Elimination of Axillary Surgery After Neoadjuvant Systemic Therapy for Well-Selected Patients With Invasive Breast Cancer

According to 5-year follow-up results from a phase 2 study, selective elimination of axillary surgery after neoadjuvant systemic therapy may be possible among patients with human epidermal growth factor receptor 2 (HER2)-positive or triple-negative invasive breast cancer. 

“Neoadjuvant systemic therapy has been associated with pathologic complete response (pCR) in up to 60% of breast cancers,” stated Henry Kurer, MD, PhD. “The findings of this trial question the necessity of surgery.”

In this single-arm, nonrandomized study, researchers enrolled 50 patients with cT1-2N0-1MO HER2-positive (n = 29) or triple-negative (n = 21) invasive breast cancer who showed residual breast lesions after neoadjuvant systemic therapy of less than 2 cm to undergo 9G (with a minimum of 12 cores) of image-guided vacuum assisted biopsy. Patients with clinically node-negative disease at diagnosis and no residual cancer post-neoadjuvant systemic therapy image-guided vacuum assisted biopsy underwent whole-breast radiotherapy with a boost without breast or axillary surgery. Patients with initial nodal disease and a breast pCR post–image-guided vacuum assisted biopsy underwent targeted axillary dissection (n = 31). Patients with residual cancer post–image-guided vacuum assisted biopsy underwent standard breast and axillary surgery (n = 8). Mammography and physical examinations were conducted every 6 months. The primary outcome was ipsilateral breast tumor recurrence. Key secondary end points included disease-free survival (DFS) and overall survival (OS) among patients who did not undergo breast surgery. 

At a median follow-up of 55.4 months, the ipsilateral breast tumor recurrence rate was 0%. Among patients who did not undergo breast surgery, the DFS and OS rates were 100%. 

“The results of this nonrandomized clinical trial that reported preplanned 5-year outcomes suggest that omission of breast surgery in select patients after [neoadjuvant systemic therapy] may be feasible, with no recurrences seen,” concluded Dr Kuerer et al. “More confirmatory studies are necessary before this new approach alters surgical practice.”

Source: 

Kurer HM, Valero V, Smith BD, et al. Selective elimination of breast surgery for invasive breast cancer. JAMA Oncol. Published online: March 28, 2025. doi: 10.1001/jamaoncol.2025.0207