P250 Sentinel lymph node biopsy in large node negative breast cancers: results of a validation study using low-cost blue dye & 99mTc-antimony colloid

Prospective Randomized Trial of Use of In‐House Prepared Low‐Cost Radiopharmaceutical Versus Commercial Radiopharmaceutical for Sentinel Lymph Node Biopsy in Patients with Early Stage Invasive Breast Cancer

“…The results of this prospective, randomized pilot trial imply that the accuracy of SLNB in EBC patients undergoing primary surgery using either low-cost in-house prepared radiopharmaceutical ( 99m Tc-Antimony-colloid) or commercially available 99m Tc-Sulphur-colloid is comparable, with equally efficacious results. These results were comparable to results of a previous study on EBC patients by our group, reported earlier (n = 70, SLN-IR 95.7% and FNR 8.7%) [8], and with the FNR of 7.5%, published in a meta-analysis of 183 studies reporting on 9220 patients [7]. These results may be less relevant in most developed countries, where, today, SLNB is the undisputed standardof-care in managing the node-negative axilla that is available to the vast majority, if not the entire population.…”

“…SLN identification rates (IR), false negative rates (FNR), sensitivity, and negative predictive value (NPV) of SLNB in predicting the histology of the axillary nodes were calculated and compared between the two groups. The results were also compared and with a meta‐analysis of SLNB studies reporting on the SLN FNR [7], and with an EBC validation study previously published by our group [8].…”

A Comparative Validation of Primary Surgical Versus Post‐neo‐adjuvant Chemotherapy Sentinel Lymph Node Biopsy for Stage III Breast Cancers

“…We have been using generic, in-house prepared methylene-blue and 99m Tc-Antimony colloid for SLNB with due approval from the institutional bodies since our initial validation study on EBC and LOBC patients [6,13]. The choice of dyes both blue-dye and the radiopharmaceutical may be considered as a factor affecting the SLN IR as well as accuracy of the SLNB in predicting axillary nodal status by some.…”

“…The commonly used commercially marketed blue‐dyes such as Lymphazurin TM or patent blue violet; and the branded radiopharmaceuticals such as 99m Tc Sulfur colloid add a substantial cost to breast cancer surgery. We have been using generic, in‐house prepared methylene‐blue and 99m Tc‐Antimony colloid for SLNB with due approval from the institutional bodies since our initial validation study on EBC and LOBC patients [6, 13]. The choice of dyes both blue‐dye and the radiopharmaceutical may be considered as a factor affecting the SLN IR as well as accuracy of the SLNB in predicting axillary nodal status by some.…”

“…There is, however, a relative paucity of literature of SLNB in the management of N0 large operable breast cancers (LOBC, T3N0). Existing data does show that despite having a higher incidence of axillary metastatic disease in this subset of patients, results of SLNB in patients with larger tumors are comparable to those of smaller (<3/5 cm) tumors [3, 4], with FNR approaching 5 % [5, 6]. More recent trials have focused on the role that SLNB could play in the management of patients in a post‐neo‐adjuvant chemotherapy (NACT) setting, and a small proportion of patients included in such trials is those with LOBC or locally advanced breast cancers (LABC) [7].…”