Glaspy John A, Tchekmedyian N Simon
UCLA School of Medicine, UCLA Oncology Center, Los Angeles, California, USA.
Oncology (Williston Park). 2002 Oct;16(10 Suppl 11):23-9.
The objectives of this study were to assess the safety and efficacy of darbepoetin alfa (Aranesp) administered every 2 weeks in anemic patients with solid tumors receiving chemotherapy. This was an open-label, randomized, active-controlled, multicenter dose-finding study evaluating a range of every-2-week darbepoetin alfa doses. The active control arm received epoetin alfa (Epogen, Procrit) at 40,000 U weekly with a dose increase to 60,000 U weekly for subjects with an inadequate response. The lowest clinically effective doses of darbepoetin alfa in this study were 3.0 and 5.0 microg/kg every 2 weeks, with no additional benefit observed at higher doses. The percentage of patients who achieved a hematopoietic response in the 3.0- and 5.0-microg/kg groups was 66% (95% confidence interval [CI] = 46%-86%) and 84% (95% CI = 67%-100%), respectively, compared with 63% (95% CI = 46%-81%) in the epoetin alfa group. Darbepoetin alfa administered at a dose of 3.0 microg/kg every 2 weeks is safe and effective for treating anemia in patients with solid tumors on chemotherapy, and is comparable to epoetin alfa. A dose increase to 5.0 microg/kg of darbepoetin alfa administered every 2 weeks may be appropriate in patients with an inadequate initial response.
本研究的目的是评估每2周给予促红细胞生成素α（阿法达贝泊汀）对接受化疗的实体瘤贫血患者的安全性和有效性。这是一项开放标签、随机、活性药物对照、多中心剂量探索性研究，评估了一系列每2周一次的促红细胞生成素α剂量。活性对照组每周接受40,000单位的促红细胞生成素α（依泊汀α），对反应不足的受试者剂量增加至每周60,000单位。本研究中促红细胞生成素α的最低临床有效剂量为每2周3.0和5.0微克/千克，更高剂量未观察到额外益处。3.0微克/千克组和5.0微克/千克组中实现造血反应的患者百分比分别为66%（95%置信区间[CI]=46%-86%）和84%（95%CI=67%-100%），而促红细胞生成素α组为63%（95%CI=46%-81%）。每2周给予3.0微克/千克剂量的促红细胞生成素α对接受化疗的实体瘤患者治疗贫血是安全有效的，且与促红细胞生成素α相当。对于初始反应不足的患者，每2周将促红细胞生成素α剂量增加至5.0微克/千克可能是合适的。
