Unkart Jonathan T, Hosseini Ava, Wallace Anne M
Department of Surgery, Moores Cancer Center, University of California, San Diego, California.
Department of Surgery, University of California, San Francisco, California.
J Surg Oncol. 2017 Dec;116(7):819-823. doi: 10.1002/jso.24735. Epub 2017 Jul 10.
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).
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.
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.
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.
此前尚无试验比较过锝-99m替莫西芬（TcTM）和锝-99m硫化胶体（TcSC）在乳腺癌（BC）中前哨淋巴结（SLN）识别的结果。
我们报告了一项随机、双盲、单术者的临床试验的次要结果，该试验比较了TcTM和TcSC注射后部位疼痛情况。患者被随机分组，术前在肿瘤周围皮内单次注射TcTM或TcSC。比较两组检测和切除的总淋巴结、“热”淋巴结及蓝色淋巴结数量。
52例（27例-TcSC和25例-TcTM）患者入组并接受了确定性手术治疗。所有患者均检测到至少一个“热”SLN。3例（5.8%）患者的SLN存在疾病阳性。TcSC组切除的SLN总数为61个（平均2.26个（标准差（SD）0.90）），TcTM组为54个（平均2.16个（SD 0.90）），P = 0.69。TcSC组“热”淋巴结总数为1.96个（SD 0.76），而TcTM组为2.04个（SD 0.73），P = 0.71。
TcTM和TcSC识别的SLN数量无显著差异。鉴于两种药物不存在显著的技术优势，外科医生应根据成本和副作用情况选择放射性药物。
