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Impact of geographic distance from transplant center on the risk of severe graft-versus-host disease after allogeneic hematopoietic cell transplantation.
Adhikari, Aakriti , Bansal, Vasu , Saha, Souvik , Mahadevia, Himil, Cossor, Furha, Mahadevia, Himil , Cossor, Furha

Mayo Clinic

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e23055 Get It

e23055 Background: Geographic distance to care has been associated with outcomes in solid tumors, reflecting differences in access, follow-up, and supportive care. However, its relationship with biologic transplant toxicities such as graft-versus-host disease (GVHD) has not been well characterized. Understanding whether access-related factors are associated with immune-mediated complications is important for systems-level optimization of post-transplant care and survivorship. Methods: We conducted a retrospective cohort study of adult patients undergoing allogeneic hematopoietic cell transplantation using the CIBMTR hs1802 publicly available dataset. Distance from patient residence to the transplant center was categorized as less than 20 miles, 20 to 50 miles, 50 to 150 miles, and greater than 150 miles, with less than 20 miles as the reference group. Primary outcomes were acute GVHD and chronic GVHD within one year after transplantation. Secondary outcomes included overall survival. Multivariable Cox proportional hazards models were used to evaluate associations between distance and outcomes, adjusting for age, sex, race and ethnicity, HCT comorbidity index, conditioning intensity, donor type, GVHD prophylaxis, transplant era, disease type, and total body irradiation use. Results: A total of 5,473 patients were included, with a median follow-up of 60.2 months. Crude rates of acute GVHD increased with greater distance from the transplant center, occurring in 40.2 percent of patients living less than 20 miles away and 45.1 percent of those living more than 150 miles away. In adjusted analyses, residence more than 150 miles from the transplant center was associated with a higher risk of acute GVHD compared with less than 20 miles, with an adjusted hazard ratio of 1.15 and a 95 percent confidence interval of 1.00 to 1.31. No significant differences were observed for intermediate distance categories. For chronic GVHD within one year, patients living more than 150 miles away had a lower recorded risk compared with those living less than 20 miles away, with an adjusted hazard ratio of 0.79 and a 95 percent confidence interval of 0.71 to 0.88. Distance to transplant center was not significantly associated with overall survival. Conclusions: Greater geographic distance from transplant centers is associated with a higher risk of severe GVHD after allo-HCT. These findings suggest that access to specialized post-transplant care and close monitoring may influence immune-mediated outcomes. Strategies to improve follow-up care, including enhanced care coordination and telemedicine, may help mitigate GVHD-related disparities and inform health policy efforts aimed at improving access to specialized transplant services, reimbursement for remote monitoring, and regional models of post-transplant care delivery.
Differential clinical and economic signatures of CAR T-cell therapy in multiple myeloma across demographic and payer strata: A national analysis.
Modi, Karnav , Mahadevia, Himil, Arya, Yajur , Syal, Arshi , Adhikari, Aakriti , Vodnala, Deepthi, Khumri, Taiyeb, Cossor, Furha, Mahadevia, Himil , Khumri, Taiyeb

