Dasatinib plus Peg-Interferon alpha 2b combination in newly diagnosed chronic phase chronic myeloid leukaemia: Results of a multicenter phase 2 study (DASA-PegIFN study).

Fiche publication

Date publication

octobre 2022

Journal

British journal of haematology

Auteurs

Membres identifiés du Cancéropôle Est :
Dr GUERCI-BRESLER Agnès , Dr AME Shanti

Tous les auteurs :
Roy L, Chomel JC, Guilhot J, Guerci-Bresler A, Escoffre-Barbe M, Giraudier S, Charbonnier A, Dubruille V, Huguet F, Johnson-Ansah H, Lenain P, Ame S, Etienne G, Nicolini FE, Rea D, Cony-Makhoul P, Courby S, Ianotto JC, Legros L, Machet A, Coiteux V, Hermet E, Cayssials E, Bouchet S, Mahon FX, Rousselot P, Guilhot F,

Lien Pubmed

https://www.ncbi.nlm.nih.gov/pubmed/36214090

Résumé

Superior rates of deep molecular response (DMR) have been reported with the combination of tyrosine kinase inhibitors and pegylated-interferon-alpha (Peg-IFN) in patients with newly diagnosed chronic phase-chronic myeloid leukaemia (CP-CML). In this setting, this study investigated the efficacy and safety of dasatinib combined to Peg-IFN-α2b (Dasa-PegIFN, NCT01872442). A total of 79 patients (age ≤65 years) started dasatinib; 61 were eligible for Peg-IFNα-2b add-on therapy at month 3 for a maximum 21-months duration. Dasatinib was continued thereafter. The primary endpoint was the cumulative rate of molecular response 4.5 log (MR ) by 12 months. The results are reported for the 5-year duration of the study. Grade 3 neutropenia was frequent with the combination but did not induce severe infection (one of grade 3). Other adverse events were generally low grade (4% of grade 3-4) and expected. Seventy-nine per cent and 61% of patients continued the Peg-IFN until months 12 and 24, respectively. Overall, at these time points, MR rates were 25% and 38%, respectively. Thereafter, 32% and 46% of patients achieved a sustained (≥2 years) MR or MR , respectively. This work established the feasibility and high rates of achievement of early and sustained DMR (a prerequisite for treatment-free-remission) with dasatinib and Peg-IFNα-2b combination as initial therapy.