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The clinical effectiveness and cost-effectiveness of different surveillance mammography regimens after the treatment for primary breast cancer:systematic reviews registry database analyses and economic evaluation

机译:原发性乳腺癌治疗后不同监测乳腺X线摄影方案的临床有效性和成本效益:系统评价注册数据库分析和经济评价

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摘要

BackgroundFollowing primary breast cancer treatment, the early detection of ipsilateral breast tumour recurrence (IBTR) or ipsilateral secondary cancer in the treated breast and detection of new primary cancers in the contralateral breast is beneficial for survival. Surveillance mammography is used to detect these cancers, but the optimal frequency of surveillance and the length of follow-up are unclear.ObjectivesTo identify feasible management strategies for surveillance and follow-up of women after treatment for primary breast cancer in a UK setting, and to determine the effectiveness and cost-effectiveness of differing regimens.MethodsA survey of UK breast surgeons and radiologists to identify current surveillance mammography regimens and inform feasible alternatives; two discrete systematic reviews of evidence published from 1990 to mid 2009 to determine (i) the clinical effectiveness and cost-effectiveness of differing surveillance mammography regimens for patient health outcomes and (ii) the test performance of surveillance mammography in the detection of IBTR and metachronous contralateral breast cancer (MCBC); statistical analysis of individual patient data (West Midlands Cancer Intelligence Unit Breast Cancer Registry and Edinburgh data sets); and economic modelling using the systematic reviews results, existing data sets, and focused searches for specific data analysis to determine the effectiveness and cost-utility of differing surveillance regimens.ResultsThe majority of survey respondents initiate surveillance mammography 12 months after breast-conserving surgery (BCS) (87%) or mastectomy (79%). Annual surveillance mammography was most commonly reported for women after BCS or after mastectomy (72% and 53%, respectively). Most (74%) discharge women from surveillance mammography, most frequently 10 years after surgery. The majority (82%) discharge from clinical follow-up, most frequently at 5 years. Combining initiation, frequency and duration of surveillance mammography resulted in 54 differing surveillance regimens for women after BCS and 56 for women following mastectomy. The eight studies included in the clinical effectiveness systematic review suggest surveillance mammography offers a survival benefit compared with a surveillance regimen that does not include surveillance mammography. Nine studies were included in the test performance systematic review. For routine IBTR detection, surveillance mammography sensitivity ranged from 64% to 67% and specificity ranged from 85% to 97%. For magnetic resonance imaging (MRI), sensitivity ranged from 86% to 100% and specificity was 93%. For non-routine IBTR detection, sensitivity and specificity for surveillance mammography ranged from 50% to 83% and from 57% to 75%, respectively, and for MRI from 93% to 100% and from 88% to 96%, respectively. For routine MCBC detection, one study reported sensitivity of 67% and specificity of 