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Real-life comparison of nilotinib versus dasatinib as second-line therapy in chronic phase chronic myeloid leukemia
Emilia Scalzulli1, Giovanni Caocci2, Fabio Efficace3
1Hematology, Department of Translational and Precision Medicine, Policlinico Umberto 1, Sapienza University, Rome, Italy.
Abstract:
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.
Insights
In chronic myeloid leukemia, dasatinib and nilotinib show similar effectiveness as second-line treatments after imatinib failure. Both tyrosine kinase inhibitors offer high molecular response rates with manageable side effects in real-world settings.
Area of Science:
- Hematology
- Oncology
- Pharmacology
Background:
- Tyrosine kinase inhibitors (TKIs) are standard for chronic phase chronic myeloid leukemia (CP-CML).
- Over 20% of CP-CML patients experience treatment failure due to resistance or intolerance to front-line therapy.
- Real-world data comparing second-line dasatinib and nilotinib is limited.
Purpose of the Study:
- To compare the efficacy and safety of dasatinib versus nilotinib as second-line therapy in CP-CML patients who failed imatinib.
- To evaluate molecular response rates and overall survival in a real-life setting.
Main Methods:
- Retrospective analysis of 131 CP-CML patients with imatinib failure.
- Patients received either nilotinib (59) or dasatinib (72) as second-line treatment.
- Data collected on treatment duration, reasons for switching, molecular response, and adverse events.
Main Results:
- Overall survival at 7 years was 78.9% (dasatinib 72%, nilotinib 85.6%).
- After 12 months, major molecular response rates were 47% with dasatinib and 38% with nilotinib (not significant).
- Grade 3-4 adverse events occurred in 35% of patients, more frequently with dasatinib (47%) than nilotinib (22%).
Conclusions:
- Dasatinib and nilotinib demonstrate comparable efficacy as second-line treatments for CP-CML in a real-world setting.
- Both TKIs achieve high molecular response rates with acceptable tolerability.
- Treatment choice may consider individual patient factors and tolerability profiles.
