[<sup>99m</sup>Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Multi-institutional Trial

Amit Agrawal, Francisco Civantos, Kevin T. Brumund, Douglas B. Chepeha, Nathan C. Hall, William R. Carroll, Russell B. Smith, Robert P. Zitsch, Walter T. Lee, Yelizaveta Shnayder, David M. Cognetti, Karen T. Pitman, Dennis W. King, Lori A. Christman, Stephen Y. Lai

Research output: Contribution to journalArticle

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Abstract

Background: [<sup>99m</sup>Tc]Tilmanocept, a novel CD206 receptor-targeted radiopharmaceutical, was evaluated in an open-label, phase III trial to determine the false negative rate (FNR) of sentinel lymph node biopsy (SLNB) relative to the pathologic nodal status in patients with intraoral or cutaneous head and neck squamous cell carcinoma (HNSCC) undergoing tumor resection, SLNB, and planned elective neck dissection (END). Negative predictive value (NPV), overall accuracy of SLNB, and the impact of radiopharmaceutical injection timing relative to surgery were assessed. Methods and Findings: This multicenter, non-randomized, single-arm trial (ClinicalTrials.gov identifier NCT00911326) enrolled 101 patients with T1–T4, N0, and M0 HNSCC. Patients received 50 µg [<sup>99m</sup>Tc]tilmanocept radiolabeled with either 0.5 mCi (same day) or 2.0 mCi (next day), followed by lymphoscintigraphy, SLNB, and END. All excised tissues were evaluated for tissue type and tumor presence. [<sup>99m</sup>Tc]Tilmanocept identified one or more SLNs in 81 of 83 patients (97.6 %). Of 39 patients identified with any tumor-positive nodes (SLN or non-SLN), one patient had a single tumor-positive non-SLN in whom all SLNs were tumor-negative, yielding an FNR of 2.56 %; NPV was 97.8 % and overall accuracy was 98.8 %. No significant differences were observed between same-day and next-day procedures. Conclusions: Use of receptor-targeted [<sup>99m</sup>Tc]tilmanocept for lymphatic mapping allows for a high rate of SLN identification in patients with intraoral and cutaneous HNSCC. SLNB employing [<sup>99m</sup>Tc]tilmanocept accurately predicts the pathologic nodal status of intraoral HNSCC patients with low FNR, high NPV, and high overall accuracy. The use of [<sup>99m</sup>Tc]tilmanocept for SLNB in select patients may be appropriate and may obviate the need to perform more extensive procedures such as END.

Original languageEnglish (US)
Pages (from-to)3708-3715
Number of pages8
JournalAnnals of Surgical Oncology
Volume22
Issue number11
DOIs
StatePublished - Oct 15 2015

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Sentinel Lymph Node Biopsy
Pathology
Neck Dissection
Radiopharmaceuticals
Neoplasms
Lymphoscintigraphy
Carcinoma, squamous cell of head and neck
Sentinel Lymph Node
technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran
Skin
Injections

ASJC Scopus subject areas

  • Surgery
  • Oncology

Cite this

[<sup>99m</sup>Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck : Results of a Phase III Multi-institutional Trial. / Agrawal, Amit; Civantos, Francisco; Brumund, Kevin T.; Chepeha, Douglas B.; Hall, Nathan C.; Carroll, William R.; Smith, Russell B.; Zitsch, Robert P.; Lee, Walter T.; Shnayder, Yelizaveta; Cognetti, David M.; Pitman, Karen T.; King, Dennis W.; Christman, Lori A.; Lai, Stephen Y.

In: Annals of Surgical Oncology, Vol. 22, No. 11, 15.10.2015, p. 3708-3715.

