The rationale for this project arises from some considerations. Clinical trials often use surrogate endpoints (response rates) rather than direct measurement of benefit (survivals) as primary objective of the study. When both are considered, in clinical studies focusing on CAR T therapy in Hematology they are often estimated starting from infusion (analysis per protocol [PP]) and not from leukapheresis (analysis per intention-to-treat [ITT]) or in a modified ITT modality, i.e.

这个项目的理由来自一些考虑。临床试验通常使用替代终点（缓解率）而不是直接测量益处（生存率）作为研究的主要目标。当两者都被考虑时，在专注于血液学CAR T治疗的临床研究中，它们通常是从输注（按照方案[PP]进行分析）开始估计的，而不是从白细胞分离术（按照意向治疗[ITT]进行分析）或以改良的ITT方式估计的，即。

counting only patients who achieved the infusion timepoint [1,2,3,4].Studies on CAR T-cell therapy lend to possible biases when they do not consider patients who undergo leukapheresis but finally are not infused for a variety of competing risks (e.g., time of leukapheresis and enrollment, use of bridging therapy [BT], lymphodepleting regimens and, and in the near future, autologous versus allogeneic products, different standard of care clinical practice or patient populations).

仅计算达到输注时间点的患者[1,2,3,4]。。

This makes difficult to perform a robust comparison of both the different available CAR T products and the drugs which share the same indication. Starting from these premises, real-world studies and national registries could be useful tools in determining a true PP versus ITT analysis as a mirror of the real benefit and feasibility of CAR T therapy if it is considered a therapeutic path, including competitive risks.

这使得很难对不同的可用CAR T产品和具有相同适应症的药物进行强有力的比较。从这些前提出发，如果将CAR T治疗视为包括竞争风险在内的治疗途径，那么现实世界的研究和国家登记册可能是确定真正的PP与ITT分析的有用工具，可以反映CAR T治疗的真正益处和可行性。

As a consequence, to test our thesis, we conceived a project to provide a comprehensive overview of the benefits of CAR T-cell therapy in patients with relapsed/refractory (r/r) large B-cell lymphomas (LBCL) in the real-world setting recomputing results in both PP and ITT basis to show that both modalities bring useful information, and to propose a new CAR T analysis specific endpoint with a dedicated event-free.

因此，为了测试我们的论文，我们构思了一个项目，以全面概述CAR T细胞治疗对复发/难治性（r/r）大B细胞淋巴瘤（LBCL）患者在现实世界中的益处。在PP和ITT的基础上重新计算结果，以表明这两种方式都带来了有用的信息，并提出了一个新的CAR T分析特定终点，具有专用的无事件。

Data availability

数据可用性

The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request.

本研究中使用和/或分析的数据集可根据合理要求从通讯作者处获得。

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Download referencesAcknowledgementsFunding was provided by Alma Mater Studiorum - University of Bologna (ID grant: ALMA IDEA 2022 CUP:J33C22001420001). We thank Massimo Agostini for data entry and AIL Bologna OdV (prot 2CSAIL21 Argnani).Author informationAuthors and AffiliationsDepartment of Medical and Surgical Sciences, University of Bologna, Bologna, ItalyRossana Di Staso, Riccardo Masetti, Alessandro Broccoli, Pier Luigi Zinzani & Lisa ArgnaniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Istituto di Ematologia “Seràgnoli”, Bologna, ItalyBeatrice Casadei, Alessandro Broccoli & Pier Luigi ZinzaniMoffitt Cancer Center, Tampa, FL, USAFrederick L.

下载参考文献致谢资金由博洛尼亚大学母校研究所提供（ID资助：Alma IDEA 2022 CUP:J33C22001420001）。我们感谢Massimo Agostini的数据输入和AIL Bologna OdV（prot 2CSAIL21 Argnani）。作者信息作者和附属机构博洛尼亚大学医学与外科科学系，博洛尼亚，意大利罗萨纳·迪斯塔索，里卡多·马塞蒂，亚历山德罗·西兰花，皮尔·路易吉·津扎尼和丽莎·阿格纳尼RCCS Azienda Ospedaliero Universitaria Di Bologna，Istituto Di Ematologia“Seràgnoli”，博洛尼亚，意大利比阿特丽斯·卡萨迪，亚历山德罗·西兰花和皮尔·路易吉·津扎尼·莫菲特癌症中心，坦帕，佛罗里达州，美国弗雷德里克·L。

Locke & Michael JainDivision of Hematology, The Ohio State University, Columbus, OH, USATimothy J. Voorhees & Adam S. KittaiInstituto de Investigación Sanitaria Gregorio Marañón, Hospital General Universitario Gregorio Marañón, Madrid, SpainMariana Bastos-OreiroUnit of Lymphoma. Department of Hematology.

