A fixed-duration, measurable residual disease-guided approach in CLL: follow-up data from the phase 2 ICLL-07 FILO trial.
Fiche publication
Date publication
novembre 2020
Journal
Blood
Auteurs
Membres identifiés du Cancéropôle Est :
Pr FEUGIER Pierre, Pr FORNECKER Luc-Matthieu
Tous les auteurs :
Michallet AS, Letestu R, Le Garff-Tavernier M, Aanei CM, Ticchioni M, Dilhuydy MS, Subtil F, Rouille V, Mahe B, Laribi K, Villemagne B, Salles GA, Tournilhac O, Delmer AJ, Portois C, Pegourie B, Leblond V, Tomowiak C, De Guibert S, Orsini Piocelle F, Banos A, Carassou P, Cartron G, Fornecker LM, Ysebaert L, Dartigeas C, Truchan-Graczyk M, Vilque JP, Aurran T, Cymbalista F, Lepretre S, Levy V, Nguyen-Khac F, Feugier P
Lien Pubmed
Résumé
Trials assessing first-line, fixed-duration approaches in chronic lymphocytic leukemia (CLL) are yielding promising activity, but few long-term data are available. We report follow-up data from a phase 2 trial (ICLL-07 FILO; NCT02666898) in previously untreated, medically-fit patients (N=135). Patients underwent obinutuzumab-ibrutinib induction for 9 months; then, following evaluation (N=130 evaluable), those in complete remission and with bone marrow measurable residual disease (BM MRD) <0.01% (n=10) received ibrutinib for 6 additional months, while those in partial remission and/or with BM MRD ≥0.01% - the majority (n=120) - also received 4 cycles of immunochemotherapy (fludarabine/cyclophosphamide-obinutuzumab). Beyond end of treatment, responses were assessed 3 monthly and peripheral blood MRD 6 monthly. At median follow-up 36.7 months from treatment start, progression-free and overall survival rates (95% confidence interval) at 3 years were 95.7% (92.0 to 99.5) and 98% (95.1 to 100), respectively. Peripheral blood MRD <0.01% rates were 97%, 96%, 90%, 84%, and 89% at months 16, 22, 28, 34, and 40, respectively. No new treatment-related or serious adverse event occurred beyond end of treatment. Thus, in previously untreated, medically-fit patients with CLL, a fixed-duration (15 months), MRD-guided approach achieved high survival rates, a persistent MRD benefit beyond the end of treatment, and low long-term toxicity.
Référence
Blood. 2020 Nov 9;: