Axillary radiotherapy instead of axillary dissection: a randomized trial. Italian Oncological Senology Group.
BACKGROUND
Surgical dissection of the axilla is a standard part of the treatment of breast cancer but, by itself, does not improve prognosis; furthermore, most patients with small-sized breast cancer and a clinically uninvolved axilla never develop axillary metastases. We evaluated disease-free and overall survival in patients with early breast cancer treated by breast-conservation surgery without dissection of axillary lymph nodes, receiving or not receiving axillary radiotherapy (RT).


METHODS
From 1995 to 1998, 435 patients older than 45 years with breast cancer up to 1.2 cm were randomized, 214 to breast conservation without axillary treatment and 221 to breast conservation plus axillary RT.


RESULTS
After a follow-up of 28 to 68 months (median, 42 months), two women (1%) in the no axillary treatment group and one (.5%) in the axillary RT group developed axillary metastases. Rates of distant metastases and local treatment failure were also very low, and 5-year overall survival was 99%.


CONCLUSIONS
After a mean of 46 months of follow-up, our results indicate that axillary dissection can be safely avoided in patients with very small invasive carcinomas and a clinically negative axilla. Whether axillary RT should be added can be assessed only by longer follow-up.
Zurrida
Stefano
S
Department of Senology, European Institute of Oncology, Milan, Italy. francesca.morelli@ieo.it
Orecchia
Roberto
R
Galimberti
Viviana
V
Luini
Alberto
A
Giannetti
Irene
I
Ballardini
Bettina
B
Amadori
Andrea
A
Veronesi
Giulia
G
Veronesi
Umberto
U
D001365:Axilla; D001943:Breast Neoplasms / Q000401:mortality / Q000532:radiotherapy* / Q000601:surgery*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007558:Italy / Q000453:epidemiology; D008198:Lymph Nodes / Q000000981:diagnostic imaging*; D015412:Mastectomy, Segmental; D008875:Middle Aged; D011859:Radiography; D015996:Survival Rate