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.

Real-life comparison of nilotinib versus dasatinib as second-line therapy in chronic phase chronic myeloid leukemia patients / Scalzulli, E.; Caocci, G.; Efficace, F.; Rizzo, L.; Colafigli, G.; Di Prima, A.; Pepe, S.; Fegatelli, D. A.; Carmosino, I.; Diverio, D.; Latagliata, R.; La Nasa, G.; Martelli, M.; Foa, R.; Breccia, M.. - In: ANNALS OF HEMATOLOGY. - ISSN 0939-5555. - 100:5(2021), pp. 1213-1219. [10.1007/s00277-021-04477-0]

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

Scalzulli E.;Efficace F.;Rizzo L.;Colafigli G.;Pepe S.;Carmosino I.;Latagliata R.;Martelli M.;Foa R.;
2021

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.
2021
Chronic myeloid leukemia; Dasatinib; Nilotinib; Second-line treatment; Tyrosine-kinase inhibitor; Adult; Aged; Aged, 80 and over; Antineoplastic Agents; Dasatinib; Drug Resistance, Neoplasm; Female; Humans; Imatinib Mesylate; Leukemia, Myeloid, Chronic-Phase; Male; Middle Aged; Protein Kinase Inhibitors; Pyrimidines; Retrospective Studies; Survival Analysis; Treatment Outcome; Young Adult
01 Pubblicazione su rivista::01a Articolo in rivista
Real-life comparison of nilotinib versus dasatinib as second-line therapy in chronic phase chronic myeloid leukemia patients / Scalzulli, E.; Caocci, G.; Efficace, F.; Rizzo, L.; Colafigli, G.; Di Prima, A.; Pepe, S.; Fegatelli, D. A.; Carmosino, I.; Diverio, D.; Latagliata, R.; La Nasa, G.; Martelli, M.; Foa, R.; Breccia, M.. - In: ANNALS OF HEMATOLOGY. - ISSN 0939-5555. - 100:5(2021), pp. 1213-1219. [10.1007/s00277-021-04477-0]
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11573/1617963
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