Mastectomy with axillary clearance versus mastectomy without it. Late results of a trial in which patients had no adjuvant chemo-, radio- or endocrine therapy.
OBJECTIVE
Long-term outcome of comparison of mastectomy with axillary clearance to mastectomy without it.


METHODS
Second analysis of a terminated prospective randomised trial.


METHODS
The Breast Clinic, Groote Schuur Hospital, Cape Town.


METHODS
Ninety-five women aged under 76 years with stages 1 and 2 (T1-2 NO-1 MO) breast cancer.


METHODS
Radical mastectomy (mastectomy and formal axillary dissection with pectoral muscle excision) or simple mastectomy (mastectomy without axillary dissection if nodes were not clinically palpable, or local excision of the nodes if they were).


METHODS
Loco-regional recurrence and survival.


RESULTS
Whereas initial analysis at 40 months had showed more axillary recurrences (P = 0.056) in the simple mastectomy group (leading to the termination of the trial), this difference has disappeared at 10 years (P = 0.113). There was no difference in rate of recurrence at all other sites, time to recurrence, or survival rates at 40 months or at 10 or 25 years.


CONCLUSIONS
Full axillary clearance offered no better long-term loco-regional control or survival. Early analysis and marginally significant differences in axillary recurrence prompted premature termination of this trial.
Dent
D M
DM
Department of Surgery, University of Cape Town.
Gudgeon
C A
CA
Murray
E M
EM
D000328:Adult; D000368:Aged; D001365:Axilla / Q000601:surgery; D001943:Breast Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D005260:Female; D006801:Humans; D008197:Lymph Node Excision; D008207:Lymphatic Metastasis; D015409:Mastectomy, Radical; D015413:Mastectomy, Simple; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D013019:South Africa