RESUMEN
Idecabtagene vicleucel (ide-cel), a chimeric antigen receptor T-cell therapy targeting B-cell maturation antigen (BCMA), received early access program (EAP) authorization in France in April 2021 for relapsed/refractory multiple myeloma (RRMM). We conducted a real-world registry-based multicentre observational study in 11 French hospitals to evaluate ide-cel outcomes. Data from 176 RRMM patients who underwent apheresis between June 2021 and November 2022 were collected from the French national DESCAR-T registry. Of these, 159 patients (90%) received ide-cel. Cytokine release syndrome occurred in 90% with 2% grade ≥3, and neurotoxicity occurred in 12% with 3% grade ≥3. Over the first 6 months, the best overall response and ≥complete response rates were 88% and 47% respectively. The median progression-free survival (PFS) from the ide-cel infusion was 12.5 months, the median overall survival (OS) was 20.8 months and the estimated OS rate at 12 months was 73.3%. Patients with extra-medullary disease (EMD) had impaired PFS (6.2 months vs. 14.8 months). On multivariable analysis, EMD and previous exposure to BCMA-targeted immunoconjugate or T-cell-redirecting GPRC5D bispecific antibody were associated with inferior PFS. Our study supports ide-cel's feasibility, safety and efficacy in real-life settings, emphasizing the importance of screening for EMD and considering prior treatments to optimize patient selection.
Asunto(s)
Inmunoterapia Adoptiva , Mieloma Múltiple , Sistema de Registros , Humanos , Mieloma Múltiple/terapia , Masculino , Femenino , Persona de Mediana Edad , Anciano , Francia , Inmunoterapia Adoptiva/efectos adversos , Inmunoterapia Adoptiva/métodos , Adulto , Antígeno de Maduración de Linfocitos B/inmunología , Anciano de 80 o más Años , Receptores Quiméricos de Antígenos/uso terapéuticoRESUMEN
INTRODUCTION: Pneumonia is one of the most common indications for antibiotic. Shortening the duration of antibiotic therapy should help reduce bacterial resistance. To date, three randomized control trials have shown non-inferiority of short courses of antibiotic therapy (3 days) compared with 7 days in non-severe pneumonia. The aim of this study was to assess this strategy in real life. METHOD: This retrospective observational cohort study included all patients with pneumonia hospitalized in an internal medical ward from 11/01/2022 to 05/31/2023. We implemented the strategy based on early discontinuation of antibiotic therapy in patients with pneumonia who were clinically stable after 3 days of ß-lactam treatment. RESULTS: Among 49 patients included, median age was 72, median antibiotic duration was 4 days (IQR 3-6), and cure rate at D30 was 88 %. At day 30, we observed one death (2 %), four new antibiotic therapy (9 %), and two new hospitalisation (5 %), among five immunosuppressed patients. Among immunosuppressed patients (n=17; 35 %), failure rate was three times higher in case of short antibiotic courses (3/8; 38 %) than long antibiotic courses (1/7; 14 %). CONCLUSION: Strategy based on early discontinuation of antibiotic therapy in immunocompetent patients with pneumonia who were clinically stable after 3 days of ß-lactam treatment is safe, and easy to implement in a medical ward.