Concordance of p16 status between US-guided core needle biopsy and surgical specimens in oropharyngeal squamous cell carcinoma

With the increasing prevalence of human papillomavirus (HPV)-driven oropharyngeal squamous cell carcinoma (OPSCC), there is a need for efficient, minimally invasive methods to evaluate p16 status. This study aimed to assess the concordance of p16 status between ultrasound (US)-guided core needle biopsy (CNB) of cervical lymph nodes and surgical specimens, and to describe the numbers of CNB and surgical sessions required to establish the histopathologic diagnosis. This retrospective study included 39 patients diagnosed with OPSCC or head and neck squamous cell carcinoma of unknown primary (SCCUP) at a single tertiary hospital between March 2019 and March 2024. All included patients underwent US-guided CNB of cervical lymph nodes and a surgical procedure (biopsy or resection), and had evaluable p16 immunohistochemistry (IHC) results on both specimen types. The concordance rate for p16 status between US-guided CNB and surgical specimens was 100.0% (39/39; 95% CI, 91.0–100.0%; 35 p16-positive and 4 p16-negative cases). Sensitivity was 100.0% (35/35; 95% CI, 90.0–100.0%) and specificity was 100.0% (4/4; 95% CI, 39.8–100.0%). In all 39 included patients, a diagnosis of metastatic squamous cell carcinoma and an evaluable p16 result were obtained at the first CNB session. Among the 35 patients with OPSCC, 10 (28.6%) required more than 1 surgical session at the primary tumor site. No immediate complications were observed following US-guided CNB. In this cohort, US-guided CNB of cervical lymph nodes showed complete observed concordance with surgical specimens for p16 status, and a diagnosis with an evaluable p16 result was obtained at the first CNB session in all patients. Prospective, multicenter validation including more p16-negative cases is required before wider adoption.