Table 1 Clinical trials for axillary management in breast cancer
Study | Design | Conclusion |
|---|---|---|
NSABP (National Surgical Adjuvant Breast and Bowel Project) B-32 trial [8] | Group 1: SLNB and ALND Group 2: SLNB alone with ALND only if SLNs were positive | OS, DFS, and the risk of recurrence had no statistically significant differences between two groups |
IBCSG (International Breast Cancer Study Group) 23–01 trial [46] | Group 1: no axillary dissection Group 2: axillary dissection | The group without axillary dissection showed no differences in DFS or OS, and less postoperative complications compared with the axillary dissection group |
AATRM 048/13 trial [47] | Control arm: complete ALND Experimental arm: clinical follow-up | In early-stage breast cancer patients with micrometastatic SLNs, ALND could be avoided without significant effect on locoregional recurrence and survival |
ACOSOG (American College of Surgeons Oncology Group) Z0011 trial [10] | Group 1: SLNB alone Group 2: ALND | SLNB alone was noninferior to ALND in terms of 10-year OS, DFS and locoregional recurrence for patients with cN0 breast cancer and no more than two positive SLNs |
SOUND (Sentinel Node vs Observation After Axillary Ultra-Sound) trial [50] | Group 1: SLNB group Group 2: no axillary surgery group | Patients with small breast cancer and negative axillary results on ultrasonography can be safely spared any axillary surgery |
SENOMAC (Sentinel Node Biopsy in Breast Cancer: Omission of Axillary Clearance After Macrometastases) trial [51] | Group 1: ALND Group 2: SLNB only | In patients with clinically node-negative breast cancer who had sentinel-node macrometastases and predominantly received nodal radiation therapy, omitting ALND was found to be noninferior to the more extensive surgical approach |
NSABP-04 trial [52] | Patients with clinically negative axillary nodes: radical mastectomy, total mastectomy with postoperative irradiation, or total mastectomy with axillary dissection Patients with clinically positive axillary nodes: radical mastectomy, or total mastectomy with postoperative irradiation | There showed no significant differences in cases of axillary recurrence or survival among patients in all treatment groups with either clinically negative or positive axillary nodes |
AMAROS (After Mapping of the Axilla: Radiotherapy Or Surgery) trial [53] | Group 1: ALND Group 2: axillary radiotherapy | In T1-2 breast cancer patients with no palpable lymphadenopathy and a positive SLN, axillary radiotherapy presented comparable axillary control and a lower risk of morbidity with no significant differences in DFS and OS compared with ALND |
OTOASOR (Optimal Treatment Of the Axilla—Surgery Or Radiotherapy) trial [54] | Standard treatment: completion of standard treatment Investigational treatment: regional nodal irradiation | Axillary nodal irradiation could be an alternative therapy for ALND in selected patients with early-stage breast cancer (cN0) and low sentinel lymph node burden (pN1) |
NSABPB-27 [55] | Group 1: SLNB and ALND Group 2: SLNB alone | SLNB may be an applicable option as an alternative for ALND in patients who have underwent NAC |
European Institute of Oncology [11] | Group 1: initially cN0 patients Group 2: initially cN1/2 patients | SLNB is acceptable in initially cN1/2 breast cancer patients who become cN0 after NAC |
SENTINA(SENTinel NeoAdjuvant) trial [56] | Arm A: initially cN0 patients treated with SLNB before NAC Arm B: pN1 patients treated with SLNB after NAC Arm C: ycN0 patients treated with SLNB and ALND Arm D: ycN1 patients treated with ALND without SLNB | SLNB is considered a reliable diagnostic technique before NAC. After systemic treatment or early SLNB, the procedure exhibits a lower detection rate and a higher false negative rate compared with SLNB done before NAC |
SN FNAC study [57] | patients with biopsy-proven node-positive breast cancer (T0-3, N1-2) underwent SLNB and ALND | A low FNR of SLNB after NAC in biopsy-proven node-positive breast cancer can be achieved with the use of IHC for sentinel node evaluation |
GANEA2 (Ganglion sentinel apres chimiotherapie NEoAdjuvante) trial [12] | Group 1: cN0 group Group 2: pN1 group | No initial node involvement and a negative SLN post NAC allow to safely spare an unnecessary ALND |