Vansteenkiste J, Tomita D, Rossi G, Pirker R
Respiratory Oncology Unit (Pulmonology), University Hospital Gasthuisberg, Herestraat 49, B-3000 Leuven, Belgium.
Support Care Cancer. 2004 Apr;12(4):253-62. doi: 10.1007/s00520-003-0583-0. Epub 2004 Jan 23.
Currently, there is some debate concerning the haemoglobin level at which treatment of anaemia with erythropoiesis-stimulating agents should be initiated in cancer patients on chemotherapy. We report several analyses of data from a phase III trial of darbepoetin alfa versus placebo, comparing outcomes for patients with mild and moderate-to-severe anaemia.
Data were obtained from a phase III trial of darbepoetin alfa versus placebo in anaemic patients with lung cancer receiving chemotherapy ( n=314). Outcomes were compared for patients with baseline haemoglobin > or =10-11 g/dl and <10 g/dl.
Darbepoetin alfa significantly reduced transfusions compared with placebo, irrespective of haemoglobin level at treatment initiation. For patients with baseline haemoglobin <10 g/dl, 31% and 59% of those receiving darbepoetin alfa and placebo, respectively, required a transfusion from week 5 to the end of the treatment phase ( P<0.038). For patients with baseline haemoglobin > or =10 g/dl, the proportions were 15% and 41%, respectively ( P<0.001). Darbepoetin alfa also improved fatigue compared with placebo in both haemoglobin categories.
These findings show that initiating treatment at haemoglobin levels both <10 g/dl and > or =10-11 g/dl results in substantial clinical benefits, supporting the use of erythropoietic therapy also in patients with mild anaemia.
目前,对于接受化疗的癌症患者开始使用促红细胞生成剂治疗贫血时的血红蛋白水平存在一些争议。我们报告了一项关于聚乙二醇化促红细胞生成素α与安慰剂的III期试验数据的多项分析,比较了轻度和中度至重度贫血患者的治疗结果。
数据来自一项聚乙二醇化促红细胞生成素α与安慰剂对比的III期试验,试验对象为接受化疗的肺癌贫血患者(n = 314)。比较了基线血红蛋白≥10 - 11 g/dl和<10 g/dl患者的治疗结果。
无论治疗开始时的血红蛋白水平如何,与安慰剂相比,聚乙二醇化促红细胞生成素α显著减少了输血次数。对于基线血红蛋白<10 g/dl的患者,从第5周直至治疗阶段结束,接受聚乙二醇化促红细胞生成素α和安慰剂治疗的患者中分别有31%和59%需要输血(P<0.038)。对于基线血红蛋白≥10 g/dl的患者,这一比例分别为15%和41%(P<0.001)。在两个血红蛋白类别中,与安慰剂相比,聚乙二醇化促红细胞生成素α还改善了疲劳症状。
这些研究结果表明,血红蛋白水平<10 g/dl以及≥10 - 11 g/dl时开始治疗均能带来显著的临床益处,支持在轻度贫血患者中也使用促红细胞生成素治疗。