Dasatinib first-line: Multicentric Italian experience outside clinical trials

作者:Breccia Massimo*; Stagno Fabio; Luciano Luigiana; Abruzzese Elisabetta; Annunziata Mario; D'Adda Mariella; Maggi Alessandro; Sgherza Nicola; Russo Rossi Antonella; Pregno Patrizia; Castagnetti Fausto; Iurlo Alessandra; Latagliata Roberto; Cedrone Michele; Di Renzo Nicola; Sora Federica; Rege Cambrin Giovanna; La Nasa Giorgio; Scortechini Anna Rita; Greco Giovanna; Franceschini Luca; Sica Simona; Bocchia Monica; Crugnola Monica; Orlandi Esther; Guarini Attilio
来源:Leukemia Research, 2016, 40: 24-29.
DOI:10.1016/j.leukres.2015.11.008

摘要

Dasatinib was approved for the treatment of chronic phase (CP) chronic myeloid leukemia (CML) patients in first line therapy based on the demonstration of efficacy and safety reported in patients enrolled in clinical trials. We describe a multicentric Italian "real-life" experience of dasatinib used as frontline treatment outside clinical trials. One hundred and nine patients (median age 54 years) were treated from January 2012 to December 2013. Increased incidence of high risk patients were detected according to stratification (26% according to Sokal score, 19% according to Euro score and 16% according to EUTOS) when compared to company sponsored studies. Median time from diagnosis to start of dasatinib was 18 days. Ten patients received unscheduled starting dose (6 patients 50 mg and 4 patients 80 mg QD), whereas 99 patients started with 100 mg QD. At 3 months, 92% of patients achieved a BCR-ABL ratio less than 10%. At 6 months, the rate of CCyR was 91% and the rate

  • 出版日期2016-1