Decitabine Versus Hydroxyurea for Advanced Proliferative Chronic Myelomonocytic Leukemia: Results of a Randomized Phase III Trial Within the EMSCO Network - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Journal of Clinical Oncology Année : 2023

Decitabine Versus Hydroxyurea for Advanced Proliferative Chronic Myelomonocytic Leukemia: Results of a Randomized Phase III Trial Within the EMSCO Network

Valeria Santini
Sylvain Thepot
Lionel Ades
Aristoteles Giagounidis
Margot Morabito
  • Fonction : Auteur
Nathalie Droin
Michael Lübbert
  • Fonction : Auteur
Rosa Sapena
  • Fonction : Auteur
Stanislas Nimubona
  • Fonction : Auteur
Jean Goasguen
  • Fonction : Auteur
Eric Wattel
  • Fonction : Auteur
Gina Zini
Jose Miguel Torregrosa Diaz
Ulrich Germing
  • Fonction : Auteur
Anna Maria Pelizzari
  • Fonction : Auteur
Sophie Park
Nadja Jaekel
Georgia Metzgeroth
  • Fonction : Auteur
Francesco Onida
Robert Navarro
  • Fonction : Auteur
Andrea Patriarca
Aspasia Stamatoullas
Katharina Götze
Martin Puttrich
  • Fonction : Auteur
Sandra Mossuto
  • Fonction : Auteur
Silke Gloaguen
  • Fonction : Auteur
Fatiha Chermat
  • Fonction : Auteur
Uwe Platzbecker
Pierre Fenaux
  • Fonction : Auteur

Résumé

PURPOSE Hydroxyurea (HY) is a reference treatment of advanced myeloproliferative neoplasms. We conducted a randomized phase III trial comparing decitabine (DAC) and HY in advanced myeloproliferative chronic myelomonocytic leukemias (CMML). PATIENTS AND METHODS Newly diagnosed myeloproliferative CMML patients with advanced disease were randomly assigned 1:1 to intravenous DAC (20 mg/m 2 /d days 1-5) or HY (1-4 g/d) in 28-day cycles. The primary end point was event-free survival (EFS), events being death and acute myelomonocytic leukemia (AML) transformation or progression. RESULTS One-hundred seventy patients received DAC (n = 84) or HY (n = 86). Median age was 72 and 74 years, and median WBC count 32.5 × 10 9 /L and 31.2 × 10 9 /L in the DAC and HY arms, respectively. Thirty-three percent of DAC and 31% of HY patients had CMML-2. Patients received a median of five DAC and six HY cycles. With a median follow-up of 17.5 months, median EFS was 12.1 months in the DAC arm and 10.3 months in the HY arm (hazard ratio [HR], 0.83; 95% CI, 0.59 to 1.16; P = .27). There was no significant interaction between treatment effect and blast or platelet count, anemia, CMML Prognostic Scoring System, Groupe Francophone des Myelodysplasies, or CMML Prognostic Scoring System–mol risk. Fifty-three (63%) DAC patients achieved a response compared with 30 (35%) HY patients ( P = .0004). Median duration of response was similar in both arms (DAC, 16.3 months; HY, 17.4 months; P = .90). Median overall survival was 18.4 months in the DAC arm and 21.9 months in the HY arm ( P = .67). Compared with HY, DAC significantly reduced the risk of CMML progression or transformation to acute myelomonocytic leukemia (cause-specific HR, 0.62; 95% CI, 0.41 to 0.94; P = .005) at the expense of death without progression or transformation (cause-specific HR, 1.55; 95% CI, 0.82 to 2.9; P = .04). CONCLUSION Compared with HY, frontline treatment with DAC did not improve EFS in patients with advanced myeloproliferative CMML (ClinicalTrials.gov identifier: NCT02214407 ).
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Dates et versions

hal-04438497 , version 1 (05-02-2024)

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Raphael Itzykson, Valeria Santini, Sylvain Thepot, Lionel Ades, Cendrine Chaffaut, et al.. Decitabine Versus Hydroxyurea for Advanced Proliferative Chronic Myelomonocytic Leukemia: Results of a Randomized Phase III Trial Within the EMSCO Network. Journal of Clinical Oncology, 2023, 41 (10), pp.1888-1897. ⟨10.1200/JCO.22.00437⟩. ⟨hal-04438497⟩
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