一线替利利单抗联合化疗治疗晚期非鳞状非小细胞肺癌：来自RATIONALE-304试验的PD-L1≥50%亚组分析
IF 3.2
Q2 ONCOLOGY
引用次数: 0
摘要
导论：RATIONALE-304比较了一线tislelizumab（一种程序性细胞死亡蛋白1抑制剂）加化疗与化疗治疗晚期非鳞状非小细胞肺癌（nsq-NSCLC）的疗效。本探索性分析的重点是肿瘤细胞程序性死亡配体1 （PD-L1）表达≥50%的患者。方法：IIIB/IV期nsq-NSCLC患者每3周随机（2:1）接受替利利单抗+铂基化疗+培美曲塞，随后进行维持性替利利单抗+培美曲塞，或铂基化疗+培美曲塞，随后进行维持性培美曲塞。主要终点是独立审查委员会（IRC）评估的无进展生存期（PFS）；次要终点包括总生存期（OS）、irc评估的客观缓解率和安全性。结果：PD-L1≥50%的人群包括110例患者（替利单抗加化疗，n = 74；化疗，n = 36）；男性占71.8% (n = 79)，女性占28.2% （n = 31）。与最终分析（中位随访16.5个月）一致，4年随访数据（中位随访23.4个月）继续显示，接受tislelizumab联合化疗的患者与接受化疗的患者相比，中位PFS （17.2 vs 4.6个月；分层HR 0.29, 95% CI 0.17-0.50）和中位OS （41.9 vs 13.1个月；分层HR 0.38, 95% CI 0.23-0.62）有所改善。另一项事后分析显示，在替利单抗加化疗组中，PD-L1 50-89%和≥90%亚组的PFS或OS无显著差异。tislelizumab联合化疗的安全性是可控的，与之前的分析一致。结论：在晚期nsq-NSCLC和PD-L1肿瘤细胞表达≥50%的患者中，一线tislelizumab加化疗与化疗相比，PFS和OS有临床意义的改善。在PD-L1肿瘤细胞高表达水平（50-89%和≥90%）的患者亚组中，疗效一致。试验注册：Clinical Trials.gov NCT03663205。本文章由计算机程序翻译，如有差异，请以英文原文为准。
First-Line Tislelizumab Plus Chemotherapy in Advanced Non-Squamous Non-Small Cell Lung Cancer: PD-L1 ≥ 50% Subgroup Analysis from the RATIONALE-304 Trial.
Introduction: RATIONALE-304 compared first-line tislelizumab (a programmed cell death protein 1 inhibitor) plus chemotherapy versus chemotherapy in advanced non-squamous non-small cell lung cancer (nsq-NSCLC). This exploratory analysis focused on patients with tumor cell programmed death ligand 1 (PD-L1) expression ≥ 50%.
Methods: Patients with stage IIIB/IV nsq-NSCLC were randomized (2:1) to tislelizumab plus platinum-based chemotherapy and pemetrexed every 3 weeks, followed by maintenance tislelizumab and pemetrexed, or platinum-based chemotherapy and pemetrexed followed by maintenance pemetrexed. The primary endpoint was independent review committee (IRC)-assessed progression-free survival (PFS); secondary endpoints included overall survival (OS), IRC-assessed objective response rates, and safety.
Results: The PD-L1 ≥ 50% population included 110 patients (tislelizumab plus chemotherapy, n = 74; chemotherapy, n = 36); 71.8% (n = 79) were male and 28.2% (n = 31) were female. Consistent with the final analysis (median follow-up 16.5 months), the 4-year follow-up data (median follow-up 23.4 months) continued to show an improvement in median PFS (17.2 vs. 4.6 months; stratified HR 0.29, 95% CI 0.17-0.50) and median OS (41.9 vs. 13.1 months; stratified HR 0.38, 95% CI 0.23-0.62) for patients who received tislelizumab plus chemotherapy versus chemotherapy. An additional post hoc analysis showed no significant differences in PFS or OS between PD-L1 50-89% and ≥ 90% subgroups in the tislelizumab plus chemotherapy arm. The safety profile of tislelizumab plus chemotherapy was manageable and consistent with previous analyses.
Conclusions: In patients with advanced nsq-NSCLC and PD-L1 tumor cell expression ≥ 50%, first-line tislelizumab plus chemotherapy demonstrated clinically meaningful improvement in PFS and OS versus chemotherapy. Efficacy was consistent across subgroups of patients with high PD-L1 tumor cell expression levels (50-89% and ≥ 90%).
Trial registration: Clinical Trials.gov NCT03663205.
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来源期刊
Oncology and Therapy
ONCOLOGY-
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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