Sentinel lymph node biopsy for breast cancer using methylene blue dye manifests a short learning curve among experienced surgeons: a prospective tabular cumulative sum (CUSUM) analysis

BACKGROUND: The benefits of sentinel lymph node biopsy (SLNB) for breast cancer patients with histologically negative axillary nodes, in whom axillary lymph node dissection (ALND) is thereby avoided, are now established. Low false negative rate, certainly with blue dye technique, mostly reflects the established high inherent accuracy of SLNB and low axillary nodal metastatic load (subject to patient selection). SLN identification rate is influenced by volume, injection site and choice of mapping agent, axillary nodal metastatic load, SLN location and skill at axillary dissection. Being more subject to technical failure, SLN identification seems to be a more reasonable variable for learning curve assessment than false negative rate. Methylene blue is as good an SLN mapping agent as Isosulfan blue and is much cheaper. Addition of radio-colloid mapping to blue dye does not achieve a sufficiently higher identification rate to justify the cost. Methylene blue is therefore the agent of choice for SLN mapping in developing countries. The American Society of Breast Surgeons recommends that, for competence, surgeons should perform 20 SLNB but admits that the learning curve with a standardized technique may be "much shorter". One appropriate remedy for this dilemma is to plot individual learning curves. METHODS: Using methylene blue dye, experienced breast surgeons performed SLNB in selected patients with breast cancer (primary tumor < 5 cm and clinically negative ipsilateral axilla). Intraoperative assessment and completion ALND were performed for standardization on the first 13 of 24 cases. SLN identification was plotted for each surgeon on a tabular cumulative sum (CUSUM) chart with sequential probability ratio test (SPRT) limits based on a target identification rate of 85%. RESULTS: The CUSUM plot crossed the SPRT limit line after 8 consecutive, positively identified SLN, signaling achievement of an acceptable level of competence. CONCLUSION: Tabular CUSUM charting, based on a justified choice of parameters, indicates that the learning curve for SLNB using methylene blue dye is completed after 8 consecutive, positively identified SLN. CUSUM charting may be used to plot individual learning curves for trainee surgeons by applying a proxy parameter for failure in the presence of a mentor (such as failed SLN identification within 15 minutes).