Locke&Michael Jaindivision of Heology，俄亥俄州立大学，哥伦布，俄亥俄州，Usatimothy J.Voorhees&Adam S.Kittai健康研究所Gregorio Marañon，Gregorio Marañon大学总医院，马德里，西班牙巴斯托斯-奥雷鲁尼特淋巴瘤。血液学系。

Son Espases University Hospital (IdISBa), Palma de Mallorca, SpainAntonio GutiérrezDepartment of Hematology, Hospital Universitario de Salamanca, IBSAL, CIBERONC, Salamanca, Spain; University of Salamanca, Salamanca, SpainAlejandro Martin Garcia-SanchoServicio de Hematología y Oncología Médica, Hospital Clinico Universitario de Valencia, Valencia, SpainMaria Jose TerolDepartment of Medicine/Division of Hematology and Oncology, UCLA Medical Center, Santa Monica, CA, USAMonica MeadDepartment of Medicine/Division of Hematology and Oncology, UCLA Medical Center, Los Angeles, CA, USAMichael J.

西班牙大学医院（IDISBA）、帕尔马·德·马洛卡、西班牙人托尼奥·古铁雷斯、萨拉曼卡大学医院血液学系、伊布萨尔、西伯隆克、萨拉曼卡、西班牙；萨拉曼卡大学，萨拉曼卡，Spainalejandro Martin Garcia-Sanchoservicio de血液学和医学肿瘤学，瓦伦西亚大学临床医院，瓦伦西亚，西班牙Jose Teroldepartment of Medicine/血液和肿瘤科，加州大学洛杉矶分校医学中心/血液和肿瘤科，加州大学洛杉矶分校医学中心，加州大学洛杉矶分校，美国迈克尔J。

MaranzanoDepartment of Hematology, University Hospital Vall d’Hebron, Barcelona, SpainGloria Iacoboni & Pere BarbaUniversitat Autònoma de Barcelona, Bellaterra, SpainGloria Iacoboni & Pere BarbaDepartment of Hematology, H.

巴塞罗纳瓦尔德希布伦大学医院马兰扎诺血液学系，巴塞罗纳，斯宾格洛里亚·艾科博尼和佩雷·巴巴巴拉大学，巴塞罗那，贝拉特拉，斯宾格洛里亚·艾科博尼和佩雷·巴巴拉血液学系，H。

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PubMed Google ScholarContributionsLA conceived and designed the study, wrote the paper and performed the analyses as principal biostatistician, collected the data, provided study materials, interpreted final results and approved the final manuscript. RM designed the study, edited the paper draft interpreted final results and approved the final manuscript.

PubMed Google ScholarContributionsLA构思并设计了这项研究，撰写了论文，并作为首席生物统计学家进行了分析，收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。RM设计了这项研究，编辑了论文草稿，解释了最终结果，并批准了最终稿件。

DG designed the study and edited the paper draft. RDS performed the analysis, wrote the paper, interpreted final results and approved the final manuscript. BC collected the data, provided study materials, interpreted final results and approved the final manuscript. FLL collected the data, provided study materials, interpreted final results and approved the final manuscript.

DG设计了这项研究并编辑了论文草稿。RDS进行了分析，撰写了论文，解释了最终结果并批准了最终手稿。。FLL收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。

MJ collected the data, provided study materials, interpreted final results and approved the final manuscript. TJV collected the data, provided study materials, interpreted final results and approved the final manuscript. ASK collected the data, provided study materials, interpreted final results and approved the final manuscript.

MJ收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。TJV收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。ASK收集了数据，提供了研究材料，解释了最终结果并批准了最终稿件。

MB collected the data, provided study materials, interpreted final results and approved the final manuscript. AG collected the data, provided study materials, interpreted final results and approved the final manuscript. AMG collected the data, provided study materials, interpreted final results and approved the final manuscript.

