Citations

Mayo Clinic

Clear

411 citation(s) found for "Obšil, Tomáš".

Real-world evidence of impact of atrial fibrillation (AF) on clinical and economic outcomes in patients with chronic lymphocytic leukemia (CLL).
Yang, Keri, Liu, Tom, Tang, Boxiong, Chanan‐Khan, Asher

Journal of Clinical Oncology | June 6, 2022 | Volume: 40 | Issue: 16_suppl | Pages: e18729-e18729

10.1200/jco.2022.40.16_suppl.e18729 Get It

e18729 Background: While the incidence of AF in CLL has been increasing, the implications of AF in real-world CLL patients remain understudied. This study aimed to assess the impact of AF on clinical and economic outcomes in CLL patients. Methods: This retrospective observational study used the US IBM MarketScan® commercial claims/Medicare supplement database (2017-2020) to identify newly diagnosed CLL patients (≥18 years) and incidence of AF after index date, defined as the first CLL diagnosis date. Patients were followed for ≥3-months pre-index, and from index to last follow-up or death. In addition to patient characteristics, clinical outcomes (incidence of heart failure [HF], bleeding and stroke) and economic outcomes (costs and healthcare resource utilization [HRU]) were compared between CLL patients with AF (CLL+AF) and CLL patients without AF (CLL-AF). HRU was evaluated by inpatient, outpatient, ER, and pharmacy visits. Multivariable regression analyses were conducted to examine the association between AF and clinical outcomes. Results: Among a total of 16,800 newly diagnosed CLL patients included in the study, 20% developed AF. CLL+AF were significantly older than CLL-AF (median: 77 vs 62 years; P < .001). Compared to CLL-AF, CLL+AF also had significantly more comorbidities at baseline, as shown by higher Charlson comorbidity index (CCI) (median: 1.0 vs 3.0; P < .001) and more patients with previous AF history (0.3% vs 8.4%; P < .001). Further assessing clinical outcomes in CLL+AF vs CLL-AF, significantly higher incidence of HF (26.3% vs 3.0%; P < .001), bleeding (12.2% vs 4.8%; P < .001) and stroke (6.6% vs 1.2%; P < .001) were observed. For HRU, CLL+AF were reported to have significantly higher rates of ER visits (29.4% vs 12.9%; P < .001) and hospitalizations (42.2% vs 14.5%; P < .001) than CLL-AF. In CLL+AF, the average total AF-related costs were $13,520.21 within 30 days after AF diagnosis, and $22,304.82 within 60 days after AF diagnosis. Controlling for demographics and comorbidities, multivariable regressions reported statistically significant associations between AF and HF, as well as AF and stroke (Table). Conclusions: This real-world study reported significantly higher incidence of HF, bleeding and stroke incurred by CLL patients who developed AF compared with those who did not. The presence of HF, bleeding and stroke further increased HRU and costs. These findings highlight the importance of better disease management and treatment selection to prevent AF in CLL patients.[Table: see text]
Development and Early Experience of a Primary Care Learning Collaborative in a Large Health Care System
Erickson, Rodney A. , Chavez, Augustine , Cristiani, Valeria, DeJesus, Ramona S. , Laabs, Susan, Presutti, R. John , Rosas, Steven , Westfall, Erin , Witt, Terrence J. , Erickson, Rodney , Chavez, Augustine S , DeJesus, R S , Presutti, Richard J , Rosas, Steven L , Westfall, Erin , Witt, Terrence , Thacher, Thomas D , Dabrh, Abd Moain Abu , Thacher, Tom D.

Journal of Primary Care & Community Health | May 21, 2022 | Volume: 13 | Issue: No issue available | Pages: No page available

10.1177/21501319221089775 | PMID 35603490 Get It

Introduction: Primary care clinicians are presented with hundreds of new clinical recommendations and guidelines. To consider practice change clinicians must identify relevant information and develop a contextual framework. Too much attention to information irrelevant to one’s practice results in wasted resources. Too little results in care gaps. A small group of primary care clinicians in a large health system sought to address the problem of vetting new information and providing peer reviewed context. This was done by engaging colleagues across the system though a primary care learning collaborative. Methods: The collaborative was a grass roots initiative between community and academic-based clinicians. They invited all the system’s primary care clinicians to participate. They selected new recommendations or guidelines and used surveys as the principal communication instrument. Surveys shared practice experience and also invited members to give narrative feedback regarding their acceptance of variation in care relate to the topic. A description of the collaborative along with its development, processes, and evolution are discussed. Process changes to address needs during the COVID-19 pandemic including expanded information sharing was necessary. Results: Collaborative membership reached across 5 states and included family medicine, internal medicine, and pediatrics. Members found involvement with the collaborative useful. Less variation in care was thought important for public health crises: the COVID pandemic and opioid epidemic. Greater practice variation was thought acceptable for adherence to multispecialty guidelines, such as diabetes, lipid management, and adult ADHD care. Process changes during the pandemic resulted in more communications between members to avoid practice gaps. Conclusion: An internet-based learning collaborative in a health system had good engagement from its members. Using novel methods, it was able to provide members with feedback related to the importance of new practice recommendations as perceived by their peers. Greater standardization was thought necessary when adopting measures to address public health crisis, and less necessary when addressing multispecialty guidelines. By employing a learning collaborative, this group was able to keep members interested and engaged. During the first year of the COVID pandemic the collaborative also served as a vehicle to share timely information.
The Movement Disorder Society Criteria for the Diagnosis of Multiple System Atrophy
Stanković, Iva , Vignatelli, Luca , Fanciulli, Alessandra , Calandra–Buonaura, Giovanna , Seppi, Klaus , Palma, Jose‐Alberto , Meissner, Wassilios G. , Krismer, Florian , Berg, Daniela , Halliday, Glenda M. , Ling, Helen , Low, Phillip A. , Panicker, Jalesh N. , Pellecchia, Maria Teresa , Quinn, Niall , Stamelou, María , Tolosa, Eduardo , Warner, Tom, Stankovic, Iva , Vignatelli, Luca , Fanciulli, Alessandra , Seppi, Klaus , Palma, Jose-Alberto , Meissner, Wassilios G , Krismer, Florian , Cortelli, Pietro , Halliday, Glenda , Höglinger, Günter U , Ling, Helen , Sakakibara, Ryuji , Stamelou, Maria , Kaufmann, Horacio , Pellecchia, Maria Teresa , Wenning, Gregor K. , Cortelli, Pietro , Freeman, Roy L. , Höglinger, Günter U. , Lang, Anthony E. , Litvan, Irene , Miki, Yasuo , Sakakibara, Ryuji , Tsuji, Shoji , Warner, Tom, Poewe, Werner H

Movement Disorders | April 21, 2022 | Volume: 37 | Issue: 6 | Pages: 1131-1148

10.1002/mds.29005 | PMID 35445419 Get It

ABSTRACT Background The second consensus criteria for the diagnosis of multiple system atrophy (MSA) are widely recognized as the reference standard for clinical research, but lack sensitivity to diagnose the disease at early stages. Objective To develop novel Movement Disorder Society (MDS) criteria for MSA diagnosis using an evidence‐based and consensus‐based methodology. Methods We identified shortcomings of the second consensus criteria for MSA diagnosis and conducted a systematic literature review to answer predefined questions on clinical presentation and diagnostic tools relevant for MSA diagnosis. The criteria were developed and later optimized using two Delphi rounds within the MSA Criteria Revision Task Force, a survey for MDS membership, and a virtual Consensus Conference. Results The criteria for neuropathologically established MSA remain unchanged. For a clinical MSA diagnosis a new category of clinically established MSA is introduced, aiming for maximum specificity with acceptable sensitivity. A category of clinically probable MSA is defined to enhance sensitivity while maintaining specificity. A research category of possible prodromal MSA is designed to capture patients in the earliest stages when symptoms and signs are present, but do not meet the threshold for clinically established or clinically probable MSA. Brain magnetic resonance imaging markers suggestive of MSA are required for the diagnosis of clinically established MSA. The number of research biomarkers that support all clinical diagnostic categories will likely grow. Conclusions This set of MDS MSA diagnostic criteria aims at improving the diagnostic accuracy, particularly in early disease stages. It requires validation in a prospective clinical and a clinicopathological study. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society
The effect of primary care clinician type and care team characteristics on health care costs
Bernard, Matthew , Halasy, Michael , Rushlow, David , Sobolik, Gerald J. , Garrison, Gregory M. , Matthews, Marc R. , Allen, Summer V. , Thacher, Tom D. , Bernard, Matthew E , Halasy, Michael P , Rushlow, David R , Thacher, Thomas D , Matthews, Marc R

Journal of Evaluation in Clinical Practice | April 18, 2022 | Volume: 28 | Issue: 6 | Pages: 1055-1060

