Davidoff Cancer Center, Rabin Medical Center-Beilinson Hospital, Petah Tikva, Israel.
Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
BMC Gastroenterol. 2024 Nov 18;24(1):414. doi: 10.1186/s12876-024-03506-2.
Colonoscopy as a common screening practice to prevent colorectal cancer lacks strong evidence. NordICC, the first randomized trial of colonoscopy screening, reported no clear clinical benefit for colonoscopy in the intention-to-screen population with suggested benefit in the risk of colorectal incidence and cancer-specific mortality in the per-protocol analyses. However, although the study was designed to perform survival analysis, no survival outcomes were reported since the underlying assumption for hazard ratio was not valid. We aimed to assess whether colonoscopy screening is associated with improved survival outcomes compared with usual care.
We reconstructed patient-level data from the Kaplan-Meier estimator of the primary endpoints reported in NordICC for the intention-to-screen and adjusted per-protocol populations. The restricted-mean survival time difference (RMST-D) and restricted-mean time loss ratio (RMTL-R), which are robust alternatives to the hazard ratio without specific model assumptions, were calculated for colorectal cancer incidence and death.
In this study, no significant difference in colorectal cancer incidence over 10 years was found in the intention-to-screen population (RMST-D: -0.68 days, 95% CI -3.9-2.6; RMTL-R: 1.04, 95% CI 0.88-1.22) or in the per-protocol analysis population (RMST-D: -2.9 days, 95% CI -6.5-0.67; RMTL-R: 1.15, 95% CI 0.97-1.35). In the intention-to-screen population, inviting individuals to colonoscopy did not improve colorectal-cancer death (RMST-D: -0.29 days, 95% CI -1.6-1.0; RMTL-R: 1.07, 95% CI 0.78-1.48). Over 10 years, in the per-protocol analysis, individuals who underwent colonoscopy survived an average of 1.1 more days free of colorectal cancer, but this difference was not statistically significant (RMST-D: 95% CI -0.13-2.3; RMTL-R: 0.72, 95% CI 0.49-1.07).
In this reanalysis of the NordICC data, no evidence of improvement in survival outcomes for participants invited to undergo colonoscopy compared to usual care was identified, even when assuming that all invited participants did undergo colonoscopy. Thus, our results do not support the use of colonoscopy as a population-wide screening test as a mean to decrease colorectal cancer incidence or death.
Not applicable.
结肠镜检查作为一种预防结直肠癌的常见筛查方法，缺乏强有力的证据。NordICC 是第一项结肠镜检查筛查的随机试验，结果表明在意向筛查人群中，结肠镜检查对结直肠癌的发病率和癌症特异性死亡率没有明显的临床获益，但在方案分析中提示有获益。然而，尽管该研究旨在进行生存分析，但由于危害比的基本假设不成立，并未报告生存结果。我们旨在评估与常规护理相比，结肠镜检查筛查是否与改善生存结果相关。
我们从 NordICC 报告的主要终点的 Kaplan-Meier 估计值中重建了意向筛查和调整后方案人群的患者水平数据。对于结直肠癌的发病率和死亡率，计算了受限平均生存时间差异（RMST-D）和受限平均时间损失比（RMTL-R），这是一种无需特定模型假设的替代危害比的稳健方法。
在这项研究中，在意向筛查人群中，10 年内结直肠癌的发病率没有显著差异（RMST-D：-0.68 天，95%CI-3.9-2.6；RMTL-R：1.04，95%CI0.88-1.22）或在方案分析人群中（RMST-D：-2.9 天，95%CI-6.5-0.67；RMTL-R：1.15，95%CI0.97-1.35）。在意向筛查人群中，邀请个体进行结肠镜检查并未改善结直肠癌的死亡（RMST-D：-0.29 天，95%CI-1.6-1.0；RMTL-R：1.07，95%CI0.78-1.48）。在 10 年内，在方案分析中，接受结肠镜检查的个体平均多存活了 1.1 天无结直肠癌，但这一差异无统计学意义（RMST-D：95%CI-0.13-2.3；RMTL-R：0.72，95%CI0.49-1.07）。
在对 NordICC 数据的重新分析中，与常规护理相比，没有发现邀请参与者进行结肠镜检查可改善生存结果的证据，即使假设所有受邀参与者都进行了结肠镜检查。因此，我们的结果不支持将结肠镜检查作为一种降低结直肠癌发病率或死亡率的人群筛查测试。
不适用。