Research output: Contribution to journalArticle

Agrawal, A, Civantos, F, Brumund, KT, Chepeha, DB, Hall, NC, Carroll, WR, Smith, RB, Zitsch, RP, Lee, WT, Shnayder, Y, Cognetti, DM, Pitman, KT, King, DW, Christman, LA & Lai, SY 2015, '[<sup>99m</sup>Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Multi-institutional Trial', Annals of Surgical Oncology, vol. 22, no. 11, pp. 3708-3715. https://doi.org/10.1245/s10434-015-4382-x
Agrawal, Amit ; Civantos, Francisco ; Brumund, Kevin T. ; Chepeha, Douglas B. ; Hall, Nathan C. ; Carroll, William R. ; Smith, Russell B. ; Zitsch, Robert P. ; Lee, Walter T. ; Shnayder, Yelizaveta ; Cognetti, David M. ; Pitman, Karen T. ; King, Dennis W. ; Christman, Lori A. ; Lai, Stephen Y. / [<sup>99m</sup>Tc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck : Results of a Phase III Multi-institutional Trial. In: Annals of Surgical Oncology. 2015 ; Vol. 22, No. 11. pp. 3708-3715.
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title = "[99mTc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck: Results of a Phase III Multi-institutional Trial",
abstract = "Background: [99mTc]Tilmanocept, a novel CD206 receptor-targeted radiopharmaceutical, was evaluated in an open-label, phase III trial to determine the false negative rate (FNR) of sentinel lymph node biopsy (SLNB) relative to the pathologic nodal status in patients with intraoral or cutaneous head and neck squamous cell carcinoma (HNSCC) undergoing tumor resection, SLNB, and planned elective neck dissection (END). Negative predictive value (NPV), overall accuracy of SLNB, and the impact of radiopharmaceutical injection timing relative to surgery were assessed. Methods and Findings: This multicenter, non-randomized, single-arm trial (ClinicalTrials.gov identifier NCT00911326) enrolled 101 patients with T1–T4, N0, and M0 HNSCC. Patients received 50 µg [99mTc]tilmanocept radiolabeled with either 0.5 mCi (same day) or 2.0 mCi (next day), followed by lymphoscintigraphy, SLNB, and END. All excised tissues were evaluated for tissue type and tumor presence. [99mTc]Tilmanocept identified one or more SLNs in 81 of 83 patients (97.6 {\%}). Of 39 patients identified with any tumor-positive nodes (SLN or non-SLN), one patient had a single tumor-positive non-SLN in whom all SLNs were tumor-negative, yielding an FNR of 2.56 {\%}; NPV was 97.8 {\%} and overall accuracy was 98.8 {\%}. No significant differences were observed between same-day and next-day procedures. Conclusions: Use of receptor-targeted [99mTc]tilmanocept for lymphatic mapping allows for a high rate of SLN identification in patients with intraoral and cutaneous HNSCC. SLNB employing [99mTc]tilmanocept accurately predicts the pathologic nodal status of intraoral HNSCC patients with low FNR, high NPV, and high overall accuracy. The use of [99mTc]tilmanocept for SLNB in select patients may be appropriate and may obviate the need to perform more extensive procedures such as END.",
author = "Amit Agrawal and Francisco Civantos and Brumund, {Kevin T.} and Chepeha, {Douglas B.} and Hall, {Nathan C.} and Carroll, {William R.} and Smith, {Russell B.} and Zitsch, {Robert P.} and Lee, {Walter T.} and Yelizaveta Shnayder and Cognetti, {David M.} and Pitman, {Karen T.} and King, {Dennis W.} and Christman, {Lori A.} and Lai, {Stephen Y.}",
year = "2015",
month = "10",
day = "15",
doi = "10.1245/s10434-015-4382-x",
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TY - JOUR

T1 - [99mTc]Tilmanocept Accurately Detects Sentinel Lymph Nodes and Predicts Node Pathology Status in Patients with Oral Squamous Cell Carcinoma of the Head and Neck

T2 - Results of a Phase III Multi-institutional Trial

AU - Agrawal, Amit

AU - Civantos, Francisco

AU - Brumund, Kevin T.

AU - Chepeha, Douglas B.

AU - Hall, Nathan C.

AU - Carroll, William R.

AU - Smith, Russell B.

AU - Zitsch, Robert P.

AU - Lee, Walter T.

