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2015 ; 22
(11
): 3708-15
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(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
#MMPMID25670018
Agrawal A
; Civantos FJ
; 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
Ann Surg Oncol
2015[Oct]; 22
(11
): 3708-15
PMID25670018
show ga
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.
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