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

Abstract

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.