接受teclistumab治疗的复发或难治性多发性骨髓瘤患者的真实世界患者特征、治疗模式和临床结果:一项面板图回顾研究。

IF 3.2 Q2 ONCOLOGY
Binod Dhakal, Moshe Y Levy, Gilbert Ko, Jinghua He, Nina Kim, Wenze Tang, Tonya Le Blanc, Jessica Fowler, Sarah Lucht, Madison Brown, Emily Bland, Camryn Craig, Sarah Giegerich, JaLyna Laney, Bruce Feinberg, Niodita Gupta-Werner, Shuchita Kaila, Peter Voorhees
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引用次数: 0

摘要

Teclistamab是基于MajesTEC-1研究结果的复发/难治性多发性骨髓瘤(RRMM)治疗的既定护理标准。基于美国(US)的teclistamab治疗的现实世界研究随访有限,在学术环境中进行和/或样本量小。这项真实世界的研究主要是在美国以社区为基础的肿瘤提供者网络中进行的,以评估teclistamab的真实世界有效性和安全性。方法:这项回顾性、观察性、队列研究使用了Cardinal Health的肿瘤学提供者扩展网络。在2022年10月25日或之后接受特司他抗治疗的成年RRMM患者通过病历审查确定。描述了患者特征、治疗模式和治疗史。临床结果包括不良事件、反应和生存率以及反应持续时间。数据提供了所有患者和美国处方信息(USPI)对齐和未对齐亚组的数据。结果:总体纳入101例患者,其中uspi对齐患者30例,uspi未对齐患者71例。中位年龄为65.4岁,86.1%的患者东部肿瘤合作组表现状态评分为1分,37.6%的患者具有高危细胞遗传学特征。大多数患者为三级暴露(93.1%)和/或难治性(65.3%)。中位随访时间为13.8个月,总体、uspi对齐和uspi未对齐亚组的总有效率分别为80.2%、90.0%和76.1%。在增加剂量期间,32.7%和8.9%的患者分别出现细胞因子释放综合征和免疫效应细胞相关神经毒性综合征;26.7%的患者在接受替司他单抗治疗期间发生感染。结论:尽管许多患者有更高的疾病负担和更差的表现状态,但与MajesTEC-1试验相比,这项现实世界的研究显示,在该人群中,数字上的反应率更高,不良事件发生率大致相似。这些主要来自社区肿瘤学环境的研究结果表明,teclistamab是现实世界中RRMM患者的有效治疗选择。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Real-World Patient Characteristics, Treatment Patterns, and Clinical Outcomes in Patients with Relapsed or Refractory Multiple Myeloma Receiving Teclistamab: A Panel Chart Review Study.

Introduction: Teclistamab is an established standard of care for the treatment of relapsed/refractory multiple myeloma (RRMM) based on MajesTEC-1 study results. United States (US)-based real-world studies of teclistamab treatment have had limited follow-up, were conducted in academic settings and/or had small sample sizes. This real-world study was conducted in a primarily US community-based oncology provider network to assess the real-world effectiveness and safety profile of teclistamab.

Methods: This retrospective, observational, cohort study used Cardinal Health's Oncology Provider Extended Network. Adult patients with RRMM who received teclistamab on or after 25 October 2022, were identified through medical chart review. Patient characteristics, treatment patterns, and treatment history were described. Clinical outcomes included adverse events, response and survival rates, and duration of response. Data are presented for all patients and US Prescribing Information (USPI)-aligned and unaligned subgroups.

Results: The overall population included 101 patients, of which 30 and 71 were USPI-aligned and USPI-unaligned, respectively. Median age was 65.4 years, 86.1% had an Eastern Cooperative Oncology Group Performance Status score of 1 and 37.6% had a high-risk cytogenetic profile. Most patients were triple-class exposed (93.1%) and/or refractory (65.3%). Median follow-up was 13.8 months and overall response rates were 80.2%, 90.0%, and 76.1% in the overall, USPI-aligned, and USPI-unaligned subgroups, respectively. During step-up dosing, 32.7% and 8.9% of all patients had cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome, respectively; 26.7% of all patients developed infections while receiving teclistamab.

Conclusion: This real-world study demonstrated numerically higher response rates and broadly similar rates of adverse events in this population compared with the MajesTEC-1 trial, despite many patients having higher disease burden and worse performance status. These findings from primarily community oncology settings suggest that teclistamab is an effective treatment option for patients with RRMM in the real world.

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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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