title: Comparative evaluation of [(99m)tc]tilmanocept for sentinel lymph node mapping in breast cancer patients: results of two phase 3 trials.
abstract: 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.
  
  
  CONCLUSIONS
  [(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.
authors.affiliation: Divisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA. amwallace@ucsd.edu
authors.forename: Anne M
authors.initials: AM
authors.lastname: Wallace
authors.forename: Linda K
authors.initials: LK
authors.lastname: Han
authors.forename: Stephen P
authors.initials: SP
authors.lastname: Povoski
authors.forename: Kenneth
authors.initials: K
authors.lastname: Deck
authors.forename: Schlomo
authors.initials: S
authors.lastname: Schneebaum
authors.forename: Nathan C
authors.initials: NC
authors.lastname: Hall
authors.forename: Carl K
authors.initials: CK
authors.lastname: Hoh
authors.forename: Karl K
authors.initials: KK
authors.lastname: Limmer
authors.forename: Helen
authors.initials: H
authors.lastname: Krontiras
authors.forename: Thomas G
authors.initials: TG
authors.lastname: Frazier
authors.forename: Charles
authors.initials: C
authors.lastname: Cox
authors.forename: Eli
authors.initials: E
authors.lastname: Avisar
authors.forename: Mark
authors.initials: M
authors.lastname: Faries
authors.forename: Dennis W
authors.initials: DW
authors.lastname: King
authors.forename: Lori
authors.initials: L
authors.lastname: Christman
authors.forename: David R
authors.initials: DR
authors.lastname: Vera
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001365:Axilla; D001943:Breast Neoplasms / Q000000981:diagnostic imaging* / Q000473:pathology*; D004396:Coloring Agents; D003911:Dextrans / Q000009:adverse effects; D005260:Female; D006801:Humans; D008198:Lymph Nodes / Q000000981:diagnostic imaging* / Q000473:pathology / Q000601:surgery; D008207:Lymphatic Metastasis; D008351:Mannans / Q000009:adverse effects; D008875:Middle Aged; D011877:Radionuclide Imaging; D019275:Radiopharmaceuticals / Q000009:adverse effects; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D016284:Technetium Tc 99m Pentetate / Q000009:adverse effects / Q000031:analogs & derivatives*
chemical_list: D004396:Coloring Agents; D003911:Dextrans; D008351:Mannans; D019275:Radiopharmaceuticals; C431884:technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran; D016284:Technetium Tc 99m Pentetate