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24 E U R O P E A N O N C O L O G I C A L D I S E A S E 2 0 0 6 Hope S Rugo is Clinical Professor of Medicine in the Division of Hematology and Oncology at the University of California San Francisco (UCSF) Comprehensive Cancer Center and Director of the Breast Oncology Clinical Trials Program at the UCSF Comprehensive Cancer Center. Dr Rugo treats patients and participates in clinical research at the Breast Care Center. Dr Rugo’s research interests include novel therapies for advanced breast cancer, evaluation of circulating endothelial and epithelial cells as novel markers of response and resistance to therapy, complementary medicine and supportive care. She has worked in the past in the field of malignant haematology and bone marrow transplantation for a variety of diseases, including breast cancer. Dr Rugo is an investigator in the Bay Area Spore at UCSF breast cancer centre, and the principal investigator of a number of clinical trials. She has published many peer-reviewed papers and has given presentations on a variety of cancer-related topics. She graduated from the University of Pennsylvania School of Medicine. Worldwide, breast cancer is the most common form of cancer in women. The incidence of breast cancer increased initially, beginning in the 1970s, then levelled off over the last two decades, and recently the mortality from this disease has been slowly decreasing.1,2 When the breast cancer tumour is localised to the breast and axillary nodes, multimodality therapy is the treatment of choice, consisting of surgery, radiotherapy and adjuvant or neoadjuvant systemic therapy with hormonal agents (tamoxifen (Tam) or an aromatase inhibitor (AI)), and/or chemotherapy.3,4 Depending on clinical and pathological criteria (including tumour size and grade, presence and number of axillary node metastases, lymphovascular invasion, and overexpression of biological markers, including oestrogen receptors (ERs), progesterone receptors (PRs) and the HER2/neu receptor), as well as host factors, such as age, and co-morbidities, patients with breast cancer are roughly classified as having high-, intermediate-, or low-risk disease, which guides the recommendations for therapy.3,4 However, even after primary therapy by surgery and/or chemotherapy, the risk of recurrence remains high.5 Although, classically, breast tumour biology has been classified on the basis of hormone receptor (HR) negativity or positivity, it is now becoming clear that multiple other subtypes exist within these broad categories.6 Indeed, a subset of HR-positive tumours may be associated with early relapse due to initial or rapid development of hormone resistance, and aggressive biology.7-9 In a review of data from seven clinical trials of adjuvant therapy for early breast cancer conducted by the Eastern Cooperative Oncology Group, the greatest risk of recurrence occurred within the first three years after surgery.5 The risk was highest among women with tumours >3cm and among those who had >4 positive nodes. Interestingly, patients who had HR-negative, highly proliferative disease had a higher risk of relapse in the first five years after diagnosis; subsequently, their relapse rate sharply declined. From years 5–10, the risk was significantly greater in women with ERpositive disease.5

The Risk of Early Recurrence and Distant Metastases—Lessons from the Monotherapy Adjuvant Aromatase Inhibitor Trials with a Focus on BIG 1–98