To determine the impact of axillary lymphadenectomy on regional recurrence, the overall and disease free survival, and upper limb morbidity in patients with breast cancer and negative sentinel node (SN).
A total of 176 patients with breast cancer and negative SN (pN0sn) were either randomised to lymphadenectomy (Group I) or to observation only (Group II). The triple technique was used to identify and remove the SN. Follow-up was carried out every 3 months for the first 3 years, and then every 6 months up to 5 years. Pain, numbness (paresthesia), limitations in shoulder mobility, and arm oedema were recorded.
No axillary lymph node recurrence was detected in the patients of Group II after 60 months follow up. The overall and disease free survival was similar in both groups. The proportion of patients with morbidity and who had more than two complications was significantly higher in Group I.
Axillary lymphadenectomy may be avoided in patients with negative SN without compromising lymph node extension studies and the patient treatment results. Axillary lymphadenectomy is associated with a higher morbidity of the upper limb compared to SN biopsy.