Spaëth D, Marchal C, Blanc-Vincent M P
Centre Alexis-Vautrin, Vandoeuvre-lès-Nancy.
Bull Cancer. 1998 Apr;85(4):337-46.
The "Standards, Options and Recommendations" (SOR), started in 1993, are a collaborative project between the Federation of the French Cancer Centres (FNCLCC), the 20 French Cancer Centres and specialists from French Public Universities, General Hospitals and Private Clinics. The main objective is the development of clinical practice guidelines to improve the quality of health care and outcomes for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary experts group, with feedback from specialists in cancer care delivery.
To develop a clinical practice guideline with definitions of Standards, Options and Recommendations for the use of recombinant human erythropoietin (rHuEPO) in oncology.
Data have been identified by literature search using Medline (up to march 1996) and Current Contents (up to october 1996) and personal references lists. The main end points considered were hemoglobin level, haematocrit, quality of life, transfusion requirements, incidence and length of hospital stays, efficacy of cancer treatment, safety and costs. Once the guideline was defined, the document was submitted to 39 reviewers for peer review, and to the medical committees of the 20 French Cancer Centres for review and agreement.
The key recommendations are: 1) the use of recombinant human erythropoietin in oncology is validated for chemotherapy-induced anemia when the chemotherapeutic regimen contains platinum. In other cases, we recommend to suggest patients participating in prospective clinical trials; 2) for chemotherapy (platinum based)-induced anemia, the benefits/risks ratio for anemia therapy (i.e. transfusion or erythropoietin therapy) must be analysed for each individual patient; 3) we recommend participation in studies to identify predictive factors for non-response to erythropoietin therapy to select non-responding patients; 4) to investigate the clinical benefit of erythropoietin therapy for anemia due to intensive cytotoxic chemotherapy and radiation therapy, we recommend to suggest patients participating in large multicentre phase III trials; 5) at the present time, there is insufficient evidence to recommend the use of erythropoietin therapy in children.
“标准、选项与建议”(SOR)项目始于1993年,是法国癌症中心联合会(FNCLCC)、20家法国癌症中心以及法国公立大学、综合医院和私立诊所的专家之间的合作项目。其主要目标是制定临床实践指南,以提高癌症患者的医疗质量和治疗效果。该方法基于多学科专家组的文献综述和批判性评估,并参考癌症护理专家的反馈意见。
制定一项关于重组人促红细胞生成素(rHuEPO)在肿瘤学中应用的临床实践指南,明确标准、选项和建议。
通过使用Medline(截至1996年3月)和《现刊目次》(截至1996年10月)进行文献检索以及个人参考文献列表来确定数据。主要考虑的终点指标包括血红蛋白水平、血细胞比容、生活质量、输血需求、住院发生率和时长、癌症治疗效果、安全性和成本。一旦指南确定,该文件将提交给3 * 9位评审人员进行同行评审,并提交给20家法国癌症中心的医学委员会进行审核和认可。
关键建议如下:1)当化疗方案包含铂类药物时,重组人促红细胞生成素在肿瘤学中用于化疗引起的贫血已得到验证。在其他情况下,我们建议建议患者参加前瞻性临床试验;2)对于化疗(铂类为基础)引起的贫血,必须为每位患者分析贫血治疗(即输血或促红细胞生成素治疗)的获益/风险比;3)我们建议参与研究以确定促红细胞生成素治疗无反应的预测因素,从而筛选出无反应的患者;4)为研究促红细胞生成素治疗强化细胞毒性化疗和放疗所致贫血的临床获益,我们建议建议患者参加大型多中心III期试验;5)目前,尚无足够证据推荐在儿童中使用促红细胞生成素治疗。