Miura Kouki, Hirakawa Hitoshi, Uemura Hirokazu, Yoshimoto Seiichi, Shiotani Akihiro, Sugasawa Masashi, Homma Akihiro, Yokoyama Junkichi, Tsukahara Kiyoaki, Yoshizaki Tomokazu, Yatabe Yasushi, Matsuo Keitaro, Ohkura Yasuo, Kosuda Shigeru, Hasegawa Yasuhisa
Department of Head and Neck Oncology and Surgery, International University of Health and Welfare, Mita Hospital, Tokyo 108-8329, Japan.
Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan; Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, University of the Ryukyus, 903-0213 Okinawa, Japan.
Auris Nasus Larynx. 2017 Jun;44(3):319-326. doi: 10.1016/j.anl.2016.07.008. Epub 2016 Aug 3.
A recent study identified a survival benefit with prophylactic neck dissection (ND) at the time of primary surgery as compared with watchful waiting followed by therapeutic neck dissection for nodal relapse, in patients with cN0 oral squamous cell carcinoma (OSCC). Alternative management of cN0 neck cancer is recommended to minimize the adverse effects of ND, indicating the need for sentinel node biopsy (SNB) and limited neck dissection. We conducted a multicenter Phase II study to examine the feasibility of SNB for clinically N0 OSCC.
Previously untreated N0 OSCC patients (n=57) with clinical late-T2 or T3 tumors were enrolled across 10 institutions. SNB navigated with multislice frozen section analysis of sentinel nodes (SNs) and SNB supported sentinel node lymphatic basin dissection (SN basin dissection) were performed in a one-stage procedure. The endpoint was to investigate the rate of false-negative metastases after SN basin dissection and SNB alone.
Most tumors were late-T2 lesions (n=50; 87.7%). SNs were identified in all patients. A total of 196 SNs were detected. Among these SNs, 35 (17.8%) were positive for metastasis (9 in level I, 12 in level II, 12 in level III, 1 in level V and 2 in the contralateral region of the neck). The false-negative rate of SNB supported by SN basin dissection and SNB alone was 4.5% and 9.1%, respectively. The concordance of the SN status in intraoperative frozen sections with the permanent histopathology was 97.4% (191/196). The sensitivity and specificity of intraoperative pathological evaluation were 85.7% (30/35) and 100% (30/30), respectively. The 3-year overall survival (OS) and disease-free survival was 89.5% and 82.5%, respectively. The OS of SN-negative patients was significantly longer than that of SN-positive patients (P=0.047).
The current study verified that SN basin dissection was a useful back-up procedure for SNB performed as a one-stage procedure, showing a low false-negative rate. SNB alone is an appropriate staging method for patients with clinical N0 staging, and a reliable procedure to determine the appropriate levels for neck dissection.
最近一项研究表明，对于cN0期口腔鳞状细胞癌（OSCC）患者，与观察等待后对淋巴结复发进行治疗性颈清扫术相比，在初次手术时进行预防性颈清扫术（ND）具有生存获益。建议对cN0期颈部癌采用替代管理方法，以尽量减少ND的不良反应，这表明需要进行前哨淋巴结活检（SNB）和有限性颈清扫术。我们开展了一项多中心II期研究，以检验SNB用于临床N0期OSCC的可行性。
10家机构纳入了57例先前未接受治疗、临床分期为晚期T2或T3肿瘤的N0期OSCC患者。通过对前哨淋巴结（SN）进行多层冰冻切片分析引导的SNB以及支持前哨淋巴结淋巴引流区清扫术（SN淋巴引流区清扫术）的SNB均在一期手术中进行。终点是调查SN淋巴引流区清扫术和单独SNB术后假阴性转移率。
大多数肿瘤为晚期T2病变（n = 50；87.7%）。所有患者均识别出SN。共检测到196枚SN。在这些SN中，35枚（17.8%）有转移阳性（I区9枚，II区12枚，III区12枚，V区1枚，颈部对侧区域2枚）。由SN淋巴引流区清扫术支持的SNB和单独SNB的假阴性率分别为4.5%和9.1%。术中冰冻切片的SN状态与永久组织病理学的一致性为97.4%（191/196）。术中病理评估的敏感性和特异性分别为85.7%（30/35）和100%（30/30）。3年总生存率（OS）和无病生存率分别为89.5%和82.5%。SN阴性患者的OS显著长于SN阳性患者（P = 0.047）。
本研究证实，SN淋巴引流区清扫术是作为一期手术进行的SNB的一种有用的备用程序，假阴性率较低。单独SNB是临床N0分期患者的一种合适的分期方法，也是确定颈清扫术合适区域的可靠程序。
