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. Design. Second analysis of a terminated prospective randomised trial. Setting. The Breast Clinic, Groote Schuur Hospital, Cape Town. Patients. Ninety-five women aged under 76 years with stages 1 and 2 (T1-2 NO-1 M0) breast cancer. Interventions. 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). Outcome measures. 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.