Journal of Clinical Oncology最新文献

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The Art of the Art of Oncology. 肿瘤学艺术的艺术。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-14 DOI: 10.1200/JCO-25-01205
Mikkael A Sekeres, Gregory A Abel, Timothy Gilligan, Stephanie L Graff, Gregory P Kalemkerian, David N Korones, Alison W Loren, Catriona McNeil, Jamie Cathleen Riches
{"title":"The Art of the Art of Oncology.","authors":"Mikkael A Sekeres, Gregory A Abel, Timothy Gilligan, Stephanie L Graff, Gregory P Kalemkerian, David N Korones, Alison W Loren, Catriona McNeil, Jamie Cathleen Riches","doi":"10.1200/JCO-25-01205","DOIUrl":"https://doi.org/10.1200/JCO-25-01205","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2501205"},"PeriodicalIF":42.1,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Erratum: Hematopoietic Stem Cell Transplantation Outcomes for High-Risk AML: A Report From the Children's Oncology Group. 来自儿童肿瘤组的一份报告:高危AML的造血干细胞移植结果。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-14 DOI: 10.1200/JCO-25-01516
Benjamin J Huang, Lauren K Meyer, Todd A Alonzo, Yi-Cheng Wang, Adam J Lamble, Rhonda E Ries, Weijie Wang, Betsy Hirsch, Gordana Raca, Xiaotu Ma, Alan S Gamis, Richard Aplenc, E Anders Kolb, Todd M Cooper, Katherine Tarlock, Michael R Loken, Soheil Meshinchi, Joseph H Chewning, William G Woods, John T Horan
{"title":"Erratum: Hematopoietic Stem Cell Transplantation Outcomes for High-Risk AML: A Report From the Children's Oncology Group.","authors":"Benjamin J Huang, Lauren K Meyer, Todd A Alonzo, Yi-Cheng Wang, Adam J Lamble, Rhonda E Ries, Weijie Wang, Betsy Hirsch, Gordana Raca, Xiaotu Ma, Alan S Gamis, Richard Aplenc, E Anders Kolb, Todd M Cooper, Katherine Tarlock, Michael R Loken, Soheil Meshinchi, Joseph H Chewning, William G Woods, John T Horan","doi":"10.1200/JCO-25-01516","DOIUrl":"https://doi.org/10.1200/JCO-25-01516","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2501516"},"PeriodicalIF":42.1,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Diabetes and Colorectal Cancer Risk and Survival According to Tumor Immunity Status. 肿瘤免疫状态对糖尿病和结直肠癌风险及生存的影响。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-14 DOI: 10.1200/JCO-25-00148
Durgesh Wankhede, Niels Halama, Matthias Kloor, Hermann Brenner, Michael Hoffmeister
{"title":"Diabetes and Colorectal Cancer Risk and Survival According to Tumor Immunity Status.","authors":"Durgesh Wankhede, Niels Halama, Matthias Kloor, Hermann Brenner, Michael Hoffmeister","doi":"10.1200/JCO-25-00148","DOIUrl":"https://doi.org/10.1200/JCO-25-00148","url":null,"abstract":"<p><strong>Purpose: </strong>Type 2 diabetes (T2D) has been associated with an increased risk of colorectal cancer (CRC) and poorer survival outcomes. However, the role of tumor immune status in influencing these relationships remains unclear.</p><p><strong>Methods: </strong>We conducted a population-based matched case-control study (n = 4,724) with prospective long-term follow-up of CRC cases (n = 2,321; median follow-up, 9.5 years). Tumor immune status was assessed using an immune cell score (ICS), derived from CD3<sup>+</sup> and CD8<sup>+</sup> T-cell densities measured at the invasive margin and tumor core of resected specimens. ICS was stratified into high (ICS<sup>Hi</sup>), intermediate (ICS<sup>Int</sup>), and low (ICS<sup>Low</sup>) immune infiltration on the basis of standard cutoffs (25% and 70%). Multivariable logistic regression estimated CRC risk, whereas time-dependent Cox regression evaluated survival outcomes. Primary end points included CRC-specific survival and disease-free survival (DFS).</p><p><strong>Results: </strong>The association between T2D and CRC risk differed significantly by ICS (<i>P</i> for heterogeneity = .02). T2D was associated with an increased risk of CRC (odds ratio [OR], 1.39 [95% CI, 1.17 to 1.66]), particularly for ICS<sup>Low</sup> (OR, 1.80 [95% CI, 1.35 to 2.39]) and ICS<sup>Int</sup> subtypes (OR, 1.42 [95% CI, 1.17 to 1.66]), but not for ICS<sup>Hi</sup> CRC subtype (OR, 1.16 [95% CI, 0.88 to 1.52]). Patients with T2D with ICS<sup>Low</sup> tumors showed poorer CRC-specific survival (hazard ratio [HR], 1.99 [95% CI, 1.30 to 3.05]) and DFS (HR, 1.53 [95% CI, 1.05 to 2.26]) than those without T2D, but not for ICS<sup>Int</sup> and ICS<sup>Hi</sup> CRC subtypes. Patients with T2D showed inferior overall and non-cancer-related survival regardless of immune subtypes.