A fixed-duration, measurable residual disease–guided approach in CLL: follow-up data from the phase 2 ICLL-07 FILO trial
- Type de publi. : Article dans une revue
- Date de publi. : 25/02/2021
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Auteurs :
Anne-Sophie MichalletRémi LetestuMagali Le Garff-TavernierCarmen AaneiMichel TicchioniMarie-Sarah DilhuydyFabien SubtilValerie RouilleBeatrice MaheKamel LaribiBruno VillemagneGilles André SallesOlivier TournilhacAlain DelmerChristelle PortoisBrigitte PegourieVeronique LeblondCécile TomowiakSophie de GuibertFrederique Orsini PiocelleAnne BanosPhilippe CarassouGuillaume CartronLuc-Matthieu ForneckerLoic YsebaertCaroline DartigeasMalgorzata Truchan-GraczykJean-Pierre VilqueThérèse AurranFlorence CymbalistaStéphane LepretreVincent LevyFlorence Nguyen-KhacPierre Feugier
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Organismes :
Centre Léon Bérard [Lyon]
Service d'hématologie biologique [Avicenne]
CHU Pitié-Salpêtrière [AP-HP]
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
Centre Hospitalier Universitaire de Nice
Centre Hospitalier Universitaire de Bordeaux
Hospices Civils de Lyon
Laboratoire de Biométrie et Biologie Evolutive - UMR 5558
Service de Biostatistiques [Lyon]
Centre Hospitalier Régional Universitaire [Montpellier]
Centre Hospitalier Universitaire de Nantes = Nantes University Hospital
Centre Hospitalier Le Mans (CH Le Mans)
Centre Hospitalier Départemental - Hôpital de La Roche-sur-Yon
Hospices Civils de Lyon
CHU Clermont-Ferrand
Service d'hématologie [Reims]
Centre Hospitalier Universitaire de Saint-Etienne [CHU Saint-Etienne]
Centre Hospitalier Universitaire [CHU Grenoble]
CHU Pitié-Salpêtrière [AP-HP]
Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Centre Hospitalier Annecy-Genevois [Saint-Julien-en-Genevois]
Centre Hospitalier de la Côte Basque
Centre hospitalier régional de Metz-Thionville
Centre Hospitalier Régional Universitaire [Montpellier]
Université de Montpellier
Centre Hospitalier Universitaire [Strasbourg]
Centre Hospitalier Universitaire de Toulouse
Service Hématologie - IUCT-Oncopole [CHU Toulouse]
Centre de Recherches en Cancérologie de Toulouse
Service d'hématologie [Tours]
Centre Hospitalier Universitaire d'Angers
Laboratoire d'Hématologie Biologique [CHU Caen]
Institut Paoli-Calmettes
Service d'hématologie biologique [Avicenne]
Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen
Unité de recherche clinique [Avicenne]
CHU Pitié-Salpêtrière [AP-HP]
Service d'Hématologie [CHRU Nancy]
Nutrition-Génétique et Exposition aux Risques Environnementaux
- Publié dans Blood le 28/10/2020
Résumé : Abstract 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 (ICLL07 FILO) 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; 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 every 3 month and peripheral blood MRD every 6 months. 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. This trial was registered at www.clinicaltrials.gov as #NCT02666898.
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