10.1111/jep.13686 | PMID 35434886 Get It

AbstractObjectiveTo evaluate health care costs as a function of assigned primary care clinician type and care team characteristics.MethodsAdministrative data were collected for 68 family medicine clinicians (40 physicians and 28 nurse practitioners [NPs]/physician assistant [PAs]), on 11 care teams (variable MD, NP and PA on teams), caring for 77,141 patients. We performed a generalized linear mixed multivariable regression model of standardized per member per month (PMPM) median cost as the outcome, with four practice sites included as random effects.ResultsIn bivariate analysis, cost was higher in physicians than NP/PAs, in more complex patients, and associated with emergency department (ED) visit rate. On multivariate analysis, patient complexity, ED visit rate and higher patient experience ratings were independently associated with greater PMPM cost. More time in practice was associated with lower PMPM cost. In the adjusted multivariate model, physicians had 8.3% lower median PMPM costs than NP/PAs (p = 0.046).ConclusionsThe primary drivers of greater PMPM cost were patient complexity, ED visits and patient satisfaction.
Abstract WP160: A Post-Hoc Assessment of Current Hormone Therapy on Revascularization Risk in Women: The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST)
Mackey, Ariane , Lutsep, Helmi L. , Milot, Geneviève , Voeks, Jenifer H. , Hughes, Susan , Tom, MeeLee , Longbottom, Mary, Sheffet, Alice J., Brott, Thomas G. , Howard, Virginia J.

Stroke | March 20, 2022 | Volume: 44 | Issue: suppl_1 | Pages: No page available

10.1161/str.44.suppl_1.awp160 Get It

Background: Hormone replacement therapy (HRT) was among factors considered in a post-hoc assessment of the risk of revascularization by carotid artery stenting (CAS) or carotid endarterectomy (CEA) in women enrolled in CREST. Methods: Of the 872 women in CREST, 775 (89%) were post-menopausal and current HRT status was known in 739 (95%). The study composite outcome was defined as any stroke, myocardial infarction, or death during the periprocedural period, plus ipsilateral stroke over a 4-year follow-up period. Treatment groups were combined and differences in the composite outcome were assessed by current HRT at baseline. Results: There were 77/739 (10%) current HRT users. HRT users were more likely to be symptomatic at baseline than non-users (65% vs. 52%; p = 0.027), and were less likely to be diabetic (19% vs. 32%; p = 0.024). However, they were similar in most other factors including age, race, hypertension, dyslipidemia, smoking status, and length of follow-up (p > 0.10). There were no (0) periprocedural events among the 77 HRT users while there were 43 (6.5%) events among the 662 non-users (p = 0.017). Among those event-free at the end of the periprocedural period, there was little evidence of an impact of baseline HRT on the risk of ipsilateral stroke with 2 (2.6%) post-procedural events among 77 HRT users and 12 (1.9%) among 619 non-users. Conclusion: We found that women on current HRT have lower periprocedural risk associated with CAS or CEA than non-users, but little difference in risk after the procedural period. The mechanism for this unexpected finding is elusive. We urge caution in the interpretation of this post-hoc observation and encourage replication or refutation by other revascularization studies with similar data.
Association of Perinatal Factors With Severe Obesity and Dyslipidemia in Adulthood
Tadese, Kristene , Ernst, Vivian, Weaver, Amy L. , Thacher, Tom D. , Rajjo, Tamim , Kumar, Seema , Kaufman, Tara K. , Lynch, Brian , Kaufman, Tara , Lynch, Brian A , Thacher, Thomas D , Ernst, Vivian, Wi, Chung‐Il

Journal of Primary Care & Community Health | March 6, 2022 | Volume: 13 | Issue: No issue available | Pages: No page available