Mayo Clinic

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e19537 Get It

e19537 Background: Chimeric antigen receptor (CAR) T cell therapy is a paradigm shifting modality for relapsed/refractory multiple myeloma (MM). Yet national scale delineation of immune effector toxicities, cardiopulmonary and renal sequelae, and economic burden across demographic and payer strata has not been adequately characterized. Methods: The National Inpatient Sample (2018–2022) was queried to identify adult MM hospitalizations receiving CAR T through ICD-10-PCS codes. Cytokine release syndrome (CRS) [all grades - 2021–2022], immune effector cell–associated neurotoxicity syndrome (ICANS) [all grades – 2022], cardiac events and infections were identified through ICD-10 codes. Age was stratified into 21-40, 41-60, 61-80, >81 years. Payer groups were Medicare, Medicaid, Private and Uninsured. Races were White, African American, Hispanic and others [Pacific Islanders, Native Indians, Asians]. Chi-square analysis was performed and multivariate regression adjusted for demographics, comorbidities and hospital characteristics. Results: Across >7,000 weighted hospitalizations, mortality, any grade CRS and ICANS were statistically similar across age, race, and payer (p>0.05). However, CRS was numerically higher in Hispanic patients (78.6%) than in White (63.2%), African American (68.1%), and other minor races (60.0%) (p=0.339). ICANS grade 4 was numerically higher in Hispanic (5.3%) versus White (0.8%) (p=0.278). Mortality was numerically highest in other minor races (9.5%) versus White (3.6%), Hispanic (2.8%), and African American (0.0%) (p=0.179). Age-stratified analyses showed significant heterogeneity in arrhythmias (22.2% [21–40 years] to 28.6% [≥81 years]; p=0.021), attenuating after adjustment. By race, arrhythmias ranged from 8.3% (Hispanic) to 25.0% (White) (p=0.113). Other cardiac events including myocardial infarction, stroke and cardiogenic shock were similar across groups. Payer stratified pneumonia varied (p=0.010) with uninsured 23.8% versus Private 5.1%, Medicare 7.3%, and Medicaid 6.4%, without persistence in adjusted models. Sepsis and septic shock rates showed no differences. Hispanic patients had higher adjusted costs versus White (Odds ratio [OR] 1.3, 1.04–1.7; p=0.023). Age-stratified costs differed (p=0.032), with elevated cost in ≥81 years (USD 394,617) versus 21–40 (USD 229,862), 41–60 (USD 214,974), and 61–80 (USD 269,844) but it was not significant in adjusted analysis. Conclusions: In this national cohort, CRS, ICANS and mortality were broadly stable across strata, while cardiac events displayed select divergences with elevated rates of arrhythmias among the elderly population suggesting robust cardiac surveillance in these patients. Cost differentials were evident with higher costs among Hispanic and elderly patients warranting validation in larger, prospectively harmonized datasets.
Impact of chronic kidney disease on toxicity patterns and economic burden in CAR T-cell therapy for multiple myeloma: A national analysis.
Mahadevia, Himil, Modi, Karnav , Arya, Yajur , Syal, Arshi , El-Husseiny, Khaled M., Modi, Shivani , Bansal, Vasu , Vodnala, Deepthi, Khumri, Taiyeb, Cossor, Furha, Mahadevia, Himil , Khumri, Taiyeb

