Dose/schedule-adjusted Rd-R vs continuous Rd for elderly, intermediate-fit patients with newly diagnosed multiple myeloma
| Autor: | Monica Galli, Federico Monaco, Sara Bringhen, Roberto Marasca, Mario Boccadoro, Giulia Benevolo, Nicola Cascavilla, Francesca Patriarca, Claudia Cellini, Annalisa Bernardini, Elisabetta Antonioli, Alessandra Pompa, Gianluca Gaidano, Nicola Giuliani, Tommaso Caravita di Toritto, Delia Rota-Scalabrini, Andrea Capra, Massimo Offidani, Francesca Bonello, Patrizia Tosi, Mattia D'Agostino, Alessandra Larocca, Paola Tacchetti, Paolo Corradini |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Male
medicine.medical_specialty Immunology Phases of clinical research Neutropenia Biochemistry Gastroenterology Dexamethasone Disease-Free Survival Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Lenalidomide Aged Aged 80 and over business.industry Standard treatment Hazard ratio Cell Biology Hematology medicine.disease Confidence interval Discontinuation Survival Rate Female business Multiple Myeloma medicine.drug Follow-Up Studies |
| Popis: | Lenalidomide-dexamethasone (Rd) is standard treatment for elderly patients with multiple myeloma (MM). In this randomized phase 3 study, we investigated efficacy and feasibility of dose/schedule-adjusted Rd followed by maintenance at 10 mg per day without dexamethasone (Rd-R) vs continuous Rd in elderly, intermediate-fit newly diagnosed patients with MM. Primary end point was event-free survival (EFS), defined as progression/death from any cause, lenalidomide discontinuation, or hematologic grade 4 or nonhematologic grade 3 to 4 adverse event (AE). Of 199 evaluable patients, 101 received Rd-R and 98 continuous Rd. Median follow-up was 37 months. EFS was 10.4 vs 6.9 months (hazard ratio [HR], 0.70; 95% confidence interval [CI], 0.51-0.95; P = .02); median progression-free survival, 20.2 vs 18.3 months (HR, 0.78; 95% CI, 0.55-1.10; P = .16); and 3-year overall survival, 74% vs 63% (HR, 0.62; 95% CI, 0.37-1.03; P = .06) with Rd-R vs Rd, respectively. Rate of ≥1 nonhematologic grade ≥3 AE was 33% vs 43% (P = .14) in Rd-R vs Rd groups, with neutropenia (21% vs 18%), infections (10% vs 12%), and skin disorders (7% vs 3%) the most frequent; constitutional and central nervous system AEs mainly related to dexamethasone were more frequent with Rd. Lenalidomide was discontinued for AEs in 24% vs 30% and reduced in 45% vs 62% of patients receiving Rd-R vs Rd, respectively. In intermediate-fit patients, switching to reduced-dose lenalidomide maintenance without dexamethasone after 9 Rd cycles was feasible, with similar outcomes to standard continuous Rd. This trial was registered at www.clinicaltrials.gov as #NCT02215980. |
| Databáze: | OpenAIRE |
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