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期刊来源：JAMA

原文链接：https://doi.org/10.1001/jama.2024.5814

摘要内容如下：

重要性

癌症筛查的随机临床试验通常使用癌症特异性死亡率作为主要终点。III-IV期癌症的发病率是一个潜在的替代终点，可能会加速完成癌症筛查的随机临床试验。

目的

在癌症筛查的随机临床试验中，将癌症特异性死亡率与III-IV期癌症作为终点进行比较。

设计、设置和参与者

该荟萃分析包括截至2024年2月19日在欧洲、北美和亚洲进行的41项癌症筛查随机临床试验。提取的数据包括干预组和对照组的参与者人数、癌症诊断和癌症死亡人数。对于每个临床试验，筛查的效果被计算为干预组和对照组之间癌症特异性死亡率和III-IV期癌症参与者的发病率降低的百分比。

曝光

在癌症筛查的临床试验中随机分配到癌症筛查试验或对照组。

主要成果和措施

癌症特异性死亡率和III-IV期癌症发病率的终点使用Pearson相关系数与95%CI、线性回归和固定效应荟萃分析进行比较。

结果

纳入的随机临床试验测试了筛查乳腺癌（n=6）、结直肠癌（n=11）、肺癌（n=12）、卵巢癌（n=4）、前列腺癌（n=4）和其他癌症（n=4）的益处。癌症特异性死亡率降低与III-IV期癌症之间的相关性因癌症类型而异（I2=65%；P=.02）。筛查卵巢癌（Pearsonρ=0.99[95%CI，0.51-1.00]）和肺癌（Pearsonρ=0.92[95%CI，0.72-0.98]）的试验相关性最高，筛查乳腺癌（Pearsonρ=0.70[95%CI，-0.26-0.96]）的试验相关性中等，筛查结直肠癌（Pearsonρ=0.39[95%CI，-0.27至0.80]）和前列腺癌（Pearsonρ=-0.69[95%CI，-0.99至0.81]）。卵巢癌的线性回归斜率估计为1.15，肺癌的线性回归斜率估计为0.75，结直肠癌的线性回归斜率估计为0.40，乳腺癌的线性回归斜率估计为0.28，前列腺癌的线性回归斜率估计为-3.58，这表明III-IV期癌症发病率的特定降低幅度会导致癌症特异性死亡率的不同变化幅度（异质性P=.004）。

结论和相关性

在癌症筛查的随机临床试验中，晚期癌症的发病率可能是某些癌症类型癌症特异性死亡率的合适替代终点，但不适用于其他癌症类型。这些结果对多癌筛查试验的临床试验具有意义。

英文原文如下：

Abstracts

Importance  Randomized clinical trials of cancer screening typically use cancer-specific mortality as the primary end point. The incidence of stage III-IV cancer is a potential alternative end point that may accelerate completion of randomized clinical trials of cancer screening.

Objective  To compare cancer-specific mortality with stage III-IV cancer as end points in randomized clinical trials of cancer screening.

Design, Setting, and Participants  This meta-analysis included 41 randomized clinical trials of cancer screening conducted in Europe, North America, and Asia published through February 19, 2024. Data extracted included numbers of participants, cancer diagnoses, and cancer deaths in the intervention and comparison groups. For each clinical trial, the effect of screening was calculated as the percentage reduction between the intervention and comparison groups in the incidence of participants with cancer-specific mortality and stage III-IV cancer.

Exposures  Randomization to a cancer screening test or to a comparison group in a clinical trial of cancer screening.

Main Outcomes and Measures  End points of cancer-specific mortality and incidence of stage III-IV cancer were compared using Pearson correlation coefficients with 95% CIs, linear regression, and fixed-effects meta-analysis.

Results  The included randomized clinical trials tested benefits of screening for breast (n = 6), colorectal (n = 11), lung (n = 12), ovarian (n = 4), prostate (n = 4), and other cancers (n = 4). Correlation between reductions in cancer-specific mortality and stage III-IV cancer varied by cancer type (I2 = 65%; P = .02). Correlation was highest for trials that screened for ovarian (Pearson ρ = 0.99 [95% CI, 0.51-1.00]) and lung (Pearson ρ = 0.92 [95% CI, 0.72-0.98]) cancers, moderate for breast cancer (Pearson ρ = 0.70 [95% CI, -0.26 to 0.96]), and weak for colorectal (Pearson ρ = 0.39 [95% CI, -0.27 to 0.80]) and prostate (Pearson ρ = -0.69 [95% CI, -0.99 to 0.81]) cancers. Slopes from linear regression were estimated as 1.15 for ovarian cancer, 0.75 for lung cancer, 0.40 for colorectal cancer, 0.28 for breast cancer, and -3.58 for prostate cancer, suggesting that a given magnitude of reduction in incidence of stage III-IV cancer produced different magnitudes of change in incidence of cancer-specific mortality (P for heterogeneity = .004).

Conclusions and Relevance  In randomized clinical trials of cancer screening, incidence of late-stage cancer may be a suitable alternative end point to cancer-specific mortality for some cancer types, but is not suitable for others. These results have implications for clinical trials of multicancer screening tests.

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