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A multicenter, randomized controlled phase III trial was conducted on sentinel lymph node biopsy (SLNB) and elective neck dissection for T1 (depth of invasion ≥ 4 mm)-T2N0M0 oral cavity squamous cell carcinoma. This study identified factors associated with poor prognosis in patients who underwent SLNB based on a subgroup analysis of this trial. We analyzed 418 sentinel lymph nodes (SLNs) from 132 patients who underwent SLNB. The metastatic SLNs were classified into three categories based on size—isolated tumor cells: <0.2 mm, micrometastasis: ≥0.2 mm and < 2 mm, and macrometastasis: ≥2 mm. Three groups were formed based on the number of metastatic SLNs: no metastasis, 1 metastatic node, and ≥ 2 metastatic nodes. The size and number of metastatic SLNs on survival was evaluated using Cox proportional hazard models. Patients with macrometastasis and ≥ 2 metastatic SLNs had worse overall survival (OS) and disease-free survival (DFS) after adjustment for potential confounders (HR for OS: macrometastasis, 4.85; 95% CI: 1.34–17.60; ≥2 metastatic SLN, 3.63; 95% CI: 1.02–12.89; HR for DFS: macrometastasis, 2.94; 95% CI: 1.16–7.44; ≥2 metastatic SLN, 2.97; 95% CI: 1.18–7.51). In patients who underwent SLNB, a poorer prognosis was associated with macrometastasis or having ≥ 2 metastatic SLNs.

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