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 FindingsThis 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.ConclusionsUse 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.
Highlights
Head and neck squamous cell carcinoma (HNSCC) of both mucosal and cutaneous origin carries variable propensity to metastasize to regional cervical nodes
It may be argued that elective neck dissection (END) is unnecessary in a large proportion of patients; for example, 70–80 % of patients initially presenting with early-stage oral cavity carcinoma (T1 or T2, cN0) prove to be free of lymphatic metastases.[8,10,11,12]
Sentinel lymph node biopsy (SLNB) has been advocated as a less invasive means of achieving accurate diagnostic assessment of regional metastatic tumor potential while reducing morbidity compared with more extensive procedures.[9]
Summary
Head and neck squamous cell carcinoma (HNSCC) of both mucosal and cutaneous origin carries variable propensity to metastasize to regional cervical nodes. As current methods, including physical examination and radiologic imaging, lack sufficient sensitivity and specificity,[4,5] elective neck dissection (END) has been the gold standard for assessing the presence or absence of lymphatic disease in patients without overt clinical or radiographic nodal metastases (cN0) undergoing surgical management of HNSCC.[6] END is associated with significant potential morbidity, including pain, contour changes, shoulder dysfunction, and lip paresis, as well as negative impact upon quality of life.[7,8,9] it may be argued that END is unnecessary in a large proportion of patients; for example, 70–80 % of patients initially presenting with early-stage oral cavity carcinoma (T1 or T2, cN0) prove to be free of lymphatic metastases.[8,10,11,12]. The small molecular size (7 nm diameter) of tilmanocept and its specific targeting to CD206 mannose-binding receptors located on reticuloendothelial cells within lymph nodes permit rapid injection site clearance and avid, stable binding within target nodes.[19]
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