Boogaerts M, Coiffier B, Kainz C
Labo Hematologie Transplant, U.Z. Gasthuisberg, Leuven, Belgium.
Br J Cancer. 2003 Apr 7;88(7):988-95. doi: 10.1038/sj.bjc.6600801.
This open-label, prospective study was conducted to compare the impact of epoetin beta vs standard care on quality of life (QoL) in anaemic patients with lymphoid or solid tumour malignancies. A total of 262 anaemic patients (haemoglobin [Hb]<or=11 g dl(-1)) were randomised to a 12-week treatment with s.c. epoetin beta (initial dose 150 IU kg(-1) three times weekly) or standard care. Transfusions were recommended for both groups at an Hb threshold of 8.5 g dl(-1). The primary efficacy variables were improvement in QoL as measured using the Short-Form-36 physical component summary (SF-36 PCS) score and the Functional Assessment of Cancer Therapy fatigue and anaemia subscales (FACT-F and FACT-An). A visual analogue scale (VAS) was also used as a global QoL measure. Clinical response was defined as a >or=2 g dl(-1) increase in Hb level without need of transfusion after the initial 4 weeks of treatment. Baseline to final visit changes in SF-36 PCS, FACT-F and VAS scores were significantly greater with epoetin beta than with standard care (P<0.05); changes in FACT-An subscale score tended to be greater with epoetin beta (P=0.076). Epoetin beta significantly increased Hb concentrations relative to standard care (responders: 47% vs 13%; P<0.001). Levels of endogenous erythropoietin <50 mIU ml(-1) were significantly predictive of response (OR 2.496, 95% CI: 1.21-5.13). Epoetin beta therapy significantly improves QoL compared with standard care in anaemic patients with solid tumours and lymphoid malignancies.
本开放性前瞻性研究旨在比较β-促红细胞生成素与标准治疗对患有淋巴瘤或实体瘤恶性肿瘤的贫血患者生活质量（QoL）的影响。共有262例贫血患者（血红蛋白[Hb]≤11 g dl⁻¹）被随机分为两组，分别接受为期12周的皮下注射β-促红细胞生成素治疗（初始剂量为150 IU kg⁻¹，每周3次）或标准治疗。两组均在Hb阈值为8.5 g dl⁻¹时建议输血。主要疗效变量为使用简明健康状况调查量表36项身体成分总结（SF-36 PCS）评分以及癌症治疗功能评估疲劳和贫血子量表（FACT-F和FACT-An）测量的QoL改善情况。还使用视觉模拟量表（VAS）作为整体QoL指标。临床反应定义为治疗最初4周后Hb水平升高≥2 g dl⁻¹且无需输血。与标准治疗相比，β-促红细胞生成素治疗组的SF-36 PCS、FACT-F和VAS评分从基线到最终访视的变化显著更大（P<0.05）；FACT-An子量表评分的变化在β-促红细胞生成素治疗组中倾向于更大（P = 0.076）。与标准治疗相比，β-促红细胞生成素显著提高了Hb浓度（有反应者：47%对13%；P<0.001）。内源性促红细胞生成素水平<50 mIU ml⁻¹是反应的显著预测指标（比值比2.496，95%置信区间：1.21 - 5.13）。与标准治疗相比，β-促红细胞生成素治疗可显著改善患有实体瘤和淋巴瘤恶性肿瘤的贫血患者的QoL。
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