Background A limited amount of data has been published in chronic-phase chronic myeloid leukemia (CP-CML) patients aged >75 years treated frontline with second-generation tyrosine kinase inhibitors. Aims To address this issue in a clinical `real-life' setting, we retrospectively analyzed 45 CP-CML patients (pts) followed in 20 Italian Centers and treated frontline with dasatinib (DAS). Patients and methods Median age was 78.4 years (range 75-89.2 years). DAS starting dose was 100 mg QD in 35 pts (77.7\%), 80 mg QD in 1 pts (2.2\%) and 50 mg QD in 9 pts (20.1\%), respectively. The median follow-up was 42.6 months (IQR 20.4 - 63.3). Results Grade 3 and 4 side effects, both hematological and non-hematological, were detected in 6 (13.3\%) and 12 (26.6\%) pts, respectively. Pleural effusions of all grades occurred in 13 pts (28.8\%) after a median period of DAS exposure of 14.7 months (IQR 3.0 - 33.1). The rates of DAS dose reduction and permanent drug discontinuation were 53.3\% and 20.0\%, respectively. As the best response, 42/45 patients (93.3\%) achieved a complete cytogenetic response (CCyR), 35/45 (77.7\%) a major molecular response (MMR) and 24/45 (53.3\%) a deep molecular response (both MR 4.0 and MR 4.5). Only 1 patient (2.2\%) progressed to the blast phase after 13 months of therapy; 8 deaths were observed (1 CML-related and 7 CML-unrelated). Cumulative event-free survival and overall survival at 36 months were 64.7\% (95\%, CI 49.4 - 80.0) and 82.3\% (95\%, CI 70.3-94.3), respectively. Conclusion These findings, although evaluated in a limited and selected cohort of patients, suggest that DAS might be effective in older patients (aged >75 years) affected by CP-CML with acceptable toxicity.
Long term follow-up of frontline Dasatinib in older patients with chronic myeloid leukemia in chronic phase treated outside clinical trials: a real-life cohort observational study / Stagno, Fabio; Breccia, Massimo; Annunziata, Mario; Trawinska, Malgorzata Monika; Iurlo, Alessandra; Sgherza, Nicola; Fava, Carmen; Gozzini, Antonella; Luciano, Luigiana; Carmosino, Ida; Bonifacio, Massimiliano; Sora, Federica; Crescenzi, Sabrina Leonetti; Crugnola, Monica; Gugliotta, Gabriele; Galimberti, Sara; Bucelli, Cristina; Colafigli, Gioia; Feo, Costanzo; Tiribelli, Mario; Mauro, Endri; Rossi, Antonella Russo; Guarini, Attilio; Abruzzese, Elisabetta; Rosti, Gianantonio; Di Raimondo, Francesco; Latagliata, Roberto. - In: ACTA ONCOLOGICA. - ISSN 0284-186X. - 60:11(2021), pp. 1527-1533. [10.1080/0284186X.2021.1971292]
Long term follow-up of frontline Dasatinib in older patients with chronic myeloid leukemia in chronic phase treated outside clinical trials: a real-life cohort observational study
Breccia, Massimo;Carmosino, Ida;Colafigli, Gioia;
2021
Abstract
Background A limited amount of data has been published in chronic-phase chronic myeloid leukemia (CP-CML) patients aged >75 years treated frontline with second-generation tyrosine kinase inhibitors. Aims To address this issue in a clinical `real-life' setting, we retrospectively analyzed 45 CP-CML patients (pts) followed in 20 Italian Centers and treated frontline with dasatinib (DAS). Patients and methods Median age was 78.4 years (range 75-89.2 years). DAS starting dose was 100 mg QD in 35 pts (77.7\%), 80 mg QD in 1 pts (2.2\%) and 50 mg QD in 9 pts (20.1\%), respectively. The median follow-up was 42.6 months (IQR 20.4 - 63.3). Results Grade 3 and 4 side effects, both hematological and non-hematological, were detected in 6 (13.3\%) and 12 (26.6\%) pts, respectively. Pleural effusions of all grades occurred in 13 pts (28.8\%) after a median period of DAS exposure of 14.7 months (IQR 3.0 - 33.1). The rates of DAS dose reduction and permanent drug discontinuation were 53.3\% and 20.0\%, respectively. As the best response, 42/45 patients (93.3\%) achieved a complete cytogenetic response (CCyR), 35/45 (77.7\%) a major molecular response (MMR) and 24/45 (53.3\%) a deep molecular response (both MR 4.0 and MR 4.5). Only 1 patient (2.2\%) progressed to the blast phase after 13 months of therapy; 8 deaths were observed (1 CML-related and 7 CML-unrelated). Cumulative event-free survival and overall survival at 36 months were 64.7\% (95\%, CI 49.4 - 80.0) and 82.3\% (95\%, CI 70.3-94.3), respectively. Conclusion These findings, although evaluated in a limited and selected cohort of patients, suggest that DAS might be effective in older patients (aged >75 years) affected by CP-CML with acceptable toxicity.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
