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意大利多中心肺癌检测试验的十年结果表明,两年一次的肺癌筛查具有安全性和有效性。

Ten-year results of the Multicentric Italian Lung Detection trial demonstrate the safety and efficacy of biennial lung cancer screening.

机构信息

Thoracic Surgery Unit, Fondazione IRCCS Istituto Nazionale Dei Tumori, Milan, Italy.

Section of Radiology, Unit of Surgical Sciences, Department of Medicine and Surgery (DiMeC), University of Parma, Parma, Italy.

出版信息

Eur J Cancer. 2019 Sep;118:142-148. doi: 10.1016/j.ejca.2019.06.009. Epub 2019 Jul 20.

Abstract

BACKGROUND

The Multicentric Italian Lung Detection (MILD) trial demonstrated that prolonged low-dose computed tomography (LDCT) screening could achieve a 39% reduction in lung cancer (LC) mortality. We have here evaluated the long-term results of annual vs. biennial LDCT and the impact of screening intensity on overall and LC-specific mortality at 10 years.

PATIENTS AND METHODS

Between 2005 and 2018, the MILD trial prospectively randomised the 2376 screening arm participants to annual (n = 1190) or biennial (n = 1186) LDCT, for a median screening period of 6.2 years and 23,083 person-years of follow-up. The primary outcomes were 10-year overall and LC-specific mortality, and the secondary end-points were the frequency of advanced-stage and interval LCs.

RESULTS

The biennial LDCT arm showed a similar overall mortality (hazard ratio [HR] 0.80, 95% confidence interval [CI] 0.57-1.12) and LC-specific mortality at 10 years (HR 1.10, 95% CI 0.59-2.05), as compared with the annual LDCT arm. Biennial screening saved 44% of follow-up LDCTs in subjects with negative baseline LDCT, and 38% of LDCTs in all participants, with no increase in the occurrence of stage II-IV or interval LCs.

CONCLUSIONS

The MILD trial provides original evidence that prolonged screening beyond five years with biennial LDCT can achieve an LC mortality reduction comparable to annual LDCT, in subjects with a negative baseline examination.

摘要

背景

多中心意大利肺癌检测(MILD)试验表明,延长低剂量计算机断层扫描(LDCT)筛查可以使肺癌(LC)死亡率降低 39%。我们在此评估了每年与每两年一次 LDCT 的长期结果,以及筛查强度对 10 年时总体和 LC 特异性死亡率的影响。

患者和方法

在 2005 年至 2018 年期间,MILD 试验前瞻性地将 2376 名筛查组参与者随机分为每年(n=1190)或每两年(n=1186)一次 LDCT,中位筛查期为 6.2 年,随访 23083 人年。主要结局是 10 年的总体和 LC 特异性死亡率,次要终点是晚期和间隔 LC 的发生率。

结果

与每年一次的 LDCT 组相比,每两年一次的 LDCT 组在 10 年内的总体死亡率(风险比 [HR]0.80,95%置信区间 [CI]0.57-1.12)和 LC 特异性死亡率(HR 1.10,95%CI0.59-2.05)相似。与每年一次的 LDCT 组相比,在基线 LDCT 为阴性的患者中,每两年一次的筛查节省了 44%的后续 LDCT,在所有参与者中节省了 38%的 LDCT,而 II-IV 期或间隔 LC 的发生率没有增加。

结论

MILD 试验提供了原始证据,表明延长五年以上的每两年一次 LDCT 筛查可以降低 LC 死亡率,与每年一次的 LDCT 相当,适用于基线检查为阴性的患者。

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