Mayo Clinic

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e19536 Get It

e19536 Background: Chronic kidney disease (CKD) may impair physiologic resilience during chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma (MM). While cytokine response syndrome (CRS) and immune cell-associated neurotoxicity syndromes (ICANS) have been described in MM CAR-T recipients with CKD, the broader cardiopulmonary, infectious, renal, and economic implications of CKD remain insufficiently defined. We examined the national impact of CKD on mortality, immune cell effector toxicities, organ dysfunction, infections and resource utilization. Methods: Adult MM hospitalizations receiving CAR T-cell therapy were identified from the National Inpatient Sample (2018–2022) using ICD-10-PCS codes. Patients with ESRD were excluded. CKD was categorized as CKD3a+ (eGFR <60 mL/min) versus no CKD/CKD1–2. Outcomes included in-hospital mortality, CRS (2021–2022), ICANS (2022), cardiac arrhythmias, acute kidney injury (AKI), renal replacement therapy, respiratory failure, infections and total hospitalization cost (calculated using TOTCHG variable and adjusted cost to charge ratio). Comparative analysis was done using chi-square testing. Multivariate analysis adjusted for demographics, comorbidities, and hospital characteristics. Results: Among 2,045 weighted MM CAR-T hospitalizations, 7.6% had CKD3a+. Overall CRS rates were similar (66.7% vs 64.9%; p=0.839) between CKD3a+ vs no/CKD1-2. Overall ICANS rates were also comparable (16.7% vs 17.3%; p=0.941). Differences in CRS/ICANS grades were not significant. CKD3a+ patients experienced sharply higher AKI (58.1% vs 13.0%; p<0.001; adjusted odds ratio [OR] 9.2, p<0.001). Renal replacement therapy was more frequent in CKD3a+ but non-significant (3.2% vs 0.8%; p=0.196). Acute respiratory failure was more frequent (9.7% vs 2.9%; p=0.045) in patients with CKD. Cardiac arrhythmias were numerically higher but non-significant (25.8% vs 20.6%; p=0.527; adjusted OR 1.3, 95% CI 0.4–4.9; p=0.673). Infections were amplified, including gram-negative bacteremia (3.2% vs 0.3%; p=0.026), sepsis (9.7% vs 2.6%; p=0.040), and septic shock (3.2% vs 0.3%; p=0.027) in patients with CKD. Inpatient mortality was numerically higher (6.5% vs 1.9%; p=0.101), though nonsignificant after adjustment (OR 6.9; p=0.319). Hospital costs were substantially higher in CKD3a+ (USD 346,769 vs 239,175; p=0.006), though not significant in adjusted models (OR 1.3; p=0.120). Conclusions: CKD3a+ is associated with markedly increased AKI, higher respiratory failure and infections, with a trend towards higher hospitalization costs. Inpatient mortality, CRS and ICANS rates were similar. CKD3a+ represents a significant vulnerability that amplifies downstream complications in MM CAR-T recipients, warranting enhanced pre-treatment risk stratification, infection surveillance and renal-preserving strategies.
Impact of chronic kidney disease on adverse event topography and economic burden in CAR T-cell therapy for DLBCL: A national analysis.
Cossor, Furha, Mahadevia, Himil, Modi, Karnav , Arya, Yajur , Syal, Arshi , Bansal, Vasu , Vodnala, Deepthi, Khumri, Taiyeb, Mahadevia, Himil , Khumri, Taiyeb

Mayo Clinic

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e19054 Get It

e19054 Background: Chronic kidney disease (CKD) may potentiate toxicity and impair organ resilience in recipients of chimeric antigen receptor (CAR) T-cell therapy for diffuse large B-cell lymphoma (DLBCL). While cytokine response syndrome (CRS) and immune cell effector neurotoxicity syndrome (ICANS) have been reported with CKD, the cardiac, infectious, and economic sequelae are insufficiently described. We evaluated these outcomes across CKD strata from a national database. Methods: Using the National Inpatient Sample (2017–2022), we identified adult DLBCL hospitalizations receiving CAR T-cell therapy. ESRD patients were excluded. CKD was examined in two frameworks: CKD3a+ (eGFR <60 mL/min) versus no/CKD1–2, and CKD3b+ (eGFR <45 mL/min) versus no–CKD3a. Outcomes included in-hospital mortality, CRS (2021–2022), ICANS (2022), cardiac events, infections, acute kidney injury (AKI), renal replacement therapy and total hospitalization costs (calculated using TOTCHG variable and adjusted cost to charge ratio) and comparative analyses was done using chi-square testing. Multivariable models adjusted for demographics, comorbidities, and hospital characteristics. Results: In a cohort of 5,400 hospitalized DLBCL patients receiving CAR-T, those with CKD stage 3a or higher (CKD3a+; n=165; 3.1%) had higher rates of AKI (33.3% vs 11.6%; p<0.001) and renal replacement therapy (6.1% vs 1.4%; p=0.040) compared to no/CKD1–2 (n=5,235. Total hospitalization cost was higher (USD 456,198 vs 365,182; p=0.024) and grade 4 ICANS occurred more frequently (10.0% vs 1.4%; p=0.046). Mortality (6.1% vs 2.8%; p=0.259), pneumonia (12.1% vs 6.1%; p=0.246) and cardiac arrhythmias (33.3% vs 21.2%; p=0.094) were increased numerically. After multivariable adjustment, most differences diminished (mortality odds ratio [OR] 1.8, p=0.617; AKI OR 1.2, p=0.735). Among patients with CKD stage 3b or higher (CKD3b+; n=80; 1.5%), complications were more pronounced. In-hospital mortality was substantially higher (12.5% vs 2.7%; p=0.017), along with grade 4 CRS (7.7% vs 1.0%; p=0.011), acute myocardial infarction (6.3% vs 0.7%; p=0.007) and AKI (50.0% vs 11.7%; p<0.001). The cost of hospitalization (USD 446,074 vs 366,826; p=0.197) trended higher. Adjusted models confirmed markedly increased mortality (OR 10.2, 1.5–67.8; p=0.016) but other outcomes were not significant. Conclusions: CKD3b+ is associated with substantially higher mortality with signal of augmented high-grade CRS and cardiac events, whereas CKD3a+ exhibited worsening in renal outcomes and higher cost that attenuated after adjustment. These findings position pre-existing renal dysfunction especially CKD3b+ as a clinically salient risk substrate warranting pre-emptive risk stratification, vigilant cardiac monitoring and proactive organ-support pathways to mitigate downstream morbidity and mortality.
Competing risks of relapse and major organ failure after allogeneic hematopoietic cell transplantation.
Adhikari, Aakriti , Mahadevia, Himil, Bansal, Vasu , Saha, Souvik , Cossor, Furha, Mahadevia, Himil

