Treatment of 100 patients with sentinel node-negative breast cancer without further axillary dissection

Background: The sentinel node biopsy technique for breast cancer has been validated extensively in phase I and II studies. However, no data from phase III randomized clinical studies are available. It remains controversial whether a histologically negative sentinel node biopsy without further axillary dissection can be considered to be good clinical practice. Methods: One hundred consecutive patients with breast cancer who had a negative sentinel node biopsy without additional axillary dissection were studied prospectively between 1997 and 2000 in order to identify tumour recurrence and to assess the morbidity of the sentinel node procedure. Special attention was paid to axillary or locoregional recurrence, distant metastases and overall survival. One year after the procedure patients were sent a questionnaire to assess any functional impairment of the arm or shoulder. Results: Median follow-up was 24 (range 16-40) months. One patient had an axillary relapse 14 months after the initial diagnosis of breast cancer. She died after 2 years from metastatic disease. There were no other local axillary recurrences. There was a 94 per cent response rate to the questionnaire. Twelve patients developed mild disabilities, of whom two said that they had to change their hobbies, sports or daily activities owing to the sentinel node procedure. No patient developed lymphoedema or needed physiotherapy after the operation. Conclusion: When strict criteria for the sentinel node biopsy procedure are used, the sentinel node biopsy without further axillary dissection after a negative histological investigation is a safe procedure. It may therefore be considered to be the standard of care for the treatment of patients with breast cancer.