达沙替尼与伊马替尼治疗初发慢性髓性白血病的疗效及安全性初步比较

Preliminary comparison of efficacy and safety of dasatinib and imatinib in newly diagnosed chronic myeloid leukemia

目的比较达沙替尼和伊马替尼一线治疗初发慢性髓性白血病（CML）慢性期（CP）患者的疗效和安全性。方法37例新近诊断的CML—CP患者随机接受达沙替尼（口服100mg，每日1次）或伊马替尼（口服400nag，每131次）治疗。比较两组患者的疗效和安全性。结果37例CML—CP患者，18例接受达沙替尼治疗，19例接受伊马替尼治疗。中位治疗时间和中位随访时问均为38个月。①12个月时的完全细胞遗传学反应（CCyR）率在达沙替尼组为89％，高于伊马替尼组的68％，但两组差异无统计学意义（P：0．232）。36个月时累计CCyR率在两组均为89％。18个月时主要分子学反应（MMR）率在达沙替尼组为76％，明显高于伊马替尼组的37％（P=0．017）。36个月时累计MMR率在达沙替尼组和伊马替尼组分别为82％和68％（P=0．451）。36个月时疾病无进展生存（PFS）率在达沙替尼组和伊马替尼组分别为83％和79％（P=0．694）。达沙替尼组达CCyR和MMR的中位时间均明显短于伊马替尼组（分别为3个月对6个月，14个月对34个月）。②达沙替尼和伊马替尼组治疗相关的不良反应多为1—2级，患者大多可耐受。达沙替尼组谷丙转氨酶升高，胸腔积液和血小板减少发生率较伊马替尼组高。伊马替尼组低磷血症、水肿和中性粒细胞减少发生率高于达沙替尼组。结论达沙替尼治疗CML—CP安全有效，可以作为CML—CP患者的一线治疗。

Objective To compare the efficacy and safety of dasatinib and imatinib in patients with newly diagnosed chronic phase chronic myeloid leukemia（CML-CP）. Methods 37 CML-CP patients were randomized to receive dasatinib 100 nag orally daily or imatinib 400 mg orally daily. The efficacy and safety data were collected and compared. Results Of 37 CML-CP patients, 18 received dasatinib and 19 received imatinib. The both of median duration of drug therapy and follow-up were 38 months. ①The rate of complete cytogenetic response（CCyR） at 12 months was higher in dastinib group than in imatinib group（89% vs 68% ） , but there was no significantly statistic significance between two groups （P--0. 232）. The cumulative CCyR rate by 36 months was 89% in both arms. The major molecular response（MMR） at 18 months was 76% in dasatinib arm, being significantly higher than that in imatinib arm（37% ） （P =0. 017）. The emnula- tire MblR rate by 36 months was 82% versus 68% in dasatinib or imatinib （P =0. 694）. The median time to CCyR and MMR was significantly faster for dasatinib than for imatinib （ 3 months vs. 6 months, and 14months vs. 34 months, respectively）. ②The drug-related adverse events were mostly grade 1/2 and were well-tolera- ted. Increase of serum glutamic pyruvie transaminase, pleural effusion and thromboeytopenia were more com- mon in dasatinib arm, while hypophosphatemia, edema and neutropenia were more common in imatinib ann. Conclusion Dasatinib is an effective and safe therapy option and can be used as first-line therapy for newly diagnosed CML-CP patients.