Although chimeric antigen receptor T (CAR-T) cell therapy has proven to be effective in treating relapsed or refractory B-cell hematological malignancies, severe hematological toxicities remain an intractable issue. This retrospective study assessed the characteristics and risk factors of new-onset severe cytopenia following CAR-T cell infusion in 76 patients with r/r acute lymphoblastic leukemia. The rates of new-onset severe cytopenia were high, including severe neutropenia (SN) (39/56, 70%), severe anemia (SA) (35/66, 53%), and severe thrombocytopenia (ST) (31/64, 48%). Comparatively, cohorts with higher cytokine release syndrome (CRS) grades had higher incidence of severe cytopenia with prolonged duration. Multivariable analyses showed that elevated maximum (max) lg D-dimer and delayed peak time of CRS are independent risk factors for SN recovery; increased max lg IL-10 and delayed CRS recovery are risk factors for SA; high max lg ferritin is a risk factor for ST; and longer period to CRS onset or CRS recovery and higher grade of CRS are risk factors for prolonged hematological toxicities. These observations led to the conclusion that profiles of CRS, including its duration, severity and serum markers are correlated to the incidence and recovery of new-onset severe cytopenia, prompting clinical intervention for post-CAR-T severe cytopenia.
Purpose: The in uence of innovative chimeric antigen receptor T cell (CAR-T) therapy for hematological malignancies on nutritional status remains unknown. Therefore, we aim to explore the alterations of nutritional status after CAR-T therapy in patients with hematological malignancies. Methods: We retrospectively collected the data of patients with acute leukemia (AL), lymphoma and multiple myeloma (MM), who underwent CAR-T therapy at our hospital from 2018 to 2020. The serum albumin, triglyceride and cholesterol before and 7, 14 and 21 days after CAR-T cells infusion were compared and analyzed.Result: A total of 117 patients were enrolled, consisting of 39 AL, 23 lymphoma and 55 MM patients. The baseline albumin, triglyceride and cholesterol were 37.43±5.08 mg/L, 1.63±0.74 mmol/L and 3.62±1.03 mmol/L, respectively. The lowest albumin level was found at 7 days after CAR-T infusion compared with baseline (P<0.001), while the levels of triglyceride increased at 14 and 21 days (P<0.001, P=0.036). The levels of cholesterol at 7, 14, 21 days after CAR-T infusion were lower than baseline (all P<0.05).Spearman correlation coe cient showed cytokine release syndrome grade was negatively correlated with the levels of albumin at 7 days and cholesterol at 21 days after CAR-T infusion (r=-0.353, P<0.001; r=-0.395, P=0.002).Conclusion: Serum albumin and total cholesterol concentration decreased at the lowest level 7 days after CAR-T cells infusion, while triglyceride increased at 14 and 21 days after infusion. The levels of albumin and total cholesterol after CAR-T cells infusion were negatively correlated with the grade of cytokine release syndrome.
Purpose: The influence of innovative chimeric antigen receptor T cell (CAR-T) therapy for hematological malignancies on nutritional status remains unknown. Therefore, we aim to explore the alterations of nutritional status after CAR-T therapy in patients with hematological malignancies.Methods: We retrospectively collected the data of patients with acute leukemia (AL), lymphoma and multiple myeloma (MM), who underwent CAR-T therapy at our hospital from 2018 to 2020. The serum albumin, triglyceride and cholesterol before and 7, 14 and 21 days after CAR-T cells infusion were compared and analyzed.Result: A total of 117 patients were enrolled, consisting of 39 AL, 23 lymphoma and 55 MM patients. The baseline albumin, triglyceride and cholesterol were 37.43±5.08 mg/L, 1.63±0.74 mmol/L and 3.62±1.03 mmol/L, respectively. The lowest albumin level was found at 7 days after CAR-T infusion compared with baseline (P<0.001), while the levels of triglyceride increased at 14 and 21 days (P<0.001, P=0.036). The levels of cholesterol at 7, 14, 21 days after CAR-T infusion were lower than baseline (all P<0.05). Spearman correlation coefficient showed cytokine release syndrome grade was negatively correlated with the levels of albumin at 7 days and cholesterol at 21 days after CAR-T infusion (r=-0.353, P<0.001; r=-0.395, P=0.002).Conclusion: Serum albumin and total cholesterol concentration decreased at the lowest level 7 days after CAR-T cells infusion, while triglyceride increased at 14 and 21 days after infusion. The levels of albumin and total cholesterol after CAR-T cells infusion were negatively correlated with the grade of cytokine release syndrome.
