Comparison of automated breast ultrasound and hand-held breast ultrasound in preoperative evaluation of early-stage breast cancer: a multicenter prospective study.

OBJECTIVE

To compare automated breast ultrasound (ABUS) and handheld breast ultrasound (HHUS) as adjuncts to digital mammography (DM) for preoperative assessment of local tumor extent in women with newly diagnosed early-stage breast cancer.

MATERIALS AND

METHODS

In this prospective study conducted at three institutions, women with newly diagnosed early-stage breast cancer and no palpable axillary nodes scheduled for surgery underwent ABUS and HHUS adjunct to DM between Oct 2019 and Apr 2021. The primary outcome was the sensitivity of ABUS with DM (ABUS/DM) and HHUS with DM (HHUS/DM) for detecting additional ipsilateral or contralateral cancers beyond the index cancer. ABUS/DM was evaluated for noninferiority with a prespecified margin of 5%. Specificity was assessed as a secondary outcome.

RESULTS

A total of 659 patients (mean age, 50.5 ± 9 years) were included. Seventy-nine patients (12.0%) had additional cancers: 64 ipsilateral (51 multifocal, 13 multicentric) and 15 contralateral. For index cancers, both ABUS/DM and HHUS/DM achieved 100% detection. ABUS/DM showed noninferior sensitivity to HHUS/DM for additional ipsilateral cancers (71.9% vs. 75.0%; p = 0.617) and higher sensitivity than HHUS/DM for contralateral cancers (86.7% vs. 60.0%; p = 0.046). Specificity did not differ significantly between ABUS/DM and HHUS/DM for additional ipsilateral (97.7% vs. 97.0%; p = 0.317) or contralateral (97.8% vs. 98.3%; p = 0.467) cancers.

CONCLUSION

ABUS/DM showed noninferior sensitivity to HHUS/DM, with similar specificity for detecting additional ipsilateral and contralateral breast cancers in early-stage breast cancer. ABUS may serve as a feasible alternative to HHUS for preoperative staging in early-stage breast cancer.

KEY POINTS: Question Is automated breast ultrasound (ABUS) noninferior to handheld ultrasound (HHUS), each with digital mammography (DM), in preoperative staging of tumor extent in early-stage breast cancer? Findings ABUS/DM demonstrated noninferior sensitivity to HHUS/DM, with similar specificity for detecting additional ipsilateral and contralateral cancers in early-stage breast cancer. Clinical relevance ABUS may serve as a feasible alternative to HHUS for preoperative staging in early-stage breast cancer, particularly in clinical settings where the HHUS use is constrained by limited staffing resources and time restrictions.