This study included patients (median age, 58 years) diagnosed with primary breast cancer in the South Swedish Health Care Region between June 1999 and May 2003 as well as patients diagnosed in Lund, Landskrona and Helsingborg. The patients underwent bone marrow aspiration from the sternal crest under anaesthesia at the time of primary surgery. The study was approved by the ethics committee at Lund University, and written informed consent was obtained from all included patients (LU699-09, LU75-02).
Patient and tumour characteristics are given in Table
1. Patients underwent either mastectomy or breast-conserving therapy based on preoperatively identified characteristics and staging. A sentinel node biopsy was performed in patients with no sign of axillary node engagement before surgery, followed by axillary lymph node dissection (level I and II) at the time of either the primary operation or a second operation if histopathological analysis showed metastatic involvement in the sentinel node biopsy. If node involvement was known preoperatively, axillary lymph node dissection was performed at the time of the primary surgery.
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.
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