• Bernard Fisher, John Bryant, James J Dignam, D Lawrence Wickerham, Eleftherios P Mamounas, Edwin R Fisher, Richard G Margolese, Lois Nesbitt, Soonmyung Paik, Thomas M Pisansky, Norman Wolmark, and National Surgical Adjuvant Breast and Bowel Project.
• National Surgical Adjuvant Breast and Bowel Project Biostatistical Center, Division of Pathology, and Breast Committee, Pittsburgh, PA, USA. bernard.fisher@nsabp.org
• J. Clin. Oncol. 2002 Oct 15; 20 (20): 4141-9.

PurposeThis trial was prompted by uncertainty about the need for breast irradiation after lumpectomy in node-negative women with invasive breast cancers of Patients And MethodsAfter lumpectomy, 1,009 women were randomly assigned to TAM (n = 336), XRT and placebo (n = 336), or XRT and TAM (n = 337). Rates of IBTR, distant recurrence, and contralateral breast cancer (CBC) were among the end points for analysis. Cumulative incidence of IBTR and of CBC was computed accounting for competing risks. Results with two-sided P values of.05 or less were statistically significant.ResultsXRT and placebo resulted in a 49% lower hazard rate of IBTR than did TAM alone; XRT and TAM resulted in a 63% lower rate than did XRT and placebo. When compared with TAM alone, XRT plus TAM resulted in an 81% reduction in hazard rate of IBTR. Cumulative incidence of IBTR through 8 years was 16.5% with TAM, 9.3% with XRT and placebo, and 2.8% with XRT and TAM. XRT reduced IBTR below the level achieved with TAM alone, regardless of estrogen receptor (ER) status. Distant treatment failures were infrequent and not significantly different among the groups (P =.28). When TAM-treated women were compared with those who received XRT and placebo, there was a significant reduction in CBC (hazard ratio, 0.45; 95% confidence interval, 0.21 to 0.95; P =.039). Survival in the three groups was 93%, 94%, and 93%, respectively (P =.93).ConclusionIn women with tumors

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