Originally published as JCO Early Release 10.1200/JCO.2009.21.8560 on October 13 2009

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Local Excision Alone Without Irradiation for Ductal Carcinoma In Situ of the Breast: A Trial of the Eastern Cooperative Oncology Group

From the North Georgia Radiation Therapy/The Hope Center, Cartersville; Emory University, Atlanta, GA; Dana-Farber Cancer Institute; Eastern Cooperative Oncology Group Coordinating Center; Beth Israel Deaconess Medical Center, Boston, MA; Vanderbilt University, Nashville, TN; University of Pennsylvania, Philadelphia, PA; Johns Hopkins Oncology Center, Baltimore, MD; Baystate Medical Center, Springfield, MA; and Mayo Clinic, Rochester, MN.

Corresponding author: Lorie L. Hughes, MD, The Hope Center, 100 Market Place Blvd, Ste 102, Cartersville, GA 30121; e-mail: lhughesmd{at}aol.com.

Purpose To determine the risk of ipsilateral breast events in patients with ductal carcinoma in situ (DCIS) treated with local excision without irradiation.

Patients and Methods Patients with either low- or intermediate-grade DCIS measuring 2.5 cm or smaller, or high-grade DCIS measuring 1 cm or smaller who had microscopic margin widths of 3 mm or wider and no residual calcifications on postoperative mammograms were eligible for a prospective trial conducted from 1997 to 2002 by the Eastern Cooperative Oncology Group and North Central Cancer Treatment Group. Patients entered in 2000 and later could take tamoxifen if they wished. Median age at last surgery for the entire population was 60 years (range, 28 to 88 years), and median tumor sizes in the two strata were 6 mm and 5 mm, respectively.

Results With a median follow-up of 6.2 years, the 5-year rate of ipsilateral breast events in the 565 eligible patients in the low/intermediate grade stratum was 6.1% (95% CI, 4.1% to 8.2%). With a median follow-up of 6.7 years, this incidence for the 105 eligible patients in the high-grade stratum was 15.3% (95% CI, 8.2% to 22.5%).

Conclusion Rigorously evaluated and selected patients with low- to intermediate-grade DCIS with margins 3 mm or wider had an acceptably low rate of ipsilateral breast events at 5 years after excision without irradiation. Patients with high-grade lesions had a much higher rate, suggesting that excision alone is inadequate treatment. Further follow-up is necessary to document long-term results.

See accompanying editorial on page 5303

Supported in part by Public Health Service Grants No. CA23318, CA66636, CA21115, CA40057, CA07190, CA25224, and CA16116 and from the National Cancer Institute, National Institutes of Health, and the Department of Health and Human Services.

This study was coordinated by the Eastern Cooperative Oncology Group (Robert L. Comis, MD, chair). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

Presented in part at the 29th Annual San Antonio Breast Cancer Symposium, December 14-18, 2006, San Antonio, TX.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00002934 [ClinicalTrials.gov] .

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