Breast Oncology

Annals of Surgical Oncology

, Volume 20, Issue 8, pp 2590-2599

Open Access This content is freely available online to anyone, anywhere at any time.

Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials

  • Anne M. WallaceAffiliated withDivisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of California Email author 
  • , Linda K. HanAffiliated withDepartment of Surgery, Indiana University Simon Breast Center
  • , Stephen P. PovoskiAffiliated withDepartment of Surgery, Wexner Medical Center of the Ohio State University
  • , Kenneth DeckAffiliated withDepartment of Surgery, South Orange County Medical
  • , Schlomo SchneebaumAffiliated withDepartment of Surgery, Sourasky Medical Center
  • , Nathan C. HallAffiliated withDivision of Nuclear Medicine, Wexner Medical Center of the Ohio State University
  • , Carl K. HohAffiliated withDivision of Nuclear Medicine, UCSD Moores Cancer Center, and the UCSD In Vivo Cancer & Molecular Imaging Program, University of California, San Diego
  • , Karl K. LimmerAffiliated withDepartment of Surgery, The UCSD Moores Cancer Center, University of California, San Diego
  • , Helen KrontirasAffiliated withDepartment of Surgery, University of Alabama
    • , Thomas G. FrazierAffiliated withDivisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of CaliforniaDepartment of Surgery, Bryn Mawr Hospital
    • , Charles CoxAffiliated withDivisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of CaliforniaDepartment of Surgery, University of South Florida
    • , Eli AvisarAffiliated withDivisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of CaliforniaDepartment of Surgery, University of Miami Hospital
    • , Mark FariesAffiliated withDivisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of CaliforniaDepartment of Surgery and Melanoma Research Program, John Wayne Cancer Institute
    • , Dennis W. KingAffiliated withDivisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of CaliforniaSTATKING Clinical Services
    • , Lori ChristmanAffiliated withDivisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of CaliforniaSTATKING Clinical Services
    • , David R. VeraAffiliated withDivision of Nuclear Medicine, UCSD Moores Cancer Center, and the UCSD In Vivo Cancer & Molecular Imaging Program, University of California, San Diego

Abstract

Background

Sentinel lymph node (SLN) surgery is used worldwide for staging breast cancer patients and helps limit axillary lymph node dissection. [99mTc]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 [99mTc]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 [99mTc]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 [99mTc]tilmanocept for a concordance rate of 99.04 % (p < 0.0001). [99mTc]tilmanocept detected a total of 320 nodes, of which 207 (64.7 %) were detected by VBD. [99mTc]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), [99mTc]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 [99mTc]tilmanocept.

Conclusion

[99mTc]Tilmanocept demonstrated success in detecting a SLN while meeting the primary endpoint. Interestingly, [99mTc]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.