10.1177/21501327211058982 | PMID 35249418 Get It

Background: Perinatal factors including gestational age, birthweight, size for gestational age, delivery route, maternal parity, maternal age, maternal education, socioeconomic status, race, and sex, are associated with the future risk of obesity and co-morbid conditions. This study evaluated the relationship of birthweight for gestational age and perinatal factors with severe obesity and dyslipidemia in adulthood. Methods: We conducted a population-based, retrospective birth cohort study of infants born to residents of Olmsted County, MN between 1976 and 1982. Outcomes were assessed after age 18 years until October 2020, including severe obesity (BMI ≥ 40 kg/m 2 ) and dyslipidemia (total cholesterol ≥200 mg/dL, non-high density lipoprotein [non-HDL] cholesterol ≥145 mg/dL or HDL cholesterol <40 mg/dL). We obtained mother’s age, education level, and parity as well as newborn sex, race, type of delivery, single/multiple birth, gestational age, and birthweight from birth certificate data. Individual-level socioeconomic status (SES) of the household at birth was determined with the HOUSES index. Results: Of 10 938 birth cohort subjects, 7394 had clinic visits after age 18 years and were included, with 2630 having severe obesity (n = 798) or dyslipidemia (n = 2357) as adults. In multivariable models, female sex, singleton birth, less maternal education, and lower SES defined by HOUSES were independently associated with an increased risk of severe obesity in adulthood. Non-white race, singleton birth, and lower birthweight were independently associated with adult dyslipidemia. Birthweight for gestational age was not associated with severe obesity or dyslipidemia. Conclusion: Perinatal factors were associated with both severe obesity and dyslipidemia in adulthood. Lower SES at birth was predictive of severe obesity in adulthood, highlighting the opportunity to investigate modifiable perinatal social determinants to reduce the risk of severe obesity.
Prospective validation of a new imaging scorecard to assess leptomeningeal metastasis: A joint EORTC BTG and RANO effort
Rhun, Émilie Le , Devos, Patrick , Winklhofer, Sebastian , Lmalem, Hafida, Brandsma, Dieta , Kumthekar, Priya , Castellano, Antonella , Compter, Annette , Dhermain, F., Franceschi, Enrico , Gempt, Jens , Hattingen, Elke , Hempel, Johann, Lukacova, Slávka , Minniti, Giuseppe , O’Brien, Barbara , Postma, Tjeerd J., Roth, Patrick , Schaefer, Niklaus , Thust, Steffi, Bent, Martin J. van den , Hoorn, Anouk van der , Vogin, Guillaume , Smits, Marion , Jaeckle, Kurt A. , Preusser, Matthias , Glantz, Michael , Wen, Patrick Y. , Weller, Michael , Le Rhun, Emilie , Gállego Pérez-Larraya, Jaime , Snijders, Tom J , Smits, Marion , Jaeckle, Kurt A , Preusser, Matthias , Weller, Michael , van den Bent, Martin J , Franceschi, Enrico , Roth, Patrick , Forsyth, Peter A , Furtner, Julia , Galldiks, Norbert , Rudà, Roberta , Schmidt, Nils Ole , Thust, Stefanie Catherine , Tonn, Joerg-Christian , Wen, Patrick Yung , Bendszus, Martin

Neuro-Oncology | February 11, 2022 | Volume: 24 | Issue: 10 | Pages: 1726-1735

10.1093/neuonc/noac043 | PMID 35157772 Get It

Abstract Background Validation of the 2016 RANO MRI scorecard for leptomeningeal metastasis failed for multiple reasons. Accordingly, this joint EORTC Brain Tumor Group and RANO effort sought to prospectively validate a revised MRI scorecard for response assessment in leptomeningeal metastasis. Methods Coded paired cerebrospinal MRI of 20 patients with leptomeningeal metastases from solid cancers at baseline and follow-up after treatment and instructions for assessment were provided via the EORTC imaging platform. The Kappa coefficient was used to evaluate the interobserver pairwise agreement. Results Thirty-five raters participated, including 9 neuroradiologists, 17 neurologists, 4 radiation oncologists, 3 neurosurgeons, and 2 medical oncologists. Among single leptomeningeal metastases-related imaging findings at baseline, the best median concordance was noted for hydrocephalus (Kappa = 0.63), and the worst median concordance for spinal linear enhancing disease (Kappa = 0.46). The median concordance of raters for the overall response assessment was moderate (Kappa = 0.44). Notably, the interobserver agreement for the presence of parenchymal brain metastases at baseline was fair (Kappa = 0.29) and virtually absent for their response to treatment. 394 of 700 ratings (20 patients x 35 raters, 56%) were fully completed. In 308 of 394 fully completed ratings (78%), the overall response assessment perfectly matched the summary interpretation of the single ratings as proposed in the scorecard instructions. Conclusion This study confirms the principle utility of the new scorecard, but also indicates the need for training of MRI assessment with a dedicated reviewer panel in clinical trials. Electronic case report forms with “blocking options” may be required to enforce completeness and quality of scoring.
Evaluating the Evidence in Clinical Studies of Vitamin D in COVID-19
Thacher, Tom D. , Thacher, Thomas D

