact For more information about the journal, including pre-submission enquiries, please contact managing editor Lydia Alborn at lydia.alborn@springer.com.
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