Frontline Dasatinib Treatment in a “Real-Life” Cohort of Patients Older than 65 Years with Chronic Myeloid Leukemia

• Published in: Neoplasia (New York, N.Y.) N.Y.), 2016-09, Vol.18 (9), p.536-540
• Main Authors: Latagliata, Roberto, Stagno, Fabio, Annunziata, Mario, Abruzzese, Elisabetta, Iurlo, Alessandra, Guarini, Attilio, Fava, Carmen, Gozzini, Antonella, Bonifacio, Massimiliano, Sorà, Federica, Leonetti Crescenzi, Sabrina, Bocchia, Monica, Crugnola, Monica, Castagnetti, Fausto, Capodanno, Isabella, Galimberti, Sara, Feo, Costanzo, Porrini, Raffaele, Pregno, Patrizia, Rizzo, Manuela, Antolino, Agostino, Mauro, Endri, Sgherza, Nicola, Luciano, Luigiana, Tiribelli, Mario, Russo Rossi, Antonella, Trawinska, Malgorzata, Vigneri, Paolo, Breccia, Massimo, Rosti, Gianantonio, Alimena, Giuliana
• Format: Article
• Language: English
• Subjects: Aged; Aged, 80 and over; Antineoplastic Agents - administration & dosage; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; Chromosome Banding; Cohort Studies; Dasatinib - administration & dosage; Dasatinib - adverse effects; Dasatinib - therapeutic use; Follow-Up Studies; Fusion Proteins, bcr-abl - genetics; Humans; In Situ Hybridization, Fluorescence; Kaplan-Meier Estimate; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - diagnosis; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality; Neoplasm Grading; Oncology; Original article; Protein Kinase Inhibitors - administration & dosage; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - therapeutic use; Treatment Outcome
• ISSN: 1476-5586; 1522-8002; 1476-5586; 1522-8002
• DOI: 10.1016/j.neo.2016.07.005

Abstract Dasatinib (DAS) has been l icensed 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.