EVALUATION OF SURROGATE END-POINT BIOMARKERS FOR DUCTAL CARCINOMA IN-SITU

Ductal carcinoma in situ (DCIS) now accounts for 20-30% of all newly d iagnosed breast cancers in centers which use mammographic surveillance as a standard part of the examination. The majority of these DCIS les ions, at least in the United States, are of very limited size, with me an estimated extents of 8-20 mm based on pathological examination. A s mall fraction of these are incidental microscopic features of the biop sy; the majority are detected on the basis of mammographic microcalcif ications. These mammographically detected DCIS lesions are biologicall y heterogeneous, and this is reflected by their histology. Moreover, a number of recent independent studies have shown that the clinical out come of patients, particularly those treated by breast conservation, i s related to the presence of reproducible and identifiable histologic features, and possibly to certain immunohistochemically demonstrable g ene markers as T well. Nuclear and proliferative features of DCIS, as well as an evaluation of the periductular stroma, will be major focuse s for the surrogate endpoint biomarker proposal. (C) 1994 Wiley-Liss, Inc.