Sentinel lymph node biopsy in breast cancer: ten-year results of a randomized controlled study.
OBJECTIVE
Sentinel node biopsy (SNB) is widely used to stage the axilla in breast cancer. We present 10-year follow-up of our single-institute trial designed to compare outcomes in patients who received no axillary dissection if the sentinel node was negative, with patients who received complete axillary dissection.


METHODS
From March 1998 to December 1999, 516 patients with primary breast cancer up to 2 cm in pathologic diameter were randomized either to SNB plus complete axillary dissection (AD arm) or to SNB with axillary dissection only if the sentinel node contained metastases (SN arm).


RESULTS
The 2 arms were well-balanced for number of sentinel nodes found, proportion of positive sentinel nodes, and all other tumor and patient characteristics. About 8 patients in the AD arm had false-negative SNs on histologic analysis: a similar number (8, 95% CI: 3-15) of patients with axillary involvement was expected in SN arm patients who did not receive axillary dissection; but only 2 cases of overt axillary metastasis occurred. There were 23 breast cancer-related events in the SN arm and 26 in the AD arm (log-rank, P = 0.52), while overall survival was greater in the SN arm (log-rank, P = 0.15).


CONCLUSIONS
Preservation of healthy lymph nodes may have beneficial consequences. Axillary dissection should not be performed in breast cancer patients without first examining the sentinel node.
Veronesi
Umberto
U
European Institute of Oncology, Milan, Italy. umberto.veronesi@ieo.it
Viale
Giuseppe
G
Paganelli
Giovanni
G
Zurrida
Stefano
S
Luini
Alberto
A
Galimberti
Viviana
V
Veronesi
Paolo
P
Intra
Mattia
M
Maisonneuve
Patrick
P
Zucca
Francesca
F
Gatti
Giovanna
G
Mazzarol
Giovanni
G
De Cicco
Concetta
C
Vezzoli
Dario
D
D000368:Aged; D001365:Axilla; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D008875:Middle Aged; D021701:Sentinel Lymph Node Biopsy; D015996:Survival Rate