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Pola-R-CHP或R-CHOEP用于高危弥漫性大B细胞淋巴瘤年轻患者的一线治疗:两项随机3期试验的回顾性比较

Pola-R-CHP or R-CHOEP for first-line therapy of younger patients with high-risk diffuse large B-cell lymphoma: a retrospective comparison of two randomized phase 3 trials

Nature 等信源发布 2024-09-25 04:03

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To the Editor:Since development of R-CHOP for newly diagnosed diffuse large B-cell lymphoma (DLBCL) [1, 2], many attempts have been made to improve first-line therapy including studies which changed the timing/dosing of rituximab [3,4,5], substituted obinutuzumab for rituximab [6], added etoposide to CHOP in R-CHOEP [7], or changed to infusional regimens like dose-adjusted EPOCH-R [8].

致编辑:自R-CHOP用于新诊断的弥漫性大B细胞淋巴瘤(DLBCL)以来,已经进行了许多尝试来改善一线治疗,包括改变利妥昔单抗(3,4,5)的时间/剂量的研究,用奥比妥珠单抗替代利妥昔单抗(6),在R-CHOEP(7)中加入依托泊苷到CHOP中,或改为输注方案,如剂量调整的EPOCH-R(8)。

While many studies combined targeted drugs with R-CHOP [9,10,11], Pola-R-CHP was the first to significantly improve progression-free survival (PFS) in patients with DLBCL aged 18–80 with an International Prognostic Index (IPI) 2–5. While overall survival (OS) was not significantly different, the reduction in relapses led to adoption of Pola-R-CHP as the new standard in many countries [12].

虽然许多研究将靶向药物与R-CHOP[9,10,11]相结合,但Pola-R-CHP是第一个显着改善18-80岁DLBCL患者无进展生存期(PFS)的国际预后指数(IPI)2-5。虽然总生存率(OS)没有显着差异,但复发率的降低导致许多国家采用Pola-R-CHP作为新标准(12)。

However, gaps in knowledge remain, in particular for younger, high-risk patients with DLBCL where R-CHOEP is a common regimen in Germany and the Scandinavian countries [13,14,15]. This study compares Pola-R-CHP and R-CHOEP using individual patient data from respective phase 3 studies.MethodsStudy design, patient eligibility, randomization, endpoints, and statistical analyses of the two prospective, randomized phase 3 studies R-MegaCHOEP and POLARIX have been reported previously [7, 12].

然而,知识差距仍然存在,特别是对于年轻的高危DLBCL患者,其中R-CHOEP是德国和斯堪的纳维亚国家的常见方案[13,14,15]。这项研究使用来自各自3期研究的个体患者数据比较了Pola-R-CHP和R-CHOEP。方法先前已经报道了两项前瞻性随机3期研究R-MegaCHOEP和POLARIX的研究设计,患者资格,随机化,终点和统计分析[7,12]。

POLARIX was an international, double-blind, placebo-controlled study, whereas R-MegaCHOEP was an open label study performed in Germany. Full inclusion and exclusion criteria of both studies were published previously [7, 12].The current analysis compared outcomes of younger DLBCL patients (18–60 years) with age adjusted IPI (aaIPI) 2 or 3 treated with R-CHOEP on the R-MegaCHOEP study and patients treated with Pola-R-CHP on the POLARIX study.

POLARIX是一项国际双盲安慰剂对照研究,而R-MegaCHOEP是在德国进行的开放标签研究。这两项研究的完全纳入和排除标准先前已发表[7,12]。目前的分析比较了在R-MegaCHOEP研究中使用R-CHOEP治疗的年龄调整后IPI(aaIPI)2或3的年轻DLBCL患者(18-60岁)和在POLARIX研究中使用Pola-R-CHP治疗的患者的结果。

Protocol details are provided in Supplementary Data.The current analysis limited .

补充数据中提供了协议详细信息。目前的分析有限。

Data availability

数据可用性

Data availability statement: For eligible studies, qualified researchers may request access to individual patient-level clinical data through the clinical study data request platform. At the time of writing this request, the platform is Vivli (https://vivli.org/ourmember/roche/). For up-to-date details on Roche’s Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here: https://go.roche.com/data_sharing.

数据可用性声明:对于符合条件的研究,合格的研究人员可以通过临床研究数据请求平台请求访问个别患者级别的临床数据。在撰写此请求时,平台是Vivli(https://vivli.org/ourmember/roche/)。https://go.roche.com/data_sharing.

Anonymized records for individual patients across more than one data source external to Roche cannot, and should not, be linked due to a potential increase in risk of patient re-identification..

由于患者重新识别风险的潜在增加,罗氏外部多个数据源中个别患者的匿名记录不能也不应该链接。。

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Download referencesAcknowledgementsThe POLARIX study (NCT03274492) was sponsored by F. Hoffmann-La Roche Ltd and Genentech, Inc. Third-party editorial assistance, under the direction of the authors, was provided by Rachel Bell, PhD, of Ashfield MedComms, an Inizio company, and was funded by F.

