对于正在接受放疗且同时或序贯接受化疗的贫血癌症患者，每周一次注射促红细胞生成素α可提高血红蛋白水平并改善生活质量。

Once-weekly dosing of epoetin-alpha increases hemoglobin and improves quality of life in anemic cancer patients receiving radiation therapy either concomitantly or sequentially with chemotherapy.

作者信息

Shasha Daniel, George Martine J, Harrison Louis B

机构信息

Blitman Department of Radiation Oncology, Beth Israel Medical Center, 10 Union Square East, New York, NY 10003, USA.

出版信息

Cancer. 2003 Sep 1;98(5):1072-9. doi: 10.1002/cncr.11616.

DOI:10.1002/cncr.11616

PMID:12942577

Abstract

BACKGROUND

The current study was performed to prospectively evaluate the effectiveness, clinical outcomes, and safety of once-weekly (QW) recombinant human erythropoietin (r-HuEPO [epoetin-alpha]) in anemic cancer patients with nonmyeloid malignancies who were receiving radiation therapy (RT) concomitantly or sequentially with chemotherapy (CT).

METHODS

A total of 777 anemic patients (hemoglobin [Hb] < or = 11 g/dL) were enrolled in this multicenter, open-label, nonrandomized, 16-week study. Patients initially received epoetin-alpha at a dose of 40,000 units (U) subcutaneously QW, escalating to a dose of 60,000 U QW if the Hb increased to < or = 1 g/dL after 4 weeks. Endpoints were changes in hematologic and quality of life (QOL) parameters.

RESULTS

Among the 442 patients evaluable for hematologic response, the mean increase in Hb from baseline to the time of final evaluation was 1.9 +/- 1.8 g/dL (P < 0.05). An increase in Hb of > or = 2 g/dL, in the absence of blood transfusions, occurred in 68.3% of patients (278 of 407 patients) who were on the study for > or = 30 days. The overall response rate (Hb increase > or = 2 g/dL or Hb > or = 12 g/dL in the absence of blood transfusions) was 74.0% (301 of 407 patients). In 359 patients who were evaluable for QOL assessment, epoetin-alpha therapy was found to significantly (P < 0.05) improve mean Linear Analog Scale Assessment (LASA) scores for energy level, ability to perform daily activities, and overall QOL from baseline to the time of final evaluation. QW epoetin-alpha therapy was found to be well tolerated.

CONCLUSIONS

Treatment with QW epoetin-alpha was found to increase Hb levels, decrease transfusion requirements, and improve functional status and QOL in anemic patients with nonmyeloid malignancies who were receiving RT concomitantly or sequentially with CT. Clinical benefits and the safety profile of QW epoetin-alpha in this setting appear to be similar to those observed in anemic cancer patients receiving CT.

摘要

背景

本研究旨在前瞻性评估每周一次（QW）重组人促红细胞生成素（r-HuEPO[阿法依泊汀]）对接受放疗（RT）联合或序贯化疗（CT）的非髓系恶性肿瘤贫血患者的有效性、临床结局及安全性。

方法

本多中心、开放标签、非随机、为期16周的研究共纳入777例贫血患者（血红蛋白[Hb]≤11g/dL）。患者最初皮下注射阿法依泊汀，剂量为40000单位（U）QW，若4周后Hb升高≤1g/dL，则剂量增至60000U QW。观察终点为血液学及生活质量（QOL）参数的变化。

结果

在442例可评估血液学反应的患者中，从基线至最终评估时Hb的平均升高值为1.9±1.8g/dL（P<0.05）。在研究≥30天的患者中，68.3%（407例中的278例）在未输血情况下Hb升高≥2g/dL。总体缓解率（未输血情况下Hb升高≥2g/dL或Hb≥12g/dL）为74.0%（407例中的301例）。在359例可评估QOL的患者中，发现阿法依泊汀治疗从基线至最终评估时能显著（P<0.05）改善能量水平、日常活动能力及总体QOL的平均线性模拟量表评估（LASA）评分。发现QW阿法依泊汀治疗耐受性良好。