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evident
Original paper
2002NEJMHematology/Oncology

NSABP B-06

Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer

RCTBreast cancer

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Overview

At 20 years, lumpectomy plus irradiation matched mastectomy on survival and reduced ipsilateral breast recurrence versus lumpectomy alone.

Clinical takeaway

Breast-conserving surgery plus irradiation remains appropriate when margins are tumor-free and the cosmetic result is acceptable. Irradiation cuts local recurrence. Survival was not better than mastectomy.

Key result

Among women assigned lumpectomy, ipsilateral breast recurrence was 14.3% with irradiation versus 39.2% without (P<0.001). Overall survival did not differ across the three groups.

Practice impact

Lumpectomy plus irradiation is equivalent to mastectomy for survival when margins are clear.

Evidence

Study design

Twenty-year follow-up of a randomized trial initiated in 1976 comparing total mastectomy, lumpectomy alone, and lumpectomy plus breast irradiation.

Enrollment

1,851

Follow-up

Twenty-year follow-up.

Geography

Not listed

Clinical question

At 20 years, is lumpectomy with or without radiation as effective as total mastectomy for invasive breast cancer?

Population

  • 1851 women with invasive breast cancer, follow-up data available, and known nodal status who underwent randomly assigned treatment.

Intervention

Lumpectomy plus breast irradiation.

Comparator

Total mastectomy, or lumpectomy without irradiation.

Primary outcome

Disease-free survival, distant-disease-free survival, overall survival, and ipsilateral breast recurrence. A single named primary end point is not restated in this follow-up report.

Survival after lumpectomy plus irradiation was not significantly different from survival after total mastectomy. Disease-free and distant-disease-free survival also did not differ among the three groups.

Hazard ratio for death / 0.97 / 95% CI 0.83-1.14 / p=0.74

Key results

  • Ipsilateral breast recurrence: 14.3% after lumpectomy plus irradiation versus 39.2% after lumpectomy without irradiation (P<0.001).
  • No significant differences among the three groups in disease-free survival, distant-disease-free survival, or overall survival.
  • HR for death, lumpectomy alone versus total mastectomy: 1.05 (95% CI 0.90-1.23; P=0.51). HR for death, lumpectomy plus irradiation versus total mastectomy: 0.97 (95% CI 0.83-1.14; P=0.74).
  • Among lumpectomy-treated women with tumor-free margins, HR for death with postoperative irradiation versus none: 0.91 (95% CI 0.77-1.06; P=0.23).

Harms

  • Radiation was associated with a marginally significant decrease in deaths due to breast cancer that was partially offset by an increase in deaths from other causes. Event counts are not given.

Clinical Use

Practice impact

  • Offer lumpectomy plus irradiation instead of mastectomy when margins will be tumor-free and the cosmetic result will be acceptable.
  • Do not omit irradiation after lumpectomy if the goal is local control; ipsilateral recurrence was much higher without it.

Applicability

  • Women with invasive breast cancer who are candidates for lumpectomy with tumor-free margins and an acceptable cosmetic result.

Limitations

  • This paper is 20-year follow-up of a trial started in 1976; systemic therapy and imaging have changed.
  • Enrollment is 1851 women with available follow-up and known nodal status, not a separately stated randomized N.
  • Radiation dose and systemic therapy are not described in the abstract.

Common misinterpretations

  • Lumpectomy plus irradiation did not improve survival over mastectomy; it matched survival and reduced local recurrence versus lumpectomy alone.
  • The clear-margin irradiation-versus-none survival comparison was not significant (HR 0.91; 95% CI 0.77-1.06).
  • This is not a license for lumpectomy without radiation if local control matters.

Related evidence

HERA - Same Disease

Citation

Fisher B, Anderson S, Bryant J, 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):1233-1241. doi:10.1056/NEJMoa022152

Lumpectomy followed by breast irradiation continues to be appropriate therapy for women with breast cancer, provided that the margins of resected specimens are free of tumor and an acceptable cosmetic result can be obtained.