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

Abstract

A B S T R A C T PurposeTo determine the risk of ipsilateral breast events in patients with ductal carcinoma in situ (DCIS) treated with local excision without irradiation. Patients and MethodsPatients 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. ResultsWith 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%). ConclusionRigorously 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 longterm results.

Accelerated Partial Breast Irradiation: Executive summary for the update of an ASTRO Evidence-Based Consensus Statement

“…Similar results were noted in the initial publication of the Eastern Cooperative Oncology Group (ECOG) 5194 trial among patients meeting similar criteria, with observation yielding a 6.1% risk of IBTR at 6.7 years' median follow-up and 14.4% risk at 12 years. 12,13 These inclusion criteria therefore define a group of patients with low-risk DCIS for whom observation confers a low absolute risk of IBTR and for whom the addition of WBI confers a small but measurable absolute benefit in prevention of IBTR. When applied to APBI, 41 patients in the MammoSite registry met the low-risk enrollment criteria for the ECOG 5194 study and experienced a 5-year risk of an IBTR of 0%.…”

The management of ductal intraepithelial neoplasia (DIN): open controversies and guidelines of the Istituto Europeo di Oncologia (IEO), Milan, Italy

“…Since then other authors proposed progressively smaller measures, i.e., 3mm [33][34][35], 2-3 mm[136-37], 2 mm [38][39][40] and 1mm [41]. At the 2009 Saint Gallen International Experts Consensus, there was consensus in avoiding the need to insist on a large (e.g.…”

“…There are two aspects that are to be taken into consideration at the moment of performing RT in DIN: the margins of resection and the tumor grading. Regarding margins, the recent ECOG report [35] showed that a margin of 3 mm or wider could be an adequate width for only excision without irradiation (in 8 G1-G2 DIN patients). Regarding tumor grading, clinicians agree that patients with high-grade DIN and with close margins benefit from adjuvant radiotherapy.…”

“…Consensus [42], the ECOG trial [35], the Newport Consensus Conference III [90], and from the National Consensus Cancer Network [91]) suggested that some DIN patient sub-groups (i.e., G1 or G2 tumors without comedonecrosis, and other low-risk sub-grups) could not be candidates to receive RT after BCS.…”

Locoregional treatment of primary breast cancer

“…35 Prospective attempts to duplicate single institution studies reporting low rates of local recurrence after wide excision and detailed tissue processing have been unsuccessful. 36,37 In patients with hormone receptor-positive DCIS, treatment with tamoxifen for 5 years reduces the risk of IBTR and contralateral cancer. 38 The risk-benefit ratio of tamoxifen varies with age and is most favorable in premenopausal women.…”