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Objectives: Systematic review of trastuzumab outcomes among breast cancer patients who have negative, equivocal, or discordant HER2 assay results; use of HER2 assay results to predict outcomes of chemotherapy or hormonal therapy regimen for breast cancer; use of serum HER2 to monitor treatment response or disease progression in breast cancer patients; and use of HER2 testing to manage patients with lung, ovarian, prostate, or head and neck tumors. Also, narrative review of concordance of HER2 assays., Data Sources: We abstracted data from: three articles plus one conference abstract on negative, equivocal, or discordant HER2 results; 26 studies on selection of chemotherapy or hormonal therapy; 15 studies on serum HER2; and 26 studies on ovarian, lung, prostate, or head and neck tumors. Foreign-language studies were included., Review Methods: We sought randomized trials or single-arm series (prospective or retrospective) of identically treated patients that presented relevant outcome data associated with HER2 status., Results: HER2 assay results are influenced by multiple biologic, technical, and performance factors. Many aspects of HER2 assays were standardized only recently, so inconsistencies confound the literature comparing different methods. The evidence is weak on outcomes of trastuzumab added to chemotherapy for HER2-equivocal, -discordant, or -negative patients. Evidence comparing chemotherapy outcomes in HER2-positive and HER2-negative patient subgroups may generate hypotheses, but is too weak to test hypotheses. Only a rigorous test can resolve whether HER2-positive patients (but not HER2-negative patients) benefit from an anthracycline regimen. Evidence is available only from uncontrolled series on whether HER2 status predicts complete pathologic response to neoadjuvant chemotherapy. Evidence also is weak regarding differences by HER2 status for outcomes of chemotherapy for advanced or metastatic disease; with most studies lacking statistical power. Data from studies of tamoxifen and aromatase inhibitors suggest that future studies should examine whether HER2 status predicts response to specific hormonal therapies among estrogen-receptor-positive patients. The evidence is weak on whether serum HER2 predicts outcome after treatment with any regimens in any setting, as is the evidence on use of serum or tissue HER2 testing for malignancies of lung, ovary, head and neck, or prostate., Conclusions: Overall, few studies directly investigated the key questions of this systematic review. Going forward, cancer therapy trial protocols should incorporate elements to facilitate robust analyses of the use of HER2 status and other biomarkers for managing treatment.

Full-field digital mammography (FFDM) is proposed as an alternative to screen-film mammography (SFM). The ability to separate and optimize the acquisition, storage, and display of images may allow greater visualization of breast cancers at equal or lower radiation doses, especially in younger women and those with denser breasts. This is a synopsis of a systematic review by the Blue Cross Blue Shield Association Technology Evaluation Center. This updated systematic review primarily incorporated the results of the ACR Imaging Network(R) Digital Mammographic Imaging Screening Trial (DMIST), which provided results on 42,760 asymptomatic women who underwent both FFDM and SFM and showed with reasonable certainty that there was no difference in the accuracy of the 2 modalities for asymptomatic women in general, with some advantages of FFDM in certain subgroups. There were no strong, new studies on the use of digital mammography compared with film mammography in a diagnostic population. However, the DMIST results indicated that tumors detected by FFDM, but not by SFM, were likely to be invasive carcinomas or medium-grade to high-grade ductal carcinoma in situ. On the basis of the suppositions that these are the cancers of greatest interest and the ones more likely to be found in a diagnostic population and that the diagnostic population may be younger on average than the screening population, it was concluded that there is sufficient evidence to support the use of FFDM for diagnostic purposes.

Imaging technologies (e.g., magnetic resonance imaging [MRI]) have been proposed as noninvasive alternatives to surgical biopsy techniques in the follow-up of women with suspicious primary breast lesions. This article is a synopsis of a systematic review by the Blue Cross and Blue Shield Association Technology Evaluation Center. According to the best available evidence, the sensitivity and specificity of MRI ranged from 91% to 99% and from 31% to 91%, respectively. Predictive values were calculated by using three likely scenarios of diagnostic performance and disease prevalence. The potential harm of failing to diagnose or delaying diagnosis of breast cancer in patients with false-negative MRI results is of significant concern. We conclude that the potential benefit of sparing some patients from unnecessary biopsy by using noninvasive imaging does not outweigh the potential harm of a missed or delayed diagnosis of breast cancer.