Hematology Division, National Cancer Center Hospital, Tokyo, Japan.
Hematology Division, Tokyo Metropolitan Cancer and Infectious diseases Center, Komagome Hospital, Tokyo, Japan.
Int J Hematol. 2011 Jun;93(6):745-749. doi: 10.1007/s12185-011-0864-1. Epub 2011 May 20.
The aim of this retrospective study was to evaluate the toxicity profiles of dasatinib in patients with Philadelphia chromosome positive chronic myeloid leukemia (CML) or acute lymphatic leukemia (ALL) who were intolerant to imatinib, and who had been enrolled in our previous clinical trials to evaluate efficacy of dasatinib in patients resistant or tolerant to imatinib therapy. Twenty-four patients with CML and four with ALL were enrolled in the clinical studies to evaluate the efficacy according to the eligibility criteria related to intolerance to imatinib therapy. The toxicities reported during imatinib therapy were non-hematological toxicities in 23 patients and hematological toxicities in six patients. Patients were administered dasatinib 50-70 mg BID or 100 mg QD. Cross intolerance was observed in four patients who showed hematological toxicity after dasatinib treatment. However, it was possible to successfully continue therapy with only temporary interruption. No cross intolerance in non-hematological toxicity was found with the exception of one patient who showed cross intolerance, which did not result in treatment interruption. Dasatinib can be safely administered to imatinib-intolerant CML or Ph-positive ALL patients.
这项回顾性研究的目的是评估达沙替尼在对伊马替尼不耐受的费城染色体阳性慢性髓性白血病（CML）或急性淋巴细胞白血病（ALL）患者中的毒性谱，这些患者曾参加过我们之前的临床试验，以评估达沙替尼在对伊马替尼治疗耐药或耐受的患者中的疗效。根据与对伊马替尼治疗不耐受相关的入选标准，有 24 例 CML 患者和 4 例 ALL 患者参加了评估疗效的临床研究。在接受伊马替尼治疗期间报告的毒性是非血液学毒性（23 例）和血液学毒性（6 例）。患者接受达沙替尼 50-70mg BID 或 100mg QD 治疗。在接受达沙替尼治疗后出现血液学毒性的 4 例患者中观察到交叉不耐受，但仅通过暂时中断治疗即可成功继续治疗。除了一名出现交叉不耐受但未导致治疗中断的患者外，未发现非血液学毒性的交叉不耐受。达沙替尼可安全用于对伊马替尼不耐受的 CML 或 Ph 阳性 ALL 患者。
