Quirt I, Micucci S, Moran L A, Pater J, Browman G
Princess Margaret Comprehensive Cancer Centre, Toronto, Ont.
Cancer Prev Control. 1997 Aug;1(3):241-8.
To make recommendations regarding the use of EPO to reduce the need for transfusion of red blood cells in patients receiving chemotherapy for a nonhematologic cancer.
First transfusion requirement from the start of chemotherapy is the main outcome of interest. Quality of life and costs are also considered.
PERSPECTIVE (VALUES): Evidence was selected and reviewed by 5 members of the Ontario Cancer Treatment Practice Guidelines Initiative (OCTPGI) and the Systemic Treatment Program Committee (STPC). Drafts of this document have been circulated to and reviewed by members of the STPC. The STPC comprises medical oncologists, pharmacists, supportive care personnel and administrators. No community representative participated in the development of this practice guideline.
Eleven randomized controlled trials (RCTs), most placebo-controlled, were available for review. A meta-analysis was performed with 8 trials that shared a clinically relevant outcome measure. Only 1 trial assessed quality of life.
The meta-analysis showed a relative risk for transfusion among EPO patients of 0.64 (95% confidence interval 0.53-0.78), which translates into a 36% relative reduction in the proportion of patients requiring transfusion (p = 0.00001). Reduction in transfusion requirements was similar across strata defined by methodological quality, EPO dose, hematologic status, tumour type at trial entry and chemotherapy regimen. In the 1 trial that assessed quality of life, EPO was associated with improved quality of life.
Hypertension has been noted rarely in EPO-treated cancer patients. The RCTs did not report adverse effects in EPO-treated patients compared with control patients during the follow-up period. Long-term adverse effects are unknown. EPO is more costly than transfusion, but formal cost-effectiveness studies are unavailable.
For patients receiving chemotherapy for nonhematologic cancer in whom symptoms of anemia are expected and in whom transfusion of red blood cells is not considered an acceptable treatment option, EPO can be recommended as a safe, effective treatment alternative. The evidence in support of using EPO is stronger for patients receiving platinum-based chemotherapy regimens that for those receiving non-platinum-based regimens. CLINICAL PRACTICE GUIDELINE DATE: Apr. 4, 1997.
1)促红细胞生成素(EPO)能否减少非血液系统癌症化疗患者对红细胞输血的需求?2)EPO的使用能否改善这些癌症患者的生活质量?
就是否使用EPO减少非血液系统癌症化疗患者对红细胞输血的需求提出建议。
从化疗开始到首次输血的需求是主要关注结果。生活质量和成本也在考虑范围内。
观点(价值观):安大略癌症治疗实践指南倡议(OCTPGI)和系统治疗项目委员会(STPC)的5名成员挑选并审查了证据。本文件草案已分发给STPC成员并由其进行审查。STPC由医学肿瘤学家、药剂师、支持治疗人员和管理人员组成。没有社区代表参与本实践指南的制定。
有11项随机对照试验(RCT)可供审查,大多数为安慰剂对照试验。对8项具有临床相关结果测量指标的试验进行了荟萃分析。只有1项试验评估了生活质量。
荟萃分析显示,接受EPO治疗患者的输血相对风险为0.64(95%置信区间0.53 - 0.78),这意味着需要输血的患者比例相对降低了36%(p = 0.00001)。在按方法学质量、EPO剂量、血液学状态、试验入组时的肿瘤类型和化疗方案定义的各亚组中,输血需求的降低情况相似。在1项评估生活质量的试验中,EPO与生活质量改善相关。
在接受EPO治疗的癌症患者中很少发现高血压。RCT未报告EPO治疗患者与对照患者在随访期间的不良反应。长期不良反应尚不清楚。EPO比输血成本更高,但尚无正式的成本效益研究。
对于预期有贫血症状且不认为红细胞输血是可接受治疗选择的非血液系统癌症化疗患者,可推荐EPO作为一种安全、有效的治疗替代方案。支持使用EPO的证据对于接受铂类化疗方案的患者比接受非铂类化疗方案的患者更强。临床实践指南日期:1997年4月4日。