Wendy Bruening, PhD; Joann Fontanarosa, PhD; Kelley Tipton, MPH; Jonathan R. Treadwell, PhD; Jason Launders, MSc; Karen Schoelles, MD, SM
Bruening W, Fontanarosa J, Tipton K, Treadwell JR, Launders J, Schoelles K. Systematic Review: Comparative Effectiveness of Core-Needle and Open Surgical Biopsy to Diagnose Breast Lesions. Ann Intern Med. 2010;152:238-246. doi: 10.7326/0003-4819-152-1-201001050-00190
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Published: Ann Intern Med. 2010;152(4):238-246.
Most women undergoing breast biopsy are found not to have cancer.
To compare the accuracy and harms of different breast biopsy methods in average-risk women suspected of having breast cancer.
Databases, including MEDLINE and EMBASE, searched from 1990 to September 2009.
Studies that compared core-needle biopsy diagnoses with open surgical diagnoses or clinical follow-up.
Data were abstracted by 1 of 3 researchers and verified by the primary investigator.
33 studies of stereotactic automated gun biopsy; 22 studies of stereotactic-guided, vacuum-assisted biopsy; 16 studies of ultrasonography-guided, automated gun biopsy; 7 studies of ultrasonography-guided, vacuum-assisted biopsy; and 5 studies of freehand automated gun biopsy met the inclusion criteria. Low-strength evidence showed that core-needle biopsies conducted under stereotactic guidance with vacuum assistance distinguished between malignant and benign lesions with an accuracy similar to that of open surgical biopsy. Ultrasonography-guided biopsies were also very accurate. The risk for severe complications is lower with core-needle biopsy than with open surgical procedures (<1% vs. 2% to 10%). Moderate-strength evidence showed that women in whom breast cancer was initially diagnosed by core-needle biopsy were more likely than women with cancer initially diagnosed by open surgical biopsy to be treated with a single surgical procedure (random-effects odds ratio, 13.7 [95% CI, 5.5 to 34.6]).
The strength of evidence was rated low for accuracy outcomes because the studies did not report important details required to assess the risk for bias.
Stereotactic- and ultrasonography-guided core-needle biopsy procedures seem to be almost as accurate as open surgical biopsy, with lower complication rates.
Agency for Healthcare Research and Quality.
There are several different methods of performing breast biopsies.
This systematic review compared open surgical biopsy and core-needle biopsy (CNB) techniques for diagnosing cancer in women with a palpable or nonpalpable breast abnormality. Multiple studies suggested that stereotactic and ultrasonography-guided CNB were almost as accurate as open biopsy and that CNB had a lower risk for complications. Also, women with cancer diagnosed by CNB were more often treated with a single surgical procedure than were women with disease that was initially diagnosed by open biopsy.
Details of the accuracy studies were poorly reported, which made it difficult to evaluate the validity of findings.
Appendix Table 1.
Appendix Table 2.
CNB = core-needle biopsy; FNA = fine-needle aspiration; KQ = key question.
Appendix Table 3.
These 5 study quality measures are, in the authors' judgment, highly important for reducing the risk for bias when addressing the key questions of this review. The measures are listed in order of importance (as judged by the authors) from top to bottom. “Reported sufficient relevant clinical information” refers to whether the study reported sufficient information about the study design, patient selection and characteristics, breast lesion characteristics, and biopsy methods to fully address the key questions and fully assess the potential for bias in the study design. “Index test results blinded” refers to whether readers of the reference standard were aware of biopsy results. “Differential verification bias avoided” refers to whether the reference standard was chosen without regard to biopsy results. “Representative spectrum enrolled” refers to whether the enrolled patient population resembles the “usual” patient population seen in clinical practice. “Avoided selection bias” refers to whether the study clearly enrolled all or consecutive patients by applying consistent inclusion and exclusion criteria.
Appendix Table 4.
Appendix Table 5.
Appendix Table 6.
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Breast Cancer, Healthcare Delivery and Policy, Hematology/Oncology, High Value Care, Prevention/Screening.
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