Size of breast cancer metastases in axillary lymph nodes: Clinical relevance of minimal lymph node involvement

Background Overt ipsilateral axillary lymph node metastases of breast cancer are the most significant prognostic indicators for women who have undergone surgery, yet the clinical relevance of minimal involvement (isolated tumor cells and micrometastases) of these nodes is uncertain. Patients and Methods We evaluated biologic features, adjuvant treatment recommendations, and prognosis for 1,959 consecutive patients with pT1-3, pN0, minimal lymph node involvement (pN1mi or pNOi+), or pN1a (single positive node) and MO, who were operated on and counseled for medical therapy from April 1997 to December 2000. Results Patients with pN1a and pN1mi/pNOi+, when compared with patients with pNO disease, were more often prescribed anthracycline-containing chemotherapy (39.1% v 33.2% v 6.1%, respectively; P < .0001) and were less likely to receive endocrine therapy alone (9.8% v 19.4% v 41.9%, respectively; P < .0001). At the multivariate analysis, a statistically significant difference in disease-free survival (DFS) and in the risk of distant metastases was observed for patients with pN1a versus pNO disease (hazard ratio [HR] 2.04; 95% Cl, 1.46 to 2.86; P < .0001 for DFS; HR = 2.32; 95% Cl, 1.42 to 3.80, P = .0007 for distant metastases) and for patients with pN1mi/pNOi+ versus pNO disease (HR = 1.58; 95% Cl, 1.01 to 2.47; P = .047 for DFS; HR = 1.94; 95% Cl, 1.04 to 3.64; P =.037 for distant metastases). Conclusion Even minimal involvement of a single axillary node in breast cancer significantly correlates with worse prognosis compared with no axillary node involvement. Further studies are required before widespread modification of clinical practice. (C) 2005 by American Society of Clinical Oncology.