Belantamab Mafodotin in Patients with Relapsed/Refractory Multiple Myeloma: Results of the Compassionate Use or the Expanded Access Program in Spain.

Belantamab-mafodotin (belamaf) is a novel antibody-drug conjugate targeting B-cell maturation antigen that showed anti-myeloma activity in patients with relapsed and refractory multiple myeloma (RRMM). We performed an observational, retrospective, and multicenter study aimed to assess the efficacy and safety of single-agent belamaf in 156 Spanish patients with RRMM. The median number of prior therapy lines was 5 (range, 1-10), and 88% of patients were triple-class refractory. Median follow-up was 10.9 months (range, 1-28.6). The overall response rate was 41.8% (≥CR 13.5%, VGPR 9%, PR 17.3%, MR 2%). The median progression-free survival was 3.61 months (95% CI, 2.1-5.1) and 14.47 months (95% CI, 7.91-21.04) in patients achieving at least MR (p < 0.001). Median overall survival in the entire cohort and in patients with MR or better was 11.05 months (95% CI, 8.7-13.3) and 23.35 (NA-NA) months, respectively (p < 0.001). Corneal events (87.9%; grade ≥ 3, 33.7%) were the most commonly adverse events, while thrombocytopenia and infections occurred in 15.4% and 15% of patients, respectively. Two (1.3%) patients discontinued treatment permanently due to ocular toxicity. Belamaf showed a noticeably anti-myeloma activity in this real-life series of patients, particularly among those achieving MR or better. The safety profile was manageable and consistent with prior studies.

Risk factors and outcome of COVID-19 in patients with hematological malignancies.

BACKGROUND: Prognostic factors of poor outcome in patients with hematological malignancies and COVID-19 are poorly defined. PATIENTS AND METHODS: This was a Spanish transplant group and cell therapy (GETH) multicenter retrospective observational study, which included a large cohort of blood cancer patients with laboratory-confirmed SARS-CoV-2 infection through PCR assays from March 1st 2020 to May 15th 2020. RESULTS: We included 367 pediatric and adult patients with hematological malignancies, including recipients of autologous (ASCT) (n = 58) or allogeneic stem cell transplantation (allo-SCT) (n = 65) from 41 hospitals in Spain. Median age of patients was 64 years (range 1-93.8). Recipients of ASCT and allo-SCT showed lower mortality rates (17% and 18%, respectively) compared to non-SCT patients (31%) (p = 0.02). Prognostic factors identified for day 45 overall mortality (OM) by logistic regression multivariate analysis included age > 70 years [odds ratio (OR) 2.1, 95% confidence interval (CI) 1.2-3.8, p = 0.011]; uncontrolled hematological malignancy (OR 2.9, 95% CI 1.6-5.2, p < 0.0001); ECOG 3-4 (OR, 2.56, 95% CI 1.4-4.7, p = 0.003); neutropenia (< 0.5 × 109/L) (OR 2.8, 95% CI 1.3-6.1, p = 0.01); and a C-reactive protein (CRP) > 20 mg/dL (OR 3.3, 95% CI 1.7-6.4, p < 0.0001). In multivariate analysis of 216 patients with very severe COVID-19, treatment with azithromycin or low dose corticosteroids was associated with lower OM (OR 0.42, 95% CI 0.2-0.89 and OR 0.31, 95% CI 0.11-0.87, respectively, p = 0.02) whereas the use of hidroxycloroquine did not show significant improvement in OM (OR 0.64, 95% CI 0.37-1.1, P = 0.1). CONCLUSIONS: In most patients with hematological malignancies COVID-19 mortality was directly driven by older age, disease status, performance status, as well as by immune (neutropenia) parameters and level of inflammation (high CRP). Use of azithromycin and low dose corticosteroids may be of value in very severe COVID-19.

