ECOG E5194 and the RTOG 9804 Trials

• Studies continue to evaluate for a subset of patients with DCIS:
  • Who may not require adjuvant radiation therapy following breast-conserving surgery
• In a prospective non-randomized trial, ECOG E5194:
  • Evaluated two cohorts of patients:
    • Group 1 had ≤ 2.5-cm low- and intermediate-grade DCIS, and
    • Group 2 had ≤ 1 cm high-grade DCIS
  • Both cohorts had margins of at least 3 mm and did not:
    • Receive adjuvant radiation therapy
  • Tamoxifen was given to:
    • 30% of patients
  • Local recurrence at 5 years was:
    • 6.1% in group 1 and 15.3% in group 2
  • The rate at 12 years was:
    • 14.4% in group 1 and 24.6% in group 2
  • There was no plateau in the incidence of local recurrence over time
• The Radiation Therapy Oncology Group (RTOG) 9804 study:
  • Randomized patients with < 2.5 cm low- and intermediate-grade DCIS and margins ≥ 3 mm:
    • To adjuvant radiation or no radiation therapy following partial mastectomy
  • Seven-year outcomes demonstrated:
    • An increase in local recurrence with the omission of radiation therapy:
      • 6.7% vs 0.9%
  • Tamoxifen was given to 62% of patients
• Similar outcomes were also noted in the Dana Farber prospective trial of excision alone
• REFERENCES
  • McCormick B, Winter K, Hudis C, et al. RTOG 9804: a prospective randomized trial for good-risk ductal carcinoma in situ comparing radiotherapy with observation. J Clin Oncol. 2015;33:709-715.
  • Solin LJ, Gray R, Hughes LL, et al. Surgical excision without radiation for ductal carcinoma in situ of the breast: 12-year results from the ECOG-ACRIN E5194 study. J Clin Oncol. 2015;33:3938-3944.
  • Wong JS, Kaelin CM, Troyan SL, et al. Prospective study of wide excision alone for ductal carcinoma in situ of the breast. J Clin Oncol. 2006;24:1031-1036.

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