2026-04-14T02:29:36Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/133982025-07-13T07:41:54Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Garcia-Manero, Guillermo
author
SANTINI, VALERIA
author
Zeidan, Amer
author
Komrokji, Rami S.
author
Pozharskaya, Veronika
author
Rose, Shelonitda
author
VALCARCEL, DAVID
2025-07-13T07:41:54Z
2025-07-13T07:41:54Z
2025-07-11T07:18:51Z2025-07-11T07:18:51Z2025-07
http://hdl.handle.net/11351/13398
Epoetin alfa; Erythroid-stimulating agents; Myelodysplastic syndromesEpoetina alfa; Agentes estimulantes de eritroides; Síndromes mielodisplásicosEpoetina alfa; Agents estimulants d'eritroides; Síndromes mielodisplàsiquesIntroduction
The efficacy of erythropoiesis-stimulating agents (ESAs) for transfusion-dependent (TD) anemia in lower-risk myelodysplastic syndromes (LR-MDS) is limited. Luspatercept achieved significantly greater rates of red blood cell (RBC) transfusion independence (TI) versus epoetin alfa (an ESA) in the phase 3 COMMANDS trial. This analysis assessed long-term RBC-TI, cumulative response, and safety with luspatercept in COMMANDS.
Methods
Eligible patients aged ≥ 18 years, with ESA-naive, RBC TD LR-MDS were randomized 1:1 to receive luspatercept (1.0 mg/kg, titration to 1.75 mg/kg permitted) or epoetin alfa (450 IU/kg, titration to 1050 IU/kg). Disease assessment was carried out at week 24 (day 169) and every 24 weeks thereafter. Treatment continued until disease progression, lack of clinical benefit, unacceptable toxicity, or consent withdrawal.
Results
At data cutoff (September 22, 2023; median follow-up: luspatercept 21.4 months, epoetin alfa 20.3 months), a greater proportion of patients treated with luspatercept (n = 182) versus epoetin alfa (n = 181) achieved a longest single RBC-TI period ≥ 1 year (44.5% vs. 27.6%; P = 0.0003) and ≥ 1.5 years (30.2% vs. 13.8%; P < 0.0001). Higher rates of RBC-TI ≥ 1.5 years with luspatercept over epoetin alfa were consistent across all prespecified subgroups, including patients with ring sideroblast-negative status and low baseline serum erythropoietin. Longer cumulative RBC-TI response [sum of all durations of RBC-TI for ≥ 12 weeks; week 1 to end of treatment (95% CI)] was observed with luspatercept [154.7 weeks (118.4–NR)] versus epoetin alfa [91.1 weeks (73.1–123.9)]. Rates of treatment-emergent adverse events, including asthenia and hypertension, generally decreased over time in both arms. Progression rates to high-risk MDS and acute myeloid leukemia were similarly low (< 5%) in both treatment arms.
Conclusions
These data demonstrated sustained, durable clinical benefit across subgroups and support luspatercept as the treatment of choice for anemia in patients with LR-MDS who are TD and ESA-naive.
Trial Registration Number
NCT03682536.The study was supported by Celgene, a Bristol-Myers Squibb Company, in collaboration with Acceleron Pharma Inc., a wholly-owned subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Study drugs were provided by Bristol Myers Squibb (Princeton, NJ, USA). Rapid Service Fees for publication were funded by Bristol Myers Squibb (Princeton, NJ, USA).
Attribution-NonCommercial 4.0 International http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess
Síndromes mielodisplàsiques - Tractament
Anèmia - Tractament
Sang - Transfusió
Eritropoetina
DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Bone Marrow Diseases::Myelodysplastic Syndromes
Other subheadings::Other subheadings::/therapy
DISEASES::Hemic and Lymphatic Diseases::Hematologic Diseases::Anemia
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Peptides::Intercellular Signaling Peptides and Proteins::Cytokines::Hematopoietic Cell Growth Factors::Colony-Stimulating Factors::Erythropoietin::Epoetin Alfa
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Blood Transfusion
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Biological Therapy::Blood Transfusion::Blood Component Transfusion::Erythrocyte Transfusion
ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::enfermedades de la médula ósea::síndromes mielodisplásicos
Otros calificadores::Otros calificadores::/terapia
ENFERMEDADES::enfermedades hematológicas y linfáticas::enfermedades hematológicas::anemia
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::péptidos::péptidos y proteínas de señalización intercelular::citocinas::factores de crecimiento de células hematopoyéticas::factores estimulantes de colonias::eritropoyetina::epoetina alfa
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::transfusión sanguínea
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::terapia biológica::transfusión sanguínea::transfusión de componentes sanguíneos::transfusión de eritrocitos
Long-Term Transfusion Independence with Luspatercept Versus Epoetin Alfa in Erythropoiesis-Stimulating Agent-Naive, Lower-Risk Myelodysplastic Syndromes in the COMMANDS Trial
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion