title: Frontline Dasatinib Treatment in a "Real-Life" Cohort of Patients Older than 65 Years with Chronic Myeloid Leukemia.
abstract: Dasatinib (DAS) has been licensed for the frontline treatment in chronic myeloid leukemia (CML). However, very few data are available regarding its efficacy and toxicity in elderly patients with CML outside clinical trials. To address this issue, we set out a "real-life" cohort of 65 chronic phase CML patients older than 65 years (median age 75.1 years) treated frontline with DAS in 26 Italian centers from June 2012 to June 2015, focusing our attention on toxicity and efficacy data. One third of patients (20/65: 30.7%) had 3 or more comorbidities and required concomitant therapies; according to Sokal classification, 3 patients (4.6%) were low risk, 39 (60.0%) intermediate risk, and 20 (30.8%) high risk, whereas 3 (4.6%) were not classifiable. DAS starting dose was 100 mg once a day in 54 patients (83.0%), whereas 11 patients (17.0%) received less than 100 mg/day. Grade 3/4 hematologic and extrahematologic toxicities were reported in 8 (12.3%) and 12 (18.5%) patients, respectively. Overall, 10 patients (15.4%) permanently discontinued DAS because of toxicities. Pleural effusions (all WHO grades) occurred in 12 patients (18.5%) and in 5 of them occurred during the first 3 months. DAS treatment induced in 60/65 patients (92.3%) a complete cytogenetic response and in 50/65 (76.9%) also a major molecular response. These findings show that DAS might play an important role in the frontline treatment of CML patients >65 years old, proving efficacy and having a favorable safety profile also in elderly subjects with comorbidities.
authors.affiliation: Department of Cellular Biotechnologies and Hematology, "Sapienza" University, Rome. Electronic address: rob.lati@libero.it.
authors.forename: Roberto
authors.initials: R
authors.lastname: Latagliata
authors.affiliation: Chair and Division of Hematology, Ferrarotto Hospital-AOU Policlinic V. Emanuele, Catania.
authors.forename: Fabio
authors.initials: F
authors.lastname: Stagno
authors.affiliation: Hematology with Transplantation, Cardarelli Hospitali, Neaples.
authors.forename: Mario
authors.initials: M
authors.lastname: Annunziata
authors.affiliation: Hematology, Sant'Eugenio Hospital, Rome.
authors.forename: Elisabetta
authors.initials: E
authors.lastname: Abruzzese
authors.affiliation: UOC Onco-hematology, IRCCS Ca' Granda Foundation-Ospedale Maggiore Policlinico, Milan.
authors.forename: Alessandra
authors.initials: A
authors.lastname: Iurlo
authors.affiliation: Hematology Unit, Cancer Institute "Giovanni Paolo II", Bari.
authors.forename: Attilio
authors.initials: A
authors.lastname: Guarini
authors.affiliation: Department of Clinical and Biological Sciences, University of Turin, San Luigi Gonzaga Hospital, Orbassano.
authors.forename: Carmen
authors.initials: C
authors.lastname: Fava
authors.affiliation: Hematology, University of Florence.
authors.forename: Antonella
authors.initials: A
authors.lastname: Gozzini
authors.affiliation: Department of Medicine, Section of Hematology, University of Verona.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Bonifacio
authors.affiliation: Hematology, Catholic University of Sacred Heart of Rome.
authors.forename: Federica
authors.initials: F
authors.lastname: Sorà
authors.affiliation: Hematology, Sandro Pertini Hospital, Rome.
authors.forename: Sabrina
authors.initials: S
authors.lastname: Leonetti Crescenzi
authors.affiliation: Division of Hematology, University of Siena.
authors.forename: Monica
authors.initials: M
authors.lastname: Bocchia
authors.affiliation: Hematology, University of Parma.
authors.forename: Monica
authors.initials: M
authors.lastname: Crugnola
authors.affiliation: Department of Hematology and Oncology "L. and A. Seràgnoli,", S. Orsola-Malpighi University Hospital, Bologna.
authors.forename: Fausto
authors.initials: F
authors.lastname: Castagnetti
authors.affiliation: Hematology, Arcispedale Santa Maria Nuova, Reggio Emilia.
authors.forename: Isabella
authors.initials: I
authors.lastname: Capodanno
authors.affiliation: Department of Clinical and Experimental Medicine-Hematology, University of Pisa.
authors.forename: Sara
authors.initials: S
authors.lastname: Galimberti
authors.affiliation: Hematology, Rummo Hospital, Benevento.
authors.forename: Costanzo
authors.initials: C
authors.lastname: Feo
authors.affiliation: Hematology, Sant'Andrea Hospital, University "Sapienza" Rome.
authors.forename: Raffaele
authors.initials: R
authors.lastname: Porrini
authors.affiliation: Hematology, San Giovanni Battista Hospital and University, Turin.
authors.forename: Patrizia
authors.initials: P
authors.lastname: Pregno
authors.affiliation: Hematology, University "Tor Vergata" of Rome.
authors.forename: Manuela
authors.initials: M
authors.lastname: Rizzo
authors.affiliation: Hematology, ASP7, Ragusa.
authors.forename: Agostino
authors.initials: A
authors.lastname: Antolino
authors.affiliation: Department of Internal Medicine, General Hospital, Pordenone.
authors.forename: Endri
authors.initials: E
authors.lastname: Mauro
authors.affiliation: Hematology, IRCCS, "Casa Sollievo della Sofferenza", San Giovanni Rotondo.
authors.forename: Nicola
authors.initials: N
authors.lastname: Sgherza
authors.affiliation: Hematology, University "Federico II" of Neaples.
authors.forename: Luigiana
authors.initials: L
authors.lastname: Luciano
authors.affiliation: Hematology, Hospital-University of Udine.
authors.forename: Mario
authors.initials: M
authors.lastname: Tiribelli
authors.affiliation: Hematology with Transplant, University of Bari.
authors.forename: Antonella
authors.initials: A
authors.lastname: Russo Rossi
authors.affiliation: Hematology, Sant'Eugenio Hospital, Rome.
authors.forename: Malgorzata
authors.initials: M
authors.lastname: Trawinska
authors.affiliation: Medical Oncology, AOU Policlinic V. Emanuele, University of Catania.
authors.forename: Paolo
authors.initials: P
authors.lastname: Vigneri
authors.affiliation: Department of Cellular Biotechnologies and Hematology, "Sapienza" University, Rome.
authors.forename: Massimo
authors.initials: M
authors.lastname: Breccia
authors.affiliation: Department of Hematology and Oncology "L. and A. Seràgnoli,", S. Orsola-Malpighi University Hospital, Bologna.
authors.forename: Gianantonio
authors.initials: G
authors.lastname: Rosti
authors.affiliation: Department of Cellular Biotechnologies and Hematology, "Sapienza" University, Rome.
authors.forename: Giuliana
authors.initials: G
authors.lastname: Alimena
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D002871:Chromosome Banding; D015331:Cohort Studies; D000069439:Dasatinib / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005500:Follow-Up Studies; D016044:Fusion Proteins, bcr-abl / Q000235:genetics; D006801:Humans; D017404:In Situ Hybridization, Fluorescence; D053208:Kaplan-Meier Estimate; D015464:Leukemia, Myelogenous, Chronic, BCR-ABL Positive / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality; D060787:Neoplasm Grading; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D047428:Protein Kinase Inhibitors; D016044:Fusion Proteins, bcr-abl; D000069439:Dasatinib