A randomized comparison of sentinel-node biopsy with routine axillary dissection in breast cancer.
BACKGROUND
Although numerous studies have shown that the status of the sentinel node is an accurate predictor of the status of the axillary nodes in breast cancer, the efficacy and safety of sentinel-node biopsy require validation.


METHODS
From March 1998 to December 1999, we randomly assigned 516 patients with primary breast cancer in whom the tumor was less than or equal to 2 cm in diameter either to sentinel-node biopsy and total axillary dissection (the axillary-dissection group) or to sentinel-node biopsy followed by axillary dissection only if the sentinel node contained metastases (the sentinel-node group).


RESULTS
The number of sentinel nodes found was the same in the two groups. A sentinel node was positive in 83 of the 257 patients in the axillary-dissection group (32.3 percent), and in 92 of the 259 patients in the sentinel-node group (35.5 percent). In the axillary-dissection group, the overall accuracy of the sentinel-node status was 96.9 percent, the sensitivity 91.2 percent, and the specificity 100 percent. There was less pain and better arm mobility in the patients who underwent sentinel-node biopsy only than in those who also underwent axillary dissection. There were 15 events associated with breast cancer in the axillary-dissection group and 10 such events in the sentinel-node group. Among the 167 patients who did not undergo axillary dissection, there were no cases of overt axillary metastasis during follow-up.


CONCLUSIONS
Sentinel-node biopsy is a safe and accurate method of screening the axillary nodes for metastasis in women with a small breast cancer.
Veronesi
Umberto
U
Division of Senology, European Institute of Oncology, Milan, Italy. umberto.veronesi@ieo.it
Paganelli
Giovanni
G
Viale
Giuseppe
G
Luini
Alberto
A
Zurrida
Stefano
S
Galimberti
Viviana
V
Intra
Mattia
M
Veronesi
Paolo
P
Robertson
Chris
C
Maisonneuve
Patrick
P
Renne
Giuseppe
G
De Cicco
Concetta
C
De Lucia
Francesca
F
Gennari
Roberto
R
D000328:Adult; D000368:Aged; D001365:Axilla; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology* / Q000601:surgery; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008198:Lymph Nodes / Q000473:pathology; D008207:Lymphatic Metastasis / Q000473:pathology*; D015412:Mastectomy, Segmental; D008875:Middle Aged; D021701:Sentinel Lymph Node Biopsy; D016019:Survival Analysis