</p><p><strong>Conclusion: </strong>T2D disproportionately affects CRC risk and survival in tumors with low immune infiltration, suggesting a continuum of T2D's impact from tumorigenesis to prognosis, through systemic and tumor-specific immune modulation. These findings highlight the need for precision prevention strategies integrating metabolic and immune-based interventions to mitigate CRC burden in patients with T2D.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"JCO2500148"},"PeriodicalIF":42.1,"publicationDate":"2025-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144637171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Use of Low-Value Cancer Treatments in Medicare Advantage Versus Traditional Medicare. 低价值癌症治疗在医疗保险优势与传统医疗保险中的应用。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-10 Epub Date: 2025-05-31 DOI: 10.1200/JCO-24-01907
Jeah Jung, Caroline Carlin, Roger Feldman, Ge Song, Aaron Mitchell
{"title":"Use of Low-Value Cancer Treatments in Medicare Advantage Versus Traditional Medicare.","authors":"Jeah Jung, Caroline Carlin, Roger Feldman, Ge Song, Aaron Mitchell","doi":"10.1200/JCO-24-01907","DOIUrl":"10.1200/JCO-24-01907","url":null,"abstract":"<p><strong>Purpose: </strong>Medicare Advantage (MA) provides beneficiaries an option to receive Medicare benefits from private plans. Although MA covers over half of the Medicare population, limited information exists about how utilization of cancer treatments in MA differs from traditional Medicare (TM). We compared use of low-value cancer treatments between MA and TM and analyzed variation in use of low-value cancer treatments across large MA insurers.</p><p><strong>Methods: </strong>Using national Medicare data, we performed retrospective analyses of beneficiaries who had a new cancer diagnosis between 2016 and 2021 and who were at risk of receiving a low-value treatment: granulocyte-colony stimulating factors (GCSFs) for patients receiving low-risk chemotherapy, denosumab for castration-sensitive prostate cancer (CSPC), nab-paclitaxel instead of paclitaxel for breast or lung cancers, adding bevacizumab to carboplatin plus paclitaxel for ovarian cancer, and branded drugs or biologics for which generic or biosimilar versions existed.</p><p><strong>Results: </strong>Use of any low-value cancer treatment was 1.7 percentage points lower in MA than in TM (34.2% <i>v</i> 35.9%; <i>P</i> < .001). MA had lower utilization rates than TM for GCSF among patients receiving low-risk chemotherapy (7.3% <i>v</i> 8.9%; <i>P</i> < .001), denosumab for CSPC (26.4% <i>v</i> 33.1%; <i>P</i> < .001), nab-paclitaxel for breast or lung cancer (7.9% <i>v</i> 8.7%; <i>P</i> < .001), addition of bevacizumab for ovarian cancer (8.3% <i>v</i> 10.5%; <i>P</i> < .001), and biologics with biosimilar alternatives (66.8% <i>v</i> 68.5%; <i>P</i> < .001). Use of branded drugs did not significantly differ between MA and TM. The differences in use of low-value cancer treatments from TM varied moderately across large MA insurers.</p><p><strong>Conclusion: </strong>MA has lower use of low-value cancer treatments than TM, with varying degrees across large MA insurers. Efforts are needed to identify effective strategies to reduce use of low-value cancer treatments.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2245-2254"},"PeriodicalIF":42.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12234249/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144191862","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
A Whipple of Choice. 惠普尔的选择。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-10 Epub Date: 2025-05-27 DOI: 10.1200/JCO-25-00413
C W Forsberg
{"title":"A Whipple of Choice.","authors":"C W Forsberg","doi":"10.1200/JCO-25-00413","DOIUrl":"10.1200/JCO-25-00413","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2335-2337"},"PeriodicalIF":42.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144159347","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
