Distant disease–free survival at 5 years was 98.0% with omission of axillary surgery vs 97.7% with SLNB (HR = 0.84, 90% CI = 0.45–1.54, P =. Median follow-up was 5.7 years (interquartile range = 5.0–6.6 years) with the omission of axillary surgery and 5.7 years (IQR = 5.0–6.8 years) with SLNB. Noninferiority was considered shown if the upper limit of the two-sided 90% confidence interval for the hazard ratio for omission of axillary surgery vs SLNB at 5 years was less than 1.74. The primary endpoint of the trial was distant disease–free survival at 5 years in the intention-to-treat population. Overall, 88% of patients had estrogen receptor–positive, HER2-nonoverexpressing disease. Median tumor size was 1.1 cm (interquartile range = 0.8–1.5 cm). Patients were randomly assigned between February 2012 and June 2017 to receive no axillary surgery (observation, n = 697) or SLNB (n = 708). ![]() The trial included 1,405 patients from sites in Italy, Switzerland, Spain, and Chile with breast tumors measuring ≤ 2 cm and a negative preoperative axillary ultrasonography result. In a noninferiority phase III trial (SOUND) reported in JAMA Oncology, Gentilini et al found that no axillary surgery was noninferior to sentinel lymph node biopsy (SLNB) in terms of distant disease–free survival among patients with small breast cancer and negative findings on preoperative ultrasonography of axillary lymph nodes.
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