Eastern Cooperative Oncology Group (ECOG) E5194 Study

• Was designed to investigate the risk of ipsilateral breast events (IBEs):
  • In patients with DCIS:
    • Treated with local excision without radiation
• The ECOG and North Central Cancer Treatment Group conducted a prospective trial:
  • From 1997 to 2002
  • Known as the E5194 study
• Patients were stratified into two groups based on grade:
  • Low- and intermediate-grade DCIS measuring 2.5 cm or smaller
  • High-grade DCIS measuring 1 cm or smaller
• Margin widths:
  • Of 3 mm or wider were required along with no residual calcifications on postoperative mammograms
• Results:
  • The low- and intermediate-grade DCIS group:
    • With 565 eligible patients:
      • Had a 5-year IBE rate of 6.1%
  • The high-grade group:
    • With 105 eligible patients:
      • Had a 5-year IBE rate of 15.3%
• These results suggested:
  • That in patients with high-grade lesions:
    • Excision alone without radiation:
      • Is inadequate treatment
• However:
  • E5194 suggested that patients with low- and intermediate-grade lesions:
    • May be considered for omission of radiation:
      • Given the acceptably low rate of IBEs
• To further answer the question:
  • Of when radiation should be considered for treatment of DCIS patients:
    • Solin et al. used samples from the E5194 study to establish the DCIS score:
      • This assay utilized quantitative RT PCR from tumor specimens for 327 patients with DCIS:
        • Treated with surgical excision without radiation:
          • From the E5194 study
      • The DCIS score from 0 to 100:
        • Low less than 39
        • Intermediate 39 to 54
        • High ≥ 55
      • The DCIS score was then designed to predict:
        • The recurrence of:
          • IBE
          • DCIS
          • Invasive cancer
      • The DCIS score correlated with 10-year IBE risk of:
        • 10.6% in the low-risk group
        • 26.7% in the intermediate-risk group
        • 25.9% in the high-risk group
• Current literature reports:
  • A 50% decrease in local recurrence with radiotherapy after surgical excision of DCIS:
    • However, there are no clear criteria to determine which patients will have the maximum benefit
• The DCIS score can be used to stratify patients:
  • Into low- and high-risk groups:
    • Based on more than clinical or pathologic features and can aid in decision making about adjuvant treatments in patients with DCIS
• To study the effect of the DCIS score on recommendations for radiotherapy following excision:
  • The treatment plans for 127 patients with DCIS were evaluated before and after knowledge of the DCIS score by the surgeon and radiation oncologist
  • The DCIS scores varied within the study population:
    • With 66% with a low-risk score, 20% with an intermediate-risk score, and 14% with a high-risk score
  • Based on clinical and pathologic factors:
    • Radiotherapy was recommended:
      • In 71.7% of the patients
  • After the DCIS score was determined:
    • There was an overall change in 26.4% of the recommendations
  • With the additional information of the DCIS score:
    • Radiotherapy was recommended:
      • For 68.1% of the patients
• The clinical utility of the DCIS score is evident in these results:
  • Giving oncologists more objective information when deciding if the benefit of radiotherapy outweighs the risk in patients with DCIS

REFERENCES

1. Hughes LL, Wang M, Page DL, et al. Local excision alone without irradiation for ductal carcinoma in situ of the breast: a trial of the Eastern Cooperative Oncology Group. J Clin Oncol. 2009;27:5319-5324.
2. Manders JB, Kuerer HM, Smith B, et al. Clinical utility of the 12-gene DCIS score assay: impact on radiotherapy recommendations for patients with ductal carcinoma in situ. Ann Surg Oncol. 2016 [Epub ahead of print].
3. Solin LJ, Gray R, Baehner FL, et al. A multigene expression assay to predict local recurrence risk for ductal carcinoma in situ of the breast. J Nat Can Inst. 2013;105:701-710.

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