BMT-CARE App: A Randomized Controlled Trial of a Psychosocial Digital Application for Caregivers of Patients Undergoing Hematopoietic Stem-Cell Transplantation. BMT-CARE应用程序:一项针对造血干细胞移植患者护理人员的社会心理数字应用程序的随机对照试验。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-10 Epub Date: 2025-05-30 DOI: 10.1200/JCO-25-00713
Jamie M Jacobs, Lara Traeger, Madison Freese, Anna Barata, Richard Newcomb, Dustin Rabideau, Nora Horick, Zachariah DeFilipp, Yi-Bin Chen, Tamryn Gray, Julia Pepper, Ella Caruso, Hermioni L Amonoo, Stephanie J Lee, Joseph A Greer, Jennifer S Temel, Areej El-Jawahri
{"title":"BMT-CARE App: A Randomized Controlled Trial of a Psychosocial Digital Application for Caregivers of Patients Undergoing Hematopoietic Stem-Cell Transplantation.","authors":"Jamie M Jacobs, Lara Traeger, Madison Freese, Anna Barata, Richard Newcomb, Dustin Rabideau, Nora Horick, Zachariah DeFilipp, Yi-Bin Chen, Tamryn Gray, Julia Pepper, Ella Caruso, Hermioni L Amonoo, Stephanie J Lee, Joseph A Greer, Jennifer S Temel, Areej El-Jawahri","doi":"10.1200/JCO-25-00713","DOIUrl":"10.1200/JCO-25-00713","url":null,"abstract":"<p><strong>Purpose: </strong>Family and friend caregivers of patients undergoing hematopoietic stem-cell transplantation (HSCT) struggle with immense caregiving burden, leading to substantial quality of life (QOL) impairments and psychological distress. Yet, interventions to address caregivers' needs are limited.</p><p><strong>Materials and methods: </strong>We conducted a randomized controlled trial of a psychosocial digital application (BMT-CARE App) versus usual care for adult caregivers of patients with hematologic malignancies undergoing HSCT. The BMT-CARE App included five modules combining psychoeducation and evidence-based behavior change strategies. Participants completed self-report measures at baseline and day 60 post-HSCT. The primary end point was QOL at day 60 assessed by the CareGiver Oncology QOL (CarGOQOL) measure. We also assessed caregiving burden (Caregiver Reaction Assessment), anxiety and depression symptoms (Hospital Anxiety and Depression Scale), and post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist [PCL-5]). We used analysis of covariance adjusting for baseline scores to assess the effect of the intervention on study outcomes.</p><p><strong>Results: </strong>Between February 2023 and July 2024, we enrolled 125 of 174 approached caregivers (71.8%). Participants assigned to the BMT-CARE App used the app for a median of 146.9 minutes (range, 0-384.8). At day 60, BMT-CARE App caregivers reported clinically and significantly better QOL than those assigned to usual care (adjusted means = 76.3 <i>v</i> 69.9, <i>P</i> = .006). BMT-CARE App participants also reported significantly lower caregiving burden (11.2 <i>v</i> 12.3, <i>P</i> = .023), depression (3.8 <i>v</i> 5.6, <i>P</i> = .002), and PTSD symptoms (26.1 <i>v</i> 31.3, <i>P</i> = .012). The groups did not differ significantly in anxiety symptoms at day 60.</p><p><strong>Conclusion: </strong>The BMT-CARE App led to significantly improved QOL, caregiving burden, depression, and PTSD symptoms among HSCT caregivers. This intervention should be tested in a multicenter study with a diverse HSCT caregiver population to determine generalizability and scalability.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2265-2275"},"PeriodicalIF":42.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144187123","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Mantle Cell Lymphoma: Optimal Treatment With Bruton Tyrosine Kinase-Targeted Approaches. 套细胞淋巴瘤:布鲁顿酪氨酸激酶靶向方法的最佳治疗。
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-10 Epub Date: 2025-05-29 DOI: 10.1200/JCO-25-00146
Toby A Eyre, Chan Y Cheah, Clémentine Sarkozy, Anita Kumar, Steven Le Gouill
