CALGB 9343 Trial

  • The Cancer and Leukemia Group B (CALGB) 9343 trial:
    • Enrolled 647 patients:
      • From 1994 until 1999
    • Long-term follow-up data:
    • Were published in 2013:
      • With a median follow-up of:
        • 12.6 years
      • Women age 70 years or older:
        • With clinical stage I:
          • cT1, cN0, cM0
          • ER-positive breast cancer
          • Treated by lumpectomy 
    • Were randomly assigned to receive:
      • Tamoxifen plus radiation therapy (TamRT) or
      • Tamoxifen alone (Tam)
    • At 10 years:
      • 98% of women:
        • Receiving TamRT were free from local and regional recurrences
      • Compared to 91% of those receiving Tam
      • The 10-year estimates of overall survival (OS) were: o 67% (95% confidence interval [CI], 62–72%) in the TamRT group versus o 66% (95% CI, 61%–71%) in the Tam group:  But the difference was not statistically significant  In addition to concluding that: • While RT (in addition to Tam): o Reduces locoregional recurrence:  The authors noted that “the impact of breast cancer in this select group of older women is much smaller than that of comorbid conditions”: • Only 3% of women in study have died as a result of breast cancer whereas 49% have died as a result of other causes • References: o Hughes KS, Schnaper LA, Bellon JR, et al. Lumpectomy plus tamoxifen with or without irradiation in women age 70 years or older with early breast cancer: long-term follow-up of CALGB 9343. J Clin Oncol. 2013;31:2382-2389.

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