West Midlands Health Technology Assessment Collaboration, Unit of Public Health, Epidemiology & Biostatistics, University of Birmingham, Birmingham, UK.
Health Technol Assess. 2010 Oct;14(50):1-103. doi: 10.3310/hta14500.
Breast cancer (BC) accounts for one-third of all cases of cancer in women in the UK. Current strategies for the detection of BC recurrence include computed tomography (CT), magnetic resonance imaging (MRI) and bone scintigraphy. Positron emission tomography (PET) and, more recently, positron emission tomography/computed tomography (PET/CT) are technologies that have been shown to have increasing relevance in the detection and management of BC recurrence.
To review the accuracy of PET and PET/CT for the diagnosis of BC recurrence by assessing their value compared with current practice and compared with each other.
MEDLINE and EMBASE were searched from inception to May 2009.
Studies were included if investigations used PET or PET/CT to diagnose BC recurrence in patients with a history of BC and if the reference standard used to define the true disease status was histological diagnosis and/or long-term clinical follow-up. Studies were excluded if a non-standard PET or PET/CT technology was used, investigations were conducted for screening or staging of primary breast cancer, there was an inadequate or undefined reference standard, or raw data for calculation of diagnostic accuracy were not available.
Quality assessment and data extraction were performed independently by two reviewers. Direct and indirect comparisons were made between PET and PET/CT and between these technologies and methods of conventional imaging, and meta-analyses were carried out. Analysis was conducted separately on patient- and lesion-based data. Subgroup analysis was conducted to investigate variation in the accuracy of PET in certain populations or contexts and sensitivity analysis was conducted to examine the reliability of the primary outcome measures.
Of the 28 studies included in the review, 25 presented patient-based data and 7 presented lesion-based data for PET and 5 presented patient-based data and 1 presented patient- and lesion-based data for PET/CT; 16 studies conducted direct comparisons with 12 comparing the accuracy of PET or PET/CT with conventional diagnostic tests and 4 with MRI. For patient-based data (direct comparison) PET had significantly higher sensitivity [89%, 95% confidence interval (CI) 83% to 93% vs 79%, 95% CI 72% to 85%, relative sensitivity 1.12, 95% CI 1.04 to 1.21, p = 0.005] and significantly higher specificity (93%, 95% CI 83% to 97% vs 83%, 95% CI 67% to 92%, relative specificity 1.12, 95% CI 1.01 to 1.24, p = 0.036) compared with conventional imaging tests (CITs)--test performance did not appear to vary according to the type of CIT tested. For patient-based data (direct comparison) PET/CT had significantly higher sensitivity compared with CT (95%, 95% CI 88% to 98% vs 80%, 95% CI 65% to 90%, relative sensitivity 1.19, 95% CI 1.03 to 1.37, p = 0.015), but the increase in specificity was not significant (89%, 95% CI 69% to 97% vs 77%, 95% CI 50% to 92%, relative specificity 1.15, 95% CI 0.95 to 1.41, p = 0.157). For patient-based data (direct comparison) PET/CT had significantly higher sensitivity compared with PET (96%, 95% CI 90% to 98% vs 85%, 95% CI 77% to 91%, relative sensitivity 1.11, 95% CI 1.03 to 1.18, p = 0.006), but the increase in specificity was not significant (89%, 95% CI 74% to 96% vs 82%, 95% CI 64% to 92%, relative specificity 1.08, 95% CI 0.94 to 1.20, p = 0.267). For patient-based data there were no significant differences in the sensitivity or specificity of PET when compared with MRI, and, in the one lesion based study, there was no significant differences in the sensitivity or specificity of PET/CT when compared with MRI.
Studies reviewed were generally small and retrospective and this may have limited the generalisability of findings. Subgroup analysis was conducted on the whole set of studies investigating PET and was not restricted to comparative studies. Conventional imaging studies that were not compared with PET or PET/CT were excluded from the review.
Available evidence suggests that for the detection of BC recurrence PET, in addition to conventional imaging techniques, may generally offer improved diagnostic accuracy compared with current standard practice. However, uncertainty remains around its use as a replacement for, rather than an add-on to, existing imaging technologies. In addition, PET/CT appeared to show clear advantage over CT and PET alone for the diagnosis of BC recurrence.
Future research should include: prospective studies with patient populations clearly defined with regard to their clinical presentation; a study of diagnostic accuracy of PET/CT compared with conventional imaging techniques; a study of PET/CT compared with whole-body MRI; studies investigating the possibility of using PET/CT as a replacement for rather than an addition to CITs; and using modelling of the impact of PET/CT on patient outcomes to inform the possibility of conducting large-scale intervention trials.
