Adjuvant systemic treatment of early breast cancer: the NORA study

Background: Despite recommendations contained in international guidelines, factors such as the type of oncology centre, geographic distribution and the introduction of scientific advances into clinical practice can influence the choice of recommended treatment for early breast cancer. The NORA study is a prospective, longitudinal cohort study aimed at investigating tumour characteristics, treatment modalities, and other factors that influence therapeutic choices in early breast cancer patients who have undergone mastectomy or breast-conserving surgery (BCS). Patients and methods: From January 2000 to early 2004, we collected data on methods of cancer diagnosis, type of surgery and adjuvant medical treatment administered to the first 10 consecutive patients treated in 2000-2002 and the first 20 consecutive patients in 2003 and 2004 at 71 oncology centres in Italy, with the approval of the ethical committee at each centre. Results: Approximately one-quarter of the cases (26.5%) were detected through screening programmes. BCS was performed in 63.7% and sentinel node biopsy (SNB) occurred in 11.1% of the patients. Of the 3515 total cases, 56.5% were node-negative. Grade 2 cancers comprised 51.3%, and 66.2% were hormone-receptor positive (ER+/PgR+). Chemotherapy (CHT) followed by hormone therapy (HT) was the most prescribed treatment (48.5%). CHT was mainly anthracycline-based (52.9%) and most patients received tamoxifen alone (77.7%) or after CHT (85.2%). For node-negative patients, HR+ and menopause status are the factors influencing the choice to add HT after CHT; patients with HR+ and pT4 tumours are more likely to receive HT instead of CHT. In node-positive patients, the addition of HT is influenced by HR+ status, the opportunity to have HT instead of CHT, and menopause. Conclusions: NORA is the first large cohort study to describe the factors that influence therapeutic choices in early breast cancer. Understanding these findings can help physicians in daily clinical practice.