Comparative evaluation of [99mTc]tilmanocept for sentinel lymph node mapping in breast cancer patients

Results of two phase 3 trials

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

Research output: Contribution to journalArticle

57 Citations (Scopus)

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.

Original languageEnglish
Pages (from-to)2590-2599
Number of pages10
JournalAnnals of Surgical Oncology
Volume20
Issue number8
DOIs
StatePublished - Aug 1 2013

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Breast Neoplasms
Coloring Agents
Pathology
Lymph Nodes
technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran
Sentinel Lymph Node
Radiopharmaceuticals
Lymph Node Excision

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

Comparative evaluation of [99mTc]tilmanocept for sentinel lymph node mapping in breast cancer patients : Results of two phase 3 trials. / Wallace, Anne M.; Han, Linda K.; Povoski, Stephen P.; Deck, Kenneth; Schneebaum, Schlomo; Hall, Nathan C.; Hoh, Carl K.; Limmer, Karl K.; Krontiras, Helen; Frazier, Thomas G.; Cox, Charles; Avisar, Eli; Faries, Mark; King, Dennis W.; Christman, Lori; Vera, David R.

In: Annals of Surgical Oncology, Vol. 20, No. 8, 01.08.2013, p. 2590-2599.

Research output: Contribution to journalArticle

Wallace, AM, Han, LK, Povoski, SP, Deck, K, Schneebaum, S, Hall, NC, Hoh, CK, Limmer, KK, Krontiras, H, Frazier, TG, Cox, C, Avisar, E, Faries, M, King, DW, Christman, L & Vera, DR 2013, 'Comparative evaluation of [99mTc]tilmanocept for sentinel lymph node mapping in breast cancer patients: Results of two phase 3 trials', Annals of Surgical Oncology, vol. 20, no. 8, pp. 2590-2599. https://doi.org/10.1245/s10434-013-2887-8
Wallace, Anne M. ; Han, Linda K. ; Povoski, Stephen P. ; Deck, Kenneth ; Schneebaum, Schlomo ; Hall, Nathan C. ; Hoh, Carl K. ; Limmer, Karl K. ; Krontiras, Helen ; Frazier, Thomas G. ; Cox, Charles ; Avisar, Eli ; Faries, Mark ; King, Dennis W. ; Christman, Lori ; Vera, David R. / Comparative evaluation of [99mTc]tilmanocept for sentinel lymph node mapping in breast cancer patients : Results of two phase 3 trials. In: Annals of Surgical Oncology. 2013 ; Vol. 20, No. 8. pp. 2590-2599.
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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.",
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T1 - Comparative evaluation of [99mTc]tilmanocept for sentinel lymph node mapping in breast cancer patients

T2 - Results of two phase 3 trials

AU - Wallace, Anne M.

AU - Han, Linda K.

AU - Povoski, Stephen P.

AU - Deck, Kenneth

AU - Schneebaum, Schlomo

AU - Hall, Nathan C.

AU - Hoh, Carl K.

AU - Limmer, Karl K.

AU - Krontiras, Helen

AU - Frazier, Thomas G.

AU - Cox, Charles

AU - Avisar, Eli

AU - Faries, Mark

AU - King, Dennis W.

AU - Christman, Lori

AU - Vera, David R.

PY - 2013/8/1

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N2 - 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.

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