ABSTRACT

This document provides guidelines for adjuvant systemic therapy according to risk stratification, based on well studied evidence about prognostic factors and the benefits of available systemic adjuvant therapies, and compiled by a panel of 40 breast cancer experts. Adjuvant systemic therapy is not recommended for women with less than 10% recurrence risk over 10 years. For all others, risk is divided into node-negative low-, intermediate-, and high-risk disease, and node-positive disease. Degree of risk in node-negative breast cancer takes into consideration tumor size, histologic and nuclear grade, hormone receptor status, tumor invasion of lymphatic and vascular spaces, and patient age (Table 14.1). Treatment recommendations for each of these categories is given for premenopausal, postmenopausal, and elderly women separately, and takes into consideration the level and amount of evidence existing about various systemic modalities, and when possible, patient preference (Table 14.2). The consensus highlights that although the Oxford overview concluded that ovarian ablation improves overall survival compared to control in young women [26], recommendation for the routine use of this modality must await mature results of comparative trials to adjuvant CT [27-29]. Five years of adjuvant tamoxifen is recommended for all women with hormone receptor-positive breast cancer with the exception of low-risk node-negative breast cancer according to patient preference; more than 5 years remains investigational. Neoadjuvant CT and endocrine therapy are acknowledged to enhance breast conserving surgery but do not alter survival compared with adjuvant delivery of these modalities. Anthracycline-based therapy is considered slightly superior to, but slightly more toxic than CMF CT. Anthracycline-tamoxifen but not CMF-tamoxifen combinations are concluded to provide superior survival over single modality. New issues since the previous St Gallen consensus [30,31] include the emerging availability of genetic testing of women at risk of hereditary breast cancer, of chemopreventive agents for highrisk and postmenopausal women, of sentinel-node biopsy, of neoadjuvant CT and endocrine therapy, of improved local control with radiation after mastectomy in women with high local recurrence risk, and preliminary results of comparisons of CT to CT plus ovarian ablation in premenopausal women. The optimal treatment for the increasing incidence of ductal carcinoma in situ, the need for full axillary dissection in cases with microscopic invasion of the sentinel node, the role of biologic therapies, of chemoprevention and the need for predictive markers of response, such as hormone receptor status and c-erbB-2 overexpression, are highlighted as areas of ongoing investigation.