Chronic myeloid leukemia (CML) treatment is based on company-sponsored and academic trials testing different tyrosine kinase inhibitors (TKIs) as first-line therapy. These studies included patients selected according to many inclusion–exclusion criteria, particularly age and comorbidities, with specific treatment obligations. In daily clinical practice (real-life), inclusion–exclusion criteria do not exist, and the treatment outcome does not only depend on the choice of first-line TKI but also on second- and third-line TKIs. To investigate in a real-life setting the response and the outcome on first-line imatinib, with switch to second generation TKIs in case of unsatisfying response or intolerance, we analyzed all newly diagnosed patients (N = 236), living in two Italian regions, registered in a prospective study according to population-based criteria and treated front-line with imatinib. A switch from imatinib to second-generation TKIs was reported in 14% of patients for side effects and in 24% for failure or suboptimal response, with an improvement of molecular response in 57% of them. The 5-year overall survival (OS) and leukemia-related survival (LRS) were 85% and 93%, respectively; the 4-year rates of MR3.0 and MR4.0 were 75% and 48%, respectively. Cardiovascular complications were reported in 4% of patients treated with imatinib alone and in 6% of patients receiving nilotinib as second-line. Older age (≥70 years) affected OS, but not LRS. These data provide an unbiased reference on the CML management and on the results of TKI treatment in real-life, according to ELN recommendations, using imatinib as first-line treatment and second-generation TKIs as second-line therapy. Am. J. Hematol. 92:82–87, 2017. © 2016 Wiley Periodicals, Inc.

A population-based study of chronic myeloid leukemia patients treated with imatinib in first line

CASTAGNETTI, FAUSTO;DE VIVO, ANTONIO;GUGLIOTTA, GABRIELE;TOSI, PATRIZIA;FOGLI, MIRIAM;RAGIONIERI, RICCARDO;ZIRONI, ALESSANDRO;SOVERINI, SIMONA;MARTINELLI, GIOVANNI;CAVO, MICHELE;ROSTI, GIANANTONIO;BACCARANI, MICHELE
2017

Abstract

Chronic myeloid leukemia (CML) treatment is based on company-sponsored and academic trials testing different tyrosine kinase inhibitors (TKIs) as first-line therapy. These studies included patients selected according to many inclusion–exclusion criteria, particularly age and comorbidities, with specific treatment obligations. In daily clinical practice (real-life), inclusion–exclusion criteria do not exist, and the treatment outcome does not only depend on the choice of first-line TKI but also on second- and third-line TKIs. To investigate in a real-life setting the response and the outcome on first-line imatinib, with switch to second generation TKIs in case of unsatisfying response or intolerance, we analyzed all newly diagnosed patients (N = 236), living in two Italian regions, registered in a prospective study according to population-based criteria and treated front-line with imatinib. A switch from imatinib to second-generation TKIs was reported in 14% of patients for side effects and in 24% for failure or suboptimal response, with an improvement of molecular response in 57% of them. The 5-year overall survival (OS) and leukemia-related survival (LRS) were 85% and 93%, respectively; the 4-year rates of MR3.0 and MR4.0 were 75% and 48%, respectively. Cardiovascular complications were reported in 4% of patients treated with imatinib alone and in 6% of patients receiving nilotinib as second-line. Older age (≥70 years) affected OS, but not LRS. These data provide an unbiased reference on the CML management and on the results of TKI treatment in real-life, according to ELN recommendations, using imatinib as first-line treatment and second-generation TKIs as second-line therapy. Am. J. Hematol. 92:82–87, 2017. © 2016 Wiley Periodicals, Inc.
2017
Castagnetti, Fausto; Di Raimondo, Francesco; De Vivo, Antonio; Spitaleri, Antonio; Gugliotta, Gabriele; Fabbiano, Francesco; Capodanno, Isabella; Mannina, Donato; Salvucci, Marzia; Antolino, Agostino; Marasca, Roberto; Musso, Maurizio; Crugnola, Monica; Impera, Stefana; Trabacchi, Elena; Musolino, Caterina; Cavazzini, Francesco; Mineo, Giuseppe; Tosi, Patrizia; Tomaselli, Carmela; Rizzo, Michele; Siragusa, Sergio; Fogli, Miriam; Ragionieri, Riccardo; Zironi, Alessandro; Soverini, Simona; Martinelli, Giovanni; Cavo, Michele; Vigneri, Paolo; Stagno, Fabio; Rosti, Gianantonio; Baccarani, Michele
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/579967
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