Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion.
Dasatinib 100 mg once daily minimizes the occurrence of pleural effusion in patients with chronic myeloid leukemia in chronic phase and efficacy is unaffected in patients who develop pleural effusion.
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DOI：
10.1002/cncr.24734
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发表时间：
2010-01-15
期刊：
影响因子：
6.2
通讯作者：
Cortes, Jorge E.
中科院分区：
文献类型：
--
作者：
Porkka, Kimmo;Khoury, H. Jean;Paquette, Ronald L.;Matloub, Yousif;Sinha, Ritwik;Cortes, Jorge E.
关键词：
背景：达沙替尼是一种高效的BCR - ABL抑制剂，可有效治疗对伊马替尼耐药、次优反应或不耐受的慢性髓系白血病慢行期（CML CP）患者。在CML CP （CA180‐034）患者的3期剂量优化试验中，与其他治疗组（70 mg每日2次，140 mg每日1次或50 mg每日2次）相比，达沙替尼100 mg每日1次（QD）显著减少了胸腔积液的发生。方法分析CA180‐034的数据，探讨达沙替尼治疗期间胸腔积液的发生和处理，以及有无胸腔积液患者的疗效。结果：在最少24个月的随访中，14%接受达沙替尼100 mg QD治疗的患者发生胸腔积液（3:2%;4:0%），而在其他研究组中，这一比例为23%至26%。胸腔积液率在12 ~ 24个月间仅有微小的增加。在100mg QD研究组中，出现胸腔积液（任何级别）的中位时间为315天，胸腔积液后，52%的患者有短暂的剂量中断，35%的患者有剂量减少，57%的患者接受利尿剂治疗，26%的患者接受皮质类固醇治疗。100mg QD研究组中有3例患者在胸腔积液后停止治疗。在所有研究组中，有或没有胸腔积液的患者表现出相似的无进展期和总生存率，有胸腔积液的患者的细胞遗传学反应率更高。结论达沙替尼100 mg QD可减少脾脏积液，其发生不影响近期和远期疗效。2010年癌症。©2010美国癌症协会。
BACKGROUNDDasatinib, a highly potent BCR‐ABL inhibitor, is an effective treatment for patients with chronic myeloid leukemia in chronic phase (CML CP) after resistance, suboptimal response, or intolerance to prior imatinib. In a phase 3 dose optimization trial in patients with CML CP (CA180‐034), the occurrence of pleural effusion was significantly minimized with dasatinib 100 mg once daily (QD) compared with other treatment arms (70 mg twice daily [twice daily], 140 mg QD, or 50 mg twice daily).METHODSTo investigate the occurrence and management of pleural effusion during dasatinib treatment, and efficacy in patients with or without pleural effusion, data from CA180‐034 were analyzed.RESULTSWith 24‐month minimum follow‐up, 14% of patients treated with dasatinib 100 mg QD incurred pleural effusion (grade 3: 2%; grade 4: 0%) compared with 23% to 26% in other study arms. The pleural effusion rate showed only a minimal increment from 12 to 24 months. In the 100 mg QD study arm, median time to pleural effusion (any grade) was 315 days, and after pleural effusion, 52% of patients had a transient dose interruption, 35% had a dose reduction, 57% received a diuretic, and 26% received a corticosteroid. Three patients in the 100 mg QD study arm discontinued treatment after pleural effusion. Across all study arms, patients with or without pleural effusion demonstrated similar progression‐free and overall survival, and cytogenetic response rates were higher in patients with a pleural effusion.CONCLUSIONSPleural effusion is minimized with dasatinib 100 mg QD dosing and its occurrence does not affect short‐ or long‐term efficacy. Cancer 2010. © 2010 American Cancer Society.
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