Morbidity after sentinel lymph node biopsy in primary breast cancer: results from a randomized controlled trial.

PURPOSE: Axillary lymph node dissection (ALND) as part of surgical treatment for patients with breast cancer is associated with significant morbidity. Sentinel lymph node biopsy (SLNB) is a newly developed method of staging the axilla and has the potential to avoid an ALND in lymph node-negative patients, thereby minimizing morbidity. The aim of this study was to investigate physical and psychological morbidity after SLNB in the treatment of early breast cancer in a randomized controlled trial. PATIENTS AND METHODS: Between November 1999 and February 2003, 298 patients with early breast cancer (tumors 3 cm or less on ultrasound examination) who were clinically node negative were randomly allocated to undergo ALND (control group) or SLNB followed by ALND if subsequently found to be lymph node positive (study group). A detailed assessment of physical and psychological morbidity was performed during a 1-year period postoperatively.
RESULTS: A significant reduction in postoperative arm swelling, rate of seroma formation, numbness, loss of sensitivity to light touch and pinprick was observed in the study group. Although shoulder mobility was less impaired on average in the study group, this was significant only for abduction at 1 month and flexion at 3 months. Scores reflecting quality of life and psychological morbidity were significantly better in the study group in the immediate postoperative period, with fewer long-term differences.
CONCLUSION: SLNB in patients undergoing surgery for breast cancer results in a significant reduction in physical and psychological morbidity.

RCT Entities:   Population Interventions Outcomes