Increasing use of chimeric antigen receptor-T (CAR-T) cell therapy has significantly improved the survival of hematologic malignancy patients, but CAR-T cell treatment is also associated with increased risk of infection. Hence, understanding the characteristics of infection may improve disease prognosis. The data of post-CAR-T therapy infections were obtained from the VigiBase database. We identified a total of 554 infection reports (1001 infection events) involving CAR-T therapy among the 3007 case reports. Infections occurred in 18.42% of cases reported in VigiBase with CAR-T therapy and were most frequently occurred during the first month. Among cases reported in VigiBase, most of the infections were controllable, and only 4.4% of the cases were fatal. Bacteria (60.7%) and respiratory tract infection (50.9%) were the most common infection types. Compared with axicabtagene ciloleucel, infection in patients receiving tisagenlecleucel-T therapy had a higher infection risk (ROR = 1.76; 95% CI = 1.46-2.12, p < 0.001). Meanwhile, fungus infection and mixed infection had poorer prognoses than virus infection. Concerning the disease prognoses, fungal and mixed infection should be given more attention, and extensive prospective studies are much needed to verify these findings.
Background The treatment of relapsed/refractory multiple myeloma (RRMM) dramatically changed with the emergence of chimeric antigen receptor T (CAR-T) cell therapy. The aim of this study was to evaluate the cost-effectiveness of two CAR-T cell treatments for RRMM patients from the perspective of the Chinese healthcare system. Methods Markov modelling was used to evaluate Idecabtagene vicleucel(Ide-cel) and Ciltacabtagene autoleucel (Cilta-cel) compared with currently available salvage chemotherapy for patients with RRMM over a lifetime horizon. The model was developed based on data from the three studies: CARTITUDE-1, KarMMa and MAMMOTH. Each CAR-T cell treatments was compared with currently available salvage chemotherapy. The healthcare cost and utility of RRMM patients were collected in a Chinese single institution. Main outcomes were life-years, discounted lifetime costs, discounted quality-adjusted life-years (QALYs), and incremental cost-effectiveness ratio. Results In the base case analysis, 3.5% and 30.4% of RRMM patients were expected to be long-term survivor after 5 years of Ide-cel and Cilta-cel treatment. Compared to salvage chemotherapy, Ide-cel and Cilta-cel were associated with the incremental QALYs of 1.14 and 3.32, and increment cost of US $166,643 and $111,225, leading to ICERs of $146,764 and $33,547 per QALY. In the scenario analyses, the ICER was $138,249 and $28,844 per QALY under assumption that the model starting age is changed from 60 to 55 for Ide-cel and Cilta-cel, and ICER was $148,486 and $40,691 per QALY under assumption that success rate of CAR-T therapy manufacturing was 100%. Conclusions Under the wiling-to-pay of 3 times China's per capita GDP in 2021, Cilta-cel was cost-effectiveness options compared to salvage chemotherapy for patients with RRMM while Ide-cel not. With younger target people, potential price discount and long-term survival improvement, the ICERs of the two CAR-T cell treatments would decrease.
Aims Patients with multiple myeloma after chimeric antigen receptor T-cell immunotherapy suffered from diarrhea. Recurrent diarrhea further conversely decreases nutritional status Methods This study enrolled 88 patients with multiple myeloma who received chimeric antigen receptor T-cell immunotherapy at one tertiary general hospital in China. Participants were categorized into diarrhea subgroup and non-diarrhea subgroup according to the occurrence of diarrhea. Demographic data and self-reported measurements and planning were obtained from questionnaires and clinical data from hospital databases. Results In total, 50 patients suffered from non-infectious diarrhea, with the prevalence of 56.8%. Multiple logistic regression analysis showed that severe cytokine release syndrome (OR = 5.980), underlying diseases (OR = 4.184), previous treatment lines ≥ 6 (OR = 6.292) were prominent hazardous factors for non-infectious diarrhea (p < 0.05). Conclusions The incidence rate of non-infectious diarrhea in patients with multiple myeloma after CAR-T therapy was at a high level. Severe cytokine release syndrome, previous treatment lines ≥ 6 and the underlying diseases were important predictors for non-infectious diarrhea. Medical staff should early evaluate these major factors to reduce the risk of diarrhea.
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