Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: Results from the IRIS study
Quality of life in patients with newly diagnosed chronic phase chronic myeloid leukemia on imatinib versus interferon alfa plus low-dose cytarabine: Results from the IRIS study
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DOI：
10.1200/jco.2003.12.154
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发表时间：
2003-06-01
影响因子：
45.3
通讯作者：
Cella, D
中科院分区：
文献类型：
--
作者：
Hahn, EA;Glendenning, GA;Cella, D
目的：慢性粒细胞白血病（CML）患者的生活质量（QOL）的结果进行了评估，在国际III期study.Patients和方法：新诊断的慢性期CML患者随机分配到伊马替尼或干扰素α加皮下低剂量阿糖胞苷（IFN+LDAC）。由于不耐受或缺乏疗效，允许交叉至其他治疗。患者在基线和治疗期间完成癌症特异性QOL（癌症治疗-生物学缓解调节剂的功能评估）和效用（Euro QoL-5D）问卷（n = 1，049）。主要QOL终点是试验结果指数（TOI;身体功能和幸福感的测量）。次要终点包括社会和家庭幸福感（SFWB），情感幸福感（EWB）和效用评分。主要分析的意图，以处理与次要分析占cross-over.Results：接受IFN+LDAC的患者经历了一个大的下降，在TOI，而那些接受伊马替尼维持其基线水平。每次访视时的治疗差异显著（P < .001），且有利于伊马替尼的临床相关性。服用伊马替尼的患者的平均SFWB、EWB和效用评分也明显更好。谁交叉伊马替尼的患者经历了一个大的增加TOI;显着（P < .001）的差异，观察患者之间谁没有交叉有利于imatinib.Conclusion：伊马替尼提供了明确的生活质量优势相比，IFN+LDAC作为慢性期CML的一线治疗。此外，与继续服用IFN + LDAC的患者相比，从IFN+ LDAC交叉至伊马替尼的患者的QOL显着改善。(C)2003年，美国临床肿瘤学会。
Purpose : Quality of life (QOL) outcomes in patients with chronic myeloid leukemia (CML) were evaluated in an international phase III study.Patients and Methods: Newly diagnosed patients with chronic phase CML were randomly assigned to imatinib or interferon alfa plus subcutaneous low-dose cytarabine (IFN+LDAC). Cross-over to the other treatment was permitted because of intolerance or lack of efficacy. Patients completed cancer-specific QOL (Functional Assessment of Cancer Therapy-Biologic Response Modifiers) and utility (Euro QoL-5D) questionnaires at baseline and during treatment (n = 1,049). The primary QOL end point was the Trial Outcome Index (TOI; a measure of physical function and well-being). Secondary end points included social and family well-being (SFWB), emotional well-being (EWB), and the utility score. Primary analyses were intention to treat with secondary analyses accounting for cross-over.Results: Patients receiving IFN+LDAC experienced a large decline in the TOI, whereas those receiving imatinib maintained their baseline level. Treatment differences at each visit were significant (P < .001) and clinically relevant in favor of imatinib. Mean SFWB, EWB, and utility scores were also significantly better for those patients taking imatinib. Patients who crossed over to imatinib experienced a large increase in TOI; significant (P < .001) differences were observed between patients who did and did not cross over in favor of imatinib.Conclusion: Imatinib offers clear QOL advantages compared with IFN+LDAC as first-line treatment of chronic phase CML. In addition, patients who cross over to imatinib from IFN+LDAC experience a significant improvement in QOL compared with patients who continue to take IFN+LDAC. (C) 2003 by American Society of Clinical Oncology.