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NCIC CTG JBR.10的经济学分析:一项关于辅助长春瑞滨加顺铂与早期非小细胞肺癌观察治疗对比的随机试验——加拿大国家癌症研究所临床试验组经济分析工作组及肺病研究组报告

Economic analysis of NCIC CTG JBR.10: a randomized trial of adjuvant vinorelbine plus cisplatin compared with observation in early stage non-small-cell lung cancer--a report of the Working Group on Economic Analysis, and the Lung Disease Site Group, National Cancer Institute of Canada Clinical Trials Group.

作者信息

Ng Raymond, Hasan Baktiar, Mittmann Nicole, Florescu Marie, Shepherd Frances A, Ding Keyue, Butts Charles Andrew, Cormier Yvon, Darling Gail, Goss Glenwood D, Inculet Richard, Seymour Lesley, Winton Timothy L, Evans William K, Leighl Natasha B

机构信息

Department of Hematology and Medical Oncology, Princess Margaret Hospital, Toronto, Ontario, Canada.

出版信息

J Clin Oncol. 2007 Jun 1;25(16):2256-61. doi: 10.1200/JCO.2006.09.4342.

Abstract

PURPOSE

National Cancer Institute of Canada Clinical Trials Group JBR.10 study is among the landmark trials that have established third generation platinum-based adjuvant chemotherapy as the standard of care after resection of stages IB-II NSCLC, improving absolute 5-year survival by 15% and median survival by 21 months. This cost-effectiveness analysis of adjuvant chemotherapy from the perspective of Canada's public health care system was undertaken based on the JBR.10 study population.

PATIENTS AND METHODS

The primary outcome of the study was the incremental cost effectiveness ratio (ICER) expressed in dollars per life-year gained (LYG). Direct medical resource utilization data were collected retrospectively from trial data and medical records of patients enrolled in the JBR.10 study at the five largest accruing Canadian centers, from the time of random assignment until death or study closure (April 2004). Survival and available costs (2005 Canadian dollars [$CAD]) are presented both with and without discounting at 5% per year.

RESULTS

Utilization data were collected from 172 Canadian patients (36% of the trial population), 85 randomly assigned to observation and 87 randomly assigned to chemotherapy. The mean costs of treatment per patient in the observation and adjuvant chemotherapy arms were $23,878 and $31,319, respectively, with an ICER of CAD$7,175/LYG discounted (95% CI, -$3,463 to $41,565), and $10,096/LYG undiscounted (95% CI, -$819 to $55,651).

CONCLUSION

Adjuvant vinorelbine plus cisplatin is a highly cost effective treatment that compares very favorably with other standard health care interventions.

摘要

目的

加拿大国家癌症研究所临床试验组JBR.10研究是具有里程碑意义的试验之一,该试验确立了第三代铂类辅助化疗作为IB-II期非小细胞肺癌切除术后的标准治疗方案,使5年绝对生存率提高了15%,中位生存期延长了21个月。基于JBR.10研究人群,从加拿大公共卫生保健系统的角度对辅助化疗进行了成本效益分析。

患者与方法

该研究的主要结局是增量成本效益比(ICER),以每获得一个生命年(LYG)的美元数表示。直接医疗资源利用数据是从加拿大五个最大入组中心参与JBR.10研究的患者的试验数据和医疗记录中回顾性收集的,从随机分组时起直至死亡或研究结束(2004年4月)。生存率和可用成本(2005年加元[$CAD])分别按每年5%的贴现率和不贴现率呈现。

结果

从172名加拿大患者(占试验人群的36%)中收集了利用数据,85名随机分配至观察组,87名随机分配至化疗组。观察组和辅助化疗组每名患者的平均治疗成本分别为23,878加元和31,319加元,贴现后的ICER为7,175加元/LYG(95%CI,-3,463至41,565美元),未贴现的为10,096加元/LYG(95%CI,-819至55,651美元)。

结论

辅助长春瑞滨加顺铂是一种成本效益很高的治疗方法,与其他标准卫生保健干预措施相比非常有利。

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