Nutrients | January 23, 2022 | Volume: 14 | Issue: 3 | Pages: 464

10.3390/nu14030464 | PMID 35276822 Get It

Laboratory evidence provides a biological rationale for the benefits of vitamin D in COVID-19, and vitamin D supplementation is associated with reduced risk of respiratory infections. Most of the clinical studies of vitamin D in COVID-19 have been observational, and the most serious problem with observational study design is that of confounding. Observational studies typically assess the relationship of 25(OH)D values with COVID-19 outcomes. Many conditions associated with low vitamin D status are also associated with worse COVID-19 outcomes. Randomized controlled trials (RCTs) overcome the problem of confounding, typically comparing outcomes between groups receiving vitamin D supplementation or placebo. However, any benefit of vitamin D in COVID-19 may be related to the dose, duration, daily vs. bolus administration, interaction with other treatments, and timing of administration prior to or during the illness. Serum 25(OH)D values >50 nmol/L have been associated with reduced infection rates, severity of COVID-19, and mortality in observational studies. Few RCTs of vitamin D supplementation have been completed, and they have shown no benefit of vitamin D in hospitalized patients. Vitamin D may benefit those with mild or asymptomatic COVID-19, and those with greater 25(OH)D values may have lower risk of acquiring infection. Because those at greatest risk of COVID-19 are also at greatest risk of vitamin D deficiency, it is reasonable to recommend vitamin D supplementation 15–20 mcg (600–800 IU) daily for the general population during the COVID-19 pandemic. Vitamin D doses greater than 100 mcg (4000 IU) daily should not be used without monitoring serum 25(OH)D and calcium.
Acute Treatment Effects on GFR in Randomized Clinical Trials of Kidney Disease Progression
Neuen, Brendon L. , Vonesh, Edward F. , Chaudhari, Juhi, Miao, Shiyuan , Fervenza, Fernando C. , Floege, Jürgen , Goicoechea, Marián , Imai, Enyu , Jafar, Tazeen H. , Lewis, Julia B. , Li, Philip Kam‐Tao , Locatelli, Francesco , Maes, Bart , Praga, Manuel , Woodward, Mark , Xie, Di , Inker, Lesley A. , Floege, Jürgen , Herrington, William G , Li, Philip Kam-Tao , Torres, Vicente E , Wanner, Christoph , Woodward, Mark , Greene, Tom , Fervenza, Fernando C , Tighiouart, Hocine , Heerspink, Hiddo J.L. , Chan, Tak Mao , Perrone, Ronald D. , Perna, Annalisa , Schena, Francesco Paolo , Wetzels, Jack F.M. , Greene, Tom

Journal of the American Society of Nephrology | December 3, 2021 | Volume: 33 | Issue: 2 | Pages: 291-303

10.1681/asn.2021070948 | PMID 34862238 Get It

Background Acute changes in GFR can occur after initiation of interventions targeting progression of CKD. These acute changes complicate the interpretation of long-term treatment effects. Methods To assess the magnitude and consistency of acute effects in randomized clinical trials and explore factors that might affect them, we performed a meta-analysis of 53 randomized clinical trials for CKD progression, enrolling 56,413 participants with at least one estimated GFR measurement by 6 months after randomization. We defined acute treatment effects as the mean difference in GFR slope from baseline to 3 months between randomized groups. We performed univariable and multivariable metaregression to assess the effect of intervention type, disease state, baseline GFR, and albuminuria on the magnitude of acute effects. Results The mean acute effect across all studies was −0.21 ml/min per 1.73 m 2 (95% confidence interval, −0.63 to 0.22) over 3 months, with substantial heterogeneity across interventions (95% coverage interval across studies, −2.50 to +2.08 ml/min per 1.73 m 2 ). We observed negative average acute effects in renin angiotensin system blockade, BP lowering, and sodium-glucose cotransporter 2 inhibitor trials, and positive acute effects in trials of immunosuppressive agents. Larger negative acute effects were observed in trials with a higher mean baseline GFR. Conclusion The magnitude and consistency of acute GFR effects vary across different interventions, and are larger at higher baseline GFR. Understanding the nature and magnitude of acute effects can help inform the optimal design of randomized clinical trials evaluating disease progression in CKD.
Prophylactic Corticosteroid Use with Axicabtagene Ciloleucel (Axi-Cel) in Patients (Pts) with Relapsed/Refractory Large B-Cell Lymphoma (R/R LBCL): One-Year Follow-up of ZUMA-1 Cohort 6 (C6)
Oluwole, Olalekan O. , Forcade, Édouard , Guibert, Sophie de , Deol, Abhinav , McSweeney, Peter A., Kersten, Marie José , Jacobson, Caron A. , Thiéblemont, Catherine , Timmerman, John M. , Stiff, Patrick J. , Tzachanis, Dimitrios , Zheng, Yan, Shen, Rhine R. , Vardhanabhuti, Saran , Oluwole, Olalekan O , Muñoz, Javier , Vose, Julie M. , Bartlett, Nancy L. , Lin, Yi , Goy, Andre Henri , Farooq, Umar , Minnema, Monique C , Avivi, Irit , Kim, Jaeyeon , Meerten, Tom van

