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- Title
CML-227: Pilot Study on a Response-Directed Switch from Nilotinib to Imatinib in Newly Diagnosed Chronic Myeloid Leukemia.
- Authors
Dalle, Iman Abou; Ibrahim, Ali; MahfouzDepartment of Pathology and Laboratory Medicine,American University of Beirut Medical Center, Beirut, Lebanon, Rami; Cheikh, Jean El; Bazarbachi, Ali
- Abstract
The frontline treatment of chronic phase (CP) chronic myeloid leukemia (CML) with nilotinib has resulted in a higher rate of major molecular response (MMR) and complete cytogenetic response (CCyR) at 12 months compared to imatinib but at a higher cumulative cost and increased risk of serious adverse events. A treatment strategy aimed at maintaining long-term efficacy while minimizing both toxicities and costs is needed. The aim of the study is to evaluate the efficacy and safety of a response-directed switch from nilotinib to imatinib in patients newly diagnosed with CP-CML. This is a single-center, prospective, pilot phase 2 open-label study including adult patients newly diagnosed with CP-CML screened and treated at the American University of Beirut Medical Center in Lebanon. Patients were treated with nilotinib 300 mg orally twice daily for 12 months, and those who achieved CCyR were shifted to imatinib 400 mg orally daily, with regular follow-ups at 3, 6, 12 months, and then every 6 months thereafter. The primary endpoint was to evaluate the efficacy of imatinib in maintaining cytogenetic and molecular responses achieved at 12 months after nilotinib treatment in at least 85% of patients. Thirteen patients were enrolled in the study. Eleven patients completed one year of nilotinib and switched to imatinib 400 mg daily as per protocol. At 3 months, all patients achieved complete hematologic response, with 7 (54%) patients having early molecular response. At 12 months, all patients achieved CCyR, of whom 5 (45%) and 4 (36%) patients achieved MMR and MR4.5, respectively. Three (27%) patients switched back to nilotinib after 18, 24, and 51 months, respectively: one patient lost CCyR after 18 months, and two patients were imatinib-intolerant. After a median follow-up of 60 months, all patients (n=12) were alive and in MMR, 6 (50%) of them in continuous MR4.5. No new safety concerns emerged in the study. These findings suggest that a response-directed switch from nilotinib to imatinib at 12 months is capable of maintaining long-term CCyR, with manageable side effects. This approach warrants further exploration with larger prospective trials.
- Publication
Clinical Lymphoma, Myeloma & Leukemia, 2021, Vol 21, pS330
- ISSN
2152-2650
- Publication type
Article
- DOI
10.1016/S2152-2650(21)01774-2