MB收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。AG收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。AMG收集数据，提供研究材料，解释最终结果并批准最终手稿。

MJT collected the data, provided study materials, interpreted final results and approved the final manuscript. MM collected the data, provided study materials, interpreted final results and approved the final manuscript. MJM collected the data, provided study materials, interpreted final results and approved the final manuscript.

MJT收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。MM收集了数据，提供了研究材料，解释了最终结果并批准了最终手稿。MJM收集数据，提供研究材料，解释最终结果并批准最终手稿。

GI collected the data, provided study material.

GI收集了数据，提供了研究材料。

Lisa Argnani.Ethics declarations

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Competing interests

相互竞争的利益

GI served as consultant and received honoraria from Novartis, Roche, Kite/Gilead, Bristol-Myers Squibb, Abbvie, Janssen, Sandoz, Miltenyi, AstraZeneca. PB as consultant and received honoraria from Allogene, Amgen, Autolus, BMS/Celgene, Kite/Gilead, Incyte, Miltenyi Biomedicine, Novartis, Nektar, Pfizer, Pierre Fabre.

GI担任顾问，并获得了诺华，罗氏，凯特/吉利德，百时美施贵宝，艾伯维，詹森，桑多兹，米尔滕尼，阿斯利康的酬金。PB担任顾问，并获得了Allogene，Amgen，Autolus，BMS/Celgene，Kite/Gilead，Incyte，Miltenyi Biomedicine，Novartis，Nektar，Pfizer，Pierre Fabre的酬金。

JLR served as consultant and received honoraria from Johnson&Johnson, Kite/Gilead, Novartis, BMS and Sanofi. RH served as consultant and received honoraria from Kite/Gilead, Novartis, Incyte, Janssen, MSD, Takeda, Roche, Bristol-Myers Squibb/Celgene, ADC Therapeutics, Incyte, Miltenyi. AMG served as consultant and received honoraria from Roche, BMS, Takeda, Janssen, Kyowa Kirin, Gilead/Kite, Incyte, Lilly, Miltenyi, Ideogen, Genmab, AbbVie, Sobi, AstraZeneca, GSK.

捷豹路虎担任顾问，并从强生、基特/吉利德、诺华、BMS和赛诺菲获得酬金。RH担任顾问，并从Kite/Gilead，Novartis，Incyte，Janssen，MSD，Takeda，Roche，Bristol-Myers Squibb/Celgene，ADC Therapeutics，Incyte，Miltenyi获得酬金。AMG担任顾问，并从罗氏（Roche）、BMS、武田（Takeda）、杨森（Janssen）、协和麒麟（Kyowa Kirin）、吉利德（Gilead）/凯特（Kite）、英杰（Incyte）、礼来（Lilly）、米尔滕尼（Miltenyi）、艾迪根（Ideogen）、根玛（Genmab）、艾伯维（AbbVie）、索比（Sobi）、阿斯。

MBO served as consultant and received honoraria from Roche, BMS, Novartis, Janssen, Kyowa Kirin, Gilead/Kite, Incyte, Lilly, Genmab, AbbVie, Sobi, AstraZeneca. The remaining authors declare no competing interests..

MBO担任顾问，并从罗氏（Roche）、BMS、诺华（Novartis）、杨森（Janssen）、协和麒麟（Kyowa Kirin）、吉利德（Gilead）/凯特（Kite）、英杰（Incyte）、礼来（Lilly）、Genmab、艾伯维（AbbVie）、索比（Sobi）、阿斯利康（AstraZeneca）获得酬金。。。

Ethics approval and consent to participate

道德批准和同意参与

Formal ethical approval was not needed as this is a secondary research and patient have already signed written informed consent for each study analyzed in the present manuscript.

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Reprints and permissionsAbout this articleCite this articleDi Staso, R., Casadei, B., Locke, F.L. et al. Is CAR T a drug or a therapeutic pathway? Intention to treat versus per protocol analysis of real world studies of CAR-T cell therapy in relapsed refractory diffuse large B cell lymphoma.

转载和许可本文引用本文Di Staso，R.，Casadei，B.，Locke，F.L。等人。CAR T是药物还是治疗途径？。

Blood Cancer J. 14, 197 (2024). https://doi.org/10.1038/s41408-024-01183-8Download citationReceived: 30 July 2024Revised: 23 October 2024Accepted: 29 October 2024Published: 07 November 2024DOI: https://doi.org/10.1038/s41408-024-01183-8Share 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.

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