摘要
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.
出处
《中华血液学杂志》
CAS
CSCD
北大核心
2013年第2期93-97,共5页
Chinese Journal of Hematology
基金
DASISION国际多中心临床研究项目
上海市科委资助项目(10411966900)