The widespread use of screening mammography has resulted in an increasing fraction of breast cancer patients presenting with early-stage disease, including ductal carcinoma in situ. One of the most controversial current management issues for DCIS involves the role of lumpectomy without radiation therapy. The criteria for this approach is not well-defined. Since DCIS patients are at increased risk for a second breast cancer, current clinical trials are addressing the role of endocrine intervention. A particularly salient issue — in view of the recently reported ATAC trial results — is whether aromatase inhibitors can replace tamoxifen in postmenopausal women.

SELECTION OF DCIS PATIENTS FOR RADIATION THERAPY

I have a reputation for not wanting to give radiation to any DCIS patient, but that’s not true. We recommend it to many, but not all, patients. It’s relatively expensive and it’s a bit inconvenient. Also, if you give radiation therapy for DCIS and you get an invasive recurrence, radiation can’t be given again. If you don’t give radiation and there is an invasive recurrence, you can excise and irradiate.

— Melvin Silverstein, MD

NSABP PROPOSED TRIAL COMPARING ANASTROZOLE TO TAMOXIFEN IN DCIS

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. Chemoprevention in DCIS is an important issue, and we need to find out how to do this best.

As enormously successful as the Prevention Trial was in reducing the incidence of cancer by 50%, everybody understands that there must be a more effective or safer drug.

The ATAC trial is answering the question about anastrozole in invasive breast cancer. We need to ask the same question in non-invasive disease.

—Richard Margolese, MD

NSABP TRIALS B-17 AND B-24: RADIATION THERAPY AND TAMOXIFEN FOR DCIS

Our randomized trials demonstrate that, no matter what the margin difference or histologic subtype, there is a clear benefit from the use of radiation therapy. There is also a clear-cut benefit from tamoxifen for both tumor recurrence and reduction in risk for contralateral breast cancers. DCIS patients are at high-risk for contralateral breast cancers, and tamoxifen reduces that risk by more than 50%. The quest to identify patients who can avoid radiation therapy is very reasonable. The problem is that even an excellent observational series is potentially fraught with methodologic bias that can produce flawed results or conclusions. This isn’t a surgeon’s disease. It is a woman’s disease. And if you have a woman in front of you who has the information available today, I feel that offering radiation therapy increases her chance of being in that zero group.

—Lawrence Wickerham, MD

RTOG-9804; RTOG-DEV-1026: PHASE III RANDOMIZED STUDY OF TAMOXIFEN WITH OR WITHOUT RADIOTHERAPY IN WOMEN WITH DUCTAL CARCINOMA IN SITU (DCIS) OF THE BREAST OPEN PROTOCOL   PROPOSED NSABP DCIS TRIAL: TAMOXIFEN VERSUS ARIMIDEX IN POSTMENOPAUSAL PATIENTS WITH DUCTAL CARCINOMA IN SITU     Margolese R. Rationale for proposed National Surgical Adjuvant Breast and Bowel Project (NSABP): DCIS Trial. Tamoxifen versus Arimidex® (anastrozole) in postmenopausal patients with ductal carcinoma in situ. Poster, 2001 Miami Breast Cancer Conference. Full-Text   PROPOSED IBIS 2 TRIAL: INTERNATIONAL BREAST INTERVENTION STUDY 2   SURGEONS About how many women with DCIS did you treat in the last year? Mean 21 What do you believe the results would be of a randomized clinical trial comparing tamoxifen to anastrozole in women with DCIS? Regarding efficacy: Greater benefits with anastrozole 60% No significant difference 30% Treat with mastectomy? 10% Regarding toxicity:   Less toxicity with anastrozole 55% No significant difference 40% Undetermined 5% About how many of these women did you: Treat with lumpectomy/radiation therapy? 13 Treat with lumpectomy/no radiation therapy? 3 Treat with mastectomy? 4 Refer to a medical oncologist? 18 Start on tamoxifen? 11 What type of research data would you require in order to use anastrozole or another aromatase inhibitor in a postmenopausal woman with DCIS? Would use it now based on ATAC data 55% Would only use it if ATAC trial continued to show similar results with longer follow-up 30% Would only use it if a trial demonstrated safety and efficacy in DCIS patients 10% Would use it if oncologists started prescribing anastrozole over tamoxifen 5%

Bijker N et al. Risk factors for recurrence and metastasis after breast-conserving therapy for ductal carcinoma-in-situ: Analysis of European Organization for Research and Treatment of Cancer Trial 10853. J Clin Oncol 2001;19:2263-71. Abstract

Bordeleau L et al. A comparison of four treatment strategies for ductal carcinoma in situ using decision analysis. Cancer 2001;92:23-9. Abstract

Fisher B et al. Prevention of invasive breast cancer in women with ductal carcinoma in situ: An update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol 2001;28:400-18. Abstract

Mokbel K et al. Predictors of positive margins after local excision of ductal carcinoma in situ. Am J Surg 2001;181:91-5. Abstract

Skinner KA, Silverstein MJ. The management of ductal carcinoma in situ of the breast. Endocr Relat Cancer 2001;8:33-45. Full-Text

Vicini FA et al. Relationship between excision volume, margin status, and tumor size with the development of local recurrence in patients with ductal carcinoma-in-situ treated with breast-conserving therapy. J Surg Oncol 2001;76:245-54. Abstract

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