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
    • 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.

#Arrangoiz #BreastSurgeon #CancerSurgeon #SurgicalOncologist #CenterforAdvancedSurgicalOncology #PalmettoGeneralHospital

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