Treatment‐Free Remission in Chronic Phase Chronic Myeloid Leukemia After Nilotinib De‐Escalation: 96‐Week Update of the DANTE Study
Year: 2025
Type: article
Study design: Clinical Trial
Abstract: Treatment-free remission (TFR) in chronic myeloid leukemia (CML) can be considered for patients in sustained deep molecular response (DMR) who can discontinue tyrosine kinase inhibitors (TKIs) while maintaining responses. Studies suggest that TKI de-escalation before TFR is feasible. This phase II study evaluated nilotinib de-escalation outcomes in adults with CML in chronic phase (CP) treated with first-line nilotinib for ≥ 3 years and in sustained DMR for ≥ 1 year. The study had four phases: screening, de-escalation (week 0-48), TFR (week 48-144) and follow-up. During de-escalation, patients received nilotinib 300 mg once daily, and those with sustained DMR entered TFR and discontinued nilotinib. Patients with major molecular response (MMR) but without sustained DMR continued nilotinib. At the data cut-off, 107 patients entered, and 98 (91.6%) completed de-escalation. TFR was entered by 90 patients (84.1%) with sustained DMR. At 96 weeks, 71/107 patients (66.4%) were in full TFR; 64/90 patients (71.1%) who entered TFR remained in ≥ MMR, and the median time-to-loss of MMR was not reached. During TFR, adverse events occurred in 64 patients (71.1%), including one serious event (pneumonia). Our data suggest that the de-escalation of nilotinib before a TFR attempt in CML-CP patients with sustained DMR can be a successful dose optimization strategy.
Source: Hematological Oncology
DOI: 10.1002/hon.70126
Authors: Alessandra Iurlo, Massimo Breccia, Fabio Stagno, Elisabetta Abruzzese, Fabrizio Pane, Immacolata Attolico, Paolo Sportoletti, Marco Cerrano, Sara Galimberti, Barbara Scappini, Maurizio Miglino, Sergio Siragusa, Isabella Capodanno, Diletta Valsecchi, Aurelio Pio Nardozza, Alessandra Misto, Paola Coco, Giuseppe Saglio, Gianantonio Rosti
Institutions: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Policlinico Umberto I, Sapienza University of Rome, University of Messina, Azienda Ospedaliera Universitaria Policlinico "G. Martino", ASL Roma, St. Eugenio Hospital, Federico II University Hospital, University of Naples Federico II, University of Bari Aldo Moro, University of Perugia, Azienda Ospedaliera Citta' della Salute e della Scienza di Torino, University of Pisa, Azienda Ospedaliero-Universitaria Careggi, University of Florence, Ospedale Policlinico San Martino, University of Palermo, Azienda Sanitaria Unità Locale di Reggio Emilia, Novartis (Italy), University of Turin, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori
Language: English
Subfield: Hematology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,650
OpenAlex ID: W4413051684