Yasuhisa Hasegawa1, Kiyoaki Tsukahara2, Seiichi Yoshimoto3, Kouki Miura4, Junkichi Yokoyama5, Shigeru Hirano6, Hirokazu Uemura7, Masashi Sugasawa8, Tomokazu Yoshizaki9, Akihiro Homma10, Kazuaki Chikamatsu11, Mikio Suzuki12, Akihiro Shiotani13, Takashi Matsuzuka1,14, Naoyuki Kohno15, Masakazu Miyazaki16, Isao Oze17, Keitaro Matsuo17, Shigeru Kosuda18, Yasushi Yatabe3. 1. Asahi University Hospital, Gifu, Japan. 2. Tokyo Medical University, Tokyo, Japan. 3. National Cancer Center Hospital, Tokyo, Japan. 4. International University of Health and Welfare, Mita Hospital, Tokyo, Japan. 5. Nadogaya Hospital, Kashiwa, Japan. 6. Kyoto Prefectural University of Medicine, Kyoto, Japan. 7. Nara Medical University, Nara, Japan. 8. Saitama Medical University International Medical Center, Hidaka, Japan. 9. Graduate School of Medical Science, Kanazawa University, Kanazawa, Japan. 10. Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan. 11. Gunma University School of Medicine, Maebashi, Japan. 12. University of the Ryukyus Faculty of Medicine, Okinawa, Japan. 13. National Defense Medical College, Tokorozawa, Japan. 14. Fukushima Medical University, Fukushima, Japan. 15. Kyorin University School of Medicine, Mitaka, Japan. 16. National Cancer Center Hospital East, Kashiwa, Japan. 17. Aichi Cancer Center Research Institute, Nagoya, Japan. 18. Kouseikai General Clinic and Hospital, Kawagoe, Japan.
Abstract
PURPOSE: This study aimed to compare patients with early oral cavity squamous cell carcinoma (OCSCC) (tumor category [T] 1-2, node-negative, and no distant metastasis) treated with traditional elective neck dissection (ND) with those managed by sentinel lymph node biopsy (SLNB) using survival and neck function and complications as end points. METHODS: Sixteen institutions in Japan participated in the study (trial registration number: UMIN000006510). Patients of age ≥ 18 years with histologically confirmed, previously untreated OCSCC (Union for International Cancer Control TNM Classification of Malignant Tumors 7th edition T1-2, node-negative no distant metastasis), with ≥ 4 mm (T1) depth of invasion, were randomly assigned to undergo standard selective ND (ND group; n = 137) or SLNB-navigated ND (SLNB group; n = 134). The primary end point was the 3-year overall survival rate, with a 12% noninferiority margin; secondary end points included postoperative neck functionality and complications and 3-year disease-free survival. Sentinel lymph nodes underwent intraoperative multislice frozen section analyses for the diagnosis. Patients with positive sentinel lymph nodes underwent either one-stage or second-look ND. RESULTS: Pathologic metastasis-positive nodes were observed in 24.8% (34 of 137) and 33.6% (46 of 134) of patients in the ND and SLNB groups, respectively (P = .190). The 3-year overall survival in the SLNB group (87.9%; lower limit of one-sided 95% CI, 82.4) was noninferior to that in the ND group (86.6%; lower limit 95% CI, 80.9; P for noninferiority < .001). The 3-year disease-free survival rate was 78.7% (lower limit 95% CI, 72.1) and 81.3% (75.0) in the SLNB and ND groups, respectively (P for noninferiority < .001). The scores of neck functionality in the SLNB group were significantly better than those in the ND group. CONCLUSION: SLNB-navigated ND may replace elective ND without a survival disadvantage and reduce postoperative neck disability in patients with early-stage OCSCC.
PURPOSE: This study aimed to compare patients with early oral cavity squamous cell carcinoma (OCSCC) (tumor category [T] 1-2, node-negative, and no distant metastasis) treated with traditional elective neck dissection (ND) with those managed by sentinel lymph node biopsy (SLNB) using survival and neck function and complications as end points. METHODS: Sixteen institutions in Japan participated in the study (trial registration number: UMIN000006510). Patients of age ≥ 18 years with histologically confirmed, previously untreated OCSCC (Union for International Cancer Control TNM Classification of Malignant Tumors 7th edition T1-2, node-negative no distant metastasis), with ≥ 4 mm (T1) depth of invasion, were randomly assigned to undergo standard selective ND (ND group; n = 137) or SLNB-navigated ND (SLNB group; n = 134). The primary end point was the 3-year overall survival rate, with a 12% noninferiority margin; secondary end points included postoperative neck functionality and complications and 3-year disease-free survival. Sentinel lymph nodes underwent intraoperative multislice frozen section analyses for the diagnosis. Patients with positive sentinel lymph nodes underwent either one-stage or second-look ND. RESULTS: Pathologic metastasis-positive nodes were observed in 24.8% (34 of 137) and 33.6% (46 of 134) of patients in the ND and SLNB groups, respectively (P = .190). The 3-year overall survival in the SLNB group (87.9%; lower limit of one-sided 95% CI, 82.4) was noninferior to that in the ND group (86.6%; lower limit 95% CI, 80.9; P for noninferiority < .001). The 3-year disease-free survival rate was 78.7% (lower limit 95% CI, 72.1) and 81.3% (75.0) in the SLNB and ND groups, respectively (P for noninferiority < .001). The scores of neck functionality in the SLNB group were significantly better than those in the ND group. CONCLUSION: SLNB-navigated ND may replace elective ND without a survival disadvantage and reduce postoperative neck disability in patients with early-stage OCSCC.
Authors: Olof Nilsson; Johan Knutsson; Fredrik J Landström; Anders Magnuson; Mathias von Beckerath Journal: Laryngoscope Investig Otolaryngol Date: 2022-08-24
Authors: Rutger Mahieu; Dominique N V Donders; Jan Willem Dankbaar; Remco de Bree; Bart de Keizer Journal: J Clin Med Date: 2022-08-31 Impact factor: 4.964