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.
Study Details
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
Tweet this quote
Key Findings
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.