Mayo Clinic

Journal of Clinical Oncology | May 28, 2026 | Volume: 44 | Issue: 16_suppl | Pages: No page available

10.1200/jco.2026.44.16_suppl.e18579 Get It

e18579 Background: Outcomes after allogeneic hematopoietic cell transplantation (allo-HCT) are often summarized using overall survival (OS) or treatment related mortality (TRM), which may obscure distinct biologic and toxicity driven pathways of failure. Major organ toxicities are important causes of morbidity and mortality but are rarely evaluated as competing events alongside relapse. We sought to characterize relapse and major organ failure as distinct competing pathways after allo-HCT. Methods: We analyzed adult allo-HCT recipients from the CIBMTR RT17-01 publicly available dataset (2008-2016). The primary endpoint was the first post transplant failure pathway, defined as relapse, major organ failure (MOF) requiring dialysis or diagnosed as thrombotic microangiopathy (TMA), veno-occlusive disease (VOD), or idiopathic pneumonia syndrome (IPS), or death without prior relapse or MOF. Competing risk methods estimated cumulative incidence, and cause specific Cox models evaluated associations between conditioning intensity and outcomes, adjusting for clinical and transplant related covariates, with the renal component of the hematopoietic cell transplantation comorbidity index (HCT-CI) removed. Results: The cohort included 13,187 adult recipients with a median age of 58.6 years, of whom 59.3 percent were male. Conditioning intensity was myeloablative (MAC) in 6,134 patients, reduced intensity (RIC) in 4,795, and non myeloablative (NMA) in 2,221. The first failure pathway was relapse in 5,157 patients, MOF in 1,511, and death without relapse or MOF in 2,535. At one year, cumulative incidence was 32.4 percent for relapse, 10.4 percent for MOF, and 13.1 percent for death without either event. IPS and dialysis requiring renal failure were the most frequent MOF events. Compared with MAC, RIC was associated with higher relapse risk (adjusted hazard ratio [aHR] 1.14; 95 percent confidence interval [CI] 1.07-1.23) and lower MOF risk (aHR 0.72; 95 percent CI 0.64-0.82). NMA conditioning showed a further shift toward relapse (aHR 1.42; 95 percent CI 1.30-1.54) with greater reduction in MOF risk (aHR 0.55; 95 percent CI 0.46-0.66). Conclusions: Relapse and MOF represent distinct competing pathways of failure after allo-HCT. Conditioning intensity influences which pathway predominates, with less intensive regimens shifting risk from organ toxicity toward relapse. Pathway based competing risk analyses provide insight beyond traditional survival endpoints and may support more individualized transplant decision making.
Differential clinical and economic signatures of CAR T-cell therapy in DLBCL across demographic and payer strata: A national analysis.
Modi, Karnav , Mahadevia, Himil, Arya, Yajur , Syal, Arshi , Adhikari, Aakriti , Vodnala, Deepthi, Khumri, Taiyeb, Cossor, Furha, Mahadevia, Himil , Khumri, Taiyeb, Cossor, Furha

