Kouki Miura1, Hitoshi Hirakawa2, Hirokazu Uemura3, Seiichi Yoshimoto4, Akihiro Shiotani5, Masashi Sugasawa6, Akihiro Homma7, Junkichi Yokoyama8, Kiyoaki Tsukahara9, Tomokazu Yoshizaki10, Yasushi Yatabe11, Keitaro Matsuo12, Yasuo Ohkura13, Shigeru Kosuda14, Yasuhisa Hasegawa15. 1. Department of Head and Neck Oncology and Surgery, International University of Health and Welfare, Mita Hospital, Tokyo 108-8329, Japan. 2. 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. 3. Department of Otolaryngology-Head and Neck Surgery, Nara Medical University, Kashihara 634-8521, Japan. 4. Department of Head and Neck Oncology, National Cancer Center Hospital, Tokyo 104-0045, Japan. 5. Department of Otolaryngology-Head and Neck Surgery, National Defense Medical College, Tokorozawa 359-8513, Japan. 6. Department of Head and Neck Surgery, Saitama Medical University International Medical Center, Saitama 350-1298, Japan. 7. Department of Otolaryngology, Head and Neck Surgery, Hokkaido University Graduate School of Medicine, Sapporo 060-8638, Japan. 8. Department of Otolaryngology, Head and Neck Surgery, Moriyama Memorial Hospital, Tokyo 134-0088, Japan. 9. Department of Otolaryngology - Head and Neck Surgery, Tokyo Medical University Hospital, Tokyo 160-0022, Japan. 10. Division of Otolaryngology, Head and Neck Surgery, Graduate School of Medical Science, Kanazawa University 920-0942, Kanazawa, Japan. 11. Department of Pathology and Molecular Diagnostics, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan. 12. Division of Molecular Medicine, Aichi Cancer Center Research Institute, Nagoya 464-8681, Japan. 13. Department of Pathology, Kyorin University School of Medicine, Tokyo 181-8612, Japan. 14. Department of Diagnostic Radiology and Nuclear Medicine, Gunma University School of Medicine, Maebashi 371-8511, Japan. 15. Department of Head and Neck Surgery, Aichi Cancer Center Hospital, Nagoya 464-8681, Japan. Electronic address: hasegawa@aichi-cc.jp.
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). CONCLUSION: 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.
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). CONCLUSION: 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.