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Kubasch, Anne Sophie; Giagounidis, Aristoteles; Metzgeroth, Georgia; Jonasova, Anna; Herbst, Regina; Diaz, Jose Miguel Torregrosa; De Renzis, Benoit; Götze, Katharina S.; Huetter-Kroenke, Marie-Luise; Gourin, Marie-Pierre; Slama, Borhane; Dimicoli-Salazar, Sophie; Cony-Makhoul, Pascale; Laribi, Kamel; Park, Sophie; Jersemann, Katja; Schipp, Dorothea; Metzeler, Klaus H.; Tiebel, Oliver; Sockel, Katja; Gloaguen, Silke; Mies, Anna; Chermat, Fatiha; Thiede, Christian; [...]

Prospective validation of a biomarker-driven response prediction model to romiplostim in lower-risk myelodysplastic neoplasms – results of the EUROPE trial by EMSCO

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  • Medientyp: E-Artikel
  • Titel: Prospective validation of a biomarker-driven response prediction model to romiplostim in lower-risk myelodysplastic neoplasms – results of the EUROPE trial by EMSCO
  • Beteiligte: Kubasch, Anne Sophie; Giagounidis, Aristoteles; Metzgeroth, Georgia; Jonasova, Anna; Herbst, Regina; Diaz, Jose Miguel Torregrosa; De Renzis, Benoit; Götze, Katharina S.; Huetter-Kroenke, Marie-Luise; Gourin, Marie-Pierre; Slama, Borhane; Dimicoli-Salazar, Sophie; Cony-Makhoul, Pascale; Laribi, Kamel; Park, Sophie; Jersemann, Katja; Schipp, Dorothea; Metzeler, Klaus H.; Tiebel, Oliver; Sockel, Katja; Gloaguen, Silke; Mies, Anna; Chermat, Fatiha; Thiede, Christian; [...]
  • Erschienen: Springer Science and Business Media LLC, 2022
  • Erschienen in: Leukemia
  • Sprache: Englisch
  • DOI: 10.1038/s41375-022-01669-z
  • ISSN: 0887-6924; 1476-5551
  • Schlagwörter: Oncology ; Cancer Research ; Hematology
  • Entstehung:
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  • Beschreibung: <jats:title>Abstract</jats:title><jats:p>The EUROPE phase 2 trial investigated the predictive value of biomarkers on the clinical efficacy of single agent romiplostim (ROM) treatment in patients with lower-risk myelodysplastic neoplasms (LR-MDS) and thrombocytopenia within the ‘European Myelodysplastic Neoplasms Cooperative Group‘ (EMSCO) network. A total of 77 patients with LR-MDS and a median platelet count of 25/nl were included, all patients received ROM at a starting dose of 750 μg by SC injection weekly. Thirty-two patients (42%) achieved a hematologic improvement of platelets (HI-P) with a median duration of 340 days. Neutrophil (HI-N) and erythroid (HI-E) responses were observed in three (4%) and seven (9%) patients, respectively. We could not confirm previous reports that HI-P correlated with baseline endogenous thrombopoietin levels and platelet transfusion history, but <jats:italic>SRSF2</jats:italic> mutation status and hemoglobin levels at baseline were significantly linked to HI-P. Sequential analysis of variant allelic frequency of mutations like <jats:italic>SRSF2</jats:italic> did not reveal an impact of ROM on clonal evolution in both responders and non-responders. In summary, our study confirms the safety and efficacy of ROM in LR-MDS patients and may allow to better define subgroups of patients with a high likelihood of response.</jats:p>