Real-life comparison of severe vascular events and other non-hematological complications in patients with chronic myeloid leukemia undergoing second-line nilotinib or dasatinib treatment

• Published in: Leukemia & lymphoma Vol. 56; no. 8; pp. 2309 - 2314
• Main Authors: Gora-Tybor, Joanna, Medras, Ewa, Calbecka, Malgorzata, Kolkowska-Leśniak, Agnieszka, Ponikowska-Szyba, Edyta, Robak, Tadeusz, Jamroziak, Krzysztof
• Format: Journal Article
• Language: English
• Published: United States Taylor & Francis 03.08.2015
• Subjects: Adult; Aged; Aged, 80 and over; Antineoplastic Agents - adverse effects; Antineoplastic Agents - therapeutic use; CML; dasatinib; Dasatinib - adverse effects; Dasatinib - therapeutic use; Drug Substitution; Female; Follow-Up Studies; Humans; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - complications; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - drug therapy; Leukemia, Myelogenous, Chronic, BCR-ABL Positive - mortality; Male; Middle Aged; nilotinib; non-hematological complication; PAOD; Peripheral Vascular Diseases - etiology; Pleural Effusion - etiology; Protein Kinase Inhibitors - adverse effects; Protein Kinase Inhibitors - therapeutic use; Pyrimidines - adverse effects; Pyrimidines - therapeutic use; Retreatment; Retrospective Studies; Treatment Failure; Treatment Outcome; vascular complication; Young Adult; CML; PAOD; dasatinib; vascular complication; nilotinib; non-hematological complication
• ISSN: 1042-8194; 1029-2403
• DOI: 10.3109/10428194.2014.994205

We retrospectively analyzed the rates of significant non-hematological adverse events (AEs) in 105 patients with chronic myeloid leukemia (CML) treated with second-generation tyrosine kinase inhibitor (TKIs) dasatinib or nilotinib used as second-line therapy in Polish tertiary care centers. Our analysis revealed that in a "real life setting," nearly half of patients with CML on second-generation TKIs suffer from therapy complications. Grade 2-5 non-hematological AEs were observed in 40% of patients treated with nilotinib and in 42% treated with dasatinib (p = 0.83). Severe vascular events including peripheral artery occlusive disease (PAOD) occurred in 11% of patients on nilotinib and 4% on dasatinib (p = 0.16). Pleural effusion occurred more often in the dasatinib group (26%) than in the nilotinib group (2%) (p = 0.003). Importantly, most AEs occurred late, after more than 1 year of treatment. Since AEs are most often the reason for poor therapy compliance, careful monitoring of tolerability is crucial for an optimal treatment response in CML.