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


Tyrosine kinase inhibitors (TKIs), the backbone of treatment for chronic phase chronic myeloid leukemia patients (CP-CML), have changed the long-term outcome of the disease. Nonetheless, over 20% of patients fail front-line therapy due to intolerance or resistance. A head-to-head comparison of dasatinib and nilotinib as second-line treatment outside of sponsored clinical trials has not been reported. We retrospectively analyzed 131 CP-CML patients who, after front-line imatinib failure, switched to a second-line therapy with nilotinib (59, 45%) or dasatinib (72, 55%). Median duration of second-line treatment was 33 months (range 2–100). The reason for switching therapy was resistance in 83.2% and intolerance in 16.8% of patients. The overall survival of the entire cohort at 7 years was 78.9%, while it was 72% and 85.6% for patients treated with dasatinib and nilotinib, respectively (p=0.287). With regard to efficacy after 12 months of treatment, 108 patients were evaluable for molecular response: 47% achieved a major molecular response and 18.2% a deep molecular response with dasatinib, compared to 38% and 16.2% with nilotinib (p=ns). We observed 35% of grade 3–4 adverse events, more frequently in the dasatinib group (47%) compared to the nilotinib group (22%), without affecting molecular responses. Our study suggests that, in the real-life setting, dasatinib and nilotinib used as second-line treatment in CP-CML are equally effective, with high molecular response rates and an acceptable tolerability.

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Authors and Affiliations



GC, LR, GC, ADP, SP, IC, and RL collected data; DAF analyzed and produced statistical reports; DD performed the molecular analysis; GLN, MM, RF, and FE critically revised the paper; and ES and MB collected data and finalized and wrote the manuscript.

Corresponding author

Correspondence to Massimo Breccia.

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Ethical approval

All procedures performed in studies involving human participants were in accordance with the ethical standards of the responsible institution and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Formal consent was obtained.

Conflict of interest

MB received honoraraia by Novartis, Pfizer, Incyte, BMS/Celgene, and AbbVie; FE reports personal fees from AbbVie, Bristol Myers Squibb, Orsenix, and Takeda; and grants (awarded to his institution) and personal fees from Amgen, outside the submitted work. MM received honoraria for advisory board outside of CML programs by Novartis, Roche, Gilead, Takeda, Janssen, and Celgene. All the other authors reported no conflict of interests.

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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 100, 1213–1219 (2021).

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  • Chronic myeloid leukemia
  • Tyrosine-kinase inhibitor
  • Nilotinib
  • Dasatinib
  • Second-line treatment