Patient and tumour characteristics are given in Table
Adjuvant therapy was recommended according to clinical standards following Regional Guidelines, and included chemotherapy for N+ premenopausal women and N+ postmenopausal women with oestrogen receptor-negative tumours (ER-) (n = 65, 16%). Endocrine therapy was delivered to 197 patients (49%); premenopausal patients with oestrogen receptor-positive (ER+) tumours and no nodal engagement received tamoxifen, and postmenopausal women with ER + tumours received tamoxifen or aromatase inhibitors regardless of nodal status. Chemoendocrine therapy was given to 22 patients; 137 patients had no adjuvant therapy. Radiotherapy to the breast was given after breast-conserving surgery (50 Gy) (n = 198, 49%) and locoregional radiotherapy was delivered if four or more axillary lymph nodes were metastatic (n = 35, 9%). A combination of radiotherapy to the breast and to the locoregional lymph nodes was delivered in 39 patients (10%).
The patients were followed by annual clinical examination and mammography. Further clinical and radiological examinations were performed when clinical signs indicated recurrence of the disease. After 5 years of follow-up, all clinical and histopathological results concerning tumour grading and staging, as well as reports of events, were abstracted from individual patient’s charts. The median follow-up for patients without any breast cancer-related event was 61 months. For patients for whom no cause of death was registered, we received information from the Swedish Register of Causes of Death (Central Statistics Office). The inclusion criteria were re-evaluated.
The original cohort included 569 patients, 544 of whom were followed according to the schedule. The exclusion criteria were no standardised surgical treatment (laser, n = 1), neoadjuvant treatment (n = 11), and local recurrence (n = 3) and the sample volume was inadequate in 36 patients. The analysis was not performed in 117 patients due to change in research strategy at our laboratory. The final cohort thus included 401 patients.