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29] Five year results of intergroup study E5194: local excision alone (without radiation treatment) for selected patients with ductal carcinoma in situ (DCIS).
Hughes L, Wang M, Page D, Gray R, Solin L, Davidson N, Lowen M, Ingle J, Wood W.. for the Eastern Cooperative Oncology Group (ECOG); The North Central Cancer Treatment Group (NCCTG)
Background: A low-risk subset of DCIS patients (pts.) that can be treated with local excision alone (without radiation treatment) has not been prospectively identified in a multi-institutional study.
Therefore, this Intergroup trial was designed to define prospectively a cohort of low-risk DCIS pts. eligible for omission of irradiation.
Materials and Methods: 711 patients with DCIS were entered in a prospective Intergroup (ECOG, NCCTG) trial from 1997 to 2002 and treated with local excision alone. In 2000, adjuvant tamoxifen was allowed. Receptor status of DCIS was not done in the era of this study.
Two cohorts were eligible: pts. with 1) low or intermediate grade DCIS <2.5 cm, and 2) high grade DCIS <1cm. Size was defined as the diameter encompassing the largest dimension of the area of the lesion histologically. A post-excision mammogram negative for residual suspicious calcifications and final margins >3mm were required.
All pts. were required to have a complete set of histologic slides documenting size and margins sent for central pathology review at Vanderbilt University. At review, pts. with lesions 3 mm and over with appropriate histology were accepted as meeting criteria for DCIS for the purposes of this study.
In the event of recurrence or second event, slides were sent for central review.
Results: Of 711 pts. entered, 29 were found to be ineligible for the study. Of eligible pts., the median age was 60 years (range 28-88). Median follow-up was 4.96 years (range 0.24-8.56). 89% were acceptable after central pathology review at study entry, which has been completed on 95% of patients.
In the low/intermediate stratum (580 eligible pts.), median size of lesion was 6mm, with only 18% >1cm in size. The median surgical margin was (5-10)mm. 31% declared their intention to take tamoxifen at the time of entry.
The ipsilateral breast event rate at 5 years was 6.8% (95% CI: 4.4%-9.1%). 50% of ipsilateral breast events were DCIS, and 50% invasive. Contralateral breast events were 3.5% at 5 years.
In the high grade stratum (102 eligible pts.), the median tumor size was 7mm, with a median margin width of (5-10)mm. 30% declared their intention to take tamoxifen. The ipsilateral breast event rate at 5 years was 13.7% (95%CI: 6.2%-21.1%), with 53% DCIS and 47% invasive. Contralateral breast events were 4.2% at 5 years.
Discussion: Rigorously evaluated and selected patients with low to intermediate grade DCIS of the breast observed without irradiation had an acceptably low risk of ipsilateral breast events with relatively early followup at 5 years. Patients with high grade lesions had a higher rate of ipsilateral breast events at 5 years, suggesting that excision alone is inadequate treatment, although the sample size was smaller.
Further followup is necessary to document long term results.
SABCS 2006
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