CAJ | 학술논문

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100 mg,每日1次)或伊马替尼(口服400 mg,每日1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间均为38个月.① 12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.
목적 비교체사체니화이마체니일선치료초발만성수성백혈병(CML)만성기(CP)환자적료효화안전성.방법 37례신근진단적CML-CP환자수궤접수체사체니(구복100 mg,매일1차)혹이마체니(구복400 mg,매일1차)치료.비교량조환자적료효화안전성.결과 37례CML-CP환자,18례접수체사체니치료,19례접수이마체니치료.중위치료시간화중위수방시간균위38개월.① 12개월시적완전세포유전학반응(CCyR)솔재체사체니조위89%,고우이마체니조적68%,단량조차이무통계학의의(P=0.232).36개월시루계CCyR솔재량조균위89%.18개월시주요분자학반응(MMR)솔재체사체니조위76%,명현고우이마체니조적37%(P=0.017).36개월시루계MMR솔재체사체니조화이마체니조분별위82%화68%(P=0.451).36개월시질병무진전생존(PFS)솔재체사체니조화이마체니조분별위83%화79%(P=0.694).체사체니조체CCyR화MMR적중위시간균명현단우이마체니조(분별위3개월대6개월,14개월대34개월).②체사체니화이마체니조치료상관적불량반응다위1~2급,환자대다가내수.체사체니조곡병전안매승고,흉강적액화혈소판감소발생솔교이마체니조고.이마체니조저린혈증、수종화중성립세포감소발생솔고우체사체니조.결론체사체니치료CML-CP안전유효,가이작위CML-CP환자적일선치료.
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 mg 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 cumulative MMR 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-tolerated. Increase of serum glutamic pyruvic transaminase, pleural effusion and thrombocytopenia were more common in dasatinib arm, while hypophosphatemia, edema and neutropenia were more common in imatinib arm. Conclusion Dasatinib is an effective and safe therapy option and can be used as first-line therapy for newly diagnosed CML-CP patients.