Authors' objectives:

This report aims to determine whether sentinel lymph node biopsy (SLNB) for breast cancer can identify patients for whom axillary clearance (AC) is not indicated (i.e. who are lymph node negative), without increasing axillary recurrence rates or decreasing long-term survival.

Authors' results and conclusions: Diagnostic accuracy of SLNB: A random effects Bayesian meta-analysis found the pooled localisation rate to be 94.1% (95% posterior interval 93.3% to 95.0%; 192 studies) and the pooled false negative rate (calculated as false negatives over all negatives) to be 4.7% (95% posterior interval 4.0% to 5.4%; 130 studies). Calculated as false negatives over all positives, the false negative rate is 7.4% (95% posterior interval 6.5% to 8.5%). Safety: In one non-randomised study, the SLNB complication rate was significantly lower than for AC and for SLNB followed by AC. There were statistically significantly fewer wound infections for SLNB than for AC in one out of two non-randomised studies. Fourteen case series studies reported whether women reacted to the blue dye, ranging from 0% to 1.6% (median 0%). Effectiveness: Significantly more AC patients experienced lymphoedema than did SLNB only patients; the median across six studies was 3.25% for SLNB and 27.05% for AC, a risk difference of 23.8%. However, this reduction in morbidity will only apply to 70% to 80% of patients undergoing SLNB, since the remaining 20% to 30% (with positive nodes) will subsequently need AC. In one randomised controlled trial there were no axillary recurrences in either the SLNB group or the SLNB+AC group after a median follow-up of 46 months. In 29 case series of SLNB, the axillary recurrence rate did not exceed 1% in patients who were node negative at the time of SLNB (follow-up ranged from 8 months to 47 months). There was insufficient evidence to assess the relative effect on survival of SLNB. In twelve SLNB case series studies, survival after at least 24 months was greater than 98% in all but two of these studies.

Authors' recommendations: Sentinel node biopsy appears to be safe and effective in identifying sentinel lymph nodes resulting in the reduction of complications due to axillary lymph node dissection, in particular lymphoedema. Long term outcomes are uncertain. MSAC recommends that interim funding for sentinel node biopsy should be provided pending the outcome of trials already in progress and should be reviewed in five years.

Authors' methods: Review

Project Status: Completed

URL for project: http://www.msac.gov.au/

Year Published: 2006

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)