Department of Leukemia, The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA.
J Clin Oncol. 2010 Jan 20;28(3):398-404. doi: 10.1200/JCO.2009.25.4920. Epub 2009 Dec 14.
Dasatinib is effective therapy for chronic myeloid leukemia (CML) after imatinib failure. In this study, we investigate the efficacy of dasatinib as initial therapy for patients with CML in early chronic phase.
Patients with newly diagnosed CML in early chronic phase were randomly assigned to receive dasatinib 100 mg once daily or 50 mg twice daily as initial therapy.
Among 50 patients observed for at least 3 months, 49 patients (98%) achieved a complete cytogenetic response (CCyR), and 41 patients (82%) achieved a major molecular response (MMR). Responses occurred rapidly, with 94% of patients achieving CCyR by 6 months. There was no difference in response rate by treatment arm. The projected event-free survival rate at 24 months is 88%, and all patients are alive after a median follow-up time of 24 months. Grade >or= 3 neutropenia and thrombocytopenia occurred in 21% and 10% of patients, respectively. Nonhematologic toxicity was usually grade 1 to 2. There was no significant difference in toxicity between the two arms, and the actual median dose at 12 months was 100 mg (range, 20 to 100 mg).
Dasatinib is an effective agent for the initial management of CML in early chronic phase, producing high rates of CCyR and MMR.
达沙替尼是治疗伊马替尼治疗失败后慢性髓性白血病（CML）的有效疗法。本研究旨在探讨达沙替尼作为 CML 早期慢性期患者初始治疗的疗效。
新诊断为 CML 早期慢性期的患者被随机分为达沙替尼 100mg 每日 1 次或 50mg 每日 2 次作为初始治疗。
50 例至少观察 3 个月的患者中，49 例（98%）达到完全细胞遗传学缓解（CCyR），41 例（82%）达到主要分子缓解（MMR）。反应迅速，94%的患者在 6 个月时达到 CCyR。两组的缓解率无差异。24 个月无事件生存预计率为 88%，中位随访 24 个月后所有患者均存活。分别有 21%和 10%的患者发生>或=3 级中性粒细胞减少和血小板减少。非血液学毒性通常为 1 级至 2 级。两组间毒性无显著差异，实际 12 个月时的中位剂量为 100mg（范围 20-100mg）。
达沙替尼是 CML 早期慢性期初始治疗的有效药物，可产生较高的 CCyR 和 MMR。
