Background
Randomized women with operable breast cancer (1,079 with clinically negative axillary nodes; a separate cohort with positive nodes) to compare radical mastectomy with less extensive surgery. 25-year follow-up.
Interventions and follow up
Arm A: Radical mastectomy
Arm B (node-negative): Total mastectomy without axillary dissection plus postop RT
Arm C (node-negative): Total mastectomy plus delayed axillary dissection only if nodes became positive
Primary endpoint: DFS and OS
mFollow up: 25yr
Arm B (node-negative): Total mastectomy without axillary dissection plus postop RT
Arm C (node-negative): Total mastectomy plus delayed axillary dissection only if nodes became positive
Primary endpoint: DFS and OS
mFollow up: 25yr
Results
Node-negative, A vs B (OS): HR 1.08, 95% CI 0.91-1.28, P=.38
Node-negative, A vs C (OS): HR 1.03, 95% CI 0.87-1.23, P=.72
Node-positive, A vs C (OS): HR 1.06, 95% CI 0.89-1.27, P=.49
Interpretation: No survival difference among surgical approaches; no benefit from adding RT to simple mastectomy in node-negative disease.
Node-negative, A vs C (OS): HR 1.03, 95% CI 0.87-1.23, P=.72
Node-positive, A vs C (OS): HR 1.06, 95% CI 0.89-1.27, P=.49
Interpretation: No survival difference among surgical approaches; no benefit from adding RT to simple mastectomy in node-negative disease.
Adverse events
Surgical: Substantial morbidity with radical mastectomy, including lymphedema and arm dysfunction.
Radiation-related: Acute skin effects with postop RT.
Overall: Less extensive surgery did not compromise long-term outcomes.
Radiation-related: Acute skin effects with postop RT.
Overall: Less extensive surgery did not compromise long-term outcomes.
Conclusions
Radical mastectomy offers no survival advantage over total mastectomy with or without RT, refuting the Halstedian rationale for extensive surgery.
Key Limitations
Predates systemic adjuvant therapy and modern axillary staging (sentinel node biopsy). Clinical (not pathologic) nodal assessment. Underpowered to exclude small survival differences. RT techniques outdated.
Clinical Context
Foundational trial overturning the radical mastectomy paradigm and enabling the shift to breast-conserving surgery (NSABP B-06). Underpins ASCO/ESMO support for less extensive axillary and breast surgery.