在英国,乳腺癌(BC)占女性所有癌症病例的三分之一。目前用于检测 BC 复发的策略包括计算机断层扫描(CT)、磁共振成像(MRI)和骨闪烁扫描。正电子发射断层扫描(PET),以及最近的正电子发射断层扫描/计算机断层扫描(PET/CT)技术在检测和管理 BC 复发方面具有越来越重要的作用。
通过评估其与当前实践的比较价值以及彼此之间的比较价值,来评估 PET 和 PET/CT 对 BC 复发的诊断准确性。
从 2009 年 5 月起,在 MEDLINE 和 EMBASE 中进行了搜索。
如果研究使用 PET 或 PET/CT 来诊断有 BC 病史的患者的 BC 复发,并且使用组织学诊断和/或长期临床随访来定义真实疾病状态的参考标准,则将研究纳入。如果使用非标准的 PET 或 PET/CT 技术,或者研究是为原发性乳腺癌的筛查或分期而进行的,或者参考标准不明确或没有提供原始数据,则排除研究。
两名评审员独立进行了质量评估和数据提取。对 PET 和 PET/CT 之间以及这些技术与常规成像方法之间进行了直接和间接比较,并进行了荟萃分析。对基于患者和基于病变的数据分析分别进行了分析。亚组分析用于调查特定人群或情况下 PET 准确性的变化,并进行敏感性分析以检验主要结局测量指标的可靠性。
在综述中,28 项研究中有 25 项报告了基于患者的数据,7 项报告了基于病变的 PET 数据,5 项报告了基于患者的数据和 1 项报告了基于患者和病变的 PET/CT 数据;16 项研究进行了直接比较,其中 12 项比较了 PET 或 PET/CT 的准确性与常规诊断测试,4 项与 MRI 进行了比较。对于基于患者的数据(直接比较),PET 具有显著更高的敏感性[89%,95%置信区间(CI)83%至 93%与 79%,95%CI 72%至 85%,相对敏感性 1.12,95%CI 1.04 至 1.21,p = 0.005]和显著更高的特异性[93%,95%CI 83%至 97%与 83%,95%CI 67%至 92%,相对特异性 1.12,95%CI 1.01 至 1.24,p = 0.036]与常规成像测试(CITs)相比——测试性能似乎不取决于所测试的 CIT 类型。对于基于患者的数据(直接比较),与 CT 相比,PET/CT 具有显著更高的敏感性[95%,95%CI 88%至 98%与 80%,95%CI 65%至 90%,相对敏感性 1.19,95%CI 1.03 至 1.37,p = 0.015],但特异性的增加并不显著[89%,95%CI 69%至 97%与 77%,95%CI 50%至 92%,相对特异性 1.15,95%CI 0.95 至 1.41,p = 0.157]。对于基于患者的数据(直接比较),与 PET 相比,PET/CT 具有显著更高的敏感性[96%,95%CI 90%至 98%与 85%,95%CI 77%至 91%,相对敏感性 1.11,95%CI 1.03 至 1.18,p = 0.006],但特异性的增加并不显著[89%,95%CI 74%至 96%与 82%,95%CI 64%至 92%,相对特异性 1.08,95%CI 0.94 至 1.20,p = 0.267]。对于基于患者的数据,与 MRI 相比,PET 的敏感性或特异性没有显著差异,并且在一项基于病变的研究中,与 MRI 相比,PET/CT 的敏感性或特异性也没有显著差异。
综述中研究通常较小且为回顾性,这可能限制了研究结果的普遍性。对整个 PET 研究组进行了亚组分析,而不是仅限于比较性研究。排除了未与 PET 或 PET/CT 进行比较的常规成像研究。
现有证据表明,与当前标准实践相比,除了常规成像技术外,PET 可能通常可提供更高的诊断准确性。然而,对于它作为现有成像技术的替代品而非附加物的使用仍然存在不确定性。此外,与 CT 和 PET 相比,PET/CT 似乎对 BC 复发的诊断具有明显优势。
未来的研究应包括:明确患者人群,明确其临床表现;对 PET/CT 与常规成像技术的诊断准确性进行研究;对 PET/CT 与全身 MRI 进行比较研究;对使用 PET/CT 作为 CIT 替代物而非附加物的可能性进行研究;以及使用 PET/CT 对患者结果的影响模型来告知进行大规模干预试验的可能性。