Mayo Clinic

Journal of Clinical Oncology | May 27, 2026 | Volume: 44 | Issue: 16_suppl | Pages: 7064-7064

10.1200/jco.2026.44.16_suppl.7064 Get It

7064 Background: Chimeric antigen receptor (CAR) T cell therapy has revolutionized care for relapsed/refractory diffuse large B cell lymphoma (DLBCL), yet granular delineation of real-world immune effector toxicities, organ-specific sequelae and economic burden across demographic and socioeconomic strata requires further exploration. Methods: Using the National Inpatient Sample (2017–2022), we identified adult DLBCL hospitalizations receiving CAR T through ICD-10-PCS codes. Cytokine release syndrome (CRS) [all grades - 2021–2022], immune effector cell–associated neurotoxicity syndrome (ICANS) [all grades – 2022], infections, cardiac events and acute kidney injury (AKI) were identified through ICD-10 codes. Age was stratified into 21-40, 41-60, 61-80 and >81 years. Payer groups were Medicare, Medicaid, Private and Uninsured. Races were White, African American, Hispanic and others [Pacific Islanders, Native Indians, Asians]. Chi-square analysis was performed, and multivariate regression adjusted for demographics, comorbidities, and hospital characteristics. Results: Across >11,000 weighted hospitalizations, inpatient mortality, all-grade CRS and ICANS were comparable across age, race, and payer groups (p>0.05). Inpatient mortality was numerically higher in other minor races (6.6%) vs White (3.3%), African American (3.1%), and Hispanic (0.9%; p=0.230). Any grade CRS was numerically higher in other minor races (72.5%) than in White (62.3%) and African American (60.6%; p=0.614). Any grade ICANS dispersion included 29.5% (White), 39.1% (African American), 22.5% (Hispanic) and 11.1% (Other; p=0.204). A race-specific signal for ICANS grade 5 (p=0.030) was seen, but numbers were small. Among cardiac events, arrhythmias rose from 7.6% (age 21–40 years) to 57.1% ( age ≥81 years) (p<0.001). By payer, arrhythmias were highest in Medicare (31.2%; p<0.001). Other cardiac events including myocardial infarction, stroke and cardiogenic shock were similar across groups. Pneumonia rates varied by payer, peaking in the Uninsured (23.8%; p=0.010). Sepsis and septic shock rates showed no differences. AKI (p=0.007) rates showed differences but attenuated after adjustment. Hispanic and other minor races had lower adjusted costs than White (Odds ratio [OR] 0.9, p=0.046; OR 0.8, p=0.006), while ages 61–80 had higher adjusted costs vs 21–40 (OR 1.2, p=0.023). Conclusions: In this national cohort, CRS, ICANS and mortality were similar across demographic and payer strata, indicating consistent immune effector safety. Cardiac arrhythmia rates were higher among the elderly and Medicare beneficiaries. There were lower expenditures among minor race groups and higher costs in elderly. These findings highlight discrete domains of variability and suggest intensified cardiac surveillance in elderly and equitable resource allocation to optimize outcomes with CAR-T.
Incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections and cardiovascular events between chimeric antigen receptor (CAR) T-cell therapy products in multiple myeloma (MM): A nationwide analys
Mahadevia, Himil, Modi, Karnav, Shah, Raj, Modi, Shivani, Vojjala, Nikhil, Vodnala, Deepthi, Khumri, Taiyeb, Cossor, Furha, Mahadevia, Himil , Modi, Karnav, Shah, Raj, Modi, Shivani, Vojjala, Nikhil, Vodnala, Deepthi, Khumri, Taiyeb, Cossor, Furha

