The NBOCC* statements and recommendations for sentinel node biopsy in early breast cancer are based on a NBOCC* systematic review3 of available evidence from randomised trials. It is recognised that there is a large body of non-randomised literature available regarding the use of sentinel node biopsy in early breast cancer management. Recommendations have been confined to randomised trial data due to the strength of evidence in these trials. These trials are limited by their inclusion and exclusion criteria detailed below.
Six randomised trials were identified that assessed:
- The benefits and harms of using sentinel node biopsy compared to axillary lymph node dissection to detect cancer spread in early (operable) breast cancer.4-12
Six additional randomised trials were identified that assessed:
- the optimal technique for sentinel node biopsy in early (operable) breast cancer
- different detection agents (blue dye, radioisotope)13-15
- different injection sites (peritumoral, periareolar, intradermal) 16,17
- different treatments after a positive sentinel node is detected (axillary lymph node dissection or no further surgery).18
Exclusion criteria across the trials included:
- women with clinically positive nodes
- women with multicentric/multifocal tumours
- pregnant or breastfeeding women
- women with known allergies to radioisotopes or blue dye
- women with previously treated breast cancer or axillary surgery on the affected breast (including those who had received neoadjuvant systemic treatment).
** The statements and recommendations in this guideline are based on the populations and data included in the trials, i.e.:
- women with clinically negative nodes and
- women with unifocal tumours equal to or less than three centimetres in diameter.
Tumour sizes varied across the trials. Tumours greater than three centimetres in diameter were not well represented in the trial populations. Median follow-up was from 12 months to five years.