Real-life comparison of Nilotinib versus Dasatinib as second-line therapy in chronic phase chronic myeloid leukemia patients

Introduction: Chronic myeloid leukemia (CML) is a rare hematologic malignancy whose management has been transformed by tyrosine kinase inhibitors (TKIs). After failure or intolerance to Imatinib, Dasatinib and Nilotinib are commonly used as second-line therapies. This study aimed to compare their tolerance and efficacy in real-world practice.

Patients and Methods: A retro-prospective study was conducted at the University Hospital of Oran (2013–2025), including 45 patients with chronic phase CML who switched from imatinib to a second-generation TKI (24 dasatinib, 21 nilotinib). Responses were assessed according to ELN 2020 and GAT-LMC criteria, toxicities were graded using CTCAE, and progression-free survival (PFS) and event-free survival (EFS) were analyzed using Kaplan-Meier.

Results and Discussion: The mean age was 45 years, and the main reason for switching was Imatinib resistance (84%). Regarding tolerance, Nilotinib was associated with metabolic and hepatobiliary toxicities (hyperbilirubinemia 19%),cutaneous toxicity (hyperkeratosis 19%), and cardiovascular toxicity (9.5%) , while Dasatinib was more frequently linked to anemia (25%) and pleural effusion (16.7%). Concerning molecular response, Nilotinib showed faster responses at 6 months (69% vs. 50% by ELN; 84.6% vs. 58.3% by GAT-LMC), but this trend reversed after 18 months, with better long-term response rates and persistence under Dasatinib. Survival analysis showed similar PFS between the two agents (101 months vs. 89.7 months; p = 0.880), while EFS favored Dasatinib (80 vs. 58.6 months). These findings suggest distinct response kinetics and safety profiles: Nilotinib induces earlier molecular responses but with more treatment interruptions, whereas Dasatinib ensures better long-term persistence.

Conclusion: In second-line therapy, Dasatinib and Nilotinib show comparable efficacy but distinct tolerance and response dynamics. Therapeutic choice should be individualized according to the patient’s clinical and comorbidity profile: Nilotinib may be preferred for rapid molecular control, while Dasatinib appears better suited for long-term consolidation. These results highlight the importance of personalized follow-up in the management of CML in Algeria.