Real-World Comparison of Dasatinib and Nilotinib as Second-Line Therapy for Chronic Phase Chronic Myeloid Leukemia
Dasatinib and nilotinib demonstrated comparable efficacy as second-line therapies for patients with chronic phase chronic myeloid leukemia (CML-CP), according to results from a real-world analysis published in Hematology.
Previous research has shown efficacy for both dasatinib and nilotinib for the treatment of CML-CP, however there is no direct comparison between the two tyrosine kinase inhibitors (TKIs). Researchers aimed to assess real-world data to compare the efficacy and tolerability of dasatinib and nilotinib as second line therapies.
The primary end points were achievement of major molecular response (MMR) at 12 months, 5-year cumulative incidence of treatment failure, and overall survival (OS). Overall, data from 73 patients with CML-CP who received was included. Patients received either dasatinib (n = 34) or nilotinib (n = 39) as second-line treatment. The median age among patients was 50 years (range; 27 to 90). Among both groups, majority of patients experienced prior imatinib failure as a first line therapy (85.3% vs 84.6%, respectively).
At 12 months, MMR achievement was higher among patients treated with dasatinib (73.5%) compared with patients treated with nilotinib (76.9%). Treatment failure was reported by 2 patients in the nilotinib group. Of patients with MMR, the 5-year cumulative probability of treatment failure was 0% with dasatinib and 7.6% with nilotinib (P= 0.25). The eight-year OS was 82.7% for the dasatinib group and 86.3% for the nilotinib group (p = 0.90).
The median follow-up for both therapies was slightly longer for the nilotinib group (8 years; range, 2 to 15) than the dasatinib group (7.5 years; range, 1 to 17). As for survival, median OS was not reached in either group. At 8 years, the OS for patients treated with dasatinib was 82.7% (95% CI, 62.9 to 92.5) which was slightly lower than patients treated with nilotinib (86.3%; 95% CI, 70.0 to 94.1; P= .90).
In terms of safety, 11 patients discontinued treatment with dasatinib and 6 patients discontinued treatment with nilotinib. The most common reason for treatment discontinuation for the dasatinib group was pleaural effusions (n = 7) while cardiovascular and thrombotic events were more frequent among the nilotinib group.
“Dasatinib and nilotinib have comparable efficacy in real-life comparison,” the researchers concluded.
Source:
Tayfur Toptas, et al. “Second-line use of dasatinib and nilotinib in a real-world patient population with chronic phase chronic myeloid leukemia.” Hematology. Published online March 17, 2025. doi: 10.1080/16078454.2025.2478344.
