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Archived: This report is greater than 3 years old. Findings may be used for research purposes, but should not be considered current.
Core needle biopsy and open surgical biopsy are the most frequently used procedures for diagnosis of suspicious breast lesions. An AHRQ evidence report on the comparative effectiveness and adverse events of breast biopsy methods was completed in 2009. The availability of additional studies and the uncertainties surrounding newer biopsy techniques prompted an update of that report.
Study eligibility criteria
We searched nine electronic databases (last search on December 16, 2013) for English-language full-text reports of prospective or retrospective cohort studies of women not previously diagnosed with breast cancer who were undergoing biopsy for diagnosis of a breast lesion.
Study appraisal and synthesis methods
A single investigator extracted quantitative and qualitative data from each study; a second reviewer verified extracted data. We assessed the strength and applicability of the evidence. We performed Bayesian meta-analyses to estimate summary test performance and performed indirect comparisons to assess the relative effectiveness of alternative core needle biopsy methods. Statistical models accounted for between-study heterogeneity.
One hundred and sixty studies of moderate to high risk of bias provided information on the test performance of alternative core needle biopsy techniques. We found one new study investigating the test performance of open biopsy. For women at average risk of cancer, both ultrasound- and stereotactically guided biopsies had average sensitivities higher than 0.97 and average specificities ranging from 0.92 to 0.99; freehand biopsy methods had average sensitivity of 0.91 and specificity of 0.98. However, evidence on the test performance of magnetic resonance imaging (MRI)-guided biopsy (6 studies) was insufficient to draw conclusions. Test performance did not differ between women at average and high baseline risk of cancer, but results were imprecise. Test performance of automated and vacuum-assisted devices (when using the same imaging guidance) was fairly similar (absolute differences in sensitivity and specificity ≤ 0.1). One hundred and forty-one studies contributed information on potential harms of different core needle biopsy techniques. Overall, core needle biopsy had a lower risk of complications than open surgical biopsy; however information on the latter was sparse. The absolute incidence of adverse events was low and the incidence of severe complications was less than 1 percent for all techniques. Vacuum-assisted procedures appeared to be associated with increased bleeding and hematoma formation; biopsies performed with patients seated upright appeared to be associated with increased risk of vasovagal reactions. Harms were reported inconsistently, raising concerns about selective outcome reporting. We found 10 case reports of patients developing tumors at the site of prior core needle biopsies. We found information on only a few patient-relevant and resource-related outcomes. Based on 42 studies, core needle biopsy obviated the need for surgical procedures in about 75 percent of women. Meta-analysis of 10 studies reporting the number of surgical procedures required after biopsy suggested that the odds of requiring only one procedure were almost 15 times as high among women receiving core needle biopsy, as compared to those receiving open surgical biopsy. However, this result may be confounded by indication.
Patient-level data were unavailable and information about study- or population-level characteristics was too limited to allow the identification of modifiers of test performance, adverse events, or clinical outcomes. Studies reported adverse events incompletely, and did not provide details of their outcome ascertainment methods.
A large body of evidence suggests that ultrasound and stereotactically guided core needle biopsy procedures have sensitivity and specificity close to that of open biopsy procedures, and are associated with fewer adverse events. The strength of the evidence on the test performance of these methods is deemed moderate because studies are at medium to high risk of bias, but provide precise and fairly consistent results. Freehand procedures have lower sensitivity than imaging-guided methods. The strength of evidence on the comparative test performance of automated and vacuum-assisted devices (when using the same imaging guidance) is deemed low, because of concerns about the risk of bias of included studies and the reliance on indirect comparisons. There were insufficient data to draw conclusions for MRI-guided biopsy or women at high baseline risk of cancer. There is low strength of evidence that vacuum-assisted procedures have a higher risk of bleeding than automated methods. There is moderate strength of evidence that women diagnosed with breast cancer by core needle biopsy are more likely to have their cancer treated with a single surgical procedure, compared with women diagnosed by open surgical biopsy.