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Ann Surg Oncol. 2015 Oct;22(11):3708-15. doi: 10.1245/s10434-015-4382-x. Epub 2015 Feb 11.

[(99m)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.

Author information

1
Department of Otolaryngology-Head and Neck Surgery, Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, The Ohio State University Wexner Medical Center, Columbus, OH, USA. amit.agrawal@osumc.edu.
2
Department of Otolaryngology, University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center, Miami, FL, USA.
3
Division of Head and Neck Surgery, Department of Surgery, Moores UCSD Cancer Center and Veteran Affairs San Diego Medical Center, San Diego, CA, USA.
4
Department of Otolaryngology, University of Toronto, Toronto, ON, Canada.
5
Division of Nuclear Medicine, Department of Radiology, The Ohio State University Wexner Medical Center, Columbus, OH, USA.
6
Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, University of Alabama at Birmingham, Birmingham, AL, USA.
7
Department of Otolaryngology-Head and Neck Surgery, University of Nebraska Medical Center, Omaha, NE, USA.
8
Department of Otolaryngology-Head and Neck Surgery, University of Missouri, Columbia, MO, USA.
9
Division of Otolaryngology-Head and Neck Surgery, Department of Surgery, Duke University Medical Center, Durham, NC, USA.
10
Department of Otolaryngology-Head and Neck Surgery, University of Kansas Medical Center, Kansas City, KS, USA.
11
Department of Otolaryngology-Head and Neck Surgery, Thomas Jefferson University, Philadelphia, PA, USA.
12
Banner MD Anderson Cancer Specialists, Gilbert, AZ, USA.
13
STATKING Clinical Services, Fairfield, OH, USA.
14
Department of Head and Neck Surgery, The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Abstract

BACKGROUND:

[(99m)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 [(99m)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. [(99m)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 [(99m)Tc]tilmanocept for lymphatic mapping allows for a high rate of SLN identification in patients with intraoral and cutaneous HNSCC. SLNB employing [(99m)Tc]tilmanocept accurately predicts the pathologic nodal status of intraoral HNSCC patients with low FNR, high NPV, and high overall accuracy. The use of [(99m)Tc]tilmanocept for SLNB in select patients may be appropriate and may obviate the need to perform more extensive procedures such as END.

PMID:
25670018
PMCID:
PMC4565859
DOI:
10.1245/s10434-015-4382-x
[Indexed for MEDLINE]
Free PMC Article

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