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Bending the Curve Trial by Trial
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NSABP B-04

Radical mastectomy versus total mastectomy with or without radiation (NSABP B-04)

N = 1,665

Population
Women with operable breast cancer, stratified by clinical axillary node status.
Design
Randomised trial begun in 1971; clinically node-negative women assigned to radical mastectomy, total mastectomy with regional irradiation (no axillary dissection) or total mastectomy with axillary dissection only if nodes became positive; clinically node-positive women assigned to radical mastectomy or total mastectomy with irradiation. 25-year report: 1079 node-negative and 586 node-positive women.
Arms
  • Radical mastectomy (control): Radical mastectomy
  • Total mastectomy + irradiation (experimental): Total mastectomy without axillary dissection but with postoperative irradiation
  • Total mastectomy alone (node-negative only) (experimental): Total mastectomy plus axillary dissection only if nodes became positive
People
Fisher B, NSABP
OSHR 1.08 (95% CI 0.91–1.28)OSHR 1.03 (95% CI 0.87–1.23)OSHR 1.06 (95% CI 0.89–1.27)
Show the numbers
Results reported for NSABP B-04
EndpointAnalysisTotal mastectomy + irradiation / Total mastectomy alone (node-negative only)Radical mastectomyEffect
OSClinically node-negative women (n=1079)long term-updateFisher 2002——HR 1.08 (95% CI 0.91–1.28)P=0.38Total mastectomy plus irradiation compared with radical mastectomy, as published.
OSClinically node-negative women (n=1079)long term-updateFisher 2002——HR 1.03 (95% CI 0.87–1.23)P=0.72Total mastectomy (axillary dissection only if nodes became positive) compared with radical mastectomy, as published.
OSClinically node-positive women (n=586)long term-updateFisher 2002——HR 1.06 (95% CI 0.89–1.27)P=0.49Total mastectomy plus irradiation compared with radical mastectomy, as published.
Results reported for NSABP B-04
EndpointAnalysisTotal mastectomy + irradiation / Total mastectomy alone (node-negative only)Radical mastectomyEffect
OSClinically node-negative women (n=1079)long term-updateFisher 2002——HR 1.08 (95% CI 0.91–1.28)P=0.38Total mastectomy plus irradiation compared with radical mastectomy, as published.
OSClinically node-negative women (n=1079)long term-updateFisher 2002——HR 1.03 (95% CI 0.87–1.23)P=0.72Total mastectomy (axillary dissection only if nodes became positive) compared with radical mastectomy, as published.
OSClinically node-positive women (n=586)long term-updateFisher 2002——HR 1.06 (95% CI 0.89–1.27)P=0.49Total mastectomy plus irradiation compared with radical mastectomy, as published.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.080.91–1.28
OS1.030.87–1.23
OS1.060.89–1.27
Primary publication: Fisher B, Redmond C, Fisher ER, Bauer M, Wolmark N, Wickerham DL, et al. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med. 1985;312(11):674-81. PubMedDOI

Appears in

Sources

  1. Fisher B, Redmond C, Fisher ER, Bauer M, Wolmark N, Wickerham DL, et al. Ten-year results of a randomized clinical trial comparing radical mastectomy and total mastectomy with or without radiation. N Engl J Med. 1985;312(11):674-81.

    PubMedDOI

  2. Fisher B, Jeong JH, Anderson S, Bryant J, Fisher ER, Wolmark N. Twenty-five-year follow-up of a randomized trial comparing radical mastectomy, total mastectomy, and total mastectomy followed by irradiation. N Engl J Med. 2002;347(8):567-75.

    PubMedDOI