NSABP PROPOSED TRIAL COMPARING ARIMIDEX® (anastrozole) TO TAMOXIFEN IN DCIS

The driving force of current research is to move away from the concept that DCIS is simply a surgical problem — and that if you obtain 10 mm margins, the patient is cured and no adjuvant therapy is needed. And it’s not really important to argue about whether there’s a set of patients who don’t need radiation therapy.

Even if we take out the index DCIS, the risk for these women to have another tumor in either breast in the future is at least as high or higher than the risk for women in the NSABP P-1 prevention trial. So, chemoprevention in DCIS is an important issue, and we need to find out how to do this best.

Nobody believed when we started with tamoxifen that it would be a "home run" and end all inquiry. Even with the prevention trial, as enormously successful as it was in reducing the incidence of cancer by 50 percent, everybody understands that there must be a more effective or safer drug.

The ATAC trial, which has past accrual and is nearing analysis, will answer the question about anastrozole in invasive breast cancer. We need to ask the same question in non-invasive disease. We are focusing on Arimidex, because it has been well-tested, and there are the two studies in advanced disease that show that it’s equal or superior to tamoxifen.

—Richard Margolese, MD

KEY PRIOR NSABP DCIS TRIALS

Modified from Lancet 1999;353(9169):1993-2000. Abstract

NSABP trials of patients receiving lumpectomy for DCIS. Cumulative incidence of all invasive and noninvasive events in the ipsilateral and contralateral breast in NSABP B-17 and B-24 studies. Note the stepwise improvements in outcome with the addition of XRT and tamoxifen to lumpectomy for DCIS. 

KEY CURRENT DCIS TRIAL

ADJUVANT THERAPY FOR DCIS PATIENTS WITH POSITIVE SENTINEL NODES

This is an extremely challenging issue. There clearly are patients with DCIS diagnosed by core biopsy techniques who have invasive cancer in their final specimens. Once they have invasive cancer, I don’t consider them in the DCIS pool. So the first step when a "DCIS patient" has a positive node by H & E is to go back and ask your pathologist to make extra sections and look very hard for invasive carcinoma. The people from Moffitt have looked retrospectively at DCIS patients with IHC-positive nodes and found no survival impact, but that study didn’t have much statistical power. We have no reliable data to guide us in that situation, which is the reason I don’t do IHC in routine practice.

—Monica Morrow, MD

NATURAL HISTORY

DCIS is over-diagnosed — certainly in premenopausal women. It is likely that only one in five, if undetected, would progress to become invasive breast cancer. But having detected it, we then have to treat it, and I think one of the most dishonest things about promoting mammographic screening for women under 50 is the idea of "Come for screening. We’ll save your life and save your breast." But your breast is not saved, because DCIS is often outside one quadrant, so you have this extraordinary paradox that women think DCIS is early breast cancer. And yet, in the U.K. and the U.S.A., about 40 percent of premenopausal women with DCIS end up having a mastectomy. Whereas, if it was left to appear as an invasive breast cancer, the treatment would be a lumpectomy. No one can explain that mismatch.

—Michael Baum, ChM, FRCS

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Editor’s Note

Sentinel Node Dissection:
Implications to Medical Oncology

Postmastectomy Radiation
Therapy

Ductal Carcinoma In Situ

ER/PR Results and Endocrine
Therapy

Adjuvant Therapy for Low-risk
Invasive Tumors

ATAC Trial: Arimidex vs
Tamoxifen vs Combination

Bisphosphonates in Primary
Breast Cancer 

Adjuvant Taxanes: Surgical
Oncology Perspective

Proposed IBIS 2 Prevention Trial:
Arimidex vs Tamoxifen vs Placebo

Predictions of Future Trends
in Breast Cancer Research

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