Survival with Axicabtagene Ciloleucel in Large B-Cell Lymphoma

被引:183
|
作者
Westin, Jason R. [1 ]
Oluwole, Olalekan O. [2 ]
Kersten, Marie Jose [3 ]
Miklos, David B. [6 ]
Perales, Miguel-Angel [8 ]
Ghobadi, Armin [10 ]
Rapoport, Aaron P. [11 ]
Sureda, Anna [12 ]
Jacobson, Caron A. [13 ]
Farooq, Umar [14 ]
van Meerten, Tom [4 ]
Ulrickson, Matthew [15 ]
Elsawy, Mahmoud [16 ,17 ]
Leslie, Lori A. [19 ]
Chaganti, Sridhar [20 ]
Dickinson, Michael [21 ,22 ]
Dorritie, Kathleen [23 ]
Reagan, Patrick M. [9 ]
McGuirk, Joseph [24 ]
Song, Kevin W. [18 ]
Riedell, Peter A. [25 ]
Minnema, Monique C. [5 ]
Yang, Yin [7 ]
Vardhanabhuti, Saran [7 ]
Filosto, Simone [7 ]
Cheng, Paul [7 ]
Shahani, Shilpa A. [7 ]
Schupp, Marco [7 ]
To, Christina [7 ]
Locke, Frederick L. [26 ]
机构
[1] Univ Texas MD Anderson Canc Ctr, Houston, TX USA
[2] Vanderbilt Ingram Canc Ctr, Nashville, TN USA
[3] Univ Amsterdam, Amsterdam Univ Med Ctr UMC, Canc Ctr Amsterdam, Amsterdam, Netherlands
[4] Univ Med Ctr Groningen, Groningen, Netherlands
[5] UMC Utrecht, Utrecht, Netherlands
[6] Stanford Univ, Sch Med, Stanford, CA USA
[7] Kite, Santa Monica, CA USA
[8] Mem Sloan Kettering Canc Ctr, New York, NY USA
[9] Univ Rochester, Sch Med, Rochester, NY USA
[10] Washington Univ, Sch Med, St Louis, MO USA
[11] Univ Maryland, Marlene & Stewart Greenebaum Canc Ctr, Sch Med, Baltimore, MD USA
[12] Univ Barcelona, Inst Catala Oncol Hosp, Inst Recerca Biomed Bellvitge, Serv Hematol Clin, Barcelona, Spain
[13] Dana Farber Canc Inst, Boston, MA USA
[14] Univ Iowa, Iowa, IA USA
[15] Banner MD Anderson Canc Ctr, Gilbert, AZ USA
[16] Dalhousie Univ, Dept Med, Div Hematol & Hematol Oncol, Halifax, NS, Canada
[17] Queen Elizabeth 2 Hlth Sci Ctr, Halifax, NS, Canada
[18] Univ British Columbia, Vancouver Gen Hosp, BC Canc, Vancouver, BC, Canada
[19] John Theurer Canc Ctr, Hackensack, NJ USA
[20] Univ Hosp Birmingham NHS Fdn Trust, Ctr Clin Haematol, Birmingham, W Midlands, England
[21] Royal Melbourne Hosp, Peter MacCallum Canc Ctr, Melbourne, Vic, Australia
[22] Univ Melbourne, Melbourne, Vic, Australia
[23] Univ Pittsburgh, UPMC Hillman Canc Ctr, Pittsburgh, PA USA
[24] Univ Kansas, Ctr Canc, Kansas City, KS USA
[25] Univ Chicago, David & Etta Jonas Ctr Cellular Therapy, Chicago, IL USA
[26] H Lee Moffitt Canc Ctr & Res Inst, Tampa, FL USA
来源
NEW ENGLAND JOURNAL OF MEDICINE | 2023年 / 389卷 / 02期
关键词
SALVAGE REGIMENS; CHEMOIMMUNOTHERAPY; TRANSPLANTATION; OUTCOMES;
D O I
10.1056/NEJMoa2301665
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
BackgroundIn an analysis of the primary outcome of this phase 3 trial, patients with early relapsed or refractory large B-cell lymphoma who received axicabtagene ciloleucel (axi-cel), an autologous anti-CD19 chimeric antigen receptor T-cell therapy, as second-line treatment had significantly longer event-free survival than those who received standard care. Data were needed on longer-term outcomes.MethodsIn this trial, we randomly assigned patients with early relapsed or refractory large B-cell lymphoma in a 1:1 ratio to receive either axi-cel or standard care (two to three cycles of chemoimmunotherapy followed by high-dose chemotherapy with autologous stem-cell transplantation in patients who had a response). The primary outcome was event-free survival, and key secondary outcomes were response and overall survival. Here, we report the results of the prespecified overall survival analysis at 5 years after the first patient underwent randomization.ResultsA total of 359 patients underwent randomization to receive axi-cel (180 patients) or standard care (179 patients). At a median follow-up of 47.2 months, death had been reported in 82 patients in the axi-cel group and in 95 patients in the standard-care group. The median overall survival was not reached in the axi-cel group and was 31.1 months in the standard-care group; the estimated 4-year overall survival was 54.6% and 46.0%, respectively (hazard ratio for death, 0.73; 95% confidence interval [CI], 0.54 to 0.98; P=0.03 by stratified two-sided log-rank test). This increased survival with axi-cel was observed in the intention-to-treat population, which included 74% of patients with primary refractory disease and other high-risk features. The median investigator-assessed progression-free survival was 14.7 months in the axi-cel group and 3.7 months in the standard-care group, with estimated 4-year percentages of 41.8% and 24.4%, respectively (hazard ratio, 0.51; 95% CI, 0.38 to 0.67). No new treatment-related deaths had occurred since the primary analysis of event-free survival.ConclusionsAt a median follow-up of 47.2 months, axi-cel as second-line treatment for patients with early relapsed or refractory large B-cell lymphoma resulted in significantly longer overall survival than standard care. (Funded by Kite; ZUMA-7 ClinicalTrials.gov number, .)
引用
收藏
页码:148 / 157
页数:10
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