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SWOG 阳性治疗试验对美国癌症患者生存的影响。

The Effect of Positive SWOG Treatment Trials on Survival of Patients With Cancer in the US Population.

机构信息

SWOG Statistical Center, Seattle, Washington.

Fred Hutchinson Cancer Research Center, Seattle, Washington.

出版信息

JAMA Oncol. 2017 Oct 1;3(10):1345-1351. doi: 10.1001/jamaoncol.2017.0762.

Abstract

IMPORTANCE

Recently, tremendous prominence has been given to the investigation of the effect of different research processes as part of the Cancer Moonshot. More than half a century ago, the National Cancer Institute (NCI) established a network of publicly funded cancer cooperative research groups to systematically evaluate new treatments for efficacy and safety.

OBJECTIVE

To examine the extent to which positive NCI-sponsored cancer treatment trials have benefited patients with cancer in the US population.

DESIGN, SETTING, AND PARTICIPANTS: This investigation used study data from SWOG, an NCI-sponsored network cooperative research group. All treatment trials during SWOG's 60-year history (1956-2016) were identified for which the new, experimental therapy provided a statistically significant improvement in overall survival. It was assumed that the new, proven treatments from these trials established new standards for cancer care in the treatment community. Twenty-three positive SWOG treatment trials were identified from a variety of different disease settings.

MAIN OUTCOMES AND MEASURES

This study estimated population life-years gained from the 23 treatment trials through 2015 by mapping the effect of the new treatments onto the US cancer population using an area under the Kaplan-Meier survival curve approach that combined trial-specific hazard function and hazard ratio results, along with Surveillance, Epidemiology, and End Results program and life table data. Calculations were age adjusted. The US dollar return on investment was estimated as the ratio of the total investment by the NCI in the treatment trial program divided by the estimate of life-years gained.

RESULTS

In total, 12 361 patients were enrolled to the 23 positive trials from 1965 to 2012. The study estimated that 3.34 million (95% confidence limit, 2.39-4.15 million) life-years were gained from these 23 trials through 2015. Estimates were greater than 2 million life-years gained under most model simulations. The US dollar return on investment was $125 per life-year gained.

CONCLUSIONS AND RELEVANCE

SWOG treatment trials have had a substantial impact on population survival for patients with cancer over 60 years. The NCI's investment in its cancer cooperative group research program has provided exceptional value and benefit to the American public through its research programs generating positive cancer treatment trials.

TRIAL REGISTRATION

clinicaltrials.gov Identifiers: NCT00004001, NCT00075764, and NCT00644228.

摘要

重要性

最近,人们非常关注作为“癌症登月计划”一部分的不同研究过程的影响。半个多世纪前,美国国家癌症研究所(NCI)建立了一个由公共资金资助的癌症合作研究小组网络,以系统地评估新疗法的疗效和安全性。

目的

检查 NCI 赞助的癌症治疗试验在多大程度上使美国癌症患者受益。

设计、设置和参与者:这项研究使用了 SWOG 的研究数据,SWOG 是一个 NCI 赞助的网络合作研究小组。确定了 SWOG 60 年历史(1956-2016 年)期间所有新的、实验性治疗在总生存期方面提供统计学显著改善的治疗试验。假设这些试验中的新的、经过验证的治疗方法为治疗社区的癌症治疗建立了新的标准。从各种不同的疾病环境中确定了 23 项阳性 SWOG 治疗试验。

主要结果和措施

本研究通过使用 Kaplan-Meier 生存曲线下面积方法将新治疗方法映射到美国癌症人群,估计了 2015 年之前 23 项治疗试验带来的人群寿命年数,该方法结合了试验特异性危险函数和危险比结果,以及监测、流行病学和最终结果计划和生命表数据。计算是年龄调整的。投资回报率的估计是 NCI 在治疗试验计划中的总投资除以估计的寿命年数。

结果

共有 12361 名患者从 1965 年到 2012 年参加了 23 项阳性试验。研究估计,从这些试验中获得了 334 万(95%置信区间为 239 万至 415 万)的寿命年数。在大多数模型模拟中,估计寿命年数超过 200 万。投资回报率为每获得 1 个生命年 125 美元。

结论和相关性

SWOG 治疗试验在过去 60 年中对癌症患者的人群生存产生了重大影响。NCI 通过其癌症合作组研究计划的投资,通过其产生阳性癌症治疗试验的研究计划,为美国公众提供了卓越的价值和收益。

试验注册

clinicaltrials.gov 标识符:NCT00004001、NCT00075764 和 NCT00644228。

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