Methylene blue dye--a safe and effective alternative for sentinel lymph node localization.

Sentinel lymph node (SLN) biopsy has emerged as an effective diagnostic tool in axillary staging in breast cancer. The commonly used technique employs isosulfan blue/patent blue V combined with radioactive colloid tracer. Methylene blue (MB) is a less expensive and readily available alternative dye. The study evaluated the safety and efficacy of MB in SLN localization. A retrospective study of 329 patients with early breast cancer who had SLN localization as part of an ethically approved prospective evaluation study of SLN localization technique was carried out. Lymph node positive, tumors >2 cm on clinical and radiological evaluation, those with previous breast and axillary surgery, neo-adjuvant chemotherapy were excluded from the study. One hundred seventy three patients underwent SLN localization using 1 mL of 1% MB, and a combined MB-radio colloid tracer technique was used in the other 156 patients. Allocation to the groups was by simple randomization. Injection of the dye and radioisotope was into the subdermal plane in the sub-areolar region. Patients underwent breast conservation surgery or mastectomy with SLN directed four node axillary sampling +/- axillary clearance. The lymph node was examined by standard microscopy. There were no reported complications with the use of MB aside from temporary tattooing. The technique failed in eight patients giving an identification rate of 97.6%. Ten of the 258 (3.9%) patients had false-negative SLN, with negative predictive value of 96.1%, sensitivity of predicting further axillary disease of 73%, specificity of 87.3%, and overall accuracy of 85.7%. Reported adverse reaction to isosulfan blue/patent blue V varied from minor to severe anaphylactic reactions (1-3%) requiring vigorous resuscitation. Subdermal sub-areolar injection of MB is safe and effective readily available dye for SLN localization in axillary staging of breast cancer with no major adverse reaction.