观察与初始治疗对局限性低危前列腺癌男性患者的效果比较：一项成本效益分析。
Observation versus initial treatment for men with localized, low-risk prostate cancer: a cost-effectiveness analysis.
机构信息
Lank Center for Genitourinary Oncology, Dana-Farber Cancer Institute, Harvard Medical School, Institute for Clinical and Economic Review, Institute for Technology Assessment, Boston, MA 02115, USA.
出版信息
Ann Intern Med. 2013 Jun 18;158(12):853-60. doi: 10.7326/0003-4819-158-12-201306180-00002.
BACKGROUND
Observation is underutilized among men with localized, low-risk prostate cancer.
OBJECTIVE
To assess the costs and benefits of observation versus initial treatment.
DESIGN
Decision analysis simulating treatment or observation.
DATA SOURCES
Medicare schedules, published literature.
TARGET POPULATION
Men aged 65 and 75 years who had newly diagnosed low-risk prostate cancer (prostate-specific antigen level <10 µg/L, stage ≤T2a, Gleason score ≤3 + 3).
TIME HORIZON
Lifetime.
PERSPECTIVE
Societal.
INTERVENTION
Treatment (brachytherapy, intensity-modulated radiation therapy, or radical prostatectomy) or observation (active surveillance [AS] or watchful waiting [WW]).
OUTCOME MEASURES
Quality-adjusted life expectancy and costs.
RESULTS OF BASE-CASE ANALYSIS: Observation was more effective and less costly than initial treatment. Compared with AS, WW provided 2 additional months of quality-adjusted life expectancy (9.02 vs. 8.85 years) at a savings of $15,374 ($24,520 vs. $39,894) in men aged 65 years and 2 additional months (6.14 vs. 5.98 years) at a savings of $11,746 ($18,302 vs. $30,048) in men aged 75 years. Brachytherapy was the most effective and least expensive initial treatment.
RESULTS OF SENSITIVITY ANALYSIS
Treatment became more effective than observation when it led to more dramatic reductions in prostate cancer death (hazard ratio, 0.47 vs. WW and 0.64 vs. AS). Active surveillance became as effective as WW in men aged 65 years when the probability of progressing to treatment on AS decreased below 63% or when the quality of life with AS versus WW was 4% higher in men aged 65 years or 1% higher in men aged 75 years. Watchful waiting remained least expensive in all analyses.
LIMITATION
Results depend on outcomes reported in the published literature, which is limited.
CONCLUSION
Among these men, observation is more effective and costs less than initial treatment, and WW is most effective and least expensive under a wide range of clinical scenarios.
PRIMARY FUNDING SOURCE
National Cancer Institute, U.S. Department of Defense, Prostate Cancer Foundation, and Institute for Clinical and Economic Review.
背景
在患有局限性低危前列腺癌的男性中，观察治疗的应用不足。
目的
评估观察与初始治疗相比的成本效益。
设计
模拟治疗或观察的决策分析。
数据来源
医疗保险计划，已发表的文献。
目标人群
新诊断为低危前列腺癌（前列腺特异性抗原水平<10μg/L、分期≤T2a、Gleason 评分≤3+3）的 65 岁和 75 岁男性。
时间范围
终身。
视角
社会。
干预措施
治疗（近距离放射治疗、调强放射治疗或根治性前列腺切除术）或观察（主动监测[AS]或观察等待[WW]）。
结局测量
质量调整生命预期和成本。
基础分析结果
与初始治疗相比，观察治疗更有效且成本更低。与 AS 相比，WW 在 65 岁男性中提供了 2 个月的额外质量调整生命预期（9.02 年比 8.85 年），节省了 15374 美元（24520 美元比 39894 美元），在 75 岁男性中提供了 2 个月的额外质量调整生命预期（6.14 年比 5.98 年），节省了 11746 美元（18302 美元比 30048 美元）。近距离放射治疗是最有效的初始治疗方法，也是最便宜的。
敏感性分析结果
当治疗导致前列腺癌死亡率显著降低时（风险比，0.47 比 WW 和 0.64 比 AS），治疗比观察更有效。在 AS 治疗中进展为治疗的概率低于 63%，或者 AS 治疗的生活质量比 WW 治疗高 4%（65 岁男性）或高 1%（75 岁男性）时，AS 治疗在 65 岁男性中与 WW 治疗一样有效。在所有分析中，观察等待仍然是最经济的。
局限性
结果取决于已发表文献中报告的结果，而这些结果是有限的。
结论
在这些男性中，观察治疗比初始治疗更有效且成本更低，在广泛的临床情况下，WW 是最有效的且成本最低的。
主要资金来源
美国国立卫生研究院、美国国防部、前列腺癌基金会和临床与经济审查研究所。
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