Axicabtagene Ciloleucel in the Non-Trial Setting: Outcomes and Correlates of Response, Resistance, and Toxicity
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- Caron A. Jacobson
- Dana-Farber Cancer Institute, Boston, MA
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- Bradley D. Hunter
- Dana-Farber Cancer Institute, Boston, MA
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- Robert Redd
- Dana-Farber Cancer Institute, Boston, MA
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- Scott J. Rodig
- Brigham and Women’s Hospital, Boston, MA
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- Pei-Hsuan Chen
- Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, MA
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- Kyle Wright
- Brigham and Women’s Hospital, Boston, MA
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- Mikel Lipschitz
- Center for Immuno-Oncology, Dana-Farber Cancer Institute, Boston, MA
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- Jerome Ritz
- Dana-Farber Cancer Institute, Boston, MA
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- Yusuke Kamihara
- Dana-Farber Cancer Institute, Boston, MA
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- Philippe Armand
- Dana-Farber Cancer Institute, Boston, MA
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- Sarah Nikiforow
- Dana-Farber Cancer Institute, Boston, MA
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- Michael Rogalski
- Dana-Farber Cancer Institute, Boston, MA
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- Joseph Maakaron
- Ohio State University, Columbus, OH
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- Samantha Jaglowski
- Ohio State University, Columbus, OH
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- Marcela V. Maus
- Massachusetts General Hospital Cancer Center, Boston, MA
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- Yi-Bin Chen
- Massachusetts General Hospital Cancer Center, Boston, MA
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- Jeremy S. Abramson
- Massachusetts General Hospital Cancer Center, Boston, MA
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- Justin Kline
- University of Chicago, Chicago, IL
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- Elizabeth Budde
- City of Hope Cancer Center, Duarte, CA
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- Alex Herrera
- City of Hope Cancer Center, Duarte, CA
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- Matthew Mei
- City of Hope Cancer Center, Duarte, CA
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- Jonathon B. Cohen
- Emory University-Winship Cancer Institute, Atlanta, GA
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- Stephen D. Smith
- University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Alliance, Seattle, WA
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- David G. Maloney
- University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Alliance, Seattle, WA
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- Ajay K. Gopal
- University of Washington/Fred Hutchinson Cancer Research Center/Seattle Cancer Alliance, Seattle, WA
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- Matthew J. Frigault
- Massachusetts General Hospital Cancer Center, Boston, MA
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- Utkarsh H. Acharya
- Dana-Farber Cancer Institute, Boston, MA
抄録
<jats:sec><jats:title>PURPOSE</jats:title><jats:p> Axicabtagene ciloleucel (axi-cel) was approved by the Food and Drug Administration for relapsed aggressive B-cell non-Hodgkin lymphoma in part on the basis of durable remission rates of approximately 40% in a clinical trial population. Whether this efficacy, and the rates of toxicity, would be consistent in a postcommercial setting, with relaxed eligibility criteria and bridging therapy, is unknown. This study describes the efficacy and safety correlates and outcomes in this setting. </jats:p></jats:sec><jats:sec><jats:title>PATIENTS AND METHODS</jats:title><jats:p> One hundred twenty-two patients from 7 medical centers in the United States were treated with axi-cel and were included in a modified intent-to-treat (mITT) analysis. Seventy-six patients (62%) were ineligible for the ZUMA-1 trial. Response and toxicity rates, duration of response (DOR), survival, and covariates are described on the basis of the mITT population. Correlative studies on blood and tumor samples were performed to investigate potential biomarkers of response and resistance. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Median follow-up was 10.4 months. In the mITT population, the best overall and complete response (CR) rates were 70% and 50%, respectively. Median DOR and progression-free survival (PFS) were 11.0 and 4.5 months in all patients and were not reached (NR) in CR patients. Median overall survival (OS) was NR; 1-year OS was 67% (95% CI, 59% to 77%). Although response rates were similar in the ZUMA-1–eligible and ZUMA-1–ineligible groups (70% v 68%), there was a statistically significant improvement in CR rate (63% v 42%, P = .016), DOR (median, NR v 5.0 months; P = .014), PFS (median, NR v 3.3 months; P = .020), and OS (1-year OS, 89% v 54%; P < .001) in patients who were ZUMA-1 eligible. Rates of grade ≥ 3 cytokine release syndrome and neurotoxicty were 16% and 35%, respectively. </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Axi-cel yields similar rates of overall response and toxicity in commercial and trial settings, although CR rates and DOR were more favorable in patients eligible for ZUMA-1. </jats:p></jats:sec>
収録刊行物
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- Journal of Clinical Oncology
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Journal of Clinical Oncology 38 (27), 3095-3106, 2020-09-20
American Society of Clinical Oncology (ASCO)