Betahidroxibutirato capilar en la monitorizacion de la cetoacidosis diabetica / Capillary beta-hydroxybutyrate determination for monitoring diabetic ketoacidosis

Fundamento y objetivo La cetoacidosis diabetica (CAD) es la complicacion aguda mas grave de la diabetes mellitus tipo 1. Su tratamiento con insulina viene guiado por los valores obtenidos en las determinaciones de glucemia y los cambios gasometricos, mientras que los niveles de beta-hidroxibutirato (BHB) raramente son determinados. El objetivo del estudio fue evaluar la utilidad de la monitorizacion de BHB capilar en el curso y resolucion de una CAD. Pacientes y metodos Se estudiaron 30 pacientes diabeticos tipo 1 con CAD a los que se les aplica un protocolo estandar, con monitorizacion de glucosa y gasometria venosas, cetonuria semicuantitativa y BHB capilar. Para el seguimiento se establecieron a priori tres grupos de acuerdo con el tiempo de recuperacion segun criterios bioquimicos (grupo 1: < 24h; grupo 2: 24-48h; grupo 3: > 48h) y se correlacionaron las (..)(AU)

Background and objective: Diabetic ketoacidosis (DKA) is the most severe acute metaboliccomplication of type 1 diabetes mellitus. Insulin treatment is commonly guided by plasmaglucose levels and changes in venous blood gases, while -hydroxibutyrate (BHB) levels arerarely measured. The study objective was to evaluate the value of capillary BHB monitoring inthe course and resolution of DKA.Patients and methods: Thirty patients with type 1 diabetes admitted for DKA were enrolled. Astandard protocol including monitoring of blood glucose, venous blood gases, semiquantitativeketonuria, and capillary BHB was used. Patients were divided into three groups by time to DKAresolution (group 1: < 24 h, group 2: 24-48 h, group 3: >48 h), and BHB results were compared toall other biochemical measurements.Results: Mean laboratory results upon admission were: blood glucose 415 (standard deviation[SD] 106) mg/dL; bicarbonate 9.6 (SD 1.5) mmol/L; pH 7.13 (SD 0.04); BHB 4.33 (SD 0.48)mmol/L, and ketonuria 3+ in 22 patients and 4+ in 6. BHB correlated well with bicarbonate(r = -0.24139; P = 0.0161) and pH (r = -0.56419; P < 0.0001). BHB normalized earlier than ketonuriain all cases (group 1: 15.5 vs 18.8 hours P < 0.05; group 2: 18.2 vs 23.5 hours P < 0.01; group3: 37.3 vs 41.7 hours P < 0.01). Ten percent of patients still had ketonuria when blood ketonelevels were already normal (<0.5 mmol/L).Conclusion: BHB measurement is an easy, practical, and reliable monitoring method in DKA andmay be used as a parameter to adjust insulin treatment (AU)

[Capillary beta-hydroxybutyrate determination for monitoring diabetic ketoacidosis]. / Betahidroxibutirato capilar en la monitorización de la cetoacidosis diabética.

BACKGROUND AND OBJECTIVE: Diabetic ketoacidosis (DKA) is the most severe acute metabolic complication of type 1 diabetes mellitus. Insulin treatment is commonly guided by plasma glucose levels and changes in venous blood gases, while ß-hydroxibutyrate (BHB) levels are rarely measured. The study objective was to evaluate the value of capillary BHB monitoring in the course and resolution of DKA. PATIENTS AND METHODS: Thirty patients with type 1 diabetes admitted for DKA were enrolled. A standard protocol including monitoring of blood glucose, venous blood gases, semiquantitative ketonuria, and capillary BHB was used. Patients were divided into three groups by time to DKA resolution (group 1:<24 h, group 2: 24-48 h, group 3: >48 h), and BHB results were compared to all other biochemical measurements. RESULTS: Mean laboratory results upon admission were: blood glucose 415 (standard deviation [SD] 106) mg/dL; bicarbonate 9.6 (SD 1.5) mmol/L; pH 7.13 (SD 0.04); BHB 4.33 (SD 0.48) mmol/L, and ketonuria 3+ in 22 patients and 4+ in 6. BHB correlated well with bicarbonate (r=-0.24139; P=0.0161) and pH (r=-0.56419; P<0.0001). BHB normalized earlier than ketonuria in all cases (group 1: 15.5 vs 18.8 hours P<0.05; group 2: 18.2 vs 23.5 hours P<0.01; group 3: 37.3 vs 41.7 hours P<0.01). Ten percent of patients still had ketonuria when blood ketone levels were already normal (<0.5 mmol/L). CONCLUSION: BHB measurement is an easy, practical, and reliable monitoring method in DKA and may be used as a parameter to adjust insulin treatment.

Una década de tirotropina recombinante humana / A decade of recombinant human thyrotropin

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Paraganglioma de vesícula biliar / Paraganglioma of the gallbladder

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