Patton Jeffrey, Kuzur Michael, Liggett William, Miranda Fernando, Varsos Helen, Porter Lester
Tennessee Oncology, Nashville, Tennessee 37211-8025, USA.
Oncologist. 2004;9(1):90-6.
Epoetin alfa administered s.c. three times weekly or once weekly increases hemoglobin (Hb) levels, decreases transfusion requirements, and improves quality of life in anemic cancer patients receiving chemotherapy. This study assessed the feasibility of using higher initial doses of once-weekly epoetin alfa followed by less frequent maintenance doses to increase and then maintain adequate Hb levels in this population.
In this open-label, nonrandomized, pilot study, anemic (baseline Hb < or = 11 g/dl) cancer patients undergoing chemotherapy received initial doses of epoetin alfa of 60,000 U s.c. once weekly to increase Hb levels by at least 2 g/dl, followed by 120,000 U s.c. every 3 weeks to maintain Hb levels. The maximum treatment duration was 24 weeks.
The mean baseline Hb level was 10.1 +/- 0.8 g/dl (n = 20). Once-weekly dosing resulted in mean Hb level increases of 1.0 +/- 1.1 g/dl by week 4 and 2.9 +/- 1.9 g/dl by week 8; 86% and 79% of patients evaluable at week 8 and week 12, respectively, demonstrated increases of at least 2 g/dl (target Hb level of > or = 12 g/dl). Thirteen patients (65%) received at least one maintenance dose; the mean Hb level increased from 12.8 +/- 1.1 g/dl before starting maintenance therapy to 13.3 +/- 1.4 g/dl at the last maintenance week. Both dosage regimens were well tolerated.
Once-weekly epoetin alfa at a dose of 60,000 U effectively increased Hb levels by week 8; 86% of patients achieved rises of at least 2 g/dl or Hb levels > or = 12 g/dl. Moreover, epoetin alfa at doses of 120,000 U every 3 weeks maintained or increased Hb levels. Results from this pilot study suggest that higher initial once-weekly dosing of epoetin alfa followed by less frequent maintenance dosing appears to be feasible for treating anemia in cancer patients undergoing chemotherapy. Further evaluation of these and other epoetin alfa dosage regimens is warranted.
对于接受化疗的贫血癌症患者,皮下注射促红细胞生成素α,每周三次或每周一次可提高血红蛋白(Hb)水平、减少输血需求并改善生活质量。本研究评估了在该人群中使用更高的初始剂量的每周一次促红细胞生成素α,随后减少维持剂量的频率以提高并维持足够的Hb水平的可行性。
在这项开放标签、非随机的试点研究中,接受化疗的贫血(基线Hb≤11g/dl)癌症患者接受初始剂量为60,000U的皮下注射促红细胞生成素α,每周一次,以使Hb水平至少提高2g/dl,随后每3周皮下注射120,000U以维持Hb水平。最大治疗持续时间为24周。
平均基线Hb水平为10.1±0.8g/dl(n = 20)。每周一次给药导致第4周时平均Hb水平升高1.0±1.1g/dl,第8周时升高2.9±1.9g/dl;在第8周和第12周可评估的患者中,分别有86%和79%的患者Hb水平升高至少2g/dl(目标Hb水平≥12g/dl)。13名患者(65%)接受了至少一次维持剂量;平均Hb水平从开始维持治疗前的12.8±1.1g/dl增加到最后一次维持治疗周时的13.3±1.4g/dl。两种给药方案耐受性均良好。
每周一次剂量为60,000U的促红细胞生成素α在第8周时有效提高了Hb水平;86%的患者Hb水平升高至少2g/dl或Hb水平≥12g/dl。此外,每3周一次剂量为120,000U的促红细胞生成素α维持或提高了Hb水平。这项试点研究的结果表明,更高的初始每周一次剂量的促红细胞生成素α随后减少维持剂量的频率对于治疗接受化疗的癌症患者的贫血似乎是可行的。有必要对这些及其他促红细胞生成素α给药方案进行进一步评估。