下载参考文献致谢POLARIX研究(NCT03274492)由F.Hoffmann La Roche Ltd和Genentech,Inc.赞助。在作者的指导下,第三方编辑协助由Inizio公司Ashfield MedComms的Rachel Bell博士提供,并由F。

Hoffmann-La Roche Ltd.FundingOpen Access funding enabled and organized by Projekt DEAL.Author informationAuthors and AffiliationsMedical Department A, University Hospital Münster, Münster, GermanyGeorg Lenz, Fabian Frontzek & Norbert SchmitzCentre Henri-Becquerel and University of Rouen, Rouen, FranceHervé TillyInstitute for Medical Informatics, Statistics and Epidemiology, University Leipzig, Leipzig, GermanyMarita Ziepert & Bettina AltmannUniversity of Montpellier, Montpellier, FranceCharles HerbauxOnkologie Lerchenfeld, Hamburg, GermanyMaike NickelsenGenentech Inc., South San Francisco, CA, USACalvin Lee, Jamie Hirata & Connie Lee BatleviF.

霍夫曼·拉罗氏有限公司(HoffmannLaRocheLtd.FundingOpen Access funding)由Projekt DEAL启用和组织。。

Hoffmann-La Roche Ltd, Basel, SwitzerlandDeniz SahinHoffmann-La Roche Ltd, Mississauga, ON, CanadaSaibah Chohan & Mark YanUniversity of Lille, Centre Hospitalier Universitaire, Lille, FranceFranck MorschhauserAuthorsGeorg LenzView author publicationsYou can also search for this author in.

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PubMed Google ScholarContributionsGL, CL, JH and NS conceived the study design; MZ, BA, CL, JH, DS, SC, CLB and MY performed data analysis; MZ, BA, DS, SC, and MY curated the data; GL, CL, JH, DS, SC, CLB, MY and NS wrote the original draft of the manuscript; all authors reviewed and edited the subsequent manuscript drafts.Corresponding authorCorrespondence to.

PubMed Google ScholarContributionsGL,CL,JH和NS构思了研究设计;MZ,BA,CL,JH,DS,SC,CLB和MY进行了数据分析;MZ,BA,DS,SC和MY策划了数据;GL,CL,JH,DS,SC,CLB,MY和NS撰写了手稿的原稿;所有作者都审查并编辑了随后的手稿草稿。对应作者对应。

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Competing interests

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GL received research grants not related to this manuscript from AGIOS, AQUINOX, AstraZeneca, Bayer, Celgene, Gilead, Janssen, MorphoSys, Novartis, F. Hoffmann-La Roche Ltd, and Verastem. GL received honoraria from ADC Therapeutics, AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, BMS, Celgene, Constellation, Genase, Genmab, Gilead, Hexal/Sandoz, Immagene, Incyte, Janssen, Karyopharm, Lilly, Miltenyi, MorphoSys, MSD, NanoString, Novartis, PentixaPharm, Pierre Fabre, F.

GL从AGIOS,AQUINOX,AstraZeneca,Bayer,Celgene,Gilead,Janssen,MorphoSys,Novartis,F.Hoffmann-La Roche Ltd和Verastem获得了与本手稿无关的研究资助。GL获得了ADC Therapeutics,AbbVie,Amgen,AstraZeneca,Bayer,BeiGene,BMS,Celgene,Constellation,Enase,Genmab,Gilead,Hexal/Sandoz,Immagene,Incyte,Janssen,Karyopharm,Lilly,Miltenyi,MorphoSys,MSD,NanoString,Novartis,PentixaPharm,Pierre Fabre,F。

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Reprints and permissionsAbout this articleCite this articleLenz, G., Tilly, H., Ziepert, M. et al. Pola-R-CHP or R-CHOEP for first-line therapy of younger patients with high-risk diffuse large B-cell lymphoma: a retrospective comparison of two randomized phase 3 trials.

转载和许可本文引用本文Lenz,G.,Tilly,H.,Ziepert,M。等人Pola-R-CHP或R-CHOEP用于高危弥漫性大B细胞淋巴瘤年轻患者的一线治疗:两项随机3期试验的回顾性比较。

Leukemia (2024). https://doi.org/10.1038/s41375-024-02420-6Download citationReceived: 15 May 2024Revised: 18 September 2024Accepted: 19 September 2024Published: 25 September 2024DOI: https://doi.org/10.1038/s41375-024-02420-6Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

白血病(2024)。https://doi.org/10.1038/s41375-024-02420-6Download引文收到日期:2024年5月15日修订日期:2024年9月18日接受日期:2024年9月19日发布日期:2024年9月25日OI:https://doi.org/10.1038/s41375-024-02420-6Share本文与您共享以下链接的任何人都可以阅读此内容:获取可共享链接对不起,本文目前没有可共享的链接。复制到剪贴板。

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