Blood | November 23, 2021 | Volume: 138 | Issue: Supplement 1 | Pages: 2832-2832

10.1182/blood-2021-147403 Get It

Abstract Background: ZUMA-1 is the registrational Phase 1/2 study of axi-cel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy, in pts with refractory LBCL. In ZUMA-1 Cohorts 1+2 (C1+2; N=101), rates of Grade (Gr) ≥3 cytokine release syndrome (CRS) and neurologic events (NEs) were 13% and 28%, respectively, at the 6-mo primary analysis; the objective response rate (ORR) was 82% (54% complete response [CR]; Neelapu et al. NEJM. 2017). ZUMA-1 safety management C6 assessed whether prophylactic and earlier corticosteroids and/or tocilizumab could reduce incidence and severity of CRS and NEs. With a median follow-up of 8.9 mo (N=40) for C6, there were no Gr ≥3 CRS, a low rate of Gr ≥3 NEs (13%), and high response rates (Oluwole et al. BJH. 2021). Here, we present a 1-yr updated analysis of C6 supported by propensity score matching (PSM) analysis to compare outcomes for pts in C6 vs C1+2. Methods: Eligible pts could receive optional bridging therapy after leukapheresis. Pts received conditioning chemotherapy for 3 d prior to a single axi-cel infusion. Pts received once-daily oral dexamethasone 10 mg on Days 0 (before axi-cel), 1, and 2; corticosteroids and/or tocilizumab for adverse event (AE) management were given earlier vs C1+2. The primary endpoints were incidence and severity of CRS and NEs. Other endpoints included efficacy outcomes and biomarker analyses. To ensure comparability for pts in C6 and C1+2, an exploratory PSM analysis was performed after balancing for key baseline disease characteristics (tumor burden, IPI score, no. of prior lines of chemotherapy, disease stage, and LDH level). Results: As of December 16, 2020, the median follow-up time was 14.9 mo. Gr ≥3 AEs were reported in all 40 treated pts, and the most common were neutropenia (45%), neutrophil count decreased (33%), and white blood cell count decreased (23%). No Gr ≥3 CRS occurred. Gr ≥3 NEs were reported in 15% of pts. Median time to CRS and NE onset was 5 and 6 d, respectively, after axi-cel infusion. Infections of any grade occurred in 50% of pts (20% Gr ≥3). Since the 6-mo analysis, no new cases of CRS were observed. Four new axi-cel-related NEs occurred in 2 pts (pt 1: Gr 2 mental status changes and seizure-like phenomena both on Day 441; pt 2: Gr 1 dementia [occurred on Day 93 but was reported late] and Gr 5 toxic encephalopathy on Day 369 [resultant from a Gr 4 event that started on Day 351]). Two new infections of Gr 2 pneumonia and Gr 1 bronchitis were observed; the latter was axi-cel-related. One death due to progressive disease occurred. The investigator-assessed ORR was 95% (80% CR). Median DOR, PFS, and OS were not reached. Kaplan-Meier estimates of the 12-mo DOR, PFS, and OS rates were 60%, 63%, and 82%, respectively. At data cutoff, 53% of pts were in ongoing response. Median peak CAR T-cell levels were comparably high in pts with ongoing response and relapse (64 cells/µL [n=21] and 66 cells/µL [n=15], respectively) at 12 mo and considerably lower in nonresponders (18 cells/µL [n=2]). In all, 32 matched pts each in C6 and C1+2 were identified during PSM analysis; 8 pts from C6 were not included due to nonavailability of matched pts in C1+2. No Gr ≥3 CRS was observed in C6 vs 13% of pts in C1+2. Incidence of Gr ≥3 NEs was comparable in C6 and C1+2 (19% and 22%, respectively), with median time to onset of 12 d in C6 vs 7 d in C1+2. The ORR was 94% in both C6 and matched C1+2 (75% and 78% CR rates, respectively); 47% and 59% of pts were in ongoing response at 12 mo. The Kaplan-Meier estimate of the 12-mo PFS rate was 61% in both C6 and matched C1+2. Median peak CAR T-cell levels were 65 and 43 cells/µL, respectively, in C6 and C1+2. Serum levels of inflammatory biomarkers associated with CAR T-cell treatment-related AEs (IFN-γ, IL-2, GM-CSF, and ferritin) were lower in C6 vs C1+2. Median cumulative corticosteroid dose including prophylaxis was 1252 mg in C6 (n=32) and 7418 mg in C1+2 (n=6). Conclusion: With ≥1-y follow-up, prophylactic and earlier corticosteroid and/or tocilizumab intervention continued to demonstrate a manageable safety profile, absence of new safety signals, and high, durable response rates, which was corroborated by PSM analysis. Although fewer pts in C1+2 received corticosteroids after matching, the median cumulative corticosteroid dose was 4-fold lower in C6 vs C1+2. These findings suggest that the C6 AE management strategy can