Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials
- Anne M. Wallace MD,
- Linda K. Han MD,
- Stephen P. Povoski MD,
- Kenneth Deck MD,
- Schlomo Schneebaum MD,
- Nathan C. Hall MD, PhD,
- Carl K. Hoh MD,
- Karl K. Limmer MD,
- Helen Krontiras MD,
- Thomas G. Frazier MD,
- Charles Cox MD,
- Eli Avisar,
- Mark Faries MD,
- Dennis W. King PhD,
- Lori Christman PhD,
- David R. Vera PhD
- … show all 16 hide
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.
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.
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.
[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.
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- Comparative Evaluation of [99mTc]Tilmanocept for Sentinel Lymph Node Mapping in Breast Cancer Patients: Results of Two Phase 3 Trials
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Annals of Surgical Oncology
Volume 20, Issue 8 , pp 2590-2599
- Cover Date
- Print ISSN
- Online ISSN
- Springer US
- Additional Links
- Industry Sectors
- Anne M. Wallace MD (1)
- Linda K. Han MD (2)
- Stephen P. Povoski MD (3)
- Kenneth Deck MD (4)
- Schlomo Schneebaum MD (5)
- Nathan C. Hall MD, PhD (6)
- Carl K. Hoh MD (7)
- Karl K. Limmer MD (8)
- Helen Krontiras MD (9)
- Thomas G. Frazier MD (10)
- Charles Cox MD (11)
- Eli Avisar (12)
- Mark Faries MD (13)
- Dennis W. King PhD (14)
- Lori Christman PhD (14)
- David R. Vera PhD (7)
- Author Affiliations
- 1. Divisions of Surgical Oncology and Plastic Surgery, UCSD Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA
- 2. Department of Surgery, Indiana University Simon Breast Center, Indianapolis, IN, USA
- 3. Department of Surgery, Wexner Medical Center of the Ohio State University, Columbus, OH, USA
- 4. Department of Surgery, South Orange County Medical, Laguna Hills, CA, USA
- 5. Department of Surgery, Sourasky Medical Center, Tel Aviv, Israel
- 6. Division of Nuclear Medicine, Wexner Medical Center of the Ohio State University, Columbus, OH, USA
- 7. Division of Nuclear Medicine, UCSD Moores Cancer Center, and the UCSD In Vivo Cancer & Molecular Imaging Program, University of California, San Diego, La Jolla, CA, USA
- 8. Department of Surgery, The UCSD Moores Cancer Center, University of California, San Diego, La Jolla, CA, USA
- 9. Department of Surgery, University of Alabama, Birmingham, AL, USA
- 10. Department of Surgery, Bryn Mawr Hospital, Bryn Mawr, PA, USA
- 11. Department of Surgery, University of South Florida, Tampa, FL, USA
- 12. Department of Surgery, University of Miami Hospital, Miami, FL, USA
- 13. Department of Surgery and Melanoma Research Program, John Wayne Cancer Institute, Santa Monica, CA, USA
- 14. STATKING Clinical Services, Fairfield, CA, USA