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桓兴医讯 新的抗肿瘤药物毒性的增加和相关费用的风险:一项Meta
文章来源:北京市朝阳区桓兴肿瘤医院 点击数: 发布时间:2014-12-05 08:48
《临床肿瘤杂志》2014年11月10日在线先发
新的抗肿瘤药物毒性的增加和相关费用的风险:一项Meta分析
目的
少有但严重的新抗癌药物所致毒性的报告不断增加,相关费用是和新药物的使用有关的。
方法
我们鉴定了自2000年至2011年美国食品药品管理局批准的抗癌药物,有重要试验支持他们的记录。在这项Meta分析中加权和汇总了12个常规3至4级不良事件。根据基于目标特异性新剂型评估增加的药物价格和计算因不良事件的处理而增加的费用。结果:我们鉴定了41项研究包括27539例患者,评估了19个试验性药物。特异性肿瘤细胞靶向药物相对于对照组3至4级毒性反应发生率低,(median risk ratio [RR], 0.67; P = .22),然而,低的特异性靶向药物包括血管生成抑制剂(median RR, 3.39; P < .001),和化学治疗药物(median RR, 1.73; P < .001)有更多的毒性。风险是增加的,不管控制组包括积极治疗(RR, 2.11; P < .001),或不积极治疗(RR, 3.02; P < .001)。中位增加的试验性药物价格是每患者每月$6,000,中位处理毒性的费用与药物价格比较是低的,但是和低特异性靶向药物和化疗药物控制治疗比较是高的。
结论
新批准的抗癌药物与毒性增加有关,除了特异性分子靶向药物。毒性的处理导致治疗总费用小的增加。常见毒性和相关费用在低选择的患者综合治疗中可能是高的。鼓励研发生物标记驱动的药物。
北京桓兴肿瘤医院 桓兴编译组 李淑娈
2014年11月10日 星期一
2014 by American Society of Clinical Oncology November 10, 2014
Risk of Incremental Toxicities and Associated Costs of New Anticancer Drugs: A Meta-Analysis
1. Saroj Niraula⇑,
2. Eitan Amir,
3. Francisco Vera-Badillo,
4. Bostjan Seruga,
5. Alberto Ocana and
6. Ian F. Tannock
+ Author Affiliations
1. Saroj Niraula, CancerCare Manitoba and University of Manitoba, Winnipeg, Manitoba; Eitan Amir, Francisco Vera-Badillo, and Ian F. Tannock, Princess Margaret Hospital and University of Toronto, Toronto, Ontario, Canada; Bostjan Seruga, Institute of Oncology Ljubljana, Ljubljana, Slovenia; and Alberto Ocana, Albacete University Hospital, Albacete, Spain.
1. Corresponding author: Saroj Niraula, MBBS, MD, MSc, Medical Oncologist and Assistant Professor, Cancer Care Manitoba (University of Manitoba), ON2068, 675 McDermot Ave, Winnipeg, MB, R3E 0V9, Canada; e-mail: saroj.niraula@cancercare.mb.ca.
Abstract
Purpose There are increasing reports of rare but serious toxicities caused by new anticancer drugs, and there are costs associated with their management.
Methods We identified anticancer drugs approved by the US Food and Drug Administration from 2000 to 2011 and pivotal trials supporting their registration. Twelve frequent grade 3 to 4 adverse event (AEs) were weighted and pooled in a meta-analysis. Estimates of incremental drug prices and incremental costs for management of AEs were calculated according to type of new agent based on target specificity.
Results We identified 41 studies comprising 27,539 patients and evaluating 19 experimental drugs. Agents directed against a specific molecular target on cancer cells had a lower incidence of grade 3 to 4 toxicities compared with controls (median risk ratio [RR], 0.67; P = .22), whereas less-specific targeted agents, including angiogenesis inhibitors (median RR, 3.39; P < .001) and chemotherapeutic agents (median RR, 1.73; P < .001), were more toxic. Risk was increased regardless of whether the control arm contained active treatment (RR, 2.11; P < .001) or not (RR, 3.02; P < .001). Median incremental drug price for experimental agents was $6,000 per patient per month. Median cost of managing toxicity was low compared with drug costs but higher than controls for treatment with less-specific targeted agents and chemotherapies.
Conclusion Newly approved anticancer drugs are associated with increased toxicity, except for agents with a specific molecular target on cancer cells. Management of toxicity leads to a small increase in overall cost of treatment. Frequency of toxicity and associated costs are likely higher in less-selected patients treated in general oncologic practice. Development of biomarker-driven agents should be encouraged.

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