title: Dasatinib first-line: Multicentric Italian experience outside clinical trials.
abstract: 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 50mg and 4 patients 80 mg QD), whereas 99 patients started with 100mg 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 of MR3 was 40%, with 8% of the patients reaching MR4.5. Ninety-three patients were evaluable at 12 months: the rate of MR3 was 62%, with MR4.5 being achieved by 19% of the patients. At a median follow-up of 12 months, 27 patients (24.7%) were receiving the drug at reduced dose. Two patients (1.8%) experienced a lymphoid blast crisis and the overall incidence of resistance was 8%. As regards safety, the major side effects recorded were thrombocytopenia, neutropenia and pleural effusions, which occurred in 22%, 10% and 8% of patients, respectively. Present results, achieved in a large cohort of patients treated outside clinical trials, further confirm the efficacy and safety of dasatinib as firstline treatment in CML.
authors.affiliation: Ematologia-Sapienza Università, Roma, Italy. Electronic address: breccia@bce.uniroma1.it.
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.affiliation: Ematologia, Ospedale Ferrarotto, Catania, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Stagno
authors.affiliation: Ematologia, Università Federico II, Napoli, Italy.
authors.forename: Luigiana
authors.initials: L
authors.lastname: Luciano
authors.affiliation: Ematologia, Ospedale S. Eugenio, Roma, Italy.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Abruzzese
authors.affiliation: Ematologia, Ospedale Cardarelli, Napoli, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Annunziata
authors.affiliation: Ematologia e Dipartimento Oncologia Medica, Spedali Civili, Brescia, Italy.
authors.forename: Mariella
authors.initials: M
authors.lastname: D'Adda
authors.affiliation: Ematologia, Ospedale S. Giuseppe Moscati, Taranto, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Maggi
authors.affiliation: UOC Ematologia-IRCSS Istituto Tumori Giovanni Paolo II-Bari, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Sgherza
authors.affiliation: Ematologia-Azienda Ospedaliero-Universitaria, Policlinico consorziale di Bari, Italy.
authors.forename: Antonella
authors.initials: A
authors.lastname: Russo-Rossi
authors.affiliation: Ematologia, A.O.U. Città della salute e della scienza di Torino, Italy.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Pregno
authors.affiliation: Ematologia-Ospedale Seragnoli, Università di Bologna, Italy.
authors.forename: Fausto
authors.initials: F
authors.lastname: Castagnetti
authors.affiliation: Oncoematologia, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, Milano, Italy.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Iurlo
authors.affiliation: Ematologia-Sapienza Università, Roma, Italy.
authors.forename: Roberto
authors.initials: R
authors.lastname: Latagliata
authors.affiliation: Ematologia, Ospedale S. Giovanni, Roma, Italy.
authors.forename: Michele
authors.initials: M
authors.lastname: Cedrone
authors.affiliation: Ematologia, Lecce, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Di Renzo
authors.affiliation: Ematologia-Università Cattolica, Roma, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Sorà
authors.affiliation: Ematologia e Medicina Interna, Università di Torino, Orbassano, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Rege-Cambrin
authors.affiliation: Ematologia, Dipartimento di Scienze Mediche, Università di Cagliari, Italy.
authors.forename: Giorgio
authors.initials: G
authors.lastname: La Nasa
authors.affiliation: Ematologia-Azienda Ospedaliero Universitaria, Ospedale Riuniti Ancona, Italy.
authors.forename: Anna Rita
authors.initials: AR
authors.lastname: Scortechini
authors.affiliation: Ematologia e Medicina Trasfusionale, Tricase, Italy.
authors.forename: Giovanna
authors.initials: G
authors.lastname: Greco
authors.affiliation: Ematologia, Università Tor Vergata, Roma, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Franceschini
authors.affiliation: Ematologia-Università Cattolica, Roma, Italy.
authors.forename: Simona
authors.initials: S
authors.lastname: Sica
authors.affiliation: Ematologia, Università di Siena, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Bocchia
authors.affiliation: Ematologia e CTMO, Azienda Ospedaliero Universitaria, Parma, Italy.
authors.forename: Monica
authors.initials: M
authors.lastname: Crugnola
authors.affiliation: Ematologia, Fondazione IRCSS Policlinico San Matteo, Pavia, Italy.
authors.forename: Esther
authors.initials: E
authors.lastname: Orlandi
authors.affiliation: UOC Ematologia-IRCSS Istituto Tumori Giovanni Paolo II-Bari, Italy.
authors.forename: Attilio
authors.initials: A
authors.lastname: Guarini
authors.affiliation: Ematologia-Azienda Ospedaliero-Universitaria, Policlinico consorziale di Bari, Italy.
authors.forename: Giorgina
authors.initials: G
authors.lastname: Specchia
authors.affiliation: Ematologia-Ospedale Seragnoli, Università di Bologna, Italy.
authors.forename: Gianantonio
authors.initials: G
authors.lastname: Rosti
authors.affiliation: Ematologia e Medicina Interna, Università di Torino, Orbassano, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Saglio
authors.affiliation: Ematologia-Sapienza Università, Roma, Italy.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Alimena
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D000069439:Dasatinib / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007558:Italy; D008297:Male; D008875:Middle Aged
chemical_list: D000970:Antineoplastic Agents; D000069439:Dasatinib
keywords: Chronic myeloid leukemia; Dasatinib; Prognosis