免疫检查点抑制剂治疗黑色素瘤和肾细胞癌期间免疫相关不良事件的临床管理和结局:英国真实世界证据研究

IF 3.2 Q2 ONCOLOGY
Anna Olsson-Brown, Ankit Jain, Ricky Frazer, David Farrugia, Judith Carser, John Houghton, Ruth D Lewis, Simon D'Mello, Gabrielle Emanuel
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引用次数: 0

摘要

免疫检查点抑制剂(ICI)疗法虽然对治疗各种晚期恶性肿瘤患者有效,但可能导致潜在的严重甚至致命的免疫相关不良事件(irAEs)。本研究旨在为英国接受nivolumab (NIVO)和/或ipilimumab (IPI)治疗的晚期(不可切除或转移性)恶性黑色素瘤(a/mMM)或晚期肾细胞癌(aRCC)患者的irAE特征、临床管理和临床结果提供真实证据。方法:这是一项多中心、回顾性队列研究,研究对象是2016年1月1日至2020年3月31日期间在英国五个专科治疗中心之一接受NIVO和/或IPI治疗的a/mMM或aRCC成年患者。描述了irAE的发生率和分级,以及irAE发生的时间,irAE的管理和总生存期(OS)。结果:研究共纳入199例患者:a/mMM患者162例,aRCC患者37例。a/mMM(75.3%)和aRCC(62.2%)队列中的大多数患者报告了任何irAE,而a/mMM和aRCC队列中的45.9%和30.4%分别报告了3级或4级irAE。结肠炎/腹泻、皮肤反应和肝炎是最常见的报告,所有irAE的主要治疗处方仅为皮质类固醇。分析表明,irAE的发展与更长的OS之间存在正相关。结论:本研究的结果支持现有文献,为irAE的特征和临床管理提供了进一步的见解,并支持这些患者组中irAE的发展与改善的OS之间的关联。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Clinical Management and Outcomes of Immune-Related Adverse Events During Treatment with Immune Checkpoint Inhibitor Therapies in Melanoma and Renal Cell Carcinoma: A UK Real-World Evidence Study.

Introduction: Immune checkpoint inhibitor (ICI) therapy, although effective in treating patients with a variety of advanced malignancies, can result in potentially severe or even fatal immune-related adverse events (irAEs). This study aimed to generate real-world evidence on irAE characteristics, clinical management and clinical outcomes among patients with advanced (unresectable or metastatic) malignant melanoma (a/mMM) or advanced renal cell carcinoma (aRCC) treated with nivolumab (NIVO) and/or ipilimumab (IPI) in the UK.

Methods: This was a multi-centre, retrospective cohort study of adult patients with a/mMM or aRCC, who received NIVO and/or IPI at one of five specialist treatment centres in the UK between 1 January 2016 and 31 March 2020. The incidence and grading of irAEs were described, as well as time to irAE onset, the management of irAEs and overall survival (OS).

Results: In total, 199 patients were included in the study: 162 with a/mMM and 37 with aRCC. The majority of patients in both a/mMM (75.3%) and aRCC (62.2%) cohorts reported any irAE, while 45.9% and 30.4% in the a/mMM and aRCC cohorts reported grade 3 or 4 irAEs, respectively. Colitis/diarrhoea, skin reactions and hepatitis were most frequently reported, and the predominant treatment prescribed for any irAE was corticosteroids only. Analysis indicated a positive association between the development of an irAE and longer OS.

Conclusions: Findings from this study support current literature, provide further insights into the characteristics and clinical management of irAEs and support an association between the development of an irAE and improved OS in these patient groups.

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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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