Affiliations of authors: Jefferson Medical College, Philadelphia, PA (GFS); The Breast Cancer Consultation Service, Tiburon, CA (MDL); Keck School of Medicine, University of Southern California, Los Angeles (MJS)
Correspondence to: Michael D. Lagios, MD, The Breast Cancer Consultation Service, P.O. Box 950, Tiburon, CA 94920-0950 (e-mail: malagios{at}aol.com)
We wish to comment on the article by Baxter et al. (1), an epidemiologic analysis of treatment trends for ductal carcinoma in situ (DCIS) in the United States. Changes in practice for DCIS that Baxter et al. describe preceded the publication of the results of the earliest randomized trial of radiation therapy for DCIS, namely, NSABP trial B-17 in 1993 (2). These changes included the introduction of breast conservation, the use of adequate excision alone without radiation therapy, and the avoidance of axillary lymph node dissection for this disease. These changes in treatment were the result of prospective observational studies, none of which were cited in the article or the editorial (35).
It is true that pathologic features cannot be used to predict which patients with DCIS will later develop invasive disease. Similarly, we cannot predict which patients with T1b, N0, low-grade invasive ductal carcinomas may develop distant metastases. However, this inability to predict outcome for an individual patient does not vitiate the utility of microscopic prognostic features for treatment planning. The use of pathologic prognostic features for DCIS permits the identification of subsets with different risks of local recurrence, whether of DCIS alone or as invasive carcinoma. Such microscopic features have been defined and standards for examination established in several consensus conferences (6,7). It is these substantial observational studies that have permitted the identification of DCIS patient subsets for whom radiation therapy provides no clinical benefit and that account for the fact that those DCIS patients treated by breast conservation alone avoid the cost and morbidity of radiation therapy.
The randomized trials for DCIS cited by the authors use pathology practices that would not currently be acceptable for the examination of any image-directed biopsy, let alone a resection for DCIS. Current pathologic standards for image-detected abnormalities including DCIS, which include mammographic pathologic correlation, specimen radiography, inking of margins, and thorough histologic examination, were not required by the protocols of the trials. Data from these randomized trials do not permit identification of low-risk subsets because such pathologic data cannot be generated retrospectively.
We are confident that the results of these observational studies will be validated, and the changes in practice that they initiated will continue to benefit patients perhaps until the predictive gene signature for an individual patient provides a more precise assessment of risk. Meanwhile, we vehemently object to the pejorative description of complete excision without radiation therapy for DCIS as "undertreatment." We, among others, have monitored patients who have undergone breast conservation without radiation therapy for up to 20 years without witnessing recurrence, either as DCIS or as invasive cancer, in a substantial majority of these patients.
Finally, and most importantly, because there is essentially no difference in the most important end point of treatment, namely overall and breast cancerspecific survival, no matter how patients with DCIS are treated (mastectomy, excision plus radiation therapy, or excision alone), why not strive for the least aggressive treatment (excision alone) whenever it is appropriate? Those who advocate more aggressive treatments should be forced to justify them from this perspective. Under the same premise that the authors considered excision alone as "undertreatment," how often is more than that "overtreatment?"
REFERENCES
1 Baxter NN, Virnig A, Durham SF, Tuttle TM. Trends in the treatment of ductal carcinoma in situ of the breast. J Natl Cancer Inst 2004;96:4438.
2 Fisher B, Costantino J, Redmond C, Fisher ER, Margolese R, Dimitrov N, et al. Lumpectomy compared with lumpectomy and radiation therapy for the treatment of intraductal breast cancer. N Engl J Med 1993;328:15816.
3 Lagios M, Margolin FR, Westdahl PR, Rose MR. Mammographically detected duct carcinoma in situ. Frequency of local recurrence following tylectomy and prognostic effect of nuclear grade on local recurrence. Cancer 1989;63:61824.[ISI][Medline]
4 Silverstein MJ, Lagios MD, Craig PH, Waisman JR, Lewinsky BS, Colburn WJ, et al. A prognostic index for ductal carcinoma in situ of the breast. Cancer 1996;77:116774.[CrossRef][ISI][Medline]
5 Silverstein MJ. An argument against routine use of radiotherapy for ductal carcinoma in situ. Oncology 2003;17:151133.[Medline]
6 Consensus Conference Committee. Consensus Conference on the Classification of Ductal Carcinoma In Situ, April 25-28, 1997. Cancer 1997;80:1798802.[CrossRef][ISI][Medline]
7 Schwartz GF, Solin LJ, Olivotto IA, Ernster VL, Pressman PI, The Consensus Conference Committee. Consensus Conference on the Treatment of In Situ Ductal Carcinoma of the Breast, April 22-25, 1999. Cancer 2000;88:94654.[CrossRef][Medline]
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