Mayo Clinic

Blood | December 5, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 6351-6351

10.1182/blood-2025-6351 Get It

Abstract Introduction: CAR T-cell therapy represents a pivotal treatment for individuals with relapsed or refractory (R/R) MM. Currently, two CAR T-cell therapeutics have received regulatory approval: Abecma (idecabtagene vicleucel, ide-cel) and Carvykti (ciltacabtagene autoleucel, cilta-cel). Although direct comparative investigations delineating the efficacy of these modalities are absent, clinical trials have shown significant disparities in response and remission rates between these therapies. Both agents are implicated in the manifestation of CRS and ICANS; however, variations in the frequency and severity of these adverse effects have been observed. We harnessed data from the National Inpatient Sample (NIS) to gain a deeper understanding of the incidence of different adverse events associated with both CAR T products in MM. Method: In this retrospective study, the 2022 NIS database was used to identify hospitalizations with MM and those who received ide-cel or cilta-cel using appropriate ICD-10-CM diagnostic and ICD-10-PCS procedure codes. Data on CRS, ICANS, infections, and adverse cardiac events were extracted using relevant ICD-10-CM codes. These outcomes were compared between the two CAR-T products using Pearson's chi-square analysis. Multivariate logistic regression was also performed, adjusting for demographics, hospital-specific characteristics, and comorbidities. Results: We identified 805 patients with MM who received CAR T-cell therapy, among whom 530 patients (60.4% male; 67% Caucasian, 14.6% African American and 17.5% other ethnicities) received ide-cel and 275 patients (70.9% male; 79.6% Caucasian, 14.3% African American and 6.1% other ethnicities) received cilta-cel. The incidence of CRS was 72.6% for ide-cel and 56.4% for cilta-cel, and the difference was almost statistically significant by chi-square analysis (p = 0.051). This difference was not statistically significant after multivariate analysis [Adjusted Odds ratio (OR) = 0.5, CI 0.2 to 1.3, p=0.154]. The incidence of ICANS was 19.8% for ide-cel and 18.2% for cilta-cel, and it was not statistically significant by chi-square analysis (p = 0.825). Among cardiovascular events, there was no significant difference in the incidence of cardiogenic shock (ide-cel vs cilta-cel, 0.9% vs 0%, p = 0.497), stroke (0.9% vs 1.8%, p = 0.661) and arrhythmias (22.6% vs 21.8%, p = 0.892) between these CAR T-cell therapies. Furthermore, there were no significant differences in the incidence of infectious complications, including pneumonia (1.9% vs 0%, p = 0.334), sepsis (0.9% vs 3.6%, p = 0.247), or septic shock (0.9% vs 0%, p = 0.430) between these CAR T-cell therapies. There was no significant difference in all-cause in-hospital mortality between these therapies (1.9% vs 5.5%, p = 0.181). Conclusion: There was no significant difference in the occurrence of CRS and ICANS between ide-cel and cilta-cel in our study. Both CAR T-cell therapies have the potential to cause infections and cardiovascular issues, necessitating careful monitoring, early detection, and timely treatment. When choosing between these CAR T-cell therapies, several factors should be considered, including the patient's previous treatment history, manufacturing time, cost, availability, and potential short-term and long-term side effects. Our study has some limitations, including its retrospective design, dependence on ICD-10 codes for identifying patients with adverse events, and the lack of long-term longitudinal data on adverse effects. However, this study provides important insights for hematologists regarding the rates of specific adverse events associated with both the CAR T-cell products in a real-world setting.
Incidence of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), infections and cardiovascular events across different chimeric antigen receptor (CAR) T-cell therapy products in large B-cell lymphoma (DLBCL): A
Mahadevia, Himil , Modi, Karnav , Shah, Raj, Modi, Shivani , Khumri, Taiyeb, Vodnala, Deepthi, Cossor, Furha, Vojjala, Nikhil

