化疗所致贫血患者中，促红细胞生成素α延长给药（80000单位，每两周一次）与每周给药（40000单位，每周一次）的随机、开放标签比较。
Randomized, open-label comparison of epoetin alfa extended dosing (80 000 U Q2W) vs weekly dosing (40 000 U QW) in patients with chemotherapy-induced anemia.
作者信息
Henry David H, Gordan Lucio N, Charu Veena, Wilhelm Francois E, Williams Denise, Xie John, Woodman Richard C
机构信息
Joan Karnell Cancer Center, Pennsylvania Hospital, Philadelphia, PA, USA.
出版信息
Curr Med Res Opin. 2006 Jul;22(7):1403-13. doi: 10.1185/030079906X115559.
OBJECTIVE
This randomized, open-label, multicenter study compared the efficacy and safety of epoetin alfa (EPO) 80 000 U every 2 weeks (Q2W) to the FDA-approved regimen of 40 000 U weekly (QW) in patients with chemotherapy-induced anemia.
RESEARCH DESIGN AND METHODS
A total of 310 patients with nonmyeloid malignancy and baseline hemoglobin (Hb) <or= 11 g/dL who were scheduled to receive chemotherapy for a minimum of 12 weeks were randomized to EPO Q2W or QW for up to 12 weeks, with dose modification to maintain Hb at approximately 12 g/dL. Efficacy analyses used the per-protocol population (patients who completed the study with a value for Hb change) for the primary endpoint only and the modified intent-to-treat (mITT) population (patients who received study drug and had at least one postbaseline Hb value) for the primary and secondary endpoints.
RESULTS
Analysis of the primary endpoint revealed that the mean change in Hb from baseline to study end was comparable between the Q2W and QW groups in the per-protocol population (1.6 g/dL vs 1.8 g/dL, respectively; treatment difference, -0.2 g/dL; one-sided 95% confidence interval [-0.56, -]); similar results were observed in the mITT population. Among patients on study at Day 29, 9.6% (13/135) and 11.1% (14/126) of patients in the Q2W and QW groups, respectively, received a transfusion between Day 29 and the end of the study (p = 0.709). Dose withholds (21% vs 42%, p < 0.001) and dose reductions (41% vs 59%, p = 0.003) were less common for Q2W than QW. Safety profiles were similar between groups; clinically relevant thrombotic vascular events occurred in 8% of patients in each group. The open-label dosing and the patient attrition rate did not appear to influence overall study results.
CONCLUSIONS
Extended dosing (80 000 U Q2W) and once-weekly dosing (40 000 U QW) of EPO provided comparable safety and efficacy for chemotherapy-induced anemia.
目的
本随机、开放标签、多中心研究比较了每2周一次皮下注射80000单位促红细胞生成素（EPO）与美国食品药品监督管理局（FDA）批准的每周一次皮下注射40000单位促红细胞生成素治疗化疗所致贫血的疗效和安全性。
研究设计与方法
总共310例非髓系恶性肿瘤患者，基线血红蛋白（Hb）≤11g/dL，计划接受至少12周的化疗，随机分为每2周一次皮下注射80000单位促红细胞生成素组或每周一次皮下注射40000单位促红细胞生成素组，治疗12周，根据Hb水平调整剂量，使Hb维持在约12g/dL。疗效分析仅对符合方案人群（完成研究且有Hb变化值的患者）进行主要终点分析，对改良意向性治疗人群（接受研究药物治疗且至少有一个基线后Hb值的患者）进行主要和次要终点分析。
结果
主要终点分析显示，符合方案人群中，每2周一次皮下注射80000单位促红细胞生成素组和每周一次皮下注射40000单位促红细胞生成素组从基线到研究结束时Hb的平均变化相当（分别为1.6g/dL和1.8g/dL；治疗差异为-0.2g/dL；单侧95%置信区间[-0.56，-]）；改良意向性治疗人群中观察到类似结果。在第29天仍在研究中的患者中，每2周一次皮下注射80000单位促红细胞生成素组和每周一次皮下注射40000单位促红细胞生成素组分别有9.6%（13/135）和11.1%（14/126）的患者在第29天至研究结束期间接受了输血（p = 0.709）。每2周一次皮下注射80000单位促红细胞生成素组的剂量中断（21%比42%，p<0.001）和剂量减少（41%比59%，p = 0.003）比每周一次皮下注射40000单位促红细胞生成素组少见。两组安全性相似；每组8%的患者发生了临床相关的血栓性血管事件。开放标签给药和患者脱落率似乎未影响总体研究结果。
结论
每2周一次皮下注射80000单位促红细胞生成素和每周一次皮下注射40000单位促红细胞生成素治疗化疗所致贫血的安全性和疗效相当。
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