Journal Article

Comparative Evaluation of 99mTcTilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials

Povoski, Stephen P., Faries, Mark, Limmer, Karl K., Wallace, Anne M., Cox, Charles, King, Dennis W., Hoh, Carl K., Schneebaum, Schlomo, Krontiras, Helen, Frazier, Thomas G., Christman, Lori, Han, Linda K., Avisar, Eli, Vera, David R., Deck, Kenneth, Hall, Nathan C.

2013

Overview

Background Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [ 99m Tc]Tilmanocept is a novel receptor-targeted radiopharmaceutical evaluated in 2 open-label, nonrandomized, within-patient, phase 3 trials designed to assess the lymphatic mapping performance. Methods A total of 13 centers contributed 148 patients with breast cancer. Each patient received [ 99m Tc]tilmanocept and vital blue dye (VBD). Lymph nodes identified intraoperatively as radioactive and/or blue stained were excised and histologically examined. The primary endpoint, concordance (lower boundary set point at 90 %), was the proportion of nodes detected by VBD and [ 99m Tc]tilmanocept. Results A total of 13 centers contributed 148 patients who were injected with both agents. Intraoperatively, 207 of 209 nodes detected by VBD were also detected by [ 99m Tc]tilmanocept for a concordance rate of 99.04 % ( p  < 0.0001). [ 99m Tc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [ 99m Tc]Tilmanocept detected at least 1 SLN in more patients (146) than did VBD (131, p  < 0.0001). In 129 of 131 patients with ≥1 blue node, all blue nodes were radioactive. Of 33 pathology-positive nodes (18.2 % patient pathology rate), [ 99m Tc]tilmanocept detected 31 of 33, whereas VBD detected only 25 of 33 ( p  = 0.0312). No pathology-positive SLNs were detected exclusively by VBD. No serious adverse events were attributed to [ 99m Tc]tilmanocept. Conclusion [ 99m Tc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [ 99m Tc]tilmanocept was additionally noted to identify more SLNs in more patients. This localization represented a higher number of metastatic breast cancer lymph nodes than that of VBD.

• Publisher: Springer US,Springer Nature B.V
• Subject: Adult / Aged / Aged, 80 and over / Axilla / Breast Neoplasms - diagnostic imaging / Breast Neoplasms - pathology / Breast Oncology / Coloring Agents / Dextrans - adverse effects / Female / Humans / Lymph Nodes - diagnostic imaging / Lymph Nodes - pathology / Lymph Nodes - surgery / Lymphatic Metastasis / Mannans - adverse effects / Medicine / Medicine & Public Health / Middle Aged / Oncology / Radionuclide Imaging / Radiopharmaceuticals - adverse effects / Sentinel Lymph Node Biopsy - methods / Surgery / Surgical Oncology / Technetium Tc 99m Pentetate - adverse effects / Technetium Tc 99m Pentetate - analogs & derivatives