Dasatinib and nilotinib are effective second-line therapies for patients with chronic phase chronic myeloid leukemia (CP-CML) based on real-world data published in Annals of Hematology.

More than 20% of patients with CML fail first-line therapy with tyrosine kinase inhibitors (TKIs) because of intolerance or resistance. Dasatinib and nilotinib have been evaluated in sponsored clinical trials, but not in a head-to-head comparison as second-line treatment.

The current study did a head-to-head comparison of the 2 treatments as second-line therapy using real-world data of 131 patients with CP-CML. 83.2% of patients switched to second-line therapy because of failure with imatinib, and 16.8% switched because of intolerance.

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A total of 72 patients received dasatinib, and 59 patients received nilotinib. Patients receiving dasatinib had an overall survival (OS) and progression-free survival (PFS) of 72%, compared with 85.6% and 84.1% for patients receiving nilotinib. The differences in outcomes were not significant.

Patients were on second-line therapy for a median duration of 33 months, with a 7-year OS of 78.9% and a PFS of 78.3% for the entire cohort. Patients at higher risk had lower OS and PFS.

At 6 months, 30.7% of patients receiving dasatinib achieved a major molecular response (MMR), and 13.8% achieved a deep molecular response (DMR). Of those receiving nilotinib, 27.2% achieved an MMR and 10.1% achieved a DMR. A total of 108 patients were evaluated at 12 months; 47% had a MMR with dasatinib, compared to 38% with nilotinib. A total of 18.2%of patients achieved DMR with dasatinib versus 16.6% with nilotinib. Differences in molecular response between the 2 treatments was not significant.

Patients who did not achieve an MMR or DMR had a poorer prognosis than patients who achieved MMR or DMR with either treatment.

Adverse events were more frequent with dasatinib (71%) compared to nilotinib (29%) (P =.003). A total of 35% of patients had a grade 3 adverse event, with pleural and pericardial effusions being most common. 

The authors concluded that dasatinib and nilotinib are similarly effective and associated with high molecular response rates and long-term survival.

Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.


Scalzulli E, Caocci G, Efficace F, et al. Real-life comparison of nilotinib versus dasatinib as second-line therapy in chronic phase chronic myeloid leukemia patients. Ann Hematol. Published online March 7, 2021. doi:10.1007/s00277-021-04477-0