ABSTRACT
Context: Triple class exposed/refractory multiple myeloma (MM) represents an unmet medical need because there is no standard of care and overall survival (OS) does not exceed 9 months. B-cell maturation antigen (BCMA) has appeared as an interesting target to treat MM. Objective: To indirectly compare the time to access therapy and hospitalization as well as the toxicity and efficacy of BCMA bispecific monoclonal antibodies (BiAbs) and CAR-T. Design: An observational retrospective study was designed including MM patients treated with BCMA CAR-T or BiAbs in clinical trials at the Hospital of Salamanca (October 2018–April 2022). Patients or Other Participants: Forty-nine patients were treated with BCMA therapy. Intervention: N/A. Main Outcome Measures: The time to access the treatment and hospitalization, global responses, cytokine release syndrome (CRS), neurotoxicity, infections, progression-free survival (PFS), and OS. Results: Twenty-seven patients (55.1%) received CAR-T and 22 (44.9%) received BiAbs. Thirty-nine (79.6%) patients were triple exposed and 28 (57.1%) were triple refractory. Patients who received BiAbs were treated earlier (12 vs. 56 days;P<0.001) and were hospitalized for less time (13 vs. 21 days;P=0.018). Overall response rate was superior in CAR-T patients (100% vs. 52.4%;P<0.001) as was percentage of CR (70.4% vs. 47.6%;P=0.110). Incidence of CRS was higher in the CAR-T group than the BiAbs group (92.6% vs. 68.2%;P=0.028) as were the percentages of grade 4 neutropenia (92.6% vs. 22.7%;P<0.001) and thrombocytopenia (70.4% vs. 9.1%;P<0.001). Infections were more frequent in the BiAbs group (especially between the first and third month of treatment initiation, 55.6% vs. 14.8%;P=0.004), including COVID-19 infection (50.0% vs. 29.6%;P=0.002). With a median follow-up of 14.3 months (1.1–41.8), PFS was superior in patients treated with CAR-T (18.9 vs. 6.1 months;P=0.045) as was OS (not reached vs. 25.5 months;P=0.016). Conclusions: The times to access therapy and hospitalization were shorter in patients treated with BiAbs. The incidences of CRS and cytopenia were higher in the CAR-T group, but mid-term and COVID-19 infections were more frequent in the BiAbs group. Response, PFS, and OS were superior in patients treated with CAR-T than those treated with BiAbs.
ABSTRACT
Patients with chronic lymphocytic leukemia (CLL) may be more susceptible to Coronavirus disease 2019 (COVID-19) due to age, disease, and treatment-related immunosuppression. We aimed to assess risk factors of outcome and elucidate the impact of CLL-directed treatments on the course of COVID-19. We conducted a retrospective, international study, collectively including 941 patients with CLL and confirmed COVID-19. Data from the beginning of the pandemic until March 16, 2021, were collected from 91 centers. The risk factors of case fatality rate (CFR), disease severity, and overall survival (OS) were investigated. OS analysis was restricted to patients with severe COVID-19 (definition: hospitalization with need of oxygen or admission into an intensive care unit). CFR in patients with severe COVID-19 was 38.4%. OS was inferior for patients in all treatment categories compared to untreated (p < 0.001). Untreated patients had a lower risk of death (HR = 0.54, 95% CI:0.41-0.72). The risk of death was higher for older patients and those suffering from cardiac failure (HR = 1.03, 95% CI:1.02-1.04; HR = 1.79, 95% CI:1.04-3.07, respectively). Age, CLL-directed treatment, and cardiac failure were significant risk factors of OS. Untreated patients had a better chance of survival than those on treatment or recently treated.
Subject(s)
COVID-19/complications , COVID-19/mortality , Leukemia, Lymphocytic, Chronic, B-Cell/complications , Leukemia, Lymphocytic, Chronic, B-Cell/mortality , COVID-19/diagnosis , COVID-19/virology , Humans , Leukemia, Lymphocytic, Chronic, B-Cell/therapy , Leukemia, Lymphocytic, Chronic, B-Cell/virology , Mortality , Prognosis , Risk Factors , SARS-CoV-2 , Severity of Illness Index , Survival AnalysisABSTRACT
The University Hospital of Salamanca, in Spain, had its first COVID-19 case on March 1st and as of May 11th, we had 1,100 positive cases. Based on the vulnerability of patients with blood cancers, on March 9th, the Hematology Department developed a protocol, amended as the new information was available, to maintain the Hematology Unit as a "free COVID-19 island." The protocol included symptom-based surveys and screening tests to patients, caregivers, and healthcare personnel to identify early potential positive cases and prevent its spread. Between March 9 and April 28, 32 asymptomatic patients and caregivers were tested and 68 rT-PCR diagnostic assays have been performed with two positive results. A 106 healthcare workers have been tested (208 rT-PCR) and seven of them were positive. In summary, the implementation of preemptive measures after the first case appeared allowed us to be able to provide treatment to our patients.
ABSTRACT
Chronic lymphocytic leukemia (CLL) is a disease of the elderly, characterized by immunodeficiency. Hence, patients with CLL might be considered more susceptible to severe complications from COVID-19. We undertook this retrospective international multicenter study to characterize the course of COVID-19 in patients with CLL and identify potential predictors of outcome. Of 190 patients with CLL and confirmed COVID-19 diagnosed between 28/03/2020 and 22/05/2020, 151 (79%) presented with severe COVID-19 (need of oxygen and/or intensive care admission). Severe COVID-19 was associated with more advanced age (≥65 years) (odds ratio 3.72 [95% CI 1.79-7.71]). Only 60 patients (39.7%) with severe COVID-19 were receiving or had recent (≤12 months) treatment for CLL at the time of COVID-19 versus 30/39 (76.9%) patients with mild disease. Hospitalization rate for severe COVID-19 was lower (p < 0.05) for patients on ibrutinib versus those on other regimens or off treatment. Of 151 patients with severe disease, 55 (36.4%) succumbed versus only 1/38 (2.6%) with mild disease; age and comorbidities did not impact on mortality. In CLL, (1) COVID-19 severity increases with age; (2) antileukemic treatment (particularly BTK inhibitors) appears to exert a protective effect; (3) age and comorbidities did not impact on mortality, alluding to a relevant role of CLL and immunodeficiency.