Table. Summary of Major Sentinel Lymph Node (SLN) Trials.
Trial | SLN Status | Comparison | No. of Patients Evaluated | |
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NSABP B-327 | Negative | SLNB alone versus SLNB + ALND in T1 to T2, cN0 patients undergoing mastectomy or BCS | SLNB alone, n = 2011 SLNB + ALND, n = 1975 | |
IBCSG 23-0167 | Positive 1 or more micrometastases | SLNB alone versus SLNB + ALND in T1 to T2 patients undergoing mastectomy or BCS | SLNB alone, n = 467 SLNB + ALND, n = 464 | |
ACOSOG Z001113,14 | Positive 1 or 2 positive SLNs | SLNB alone versus SLNB + ALND in T1 to T2, cN0 patients undergoing BCS and whole-breast RT | SLNB alone, n = 436 SLNB + ALND, n = 420 | |
AMAROS76 | Positive 1 or 2 positive SLNs | ALND versus axillary RT in T1 to T2, cN0 patients treated with BCS or mastectomy | ALND, n = 744 Axillary RT, n = 681 | |
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Extended | ||||
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Follow-up | Metastatic Non-SLNs in ALND, % | Axillary Recurrence, % | Overall Survival, % | Disease-Free Survival, % |
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95.6 mo (mean) | SLNB alone, 0.7 SLNB + ALND, 0.4 (P = .22) | SLNB alone, 90.3a SLNB + ALND, 91.8a (P = .12) | SLNB alone, 81.5a SLNB + ALND, 82.4a (P = .54) | |
5 y (median) | 13 | SLNB alone, 0.86 SLNB + ALND, 0.22 | SLNB alone, 97.5 SLNB + ALND, 97.6 (P = .73) | SLNB alone, 87.8 SLNB + ALND, 84.4 (P = .16) |
6.3 y (median) | 27 | SLNB alone, 0.9 SLNB + ALND, 0.5 (P = .45) | SLNB alone, 91.8 SLNB + ALND, 92.5 (P = .25) | SLNB alone, 83.8 SLNB + ALND, 82.2 (P = .14) |
6.1 y (median) | 33 | ALND, 0.43 Axillary RT, 1.19 | ALND, 93.3 Axillary RT, 92.5 (P = .34) | ALND, 86.9 Axillary RT, 82.7 (P = .18) |
Abbreviations: ACOSOG, American College of Surgeons Oncology Group; ALND, axillary lymph node dissection; AMAROS, After Mapping of the Axilla: Radiotherapy or Surgery?; BCS, breast-conserving surgery; cN0, clinically node negative; IBCSG, International Breast Carcinoma Study Group; NSABP, National Surgical Adjuvant Breast and Bowel Project; RT, radiotherapy; SLNB, sentinel lymph node biopsy.
8-year Kaplan-Meier estimates.