{"title":"Mantle Cell Lymphoma: Optimal Treatment With Bruton Tyrosine Kinase-Targeted Approaches.","authors":"Toby A Eyre, Chan Y Cheah, Clémentine Sarkozy, Anita Kumar, Steven Le Gouill","doi":"10.1200/JCO-25-00146","DOIUrl":"10.1200/JCO-25-00146","url":null,"abstract":"<p><p>Mantle cell lymphoma (MCL) represents a relatively uncommon, heterogeneous lymphoma associated with limited overall survival. Targeting of the B-cell receptor pathway in relapsed disease with covalent Bruton tyrosine kinase (cBTK) inhibition has been demonstrated to be highly effective with cBTK inhibitor monotherapy, an established standard of care in relapsed MCL. This review summarizes the recent data strongly suggesting a role for the integration of covalent BTK inhibition in the first-line treatment setting, after the recent presentation and publication of multiple phase II and randomized phase II/III clinical trials demonstrating benefit for the addition of cBTK inhibitors first line. The authors discuss herein the strength and quality of the evidence for therapeutic strategies integrating cBTK inhibitors first line and proposal treatment algorithms on the basis of assumed future availability of this highly active small molecules first line in the near future.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2300-2310"},"PeriodicalIF":42.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144181179","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Retraction: Phase 1 Clinical Trial of EpCAM CAR-T Cell Therapy in Patients With Gastrointestinal Cancers. 撤回:EpCAM CAR-T细胞治疗胃肠道癌症患者的一期临床试验
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-10 Epub Date: 2025-06-02 DOI: 10.1200/JCO-25-01268
{"title":"Retraction: Phase 1 Clinical Trial of EpCAM CAR-T Cell Therapy in Patients With Gastrointestinal Cancers.","authors":"","doi":"10.1200/JCO-25-01268","DOIUrl":"10.1200/JCO-25-01268","url":null,"abstract":"","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2338"},"PeriodicalIF":42.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144199182","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Updated Overall Survival and Long-Term Safety With Ripretinib Versus Sunitinib in Patients With GI Stromal Tumor: Final Overall Survival Analysis From INTRIGUE. 利普雷替尼与舒尼替尼在胃肠道间质瘤患者中的最新总生存期和长期安全性:最终的总生存期分析
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-10 Epub Date: 2025-05-23 DOI: 10.1200/JCO-24-02818
Michael C Heinrich, Jean-Yves Blay, Hans Gelderblom, Suzanne George, Patrick Schöffski, Margaret von Mehren, John R Zalcberg, Robin L Jones, Yoon-Koo Kang, Albiruni Abdul Razak, Jonathan Trent, Steven Attia, Axel Le Cesne, Kjetil Boye, David Goldstein, César Sánchez, Brittany L Siontis, Paulina Cox, Erika Davis, Matthew L Sherman, Rodrigo Ruiz-Soto, Sebastian Bauer
{"title":"Updated Overall Survival and Long-Term Safety With Ripretinib Versus Sunitinib in Patients With GI Stromal Tumor: Final Overall Survival Analysis From INTRIGUE.","authors":"Michael C Heinrich, Jean-Yves Blay, Hans Gelderblom, Suzanne George, Patrick Schöffski, Margaret von Mehren, John R Zalcberg, Robin L Jones, Yoon-Koo Kang, Albiruni Abdul Razak, Jonathan Trent, Steven Attia, Axel Le Cesne, Kjetil Boye, David Goldstein, César Sánchez, Brittany L Siontis, Paulina Cox, Erika Davis, Matthew L Sherman, Rodrigo Ruiz-Soto, Sebastian Bauer","doi":"10.1200/JCO-24-02818","DOIUrl":"10.1200/JCO-24-02818","url":null,"abstract":"<p><p>In the INTRIGUE phase III trial (ClinicalTrials.gov identifier: NCT03673501), adult patients with advanced gastrointestinal stromal tumor previously treated with imatinib were randomly assigned 1:1 to ripretinib 150 mg once daily or sunitinib 50 mg once daily (4 weeks on/2 weeks off). In the primary analysis, overall survival (OS) was immature. In this study, we report the final planned analysis of OS (key secondary end point), progression-free survival (PFS) on third-line therapy (second PFS; prespecified exploratory end point), and long-term safety. Final OS analysis was prespecified to occur with approximately 200 and ≥145 events in the overall and <i>KIT</i> exon 11 intention-to-treat (ITT) populations, respectively. As of March 15, 2023, there were 211 and 151 OS events in the overall ITT and <i>KIT</i> exon 11 ITT populations, respectively. Median OS was similar between second-line ripretinib and sunitinib in both populations (overall, 35.5 <i>v</i> 31.5 months; <i>KIT</i> exon 11, 35.5 <i>v</i> 32.8 months). Median second PFS (on third-line therapy) for the overall ITT population was similar between the ripretinib and sunitinib arms (7.7 <i>v</i> 7.4 months). Safety was consistent with the primary analysis. OS from this analysis was similar between arms, and second PFS suggests that receiving ripretinib did not adversely affect the PFS of third-line therapy.