(CTN News) – Research published in JAMA Oncology indicates that some patients with breast cancer can safely avoid axillary surgery in order to save their lives.
In a study published in the Journal of Clinical Oncology, researchers found that patients with no axillary lymph node involvement and tumors less than 2 cm in size had similar treatment outcomes regardless of whether they underwent sentinel lymph node biopsy (SLNB) or had no surgery performed on the axilla.
In this phase 3 trial (SOUND; ClinicalTrials.gov Identifier: NCT02167490), 1405 women with breast cancer with tumors between 2 cm and 4 cm in diameter and a negative preoperative ultrasonography result of the axilla were included in the study.
Among the patients, the median age was 60 years old (range, 52-68 years old), the median tumor size was 1.1 cm, and 87.8% of them had an estrogen receptor-positive, HER2-negative breast cancer at baseline.
There was a random assignment of the patients between SLNB (n=708) and no axillary surgery (n=697). There were no significant differences in baseline characteristics between the two groups.
Likewise, the recommended adjuvant systemic therapy and radiotherapy were similar as well.
Both Breast Cancer groups had a median follow-up of 5.7 years at the end of the study. As a result, the 5-year distant disease-free survival rate for SLNB was 97.7% and the 5-year distant disease-free survival rate for no axillary surgery was 98.0% (hazard ratio, 0.84; 90% CI, 0.45-1.54; P for noninferiority = .02).
After five years, the disease-free survival rate with SLNB was 94.7%, and without axillary surgery, it was 93.9% (P =.30). At the end of the five-year period, the cumulative incidence of distant metastases was 2.3% and 1.9%, respectively (P = .69).
In both groups of patients, the cumulative incidence of axillary recurrences was 0.4% (P = .91) in both groups.
With SLNB, the 5-year overall survival rate was 98.2%, and with no axillary surgery, the overall survival rate was 98.4% (P =.72).
According to the researchers, “This randomized clinical trial found that omitting axillary surgery in women with small BC [breast cancer] and negative results on ultrasonography of the axillary lymph nodes compared with SLNB for women with small BC.”
Based on these findings, it is suggested that patients with these characteristics can be safely spared from axillary surgery if the lack of pathological information does not influence the postoperative treatment plan in any adverse way.
It should be noted that some of the study authors have declared affiliations with biotech, pharmaceutical, and/or device companies. A full list of Breast Cancer disclosures can be found in the original reference, which can be found here.