Tc‐99m tilmanocept versus Tc‐99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial

摘要

Introduction No prior trials have compared sentinel lymph node (SLN) identification outcomes between Tc‐99m tilmanocept (TcTM) and Tc‐99m sulfur colloid (TcSC) in breast cancer (BC). Methods We report on the secondary outcomes from a randomized, double‐blinded, single surgeon clinical trial comparing post‐injection site pain between TcTM and TcSC. Patients were randomized to receive a preoperative single, peritumoral intradermal injection of TcTM or TcSC. The number of total, “hot”, and blue nodes detected and removed were compared between groups. Results Fifty‐two (27‐TcSC and 25‐TcTM) patients were enrolled and underwent definitive surgical treatment. At least one “hot” SLN was detected in all patients. Three (5.8%) patients had a disease positive‐SLN. The total number of SLNs removed was 61 (mean 2.26 (standard deviation (SD) 0.90)) in the TcSC group and 54 (mean 2.16 (SD 0.90)) in the TcTM group, P ?=?0.69. The total number of “hot” nodes in the TcSC group was 1.96 (SD 0.76) compared to 2.04 (SD 0.73) in the TcTM group, P ?=?0.71. Conclusions The number of identified SLNs did not differ significantly between TcTM and TcSC. Given that no significant technical advantages exist between the two agents, surgeons should choose a radiopharmaceutical based on cost and side effect profile.