Agrawal Amit, Civantos Francisco J, 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
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.
Department of Otolaryngology, University of Miami Hospital and Clinics/Sylvester Comprehensive Cancer Center, Miami, FL, USA.
Ann Surg Oncol. 2015 Oct;22(11):3708-15. doi: 10.1245/s10434-015-4382-x. Epub 2015 Feb 11.
[(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.
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.
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.
[(99m)Tc]替莫西肽是一种新型的靶向CD206受体的放射性药物，在一项开放标签的III期试验中进行了评估，以确定在接受肿瘤切除、前哨淋巴结活检（SLNB）和计划选择性颈清扫术（END）的口腔或皮肤头颈鳞状细胞癌（HNSCC）患者中，前哨淋巴结活检相对于病理淋巴结状态的假阴性率（FNR）。评估了阴性预测值（NPV）、SLNB的总体准确性以及放射性药物注射时间相对于手术的影响。
这项多中心、非随机、单臂试验（ClinicalTrials.gov标识符NCT00911326）纳入了101例T1-T4、N0和M0期的HNSCC患者。患者接受50μg用0.5mCi（同一天）或2.0mCi（第二天）标记的[(99m)Tc]替莫西肽，随后进行淋巴闪烁显像、SLNB和END。对所有切除的组织进行组织类型和肿瘤存在情况的评估。[(99m)Tc]替莫西肽在83例患者中的81例（97.6%）中识别出一个或多个前哨淋巴结。在39例被确定有任何肿瘤阳性淋巴结（前哨淋巴结或非前哨淋巴结）的患者中，有1例患者有一个单一的肿瘤阳性非前哨淋巴结，而所有前哨淋巴结均为肿瘤阴性，FNR为2.56%；NPV为97.8%，总体准确性为98.8%。同一天和第二天的操作之间未观察到显著差异。
使用靶向受体的[(99m)Tc]替莫西肽进行淋巴绘图可使口腔和皮肤HNSCC患者的前哨淋巴结识别率很高。采用[(99m)Tc]替莫西肽的SLNB能够准确预测口腔HNSCC患者的病理淋巴结状态，FNR低、NPV高且总体准确性高。在选定的患者中使用[(99m)Tc]替莫西肽进行SLNB可能是合适的，并且可能无需进行更广泛的手术，如END。
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