Mayo Clinic

Blood | December 4, 2025 | Volume: 146 | Issue: Supplement 1 | Pages: 8012-8012

10.1182/blood-2025-8012 Get It

Abstract Introduction: CAR T-cell therapy is an important treatment option for patients with relapsed or refractory (R/R) DLBCL. Three CAR T-cell products have received approval: axicabtagene ciloleucel (Yescarta), lisocabtagene maraleucel (Breyanzi), and tisagenlecleucel (Kymriah). Although direct head-to-head studies comparing the three therapies do not exist, clinical trials have revealed notable differences in response rates and remission rates among them. All three products induce CRS and ICANS; however, variations in the incidence and severity of these adverse effects have been observed. We utilized data from the National Inpatient Sample (NIS) to gain further insights into the incidence of various adverse events associated with different CAR-T products in DLBCL. Method: In this retrospective study, the 2022 NIS database was used to identify hospitalizations with DLBCL and those who received Yescarta, Breyanzi, or Kymriah using appropriate ICD-10-CM diagnostic and ICD-10-PCS procedure codes. Data on CRS, ICANS, infections, and adverse cardiac events were extracted using relevant ICD-10-CM codes. These outcomes were compared across different CAR-T products using Pearson's chi-square analysis. Multivariate logistic regression was also performed, adjusting for demographics, hospital-specific characteristics, and comorbidities. Results: We identified 1440 patients with DLBCL. Among these, 1100 patients (64.6% male; 70.7% Caucasian, 8.8% African American, 20.5% other ethnicities) received Yescarta, 90 patients (66.7% male; 82.4% Caucasian, 0% African American, 17.7% other ethnicities) received Kymriah and 250 patients (64% male; 82.6% Caucasian, 10.9% African American, 6.5% other ethnicities) received Breyanzi. The incidence of CRS was 52% for Breyanzi, 44.4% for Kymriah and 68.6% for Yescarta, and the difference was statistically significant by chi-square analysis (p = 0.03). This difference remained statistically significant for Kymriah after multivariate analysis [Adjusted Odds ratio (OR) = 0.3, CI 0.1 to 0.9, p=0.032], but not for Breyanzi (Adjusted OR = 0.3, CI 0.1 to 0.9, p=0.032) in comparison to Yescarta. The incidence of ICANS was 16% for Breyanzi, 22.2% for Kymriah, and 33.2% for Yescarta, with a statistically significant difference observed by chi-square analysis (p = 0.05). This difference remained statistically significant for Breyanzi after multivariate analysis [Adjusted OR = 0.3, CI 0.1 to 0.6, p=0.002], but not for Kymriah (Adjusted OR = 0.6, CI 0.1 to 2.9, p=0.551) in comparison to Yescarta. Among cardiovascular events, there was no significant difference in the incidence of acute myocardial infarction (Yescarta vs Kymriah vs Breyanzi, 0.5% vs 0% vs 0.2%, p = 0.487), stroke (0.5% vs 5.6% vs 2%, p = 0.07), cardiogenic shock (0.5% vs 0% vs 0%, p = 0.880), and arrhythmias (20.9% vs 27.8% vs 32%, p = 0.258) among these CAR T-cell therapies. Furthermore, there were no significant differences in the incidence of infectious complications, including pneumonia (5.9% vs 5.6% vs 2%, p = 0.510), sepsis (5% vs 5.6% vs 6%, p = 0.962), or septic shock (2.3% vs 0% vs 0%, p = 0.535) among these CAR T-cell therapies. There was no difference in all-cause in-hospital mortality across these therapies (2.3% vs 5.6% vs 2%, p = 0.692). Conclusion: Kymriah showed lower CRS rates and Breyanzi showed lower ICANS rates in comparison to Yescarta in our study. All CAR T-cell therapies have the potential to cause infections and cardiac events, which require monitoring, early identification and prompt treatment. When selecting among various CAR T-cell products, several factors must be considered, including the patient's lymphoma type, prior treatment history, manufacturing turnaround time, cost, availability, and potential short-term and long-term side effects. The limitations of our study include its retrospective nature, reliance on ICD-10 codes to identify patients with adverse events, and the absence of longitudinal data on long-term adverse events. Nevertheless, this study provides essential insights for hematologists regarding the incidence of specific adverse events associated with different CAR T-cell products within the real-world population.
Incidence of infections, cardiac events, neurological toxicity and cytokine response syndrome (CRS) in patients treated with chimeric antigen receptor (CAR) T cell therapy: A 3-year nationwide analysis.
Mahadevia, Himil , Modi, Karnav , Shah, Raj, Modi, Shivani , Batra, Nitya, Arya, Yajur , Syal, Arshi , Shah, Kashish, Savani, Saloni , Chaudhari, Jahnavi, Vodnala, Deepthi, Khumri, Taiyeb, Cossor, Furha, Sharma, Parth , Peshin, Supriya , Jain, Akhil , Gupta, Kush , Ponvilawan, Ben