50% for both surveillance mammography and MRI, although this was a highly select population. Data set analysis showed that IBTR has an adverse effect on survival. Furthermore, women experiencing a second tumour measuring >20 mm in diameter were at a significantly greater risk of death than those with no recurrence or those whose tumour was <10 mm in diameter. In the base-case analysis, the strategy with the highest net benefit, and most likely to be considered cost-effective, was surveillance mammography alone, provided every 12 months at a societal willingness to pay for a quality-adjusted life-year of either £20,000 or £30,000. The incremental cost-effectiveness ratio for surveillance mammography alone every 12 months compared with no surveillance was £4727.LimitationsFew studies met the review inclusion criteria and none of the studies was a randomised controlled trial. The limited and variable nature of the data available precluded any quantitative analysis. There was no useable evidence contained in the Breast Cancer Registry database to assess the effectiveness of surveillance mammography directly. The results of the economic model should be considered exploratory and interpreted with caution given the paucity of data available to inform the economic model.ConclusionsSurveillance is likely to improve survival and patients should gain maximum benefit through optimal use of resources, with those women with a greater likelihood of developing IBTR or MCBC being offered more comprehensive and more frequent surveillance. Further evidence is required to make a robust and informed judgement on the effectiveness of surveillance mammography and follow-up. The utility of national data sets could be improved and there is a need for high-quality, direct head-to-head studies comparing the diagnostic accuracy of tests used in the surveillance population.
机译:背景技术在原发性乳腺癌治疗之后,在治疗的乳腺癌中及早发现同侧乳腺肿瘤复发(IBTR)或同侧继发性癌症,并在对侧乳腺中发现新的原发性癌症对生存有利。目的使用监视乳腺X线照相术来检测这些癌症,但尚不清楚最佳监视频率和随访时间。目的在英国背景下,确定可行的治疗策略,对女性进行原发性乳腺癌治疗后的监视和随访,以及方法对英国的乳腺外科医师和放射科医生进行一项调查,以查明当前的乳房X线照相术监测方案并提供可行的替代方案;从1990年至2009年中发表了两次离散的系统证据回顾,以确定(i)不同的乳房X线检查方案对患者健康状况的临床有效性和成本效益,以及(ii)乳房X线检查在IBTR和异时性检查中的测试性能对侧乳腺癌(MCBC);对单个患者数据进行统计分析(西米德兰兹癌症情报局乳腺癌登记处和爱丁堡数据集);使用系统评价结果,现有数据集和针对特定数据分析的集中搜索进行经济和经济建模,以确定不同监测方案的有效性和成本效用。结果大多数接受调查的被调查者在保乳手术后12个月进行了乳房X线检查)(87%)或乳房切除术(79%)。在BCS或乳房切除术后,女性最常接受年度乳房X线检查(分别为72%和53%)。大多数(74%)的妇女从监控乳房X线检查中退出,最常见的是术后10年。大多数(82%)患者从临床随访中排出,最常见于5年。结合乳房X线摄片的开始,频率和持续时间,BCS后女性和乳房切除术后的女性有54种不同的监视方案。临床有效性系统评价中包括的八项研究表明,与不包括乳房X线摄影的监测方案相比,乳房X线摄影可提供生存获益。九项研究被纳入测试表现的系统评价中。对于常规IBTR检测,监控乳房X线照相术的敏感性范围为64%至67%,特异性范围为85%至97%。对于磁共振成像(MRI),灵敏度范围为86%至100%,特异性为93%。对于非常规IBTR检测,监控乳腺摄影的灵敏度和特异性分别为50%至83%和57%至75%,而MRI的敏感性和特异性分别为93%至100%和88%至96%。对于常规MCBC检测,尽管这是一个高度选择的人群,但一项研究报告其对监控X线摄影和MRI的敏感性为67%,特异性为50%。数据集分析表明,IBTR对生存有不利影响。此外,发生第二个直径> 20 mm的肿瘤的妇女比没有复发或直径<10 mm的妇女有更大的死亡风险。在基本案例分析中,净收益最高且最有可能被认为具有成本效益的策略是仅进行乳房X线照相,每12个月根据社会意愿为这两种方法支付质量调整后的生命年£20,000或£30,000。与不进行监视相比,每12个月进行一次乳房X线照相术的成本效益比为4727英镑。限制很少有研究符合评价纳入标准,而且没有一项研究是随机对照试验。现有数据的局限性和可变性限制了任何定量分析的可能性。乳腺癌注册数据库中没有可用的证据直接评估乳房X线照相术的有效性。考虑到缺乏可用于经济模型的数据,经济模型的结果应被认为是探索性的,并应谨慎解释。结论监视可能会改善生存率,患者应通过最佳利用资源获得最大收益,而那些女性则更多。提供更全面,更频繁的监视以发展IBTR或MCBC的可能性。需要进一步的证据来对乳腺钼靶监视和随访的有效性做出有力且明智的判断。国家数据集的实用性可能会得到改善,因此需要进行高质量的直接面对面研究,以比较用于监视人群的测试的诊断准确性。

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