PMID- 32401634 OWN - NLM STAT- MEDLINE DCOM- 20210302 LR - 20240207 IS - 1527-7755 (Electronic) IS - 0732-183X (Print) IS - 0732-183X (Linking) VI - 38 IP - 27 DP - 2020 Sep 20 TI - Standard-of-Care Axicabtagene Ciloleucel for Relapsed or Refractory Large B-Cell Lymphoma: Results From the US Lymphoma CAR T Consortium. PG - 3119-3128 LID - 10.1200/JCO.19.02104 [doi] AB - PURPOSE: Axicabtagene ciloleucel (axi-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory large B-cell lymphoma (LBCL) on the basis of the single-arm phase II ZUMA-1 trial, which showed best overall and complete response rates in infused patients of 83% and 58%, respectively. We report clinical outcomes with axi-cel in the standard-of-care (SOC) setting for the approved indication. PATIENTS AND METHODS: Data were collected retrospectively from all patients with relapsed/refractory LBCL who underwent leukapheresis as of September 30, 2018, at 17 US institutions with the intent to receive SOC axi-cel. Toxicities were graded and managed according to each institution's guidelines. Responses were assessed as per Lugano 2014 classification. RESULTS: Of 298 patients who underwent leukapheresis, 275 (92%) received axi-cel therapy. Compared with the registrational ZUMA-1 trial, 129 patients (43%) in this SOC study would not have met ZUMA-1 eligibility criteria because of comorbidities at the time of leukapheresis. Among the axi-cel-treated patients, grade >/= 3 cytokine release syndrome and neurotoxicity occurred in 7% and 31%, respectively. Nonrelapse mortality was 4.4%. Best overall and complete response rates in infused patients were 82% (95% CI, 77% to 86%) and 64% (95% CI, 58% to 69%), respectively. At a median follow-up of 12.9 months from the time of CAR T-cell infusion, median progression-free survival was 8.3 months (95% CI, 6.0 to15.1 months), and median overall survival was not reached. Patients with poor Eastern Cooperative Oncology Group performance status of 2-4 and elevated lactate dehydrogenase had shorter progression-free and overall survival on univariable and multivariable analysis. CONCLUSION: The safety and efficacy of axi-cel in the SOC setting in patients with relapsed/refractory LBCL was comparable to the registrational ZUMA-1 trial. FAU - Nastoupil, Loretta J AU - Nastoupil LJ AD - The University of Texas MD Anderson Cancer Center, Houston, TX. FAU - Jain, Michael D AU - Jain MD AD - Moffitt Cancer Center, Tampa, FL. FAU - Feng, Lei AU - Feng L AD - The University of Texas MD Anderson Cancer Center, Houston, TX. FAU - Spiegel, Jay Y AU - Spiegel JY AD - Stanford University Medical Center, Stanford, CA. FAU - Ghobadi, Armin AU - Ghobadi A AD - Washington University School of Medicine and Siteman Cancer Center, St Louis, MO. FAU - Lin, Yi AU - Lin Y AD - Mayo Clinic, Rochester, MN. FAU - Dahiya, Saurabh AU - Dahiya S AD - University of Maryland School of Medicine and Greenebaum Comprehensive Cancer Center, Baltimore, MD. FAU - Lunning, Matthew AU - Lunning M AD - University of Nebraska Medical Center, Omaha, NE. FAU - Lekakis, Lazaros AU - Lekakis L AD - University of Miami Miller School of Medicine, Miami, FL. FAU - Reagan, Patrick AU - Reagan P AD - University of Rochester Medical Center, Rochester, NY. FAU - Oluwole, Olalekan AU - Oluwole O AD - Vanderbilt-Ingram Cancer Center, Nashville, TN. FAU - McGuirk, Joseph AU - McGuirk J AD - University of Kansas Medical Center, Kansas City, KS. FAU - Deol, Abhinav AU - Deol A AD - Karmanos Cancer Institute, Wayne State University, Detroit, MI. FAU - Sehgal, Alison R AU - Sehgal AR AD - UPMC Hillman Cancer Center, Pittsburgh, PA. FAU - Goy, Andre AU - Goy A AD - John Theurer Cancer Center, Hackensack Meridian Health, Hackensack, NJ. FAU - Hill, Brian T AU - Hill BT AD - Cleveland Clinic, Cleveland, OH. FAU - Vu, Khoan AU - Vu K AD - University of California, San Francisco, San Francisco, CA. FAU - Andreadis, Charalambos AU - Andreadis C AD - University of California, San Francisco, San Francisco, CA. FAU - Munoz, Javier AU - Munoz J AD - Banner MD Anderson Cancer Center, Gilbert, AZ. FAU - Westin, Jason AU - Westin J AD - The University of Texas MD Anderson Cancer Center, Houston, TX. FAU - Chavez, Julio C AU - Chavez JC AD - Moffitt Cancer Center, Tampa, FL. FAU - Cashen, Amanda AU - Cashen A AD - Washington University School of Medicine and Siteman Cancer Center, St Louis, MO. FAU - Bennani, N Nora AU - Bennani NN AD - Mayo Clinic, Rochester, MN. FAU - Rapoport, Aaron P AU - Rapoport AP AD - University of Maryland School of Medicine and Greenebaum Comprehensive Cancer Center, Baltimore, MD. FAU - Vose, Julie M AU - Vose JM AD - University of Nebraska Medical Center, Omaha, NE. FAU - Miklos, David B AU - Miklos DB AD - Stanford University Medical Center, Stanford, CA. FAU - Neelapu, Sattva S AU - Neelapu SS AD - The University of Texas MD Anderson Cancer Center, Houston, TX. FAU - Locke, Frederick L AU - Locke FL AD - Moffitt Cancer Center, Tampa, FL. LA - eng GR - K23 CA201594/CA/NCI NIH HHS/United States GR - P30 CA016672/CA/NCI NIH HHS/United States GR - P30 CA076292/CA/NCI NIH HHS/United States PT - Journal Article PT - Research Support, N.I.H., Extramural DEP - 20200513 PL - United States TA - J Clin Oncol JT - Journal of clinical oncology : official journal of the American Society of Clinical Oncology JID - 8309333 RN - 0 (Antigens, CD19) RN - 0 (Biological Products) RN - EC 1.1.1.27 (L-Lactate Dehydrogenase) RN - U2I8T43Y7R (axicabtagene ciloleucel) SB - IM CIN - J Clin Oncol. 2020 Sep 20;38(27):3085-3087. PMID: 32667832 MH - Adult MH - Aged MH - Aged, 80 and over MH - Antigens, CD19/adverse effects/*therapeutic use MH - Biological Products MH - Clinical Trials, Phase II as Topic MH - Comorbidity MH - Cytokine Release Syndrome/etiology MH - Female MH - Humans MH - Immunotherapy, Adoptive/adverse effects MH - L-Lactate Dehydrogenase/blood MH - Leukapheresis MH - Lymphoma, Large B-Cell, Diffuse/*therapy MH - Male MH - Middle Aged MH - Organizational Policy MH - Patient Selection MH - Progression-Free Survival MH - Recurrence MH - Retrospective Studies MH - Severity of Illness Index MH - Standard of Care/standards MH - Survival Rate MH - Young Adult PMC - PMC7499611 EDAT- 2020/05/14 06:00 MHDA- 2021/03/03 06:00 PMCR- 2021/09/20 CRDT- 2020/05/14 06:00 PHST- 2020/05/14 06:00 [pubmed] PHST- 2021/03/03 06:00 [medline] PHST- 2020/05/14 06:00 [entrez] PHST- 2021/09/20 00:00 [pmc-release] AID - 1902104 [pii] AID - 10.1200/JCO.19.02104 [doi] PST - ppublish SO - J Clin Oncol. 2020 Sep 20;38(27):3119-3128. doi: 10.1200/JCO.19.02104. Epub 2020 May 13.