In a Japanese noninferiority phase III trial reported in the Journal of Clinical Oncology, Hasegawa et al found noninferior survival and improved neck functionality with sentinel lymph node biopsy (SLNB)-navigated neck dissection vs elective neck dissection in patients with previously untreated early oral cavity squamous cell carcinoma.
In the multicenter trial, 271 patients with T1–2, node-negative disease, and no distant metastasis were randomly assigned between 2011 and 2016 to undergo SLNB-navigated neck dissection (SLNB group, n = 134) or elective neck dissection (ND group, n = 137) consisting of supraomohyoid ND. The primary endpoint was 3-year overall survival rate, with a 12% noninferiority margin for the SLNB vs ND group.
SLNB-navigated [neck dissection] may replace elective [neck dissection] without a survival disadvantage and reduce postoperative neck disability in patients with early-stage oral cavity squamous cell carcinoma.— Hasegawa et al
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Neck dissection was performed in 97.1% of patients in the ND group and in 39.5% of the SLNB group after one-stage or second-look surgery. Pathologic metastasis–positive nodes were observed in 33.6% of patients in the SLNB group vs 24.8% of the ND group (P = .190). Median follow-up was 37 months (interquartile range = 36–39 months).
Three-year overall survival was 87.9% (lower limit of one-sided 95% confidence interval [CI] = 82.4%) in the SLNB group vs 86.6% (lower limit of one-sided 95% CI = 80.9%), thus meeting the noninferiority criterion, with P for noninferiority of < .001. Three-year disease-free survival was 78.7% (lower limit of one-sided 95% CI = 72.1%) vs 81.3% (lower limit of one-sided 95% CI = 75.0%), with P for noninferiority of < .001.
Mean neck functionality test scores at 1, 3, 6, and 12 months after surgery were significantly better in the SLNB group vs ND group for neck stiffness (all P < .01), with similar outcomes observed for constriction, pain, numbness, shoulder drop, reach above, appearance, and arm adduction scores. Overall, postoperative complications occurred in 9.0% vs 14.6% of patients. One postoperative death due to pneumonia was observed in the SLNB group, and one due to myocardial infarction was observed in the ND group.
The investigators concluded, “SLNB-navigated [neck dissection] may replace elective [neck dissection] without a survival disadvantage and reduce postoperative neck disability in patients with early-stage oral cavity squamous cell carcinoma.”
Yasuhisa Hasegawa, MD, PhD, of Asahi University Hospital, Gifu, is the corresponding author for the Journal of Clinical Oncology article.
Disclosure: The study was supported by a grant from the Ministry of Health, Labour and Welfare in Japan. For full disclosures of the study authors, visit ascopubs.org.The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.