Real-World Evidence of Axicabtagene Ciloleucel for the Treatment of Large B Cell Lymphoma in the United States.

Autor: Jacobson CA; Dana-Farber Cancer Institute, Boston, Massachusetts., Locke FL; H. Lee Moffitt Cancer Center & Research Institute, Tampa, Florida., Ma L; Kite Pharma, a Gilead Company, Santa Monica, California., Asubonteng J; Kite Pharma, a Gilead Company, Santa Monica, California., Hu ZH; Kite Pharma, a Gilead Company, Santa Monica, California., Siddiqi T; City of Hope National Medical Center, Duarte, California., Ahmed S; Department of Lymphoma/Myeloma, The University of Texas MD Anderson Cancer Center, Houston, Texas., Ghobadi A; Washington University School of Medicine, St. Louis, Missouri., Miklos DB; Stanford University School of Medicine, Stanford, California., Lin Y; Division of Hematology, Mayo Clinic, Rochester, Minnesota., Perales MA; Memorial Sloan Kettering Cancer Center, New York, New York., Lunning MA; University of Nebraska Medical Center, Omaha, Nebraska., Herr MM; Roswell Park Comprehensive Cancer Center, Buffalo, New York., Hill BT; Cleveland Clinic Foundation, Cleveland, Ohio., Ganguly S; Houston Methodist Hospital and Cancer Center, Houston, Texas., Dong H; Kite Pharma, a Gilead Company, Santa Monica, California., Nikiforow S; Dana-Farber Cancer Institute, Boston, Massachusetts., Hooper M; Kite Pharma, a Gilead Company, Santa Monica, California., Kawashima J; Kite Pharma, a Gilead Company, Santa Monica, California., Xu H; Kite Pharma, a Gilead Company, Santa Monica, California., Pasquini MC; Medical College of Wisconsin/Center for International Blood and Marrow Transplant Research, Milwaukee, Wisconsin. Electronic address: mpasquini@mcw.edu.
Jazyk: angličtina
Zdroj: Transplantation and cellular therapy [Transplant Cell Ther] 2022 Sep; Vol. 28 (9), pp. 581.e1-581.e8. Date of Electronic Publication: 2022 May 21.
DOI: 10.1016/j.jtct.2022.05.026
Abstrakt: Axicabtagene ciloleucel (axi-cel) is a standard-of-care for patients with relapsed or refractory (r/r) large B cell lymphoma who have received 2 or more lines of prior therapy. Patients receiving axi-cel in the real world could have broader a demographic, disease, and treatment profile compared with that of the cohort in the pivotal ZUMA-1 trial. The present study was conducted to evaluate the outcomes of axi-cel therapy in the real-world setting. A total of 1297 patients receiving commercial axi-cel between 2017 and 2020 were selected from the Center for International Blood and Marrow Transplant Research's data registry, of whom 739 (57%) would have been ineligible for inclusion in the ZUMA-1 cohort. Efficacy and safety outcomes were described for the entire cohort and by ZUMA-1 eligibility. Their associations with age, Eastern Cooperative Oncology Group Performance Score, and comorbidities were evaluated using multivariable logistic and Cox regressions. At a median follow-up of 12.9 months, the overall response rate (ORR) was 73%, with a 56% complete response (CR) rate. Median overall survival (OS) and progression-free survival (PFS) were 21.8 months (95% confidence interval [CI], 17.4 to 28.8 months) and 8.6 months (95% CI, 6.5 to 12.1 months), respectively. Duration of response (DOR) was comparable in the ZUMA-1 ineligible patients and ZUMA-1 eligible patients (62% by 1 year [95% CI, 57% to 66%] versus 67% [95% CI, 62% to 72%]). Patients age ≥65 years had favorable ORR (odds ratio [OR], 1.39; 95% CI, 1.05 to 1.83) despite having a higher risk of cytokine release syndrome (CRS) (OR, 1.41; 95% CI, 1.02 to 1.94) and immune effector cell-associated neurotoxicity syndrome (ICANS) (OR, 1.77; 95% CI, 1.39-2.26). Eastern Cooperative Oncology Group Performance Score ≥2 was associated with inferior efficacy outcomes (OR for ORR, 0.32; 95% CI, 0.18-0.56; hazard ratio [HR] for OS, 3.27; 95% CI, 2.37 to 4.52) and higher incidence of ICANS (OR, 2.63; 95% CI, 1.40 to 4.93). The patients ineligible for ZUMA-1 still had a durable response with axi-cel. Elderly patients had favorable efficacy outcomes despite higher rates of CRS and ICANS. Patient selection for standard-of-care axi-cel should consider comorbidities and risk-to-benefit ratio rather than be based strictly on ZUMA-1 eligibility.
(Copyright © 2022 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights reserved.)
Databáze: MEDLINE
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