Annals of surgery · 2026
De-escalation of Axillary Surgery in Early Breast Cancer: Translating SOUND and INSEMA into Clinical Practice.
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Allen Lisa R, Plitas George, Sawka Ross, Barrio Andrea V, Feigin Kimberly N, Roth O'Brien Diana A, Capko Deborah, Choi Daniel X, Downs-Canner Stephanie, El-Tamer Mahmoud, Giannakou Andreas, Goel Neha, Heerdt Alexandra S, Kirstein Laurie J, Lee Minna K, Mamtami Anita, Montagna Giacomo, Moo Tracy-Ann, Pawloski Kate R, Sacchini Virgilio, Tadros Audree B, Varadan Sevilimedu, Morrow Monica
Аннотация
OBJECTIVE: To prospectively evaluate how often axillary staging can successfully be omitted in postmenopausal HR+/HER2- patients.
BACKGROUND: Three randomized trials showed no difference in recurrence or survival outcomes with omission of sentinel lymph node biopsy (SLNB) in cT1-T2N0 patients with a negative axillary ultrasound (AUS) undergoing breast-conserving surgery (BCS). We prospectively evaluated applicability of this approach.
METHODS: From 3/1/24 to 9/1/25, SLNB was omitted in postmenopausal women age 50-70 years with unicentric or multifocal, clinical stage 1, grade 1/2, HR+/HER2- cancers and a normal AUS undergoing BCS. After the results of INSEMA were reported, tumors up to 2.5 cm were included. Patients with pathology showing grade 3, T≥3 cm, or HR- or HER2+ underwent multidisciplinary discussion regarding the need for SLNB.
RESULTS: In 437 patients with 442 cancers, the median patient age was 63 years, median mammographic tumor size was 0.9 cm, and 74% were grade 2. A total of 34 patients (8%) had high-risk features on final pathology (grade 3, n=20; T≥3 cm, n=11; HER2+, n=3) and 14 (3.2%) had SLNB. Of these, 2 had SLN metastases. A total of 96% of patients received radiotherapy (40% whole breast, 56% partial breast), 415 (95%) received adjuvant endocrine therapy, and 31 (7%) received chemotherapy. At 7.7-month median follow-up, there have been no axillary recurrences.
CONCLUSION: Adoption of the SOUND, INSEMA, and BOOG 13-08 data allowed omission of SLNB in 97% of postmenopausal patients age ≤70 years with cT1-2N0, grade 1/2, HR+/HER2- cancers and a normal AUS, reducing the burden of treatment.
BACKGROUND: Three randomized trials showed no difference in recurrence or survival outcomes with omission of sentinel lymph node biopsy (SLNB) in cT1-T2N0 patients with a negative axillary ultrasound (AUS) undergoing breast-conserving surgery (BCS). We prospectively evaluated applicability of this approach.
METHODS: From 3/1/24 to 9/1/25, SLNB was omitted in postmenopausal women age 50-70 years with unicentric or multifocal, clinical stage 1, grade 1/2, HR+/HER2- cancers and a normal AUS undergoing BCS. After the results of INSEMA were reported, tumors up to 2.5 cm were included. Patients with pathology showing grade 3, T≥3 cm, or HR- or HER2+ underwent multidisciplinary discussion regarding the need for SLNB.
RESULTS: In 437 patients with 442 cancers, the median patient age was 63 years, median mammographic tumor size was 0.9 cm, and 74% were grade 2. A total of 34 patients (8%) had high-risk features on final pathology (grade 3, n=20; T≥3 cm, n=11; HER2+, n=3) and 14 (3.2%) had SLNB. Of these, 2 had SLN metastases. A total of 96% of patients received radiotherapy (40% whole breast, 56% partial breast), 415 (95%) received adjuvant endocrine therapy, and 31 (7%) received chemotherapy. At 7.7-month median follow-up, there have been no axillary recurrences.
CONCLUSION: Adoption of the SOUND, INSEMA, and BOOG 13-08 data allowed omission of SLNB in 97% of postmenopausal patients age ≤70 years with cT1-2N0, grade 1/2, HR+/HER2- cancers and a normal AUS, reducing the burden of treatment.