Systematic Review: Comparative Effectiveness of Core-Needle and Open Surgical Biopsy to Diagnose Breast Lesions

Background: Most women undergoing breast biopsy are found not to have cancer. Purpose: To compare the accuracy and harms of different breast biopsy methods in average-risk women suspected of having breast cancer. Data Sources: Databases, including MEDLINE and EMBASE, searched from 1990 to September 2009. Study Selection: Studies that compared core-needle biopsy diagnoses with open surgical diagnoses or clinical follow-up. Data Extraction: Data were abstracted by 1 of 3 researchers and verified by the primary investigator. Data Synthesis: 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]). Limitation: 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. Conclusion: Stereotactic- and ultrasonography-guided core-needle biopsy procedures seem to be almost as accurate as open surgical biopsy, with lower complication rates. Primary Funding Source: Agency for Healthcare Research and Quality.