Table 1.
Prospective randomized clinical trials comparing ALND versus no axillary surgery
| Author, study | Patients | N | Follow-up, years | Axillary recurrence | DFS | OS |
|---|---|---|---|---|---|---|
| Fisher et al. (2002) [8], NSABP B-04 | cN0, any age, radical ME vs. ME alone vs. ME + irradiation, no systemic therapy | 1,079 | 25 | 18.6% in ME-alone arm | 19% vs. 19% vs. 13%; p = 0.65 | 25% vs. 26% vs. 19%; p = 0.68 |
| International Breast Cancer Study Group (2006) [43], IBCSG 10–93 | pT1–2a, cN0, ≥ 60 years, Tam | 473 | 6.6 | 0.9% vs. 2.5%; n.s. | 67% vs. 66%; p = 0.69 | 75% vs. 73%; p = 0.77 |
| Martelli et al. (2012) [45] | cN0, pT1/T2 (≤ 2.5 cm), ≥ 65 years, Tam | 219 | 15 | 0 vs. 3.6% | DDFS p = 0.95 | p = 0.64 |
| Agresti et al. (2013) [44], INT09/98 | cT1N0, 30–65 years, Tam, ± chemotherapy | 565 | 10 | 0 vs. 9% | 92.4% vs. 91.3%; p = 0.9 | 93.3% vs. 91.5%; p = 0.78 |
a
42% of the patients with tumors > 2 cm.
ME = Mastectomy, Tam = tamoxifen, n.s. = non-significant, DDFS = distant disease-free survival.