Libesman Sol, Li Tong, Marinovich M Luke, Seidler Anna Lene, Tagliafico Alberto Stefano, Houssami Nehmat
The NHMRC Clinical Trial Centre, The University of Sydney, A Joint Venture with Cancer Council NSW, Sydney, NSW, Australia.
The Daffodil Centre, The University of Sydney, A Joint Venture with Cancer Council NSW, Sydney, NSW, Australia.
Eur Radiol. 2025 Mar;35(3):1478-1489. doi: 10.1007/s00330-024-11085-9. Epub 2024 Oct 3.
We aimed to synthesise evidence from prospective studies of digital breast tomosynthesis (DBT) screening to assess its effectiveness compared to digital mammography (DM). Specifically, we examined whether DBT reduces interval cancer rates (ICRs) in population breast cancer screening.
We performed a systematic review and meta-analysis of DBT screening studies (identified from January 2013 to March 2024). We included both RCTs and non-randomised prospective studies that used an independent comparison for our primary outcome ICRs. The risk of bias was assessed with QUADAS-2. We compared the ICR, cancer detection rate (CDR), and recall rate of DBT and DM screening using random effects meta-analysis models. Subgroup analyses estimated outcomes by study design. Sensitivity analyses estimated absolute effects from relative effects.
Ten prospective studies (three RCTs, seven non-randomised) were eligible; all had a low risk of bias. There were 205,245 DBT-screened and 306,476 DM-screened participants with follow-up for interval cancer data. The pooled absolute ICR did not significantly differ between DBT and DM: -2.92 per 10,000 screens (95% CI: -6.39 to 0.54); however subsequent subgroup analysis indicated certain study designs may have biased this ICR estimate. Pooled ICR from studies that only sampled groups from the same time and region indicated DBT led to 5.50 less IC per 10,000 screens (95% CI: -9.47 to -1.54). Estimates from subgroup analysis that compared randomised and non-randomised trials did not significantly differ.
This meta-analysis provides suggestive evidence that DBT decreases ICR relative to DM screening; further evidence is needed to reduce uncertainty regarding ICR differences between DBT and DM.
Question Does DBT have long-term benefits over standard DM? Finding We find suggestive evidence in our primary analysis and stronger evidence in a follow-up analysis that DBT reduces interval cancers. Clinical relevance This meta-analysis provides the first indication that DBT may detect additional cancers that are clinically meaningful, based on suggestive evidence of a reduction in ICR. This finding does not preclude the simultaneous possibility of overdiagnosis.
我们旨在综合数字乳腺断层合成（DBT）筛查前瞻性研究的证据，以评估其与数字乳腺钼靶（DM）相比的有效性。具体而言，我们研究了DBT在人群乳腺癌筛查中是否能降低间期癌发生率（ICR）。
我们对DBT筛查研究（2013年1月至2024年3月期间确定）进行了系统评价和荟萃分析。我们纳入了随机对照试验（RCT）和非随机前瞻性研究，这些研究对我们的主要结局ICR进行了独立比较。使用QUADAS - 2评估偏倚风险。我们使用随机效应荟萃分析模型比较了DBT和DM筛查的ICR、癌症检出率（CDR）和召回率。亚组分析按研究设计估计结局。敏感性分析从相对效应估计绝对效应。
十项前瞻性研究（三项RCT，七项非随机）符合条件；所有研究的偏倚风险均较低。有205,245名接受DBT筛查的参与者和306,476名接受DM筛查的参与者有间期癌数据随访。DBT和DM之间的合并绝对ICR无显著差异：每10,000次筛查-2.92例（95%置信区间：-6.39至0.54）；然而，随后的亚组分析表明，某些研究设计可能使该ICR估计产生偏倚。仅对同一时间和地区的组进行抽样的研究的合并ICR表明，DBT导致每10,000次筛查的间期癌减少5.50例（95%置信区间：-9.47至-1.54）。比较随机试验和非随机试验的亚组分析估计值无显著差异。
这项荟萃分析提供了提示性证据，表明DBT相对于DM筛查可降低ICR；需要更多证据来减少关于DBT和DM之间ICR差异的不确定性。
问题DBT相对于标准DM有长期益处吗？发现我们在主要分析中发现了提示性证据，在后续分析中发现了更强的证据，表明DBT可减少间期癌。临床相关性这项荟萃分析首次表明，基于ICR降低的提示性证据，DBT可能检测到具有临床意义的额外癌症。这一发现并不排除同时存在过度诊断的可能性。
