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):197-205. doi: 10.1634/theoncologist.11-2-197.
To evaluate the effect of epoetin alfa on quality of life (QOL) in patients with solid tumors and mild-to-moderate anemia receiving platinum-based chemotherapy relative to population norms.
In the original study, patients (n = 316) with hemoglobin (Hb) levels < or =12.1 g/dl were randomized 2:1 to receive either epoetin alfa at a dose of 10,000 U thrice weekly s.c. or best supportive care (BSC) to compare the effects on transfusion use, hematologic response, and QOL (measured by the Functional Assessment of Cancer Therapy-Anemia [FACT-An]and Cancer Linear Analogue Scale [CLAS]). The QOL data from this previously reported trial were reanalyzed here relative to population norms.
Mean baseline QOL scores were similar between groups. At study completion, mean CLAS, FACT-An, FACT-An Anemia subscale, and FACT-An Fatigue subscale scores were significantly higher for patients given epoetin alfa than for those treated with BSC. Compared with population norms, both groups had impaired QOL at baseline. Differences in mean QOL change scores from baseline to study end for epoetin alfa versus BSC were 3.17 points for the FACT-General Total, 9.90 for the FACT-An Fatigue subscale, and 7.30 for the FACT-An Anemia subscale. This was equivalent to corrections in QOL deficits attributable to epoetin alfa of 97.3%, 40.7%, and 38.0% for the FACT-General Total, FACT-An Fatigue, and FACT-An Anemia subscale scores, respectively, versus BSC. A somewhat greater QOL benefit was observed for the FACT-An Fatigue and FACT-An Anemia subscales in the subset of patients with baseline Hb levels >10.5 g/dl.
Patients in this study had impaired QOL compared with population norms. Early treatment with epoetin alfa to correct anemia improved QOL in a statistically significant and clinically meaningful way, and improvements were greater in patients with baseline Hb levels >10.5 g/dl.
评估促红细胞生成素α对接受铂类化疗的实体瘤合并轻至中度贫血患者生活质量（QOL）的影响，并与总体人群标准进行比较。
在原研究中，血红蛋白（Hb）水平≤12.1 g/dl的患者（n = 316）按2:1随机分组，分别接受每周三次皮下注射10,000 U促红细胞生成素α或最佳支持治疗（BSC），以比较对输血使用、血液学反应和生活质量（通过癌症治疗贫血功能评估[FACT-An]和癌症线性模拟量表[CLAS]测量）的影响。在此，相对于总体人群标准，对该先前报道试验的生活质量数据进行了重新分析。
两组的平均基线生活质量评分相似。在研究结束时，接受促红细胞生成素α治疗的患者的平均CLAS、FACT-An、FACT-An贫血子量表和FACT-An疲劳子量表评分显著高于接受BSC治疗的患者。与总体人群标准相比，两组在基线时生活质量均受损。促红细胞生成素α组与BSC组从基线到研究结束时的平均生活质量变化评分差异为：FACT-通用总量表为3.17分，FACT-An疲劳子量表为9.90分，FACT-An贫血子量表为7.30分。这相当于促红细胞生成素α相对于BSC分别纠正了FACT-通用总量表、FACT-An疲劳和FACT-An贫血子量表评分中生活质量缺陷的97.3%、40.7%和38.0%。在基线Hb水平>10.5 g/dl的患者亚组中，FACT-An疲劳和FACT-An贫血子量表的生活质量获益更大。
与总体人群标准相比，本研究中的患者生活质量受损。早期使用促红细胞生成素α纠正贫血以统计学显著且临床有意义的方式改善了生活质量，且基线Hb水平>10.5 g/dl的患者改善更大。
