Ont Health Technol Assess Ser. 2016 Jul 1;16(15):1-71. eCollection 2016.
Screening with mammography can detect breast cancer early, before clinical symptoms appear. Some cancers, however, are not captured with mammography screening alone. Ultrasound has been suggested as a safe adjunct screening tool that can detect breast cancers missed on mammography. We investigated the benefits, harms, cost-effectiveness, and cost burden of ultrasound as an adjunct to mammography compared with mammography alone for screening women at average risk and at high risk for breast cancer.
We searched Ovid MEDLINE, Ovid Embase, EBM Reviews, and the NHS Economic Evaluation Database, from January 1998 to June 2015, for evidence of effectiveness, harms, diagnostic accuracy, and cost-effectiveness. Only studies evaluating the use of ultrasound as an adjunct to mammography in the specified populations were included. We also conducted a cost analysis to estimate the costs in Ontario over the next 5 years to fund ultrasound as an adjunct to mammography in breast cancer screening for high-risk women who are contraindicated for MRI, the current standard of care to supplement mammography.
No studies in average-risk women met the inclusion criteria of the clinical review. We included 5 prospective, paired cohort studies in high-risk women, 4 of which were relevant to the Ontario context. Adjunct ultrasound identified between 2.3 and 5.9 additional breast cancers per 1,000 screens. The average pooled sensitivity of mammography and ultrasound was 53%, a statistically significant increase relative to mammography alone (absolute increase 13%; P < .05). The average pooled specificity of the combined test was 96%, an absolute increase in the false-positive rate of 2% relative to mammography screening alone. The GRADE for this body of evidence was low. Additional annual costs of using breast ultrasound as an adjunct to mammography for high-risk women in Ontario contraindicated for MRI would range from $15,500 to $30,250 in the next 5 years.
We found no evidence that evaluated the comparative effectiveness or diagnostic accuracy of screening breast ultrasound as an adjunct to mammography among average-risk women aged 50 years and over. In women at high risk of developing breast cancer, there is low-quality evidence that screening with mammography and adjunct ultrasound detects additional cases of disease, with improved sensitivity compared to mammography alone. Screening with adjunct ultrasound also increases the number of false-positive findings and subsequent biopsy recommendations. It is unclear if the use of screening breast ultrasound as an adjunct to mammography will reduce breast cancer-related mortality among high-risk women. The annual cost burden of using adjunct ultrasound to screen high-risk women who cannot receive MRI in Ontario would be small.
乳腺钼靶筛查可在临床症状出现之前早期检测出乳腺癌。然而，一些癌症仅通过乳腺钼靶筛查无法发现。超声已被提议作为一种安全的辅助筛查工具，可检测出乳腺钼靶筛查遗漏的乳腺癌。我们研究了与单纯乳腺钼靶筛查相比，超声作为乳腺钼靶辅助手段对平均风险和高风险乳腺癌女性进行筛查的益处、危害、成本效益和成本负担。
我们检索了1998年1月至2015年6月的Ovid MEDLINE、Ovid Embase、循证医学综述和英国国家医疗服务体系经济评估数据库，以获取有效性、危害、诊断准确性和成本效益的证据。仅纳入评估在特定人群中使用超声作为乳腺钼靶辅助手段的研究。我们还进行了成本分析，以估计安大略省未来5年为磁共振成像（MRI）检查禁忌的高风险女性在乳腺癌筛查中使用超声作为乳腺钼靶辅助手段的资金成本。
没有针对平均风险女性的研究符合临床综述的纳入标准。我们纳入了5项针对高风险女性的前瞻性配对队列研究，其中4项与安大略省的情况相关。辅助超声检查每1000次筛查可额外发现2.3至5.9例乳腺癌。乳腺钼靶和超声联合检查的平均合并敏感度为53%，相对于单纯乳腺钼靶检查有统计学显著提高（绝对提高13%；P < 0.05）。联合检查的平均合并特异度为96%，相对于单纯乳腺钼靶筛查，假阳性率绝对增加2%。这一证据体的推荐等级较低。在安大略省，未来5年对MRI检查禁忌的高风险女性使用乳腺超声作为乳腺钼靶辅助手段的额外年度成本将在15,500美元至30,250美元之间。
我们没有发现评估50岁及以上平均风险女性中乳腺超声作为乳腺钼靶辅助手段进行筛查的比较有效性或诊断准确性的证据。在患乳腺癌高风险的女性中，有低质量证据表明乳腺钼靶和辅助超声筛查能检测出更多病例，与单纯乳腺钼靶检查相比敏感度有所提高。辅助超声筛查也会增加假阳性结果的数量以及后续活检建议。目前尚不清楚乳腺超声作为乳腺钼靶辅助手段进行筛查是否会降低高风险女性的乳腺癌相关死亡率。在安大略省，对无法接受MRI检查的高风险女性使用辅助超声筛查的年度成本负担较小。
