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Bending the Curve Trial by Trial
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NSABP B-06

Total mastectomy versus lumpectomy with or without breast irradiation for invasive breast cancer (NSABP B-06)

Population
Women with Stage I or II breast tumours of 4 cm or less (1985 report); invasive breast cancer.
Design
Randomised trial begun in 1976; all patients had axillary dissection and node-positive patients received chemotherapy (1985 report); 20-year analysis of 1851 women with follow-up data and known nodal status.
Arms
  • Total mastectomy (control): Total mastectomy
  • Lumpectomy alone (experimental): Lumpectomy (segmental mastectomy) without breast irradiation
  • Lumpectomy + breast irradiation (experimental): Lumpectomy (segmental mastectomy) followed by breast irradiation
People
Fisher B, NSABP
OSHR 1.05 (95% CI 0.90–1.23)OSHR 0.97 (95% CI 0.83–1.14)
Show the numbers
Results reported for NSABP B-06
EndpointAnalysisLumpectomy alone / Lumpectomy + breast irradiationTotal mastectomyEffect
IBTR1851 women with follow-up data and known nodal statusCumulative incidence of recurrent tumour in the ipsilateral breast, 20-year analysislong term-updateFisher 200214.3%—P<0.001
OS1851 women with follow-up data and known nodal statuslong term-updateFisher 2002——HR 1.05 (95% CI 0.90–1.23)P=0.51Lumpectomy alone compared with total mastectomy, as published.
OS1851 women with follow-up data and known nodal statuslong term-updateFisher 2002——HR 0.97 (95% CI 0.83–1.14)P=0.74Lumpectomy plus breast irradiation compared with total mastectomy, as published.
Results reported for NSABP B-06
EndpointAnalysisLumpectomy alone / Lumpectomy + breast irradiationTotal mastectomyEffect
IBTR1851 women with follow-up data and known nodal statusCumulative incidence of recurrent tumour in the ipsilateral breast, 20-year analysislong term-updateFisher 200214.3%—P<0.001
OS1851 women with follow-up data and known nodal statuslong term-updateFisher 2002——HR 1.05 (95% CI 0.90–1.23)P=0.51Lumpectomy alone compared with total mastectomy, as published.
OS1851 women with follow-up data and known nodal statuslong term-updateFisher 2002——HR 0.97 (95% CI 0.83–1.14)P=0.74Lumpectomy plus breast irradiation compared with total mastectomy, as published.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
OSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
OS1.050.9–1.23
OS0.970.83–1.14
Primary publication: Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med. 1985;312(11):665-73. PubMedDOI

Appears in

Sources

  1. Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, et al. Five-year results of a randomized clinical trial comparing total mastectomy and segmental mastectomy with or without radiation in the treatment of breast cancer. N Engl J Med. 1985;312(11):665-73.

    PubMedDOI

  2. Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, et al. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002;347(16):1233-41.

    PubMedDOI