improve long-term safety of axi-cel in R/R LBCL without compromising durability of responses. Disclosures Oluwole: Pfizer: Consultancy; Curio Science: Consultancy; Janssen: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding. Forcade: Jazz: Other: Travel Support, Speakers Bureau; MSD: Other: Travel Support; Gilead: Other: Travel Support, Speakers Bureau; Novartis: Consultancy, Other: Travel Support, Speakers Bureau. Muñoz: Targeted Oncology: Honoraria; Seagen: Consultancy, Honoraria, Speakers Bureau; Physicians' Education Resource: Honoraria; Kyowa Kirin: Consultancy, Honoraria, Speakers Bureau; OncView: Honoraria; Pharmacyclics: Consultancy, Speakers Bureau; Bayer: Consultancy, Speakers Bureau; Kite, a Gilead Company: Consultancy, Speakers Bureau; Pfizer: Consultancy; Janssen: Consultancy, Speakers Bureau; Juno/Celgene: Consultancy; Bristol Myers Squibb: Consultancy; Alexion: Consultancy; BeiGene: Consultancy, Speakers Bureau; Fosunkite: Consultancy; Innovent: Consultancy; Debiopharma: Consultancy; Karyopharm: Consultancy; Genmab: Consultancy; ADC Therapeutics: Consultancy; Epizyme: Consultancy; Servier: Consultancy; Acrotech: Speakers Bureau; Verastem: Speakers Bureau; AstraZeneca: Speakers Bureau; Celgene/Bristol Myers Squibb: Speakers Bureau; Genentech: Speakers Bureau; Aurobindo: Speakers Bureau. de Guibert: Gilead: Consultancy, Honoraria; AbbVie: Consultancy, Honoraria; Janssen: Consultancy, Honoraria. Vose: Kite, a Gilead Company: Honoraria, Research Funding. Bartlett: Roche/Genentech: Consultancy; Seagen: Consultancy, Research Funding; Autolus: Research Funding; Bristol Myers Squibb: Research Funding; Celgene: Research Funding; Forty Seven: Research Funding; Genentech: Research Funding; Janssen: Research Funding; Kite, a Gilead Company: Research Funding; Merck: Research Funding; Millennium: Research Funding; Pharmacyclics: Research Funding; ADC Therapeutics: Consultancy, Research Funding. Lin: Juno: Consultancy; Takeda: Research Funding; Gamida Cell: Consultancy; Vineti: Consultancy; Merck: Research Funding; Sorrento: Consultancy; Legend: Consultancy; Celgene: Consultancy, Research Funding; Novartis: Consultancy; Janssen: Consultancy, Research Funding; Bluebird Bio: Consultancy, Research Funding; Kite, a Gilead Company: Consultancy, Research Funding. Deol: Kite, a Gilead Company: Consultancy. McSweeney: Kite, a Gilead Company: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Research Funding; Autolus: Research Funding; Allovir: Research Funding. Goy: Acerta: Consultancy, Research Funding; AstraZeneca: Membership on an entity's Board of Directors or advisory committees; Xcenda: Consultancy, Honoraria; Vincerx: Honoraria, Membership on an entity's Board of Directors or advisory committees; Elsevier's Practice Update Oncology, Intellisphere, LLC(Targeted Oncology): Consultancy; MorphoSys: Honoraria, Other; Janssen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Novartis: Consultancy, Honoraria; Bristol Meyers Squibb: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees; AbbVie/Pharmacyclics: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; LLC(Targeted Oncology): Consultancy; Kite Pharma: Membership on an entity's Board of Directors or advisory committees; OncLive Peer Exchange: Honoraria; Rosewell Park: Consultancy; Genomic Testing Cooperative: Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Other: Leadership role; COTA (Cancer Outcome Tracking Analysis): Current holder of stock options in a privately-held company, Membership on an entity's Board of Directors or advisory committees, Other: Leadership role; Celgene: Consultancy, Honoraria, Research Funding; Xcenda: Consultancy; Gilead: Membership on an entity's Board of Directors or advisory committees; Michael J Hennessey Associates INC: Consultancy; Bristol Meyers Squibb: Membership on an entity's Board of Directors or advisory committees; Medscape: Consultancy; AbbVie/Pharmacyclics: Membership on an entity's Board of Directors or advisory committees; Hoffman la Roche: Consultancy; Infinity/Verastem: Research Funding; Genentech/Hoffman la Roche: Research Funding; Physicians' Education Resource: Consultancy, Other: Meeting/travel support; Janssen: Membership on an entity's Board of Directors or advisory committees; Vincerx pharma: Membership on an entity's Board of Directors or advisory committees; Incyte: Honoraria; AstraZeneca: Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Kite, a Gilead Company: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Research