AU - Shnayder, Yelizaveta

AU - Cognetti, David M.

AU - Pitman, Karen T.

AU - King, Dennis W.

AU - Christman, Lori A.

AU - Lai, Stephen Y.

PY - 2015/10/15

Y1 - 2015/10/15

N2 - Background: [99mTc]Tilmanocept, a novel CD206 receptor-targeted radiopharmaceutical, was evaluated in an open-label, phase III trial to determine the false negative rate (FNR) of sentinel lymph node biopsy (SLNB) relative to the pathologic nodal status in patients with intraoral or cutaneous head and neck squamous cell carcinoma (HNSCC) undergoing tumor resection, SLNB, and planned elective neck dissection (END). Negative predictive value (NPV), overall accuracy of SLNB, and the impact of radiopharmaceutical injection timing relative to surgery were assessed. Methods and Findings: This multicenter, non-randomized, single-arm trial (ClinicalTrials.gov identifier NCT00911326) enrolled 101 patients with T1–T4, N0, and M0 HNSCC. Patients received 50 µg [99mTc]tilmanocept radiolabeled with either 0.5 mCi (same day) or 2.0 mCi (next day), followed by lymphoscintigraphy, SLNB, and END. All excised tissues were evaluated for tissue type and tumor presence. [99mTc]Tilmanocept identified one or more SLNs in 81 of 83 patients (97.6 %). Of 39 patients identified with any tumor-positive nodes (SLN or non-SLN), one patient had a single tumor-positive non-SLN in whom all SLNs were tumor-negative, yielding an FNR of 2.56 %; NPV was 97.8 % and overall accuracy was 98.8 %. No significant differences were observed between same-day and next-day procedures. Conclusions: Use of receptor-targeted [99mTc]tilmanocept for lymphatic mapping allows for a high rate of SLN identification in patients with intraoral and cutaneous HNSCC. SLNB employing [99mTc]tilmanocept accurately predicts the pathologic nodal status of intraoral HNSCC patients with low FNR, high NPV, and high overall accuracy. The use of [99mTc]tilmanocept for SLNB in select patients may be appropriate and may obviate the need to perform more extensive procedures such as END.

AB - Background: [99mTc]Tilmanocept, a novel CD206 receptor-targeted radiopharmaceutical, was evaluated in an open-label, phase III trial to determine the false negative rate (FNR) of sentinel lymph node biopsy (SLNB) relative to the pathologic nodal status in patients with intraoral or cutaneous head and neck squamous cell carcinoma (HNSCC) undergoing tumor resection, SLNB, and planned elective neck dissection (END). Negative predictive value (NPV), overall accuracy of SLNB, and the impact of radiopharmaceutical injection timing relative to surgery were assessed. Methods and Findings: This multicenter, non-randomized, single-arm trial (ClinicalTrials.gov identifier NCT00911326) enrolled 101 patients with T1–T4, N0, and M0 HNSCC. Patients received 50 µg [99mTc]tilmanocept radiolabeled with either 0.5 mCi (same day) or 2.0 mCi (next day), followed by lymphoscintigraphy, SLNB, and END. All excised tissues were evaluated for tissue type and tumor presence. [99mTc]Tilmanocept identified one or more SLNs in 81 of 83 patients (97.6 %). Of 39 patients identified with any tumor-positive nodes (SLN or non-SLN), one patient had a single tumor-positive non-SLN in whom all SLNs were tumor-negative, yielding an FNR of 2.56 %; NPV was 97.8 % and overall accuracy was 98.8 %. No significant differences were observed between same-day and next-day procedures. Conclusions: Use of receptor-targeted [99mTc]tilmanocept for lymphatic mapping allows for a high rate of SLN identification in patients with intraoral and cutaneous HNSCC. SLNB employing [99mTc]tilmanocept accurately predicts the pathologic nodal status of intraoral HNSCC patients with low FNR, high NPV, and high overall accuracy. The use of [99mTc]tilmanocept for SLNB in select patients may be appropriate and may obviate the need to perform more extensive procedures such as END.

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