Gora-Tybor Joanna, Medras Ewa, Calbecka Malgorzata, Kolkowska-Leśniak Agnieszka, Ponikowska-Szyba Edyta, Robak Tadeusz, Jamroziak Krzysztof
a Institute of Hematology and Transfusion Medicine , Warsaw , Poland.
b Department and Clinic of Hematology , Blood Neoplasms, and Bone Marrow Transplantation , Wroclaw , Poland.
Leuk Lymphoma. 2015;56(8):2309-14. doi: 10.3109/10428194.2014.994205. Epub 2015 Mar 5.
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.
我们回顾性分析了在波兰三级医疗中心接受第二代酪氨酸激酶抑制剂(TKI)达沙替尼或尼洛替尼作为二线治疗的105例慢性髓性白血病(CML)患者中严重非血液学不良事件(AE)的发生率。我们的分析显示,在“现实生活环境”中,近一半接受第二代TKI治疗的CML患者存在治疗并发症。接受尼洛替尼治疗的患者中有40%观察到2 - 5级非血液学AE,接受达沙替尼治疗的患者中有42%观察到此类情况(p = 0.83)。接受尼洛替尼治疗的患者中有11%发生包括外周动脉闭塞性疾病(PAOD)在内的严重血管事件,接受达沙替尼治疗的患者中有4%发生此类情况(p = 0.16)。胸腔积液在达沙替尼组(26%)比在尼洛替尼组(2%)更常发生(p = 0.003)。重要的是,大多数AE发生在治疗1年多以后。由于AE往往是治疗依从性差的原因,因此仔细监测耐受性对于CML的最佳治疗反应至关重要。