Funding; Elsevier PracticeUpdate: Oncology: Consultancy, Honoraria; Janssen: Research Funding; Karyopharm: Research Funding; Phamacyclics: Research Funding; Constellation: Research Funding; Hackensack Meridian Health, Regional Cancer Care Associates/OMI: Current Employment. Kersten: Miltenyi Biotec: Consultancy, Honoraria, Other: Travel support; Roche: Consultancy, Honoraria, Other: Travel support, Research Funding; BMS/Celgene: Consultancy, Honoraria; Takeda: Research Funding; Celgene: Research Funding; Kite, a Gilead Company: Consultancy, Honoraria, Other: Travel support, Research Funding; Novartis: Consultancy, Honoraria, Other: Travel support. Jacobson: Nkarta: Consultancy, Honoraria; Novartis Pharmaceuticals Corporation: Consultancy, Honoraria, Other: Travel support; Humanigen: Consultancy, Honoraria, Other: Travel support; Lonza: Consultancy, Honoraria, Other: Travel support; AbbVie: Consultancy, Honoraria; Pfizer: Consultancy, Honoraria, Other: Travel support, Research Funding; Precision Biosciences: Consultancy, Honoraria, Other: Travel support; Kite, a Gilead Company: Consultancy, Honoraria, Other: Travel support; Celgene: Consultancy, Honoraria, Other: Travel support; Axis: Speakers Bureau; Clinical Care Options: Speakers Bureau. Farooq: Kite, a Gilead Company: Honoraria. Minnema: Cilag: Consultancy; BMS: Consultancy; Janssen: Consultancy; Celgene: Other: Travel expenses; Kite/Gilead: Consultancy; Alnylam: Consultancy. Thieblemont: Bristol Myers Squibb/Celgene: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses ; Kyte: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses ; Takeda: Honoraria, Membership on an entity's Board of Directors or advisory committees; Janssen: Honoraria, Membership on an entity's Board of Directors or advisory committees; Novartis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses ; Roche: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses , Research Funding; Gilead Sciences: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses ; Incyte: Honoraria, Membership on an entity's Board of Directors or advisory committees; Abbvie: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses ; Cellectis: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses ; Hospira: Research Funding; Bayer: Honoraria; Amgen: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees, Other: Travel, Accommodations, Expenses . Timmerman: Spectrum Pharmaceuticals: Research Funding; Bristol Myers Squibb: Research Funding; Kite, a Gilead Company: Consultancy, Research Funding; Bluebird Bio: Current equity holder in publicly-traded company; TG Therapeutics: Current equity holder in publicly-traded company; Marker Therapeutics: Current equity holder in publicly-traded company; Corvus: Current equity holder in publicly-traded company; Genmab: Current equity holder in publicly-traded company; Merck: Research Funding. Stiff: Macrogenics: Research Funding; Amgen: Research Funding; Kite, a Gilead Company: Research Funding; Seagen: Research Funding; Gamida Cell: Research Funding; Janssen: Research Funding; CRISPR Therapeutics: Consultancy, Honoraria; Karyopharm: Consultancy, Honoraria; Cellectar: Research Funding; Bristol Myers Squibb: Research Funding; Incyte: Research Funding; BioLineRX: Research Funding; Cellectar: Research Funding; MorphoSys: Consultancy, Honoraria; Actinium: Research Funding. Avivi: Novartis: Speakers Bureau; Kite, a Gilead Company: Speakers Bureau. Tzachanis: Fate Therapeutics: Research Funding; Incyte: Research Funding; Genentech: Research Funding; Bristol Myers Squibb: Research Funding; Magenta: Consultancy; Kyowa Kirin: Consultancy; Kite, a Gilead Company: Consultancy, Research Funding, Speakers Bureau; EUSA: Consultancy; Takeda: Consultancy, Speakers Bureau; Partner: Consultancy. Kim: Kite, a Gilead Company: Current Employment; Gilead Sciences: Current equity holder in publicly-traded company. Zheng: Kite, a Gilead Company: Current Employment; Gilead Sciences: Current equity holder in publicly-traded company. Shen: Gilead Sciences: Current equity holder in publicly-traded company; Atara: Current Employment, Current equity holder in publicly-traded company, Other: Leadership role, Patents & Royalties; Kite, a Gilead Company: Current Employment, Other: Leadership role, Patents & Royalties. Vardhanabhuti: Kite, a Gilead Company: Current Employment, Other: Travel support, Research Funding; Gilead Sciences: Current equity holder in publicly-traded company. Van Meerten: Kite, a Gilead Company: Honoraria; Janssen: Consultancy.