Some breast cancer patients can safely forgo axillary surgery, according to research published in JAMA Oncology.
Researchers found that patients without axillary lymph node involvement who had tumors no larger than 2 cm had similar treatment outcomes whether they underwent sentinel lymph node biopsy (SLNB) or had no axillary surgery.
This phase 3 trial (SOUND; ClinicalTrials.gov Identifier: NCT02167490) included 1405 women with breast cancer who had tumors up to 2 cm in diameter and a negative preoperative axillary ultrasonography result. The patients’ median age at baseline was 60 (range, 52-68) years, their median tumor size was 1.1 cm, and 87.8% of patients had estrogen receptor-positive, HER2-negative breast cancer.
The patients were randomly assigned to undergo SLNB (n=708) or no axillary surgery (n=697). Baseline characteristics were similar between the groups. The recommended adjuvant systemic therapy and radiotherapy were similar as well.
The median follow-up was 5.7 years in both groups. The 5-year distant disease-free survival rate was 97.7% with SLNB and 98.0% with no axillary surgery (hazard ratio, 0.84; 90% CI, 0.45-1.54; P for noninferiority =.02).
The 5-year disease-free survival rate was 94.7% with SLNB and 93.9% with no axillary surgery (P =.30). The cumulative incidence of distant metastases at 5 years was 2.3% and 1.9%, respectively (P =.69). The cumulative incidence of axillary recurrences was 0.4% in both groups (P =.91).
The 5-year overall survival rate was 98.2% with SLNB and 98.4% with no axillary surgery (P =.72).
“This randomized clinical trial found that omission of axillary surgery was noninferior to SLNB in women with small BC [breast cancer] and negative results on ultrasonography of the axillary lymph nodes,” the researchers concluded. “These results suggest that patients with these features can be safely spared any axillary surgery whenever the lack of pathological information does not affect the postoperative treatment plan.”
Disclosures: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.
Reference
Gentilini OD, Botteri E, Sangalli C, et al. Sentinel lymph node biopsy vs no axillary surgery in patients with small breast cancer and negative results on ultrasonography of axillary lymph nodes: The SOUND randomized clinical trial. JAMA Oncol. Published online September 21, 2023. doi:10.1001/jamaoncol.2023.3759
This article originally appeared on Cancer Therapy Advisor