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2239-2244"},"PeriodicalIF":42.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12225728/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144132447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Phase I/II Study of Adaptive Manufactured Lentiviral Anti-CD20/Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed, Refractory Mantle Cell Lymphoma. 适应性制造慢病毒抗cd20 /抗cd19嵌合抗原受体T细胞治疗复发、难治性套细胞淋巴瘤的I/II期研究
IF 42.1 1区 医学
Journal of Clinical Oncology Pub Date : 2025-07-10 Epub Date: 2025-03-31 DOI: 10.1200/JCO-24-02158
Nirav N Shah, Alfredo S Colina, Bryon D Johnson, Aniko Szabo, Fateeha Furqan, Tyce Kearl, Dina Schneider, Marlenny Vargas-Cortes, Jessica L Schmeling, Michael B Dwinell, Katie Palen, Walter Longo, Peiman Hematti, Anthony E Zamora, Parameswaran Hari, Daniel Bucklan, Ashley Cunningham, Mehdi Hamadani, Timothy S Fenske
{"title":"Phase I/II Study of Adaptive Manufactured Lentiviral Anti-CD20/Anti-CD19 Chimeric Antigen Receptor T Cells for Relapsed, Refractory Mantle Cell Lymphoma.","authors":"Nirav N Shah, Alfredo S Colina, Bryon D Johnson, Aniko Szabo, Fateeha Furqan, Tyce Kearl, Dina Schneider, Marlenny Vargas-Cortes, Jessica L Schmeling, Michael B Dwinell, Katie Palen, Walter Longo, Peiman Hematti, Anthony E Zamora, Parameswaran Hari, Daniel Bucklan, Ashley Cunningham, Mehdi Hamadani, Timothy S Fenske","doi":"10.1200/JCO-24-02158","DOIUrl":"10.1200/JCO-24-02158","url":null,"abstract":"<p><strong>Purpose: </strong>Mantle cell lymphoma (MCL) is an aggressive B-cell malignancy characterized by t(11;14) and bright CD20 expression. To improve outcomes from single targeted CD19 chimeric antigen receptor (CAR) T cells, we used dual targeted lentiviral anti-CD20/anti-CD19 (LV20.19) CAR T cells as part of a phase I/II clinical trial in relapsed, refractory (R/R) MCL (ClinicalTrials.gov identifier: NCT04186520).</p><p><strong>Methods: </strong>Patients with MCL who had failed two lines of therapy or relapsed post-transplant were eligible. LV20.19 CAR T cells were manufactured on-site via CliniMACS Prodigy using an adaptive 8- to 12-day process to optimize the final CAR product for increased numbers of naïve and stem-cell memory (SCM) like T cells.</p><p><strong>Results: </strong>Seventeen patients with R/R MCL received a single dose of LV20.19 CAR T cells at 2.5 × 10<sup>6</sup> cells/kg (phase I = three patients; phase II = 14 patients). The best overall response rate (ORR) was 100% (complete response [CR] = 88%; partial response = 12%) and the phase II efficacy threshold for day-90 CR rate was exceeded. Two patients have relapsed as of the data cutoff and neither the median progression-free survival nor overall survival has been reached with a median follow-up of 15.8 months. Ninety-four percent (n = 16) experienced cytokine release syndrome, all grade 1-2. Eighteen percent (n = 3) had immune effector cell-associated neurotoxicity syndrome in the first 28-days, two with reversible grade 3 toxicity. Three patients had nonrelapse mortality events; all occurred in the setting of ongoing B-cell aplasia. The final LV20.19 CAR products were enriched for higher percentages of T-<sub>SCM</sub>/T-naïve cells and most patients received CAR T cells within 8 days of apheresis.</p><p><strong>Conclusion: </strong>In conclusion, we demonstrate that on-site adaptive manufactured LV20.19 CAR T cells are feasible, safe, and efficacious for R/R MCL with best ORR of 100%, a favorable safety profile, and few relapses to date.</p>","PeriodicalId":15384,"journal":{"name":"Journal of Clinical Oncology","volume":" ","pages":"2285-2295"},"PeriodicalIF":42.1,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143752957","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
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