Tuesday, November 10, 2009

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

This weeks JCO:

A very interesting article on lumpectomy alone in selected DCIS patients is reported from ECOG and the NCTG. This was a phase II trial of lumpectomy alone small (<2.5cm)>3mm). The five year results meet their goals in the low-intermediate grade group with 6.1% ipsilateral events, however was unacceptably high in the high grade group. These two cohorts were planned from the start to be analyzed separately.

The only comment that I would have is that I will like to see the 10 year data when it is available, as the failure curves in the manuscript look like they are begining to jump after the currently reported endpoint.

Of course, the real test of lumpectomy alone in selected DCIS will be the randomized RTOG trial 98-04 which will be maturing with the next few years.

Link and Abstract:

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

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