title: Sentinel node biopsy for oral cancer: A prospective multicenter Phase II trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  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.
authors: Department of Head and Neck Oncology and Surgery, International University of Health and Welfare, Mita Hospital, Tokyo 108-8329, Japan.
authors: Kouki
authors: K
authors: Miura
authors: 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.
authors: Hitoshi
authors: H
authors: Hirakawa
authors: Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara 634-8521, Japan.
authors: Hirokazu
authors: H
authors: Uemura
authors: Department of Head and Neck Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan.
authors: Seiichi
authors: S
authors: Yoshimoto
authors: Department of Otolaryngology-Head and Neck Surgery, National Defense Medical College, Tokorozawa 359-8513, Japan.
authors: Akihiro
authors: A
authors: Shiotani
authors: Department of Head and Neck Surgery, Saitama Medical University International Medical Center, Saitama 350-1298, Japan.
authors: Masashi
authors: M
authors: Sugasawa
authors: Department of Otolaryngology, Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Sapporo 060-8638, Japan.
authors: Akihiro
authors: A
authors: Homma
authors: Department of Otolaryngology, Head and Neck Surgery, Moriyama Memorial Hospital, Tokyo 134-0088, Japan.
authors: Junkichi
authors: J
authors: Yokoyama
authors: Department of Otolaryngology - Head and Neck Surgery, Tokyo Medical University Hospital, Tokyo 160-0022, Japan.
authors: Kiyoaki
authors: K
authors: Tsukahara
authors: Division of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Science, Kanazawa University 920-0942, Kanazawa, Japan.
authors: Tomokazu
authors: T
authors: Yoshizaki
authors: Department of Pathology and Molecular Diagnostics, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan.
authors: Yasushi
authors: Y
authors: Yatabe
authors: Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya 464-8681, Japan.
authors: Keitaro
authors: K
authors: Matsuo
authors: Department of Pathology, Kyorin University School of Medicine, Tokyo 181-8612, Japan.
authors: Yasuo
authors: Y
authors: Ohkura
authors: Department of Diagnostic Radiology and Nuclear Medicine, Gunma University School of Medicine, Maebashi 371-8511, Japan.
authors: Shigeru
authors: S
authors: Kosuda
authors: Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan. Electronic address: hasegawa@aichi-cc.jp.
authors: Yasuhisa
authors: Y
authors: Hasegawa
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002294:Carcinoma, Squamous Cell / Q000473:pathology* / Q000628:therapy; D018572:Disease-Free Survival; D005188:False Negative Reactions; D005240:Feasibility Studies; D005260:Female; D005629:Frozen Sections; D006258:Head and Neck Neoplasms / Q000473:pathology* / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D009062:Mouth Neoplasms / Q000473:pathology* / Q000628:therapy; D037981:Neck Dissection / Q000379:methods*; D009367:Neoplasm Staging; D013517:Otorhinolaryngologic Surgical Procedures / Q000379:methods*; D011446:Prospective Studies; D018714:Radiotherapy, Adjuvant; D021701:Sentinel Lymph Node Biopsy / Q000379:methods*; D000077195:Squamous Cell Carcinoma of Head and Neck
keywords: Metastasis; Neck dissection; Oral cancer; Sentinel lymph node biopsy