Mayo Clinic

Journal of Clinical Oncology | May 28, 2025 | Volume: 43 | Issue: 16_suppl | Pages: 7018-7018

10.1200/jco.2025.43.16_suppl.7018 Get It

7018 Background: CAR-T cell therapy represents a notable advancement in treating relapsed/refractory (R/R) hematological malignancies. Adverse events include CRS, infections, and neurological and cardiac complications. While there are reports from major academic institutions on the adverse effects of CAR-T therapy, we used data from the National Inpatient Sample (NIS) to gather national estimates of complications related to CAR-T therapy. Methods: A retrospective study was conducted to analyze patients who underwent CAR-T cell therapy by utilizing appropriate ICD-10-PCS procedure codes (XW033C3, XW043C3, XW23346, XW24346, XW23376, and XW24376) from NIS 2019 to 2021. Data regarding infections, toxic encephalopathy (a surrogate for neurological toxicity), and adverse cardiac events were extracted using relevant ICD-10-CM diagnostic codes. Patients experiencing various grades of CRS were identified through specific ICD-10 codes available in 2021 (Grades 1-5: D89.831-D89.835). Results: This study analyzed 6515 patients who underwent CAR-T cell therapy from January 2019 to December 2021. Among them, 60.7% were male. 74.6% were Caucasian, 11.7% were Asian and 6.7% were African American. 49.8% of patients had private insurance, 36.2% had Medicare, and 8.6% had Medicaid. 6.8% of patients were diagnosed with pneumonia, while sepsis occurred in 7.4% of patients and 3% experienced septic shock. 19.4% of patients experienced cardiac arrhythmias, and major cardiovascular events were recorded in 4.7% of the cohort. Acute myocardial infarction and stroke were documented in 0.6 and 1.2% of patients, respectively. Toxic encephalopathy was reported in 19.7% of patients. Among 2235 patients identified to have received CAR-T in 2021, 59.7% developed CRS. Grade 1 and grade 2 CRS were reported in 32% and 21% of patients, respectively, while grade 3 and grade 4 reactions were noted in 4.7% and 2% of patients, with no cases of grade 5 identified. The mean total cost of hospitalization was 308,364$, and the mean length of hospital stay was 19.5 days. The overall in-hospital mortality rate was 3.4%. Conclusions: Our study describes real-world outcomes from a large dataset of CAR-T patients. Infections pose a significant challenge with CAR-T therapy, highlighting the importance of early detection and timely antimicrobial treatment. CRS is common, with a 60% incidence, similar to previous clinical trials (55%). Immediate management is crucial for addressing CRS toxicity. Adverse neurological and cardiovascular incidents are often reported, emphasizing the need for meticulous monitoring and coordinating multidisciplinary care plans. The financial burdens also bear mentioning: CAR-T therapy costs significantly higher than autologous stem cell transplants. Further studies to address these issues are warranted.