Aapro Matti, Abraham Ivo, Bokemeyer Carsten, Ludwig Heinz, Macdonald Karen, Soubeyran Pierre, Turner Matthew
Multidisciplinary Oncology Institute, Genolier, Switzerland.
Support Care Cancer. 2008 Feb;16(2):193-200. doi: 10.1007/s00520-007-0311-2. Epub 2007 Sep 14.
The benefit of supportive care with erythropoiesis-stimulating agents (ESAs) for patients with cancer-related anaemia is well known. However, the European Cancer Anaemia Survey (ECAS, data from 2001) showed that about 60% of cancer patients with anaemia do not receive any treatment. Since ECAS, evidence-based guidelines have provided recommendations for ESA use, but it is not known to what extent current treatment patterns follow these guidelines. To address this issue, the Anaemia Cancer Treatment (A.C.T.) study was initiated. The background to the development of the A.C.T. study and study methodology are described.
The A.C.T. study is a global, retrospective, pharmacoepidemiologic study of at least 2,560 medical records of anaemic patients with cancer who were previously treated with an ESA from a minimum of 186 centres. Records from patients aged greater than or equal to 18 years with a diagnosis of solid tumour or myeloma or lymphoma and who were started on ESAs 3-12 months before inclusion and followed for 8-10 weeks will be eligible. Factors associated with ESA non-responsiveness will also be evaluated.
Completion of the European phase of the study is anticipated in late 2007 with the rest of the world closing in late 2007 or early 2008. Publication of findings is anticipated in 2008.
By examining the extent to which anaemia management in clinical practice is congruent with best practice guidelines, the A.C.T. study will provide a further foundation for the development of evidence-based supportive cancer care.
促红细胞生成素(ESA)用于支持治疗癌症相关性贫血患者的益处已广为人知。然而,欧洲癌症贫血调查(ECAS,2001年数据)显示,约60%的癌症贫血患者未接受任何治疗。自ECAS以来,循证指南已就ESA的使用提供了建议,但目前的治疗模式在多大程度上遵循这些指南尚不清楚。为解决这一问题,启动了贫血癌症治疗(A.C.T.)研究。本文描述了A.C.T.研究的开展背景及研究方法。
A.C.T.研究是一项全球性、回顾性、药物流行病学研究,至少纳入来自186个中心的2560例曾接受ESA治疗的癌症贫血患者的病历。年龄大于或等于18岁、诊断为实体瘤或骨髓瘤或淋巴瘤、在入组前3 - 12个月开始使用ESA并随访8 - 10周的患者记录将符合条件。还将评估与ESA无反应相关的因素。
预计该研究的欧洲阶段将于2007年末完成,世界其他地区将于2007年末或2008年初完成。预计2008年公布研究结果。
通过研究临床实践中贫血管理与最佳实践指南的符合程度,A.C.T.研究将为循证支持性癌症护理的发展提供进一步的基础。