Hess Gregory, Hill Jerrold, Clough Jeffrey, Hulnick Scott, Nordyke Robert J
Surveillance Data, Inc., Plymouth Meeting, PA 19462, USA.
Curr Med Res Opin. 2008 Mar;24(3):815-9. doi: 10.1185/030079908X280383. Epub 2008 Feb 6.
Previous labeling and guidelines recommended initiating erythropoiesis agents (ESAs) for chemotherapy-induced anemia (CIA) at hemoglobin (Hb) levels < 11 g/dL, maintaining near 12 g/dL, and withholding at > or = 13 g/dL. This study analyzed adherence with recommendations in administration of darbepoetin (DA) to cancer patients.
DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of Hb levels at which DA was administered using Varian electronic medical records (EMRs). The dataset comprises 141 694 cancer patients from 82 sites across 13 states. The study evaluated DA administrations with respect to recorded Hb for 8988 patients from 1/1/05 to 5/31/07.
Proportion of DA administrations at Hb > or = 12 and Hb > or = 13 g/dL. Hb level was analyzed for all administrations, stratified by year and anemia type (CIA, anemia-of-cancer, and myelodysplastic syndrome).
There were 51 111 DA administrations with Hb results. The proportion of administrations at Hb > or = 12 g/dL was 7.2% and at Hb > or = 13 g/dL was 0.6%, and for CIA 6.9%/0.6%, anemia of cancer (AOC) 8.8%/0.8%, and myelodysplastic syndrome (MDS) 6.5%/0.6%. The proportion of all DA administrations at Hb > or = 12 g/dL and > or = 13 g/dL declined from 8.6% to 5.3% (p < 0.0001) and from 0.7% to 0.4% (p < 0.0007), respectively during 1/1/05-5/31/07.
In this population, DA administration at Hb > or = 12 g/dL and Hb > or = 13 g/dL occurred in 7.2% and 0.6% of administrations, respectively, a approximately 93% adherence rate with recommendations. Further research is required to understand dose titrations at Hb 12-13 g/dL, and whether similar patterns are observed for other ESAs, and in other practice settings. This study provides context for the debate regarding the utilization, benefits and risks of ESAs in cancer patients.
既往的药品标签及指南建议，对于化疗所致贫血（CIA），当血红蛋白（Hb）水平低于11g/dL时开始使用促红细胞生成剂（ESA），维持Hb水平在12g/dL左右，当Hb水平达到或高于13g/dL时停药。本研究分析了癌症患者使用达贝泊汀（DA）时遵循这些建议的情况。
设计、研究地点及参与者：使用瓦里安电子病历（EMR）对使用DA时的Hb水平进行回顾性分析。数据集包括来自13个州82个地点的141694例癌症患者。本研究评估了2005年1月1日至2007年5月31日期间8988例患者使用DA时记录的Hb水平。
Hb水平达到或高于12g/dL以及达到或高于13g/dL时使用DA的比例。分析了所有用药时的Hb水平，并按年份和贫血类型（CIA、癌症相关性贫血和骨髓增生异常综合征）进行分层。
有51111次使用DA的记录有Hb检测结果。Hb水平达到或高于12g/dL时使用DA的比例为7.2%，达到或高于13g/dL时使用DA的比例为0.6%；对于CIA，相应比例分别为6.9%/0.6%，癌症相关性贫血（AOC）为8.8%/0.8%，骨髓增生异常综合征（MDS）为6.5%/0.6%。在2005年1月1日至2007年5月31日期间，所有使用DA时Hb水平达到或高于12g/dL以及达到或高于13g/dL的比例分别从8.6%降至5.3%（p<0.0001）和从0.7%降至0.4%（p<0.0007）。
在该人群中，Hb水平达到或高于12g/dL以及达到或高于13g/dL时使用DA的比例分别为7.2%和0.6%，遵循建议的比例约为93%。需要进一步研究以了解Hb水平在12 - 13g/dL时的剂量滴定情况，以及其他ESA是否有类似模式，以及在其他实际应用场景中是否如此。本研究为关于癌症患者使用ESA的效用、益处和风险的辩论提供了背景信息。
