Savonije Jorine H, van Groeningen Cees J, Wormhoudt Lars W, Giaccone Guiseppe
VU Medisch Centrum, De Boelelaan 1117, 1081 HV Amsterdam, The Netherlands.
Oncologist. 2006 Feb;11(2):206-16. doi: 10.1634/theoncologist.11-2-206.
This analysis of the results of a randomized, controlled trial evaluating the effects of epoetin alfa (EPO) therapy on transfusion requirements, hemoglobin (Hb), and quality of life (QOL) in patients with cancer receiving platinum-based chemotherapy was conducted to evaluate the effect of initial Hb level on study outcomes.
Patients with Hb levels < or =12.1 g/dl were randomized 2:1 to receive EPO, 10,000 U three times weekly s.c. or best supportive care (BSC) until 4 weeks after their last chemotherapy cycle. For this analysis, patients were stratified by baseline Hb level (< or =9.7 g/dl, >9.7 g/dl to < or =10.5 g/dl, >10.5 g/dl to < or =11.3 g/dl, and >11.3 g/dl to < or =12.1 g/dl), and study results were reanalyzed.
Significantly fewer EPO patients than BSC patients with initial Hb levels >9.7 g/dl to < or =12.1 g/dl required transfusions. EPO maintained Hb levels throughout the study for patients with Hb levels >11.3 g/dl to < or =12.1 g/dl, compared with a decrease with BSC. For patients with baseline Hb levels >10.5 g/dl, for whom the mean changes from baseline to last assessment were measured by the Cancer Linear Analogue Scale assessments of energy and overall QOL as well as by the Functional Assessment of Cancer Therapy (FACT)-Fatigue and FACT-An Anemia subscale, QOL scores were significantly greater with EPO than with BSC. QOL declined in patients receiving BSC, and the mean decreases in QOL scores were greater for BSC patients with baseline Hb levels >10.5 g/dl, compared with the overall BSC group.
In patients with cancer receiving platinum-based chemotherapy and with baseline Hb levels >10.5 g/dl, early intervention with EPO reduces transfusions, maintains Hb level, and maintains or improves QOL. This study supports the positive effects of early intervention when analyzed according to initial Hb value.
本分析对一项随机对照试验的结果进行了研究，该试验评估了促红细胞生成素α（EPO）疗法对接受铂类化疗的癌症患者输血需求、血红蛋白（Hb）水平及生活质量（QOL）的影响，旨在评估初始Hb水平对研究结果的影响。
将Hb水平≤12.1 g/dl的患者按2:1随机分组，分别接受皮下注射EPO（10,000 U，每周3次）或最佳支持治疗（BSC），直至最后一个化疗周期后4周。在此分析中，患者按基线Hb水平分层（≤9.7 g/dl、>9.7 g/dl至≤10.5 g/dl、>10.5 g/dl至≤11.3 g/dl、>11.3 g/dl至≤12.1 g/dl），并对研究结果进行重新分析。
初始Hb水平>9.7 g/dl至≤12.1 g/dl的患者中，接受EPO治疗的患者输血需求显著少于接受BSC治疗的患者。对于Hb水平>11.3 g/dl至≤12.1 g/dl的患者，EPO在整个研究过程中维持了Hb水平，而BSC组则出现下降。对于基线Hb水平>10.5 g/dl的患者，通过癌症线性模拟量表评估的能量和总体生活质量以及癌症治疗功能评估量表（FACT）-疲劳量表和FACT-贫血子量表测量从基线到最后评估的平均变化，接受EPO治疗的患者生活质量得分显著高于接受BSC治疗的患者。接受BSC治疗的患者生活质量下降，基线Hb水平>10.5 g/dl的BSC组患者生活质量得分的平均下降幅度大于总体BSC组。
在接受铂类化疗且基线Hb水平>10.5 g/dl的癌症患者中，早期使用EPO进行干预可减少输血需求、维持Hb水平并维持或改善生活质量。根据初始Hb值进行分析时，本研究支持早期干预的积极效果。
