Schwartzberg Lee, Shiffman Roger, Tomita Dianne, Stolshek Bradley, Rossi Greg, Adamson Robert
Supportive Oncology Services, Inc., The West Clinic, Memphis, Tennessee 38120, USA.
Clin Ther. 2003 Nov;25(11):2781-96. doi: 10.1016/s0149-2918(03)80333-8.
Darbepoetin alfa is the second erythropoietic protein to be approved for the treatment of chemotherapy-induced anemia (CIA). In the clinical setting, darbepoetin alfa can be administered less frequently than epoetin alfa with similar efficacy. Practice patterns and outcomes associated with the use of darbepoetin alfa and epoetin alfa in the clinical setting have not been reported.
This study compared practice patterns and clinical outcomes of the use of darbepoetin alfa and epoetin alfa for CIA at oncology practices in the United States.
This was a multicenter retrospective cohort study. Data were abstracted from the medical charts of consecutive patients who began darbepoetin alfa treatment between August 1 and October 4, 2002, or epoetin alfa treatment between April 1 and July 31, 2002, and were receiving concurrent chemotherapy. These data were used to determine the initial dose and dosing schedule, dose changes, and changes in hemoglobin concentrations after 4, 8, and 12 weeks of treatment, adjusted for red blood cell (RBC) transfusions, and the incidence of RBC transfusions over time. To minimize potential bias, the study protocol defined specific end points and prespecified analytic techniques for assessing clinical outcomes with the 2 agents.
The records of 1391 patients from 16 community and hospital outpatient oncology clinics were abstracted. Of these, 1293 patients (93.0%) received only 1 erythropoietic agent (darbepoetin alfa, 735 [56.8%]; epoetin alfa, 558 [43.2%]); the remainder received both agents. In the patients who received darbepoetin alfa, most (553 [75.2%]) received an initial dosage of 200 microg q2wk. A similar proportion (414 [74.2%]) received epoetin alfa at an initial dosage of 40,000 U qwk. As these were the regimens for the majority of patients whose records were abstracted, the results reported here are for these patients. The dose was increased in 63 darbepoetin alfa recipients (11.4%) and 58 epoetin alfa recipients (14.0%) at a median of 7 weeks. After 12 weeks, the 2 groups had an identical mean imputed change from baseline in hemoglobin concentration (1.0 g/dL), and the incidence of RBC transfusions during treatment was also similar between groups (darbepoetin alfa, 44553 [8.0%]; epoetin alfa, 39414 [9.4%]).
Darbepoetin alfa 200 microg q2wk was used as a standard regimen for CIA at the 16 US oncology practices participating in this study. It appeared to be as effective as epoetin alfa 40,000 U qwk, with a reduced frequency of dosing.
达贝泊汀α是第二种被批准用于治疗化疗所致贫血(CIA)的促红细胞生成蛋白。在临床环境中,达贝泊汀α的给药频率低于促红细胞生成素α,而疗效相似。关于在临床环境中使用达贝泊汀α和促红细胞生成素α的实践模式及结果尚未见报道。
本研究比较了美国肿瘤治疗机构中使用达贝泊汀α和促红细胞生成素α治疗CIA的实践模式和临床结果。
这是一项多中心回顾性队列研究。数据取自2002年8月1日至10月4日开始接受达贝泊汀α治疗或2002年4月1日至7月31日开始接受促红细胞生成素α治疗且同时接受化疗的连续患者的病历。这些数据用于确定初始剂量和给药方案、剂量变化以及治疗4、8和12周后血红蛋白浓度的变化,并对红细胞(RBC)输注情况进行校正,以及随时间推移RBC输注的发生率。为尽量减少潜在偏倚,研究方案定义了特定的终点和预先设定的分析技术,用于评估这两种药物的临床结果。
从16家社区和医院门诊肿瘤诊所提取了1391例患者的记录。其中,1293例患者(93.0%)仅接受了1种促红细胞生成药物(达贝泊汀α,735例[56.8%];促红细胞生成素α,558例[43.2%]);其余患者接受了两种药物。在接受达贝泊汀α治疗的患者中,大多数(553例[75.2%])接受的初始剂量为每2周200μg。类似比例(414例[74.2%])接受促红细胞生成素α的初始剂量为每周40000U。由于这些是大多数被提取记录患者的治疗方案,因此这里报告的结果是针对这些患者的。63例(11.4%)接受达贝泊汀α治疗的患者和58例(14.0%)接受促红细胞生成素α治疗的患者在中位时间7周时增加了剂量。12周后,两组从基线开始的血红蛋白浓度平均推算变化相同(1.0g/dL),且治疗期间RBC输注的发生率在两组间也相似(达贝泊汀α,44/553例[8.0%];促红细胞生成素α,39/414例[9.4%])。
每2周200μg的达贝泊汀α被用作参与本研究的16家美国肿瘤治疗机构治疗CIA的标准方案。它似乎与每周40000U的促红细胞生成素α效果相同,但给药频率更低。