Stolyarov V.I., Agakina Yu.S., Samoilova S.I., Sukortseva N.S., Reshetov I.V. Retrospective analysis of the impact of p16 protein expression on drug-induced pathomorphosis in patients with squamous cell carcinoma of the head and neck. Head and neck. Russian Journal. 2023;11(2):31–37 The authors are responsible for the originality of the data presented and the possibility of publishing illustrative material – tables, drawings, photographs of patients.


Treatment of squamous cell carcinoma of the head and neck represents one of the most significant challenges in modern oncology. These tumors require coordinated multidisciplinary work of highly qualified specialists and cutting-edge technologies to achieve a positive outcome.
In recent years, it has become clear that head and neck tumors can be divided into two large etiological groups: tumors associated with the human papillomavirus (HPV) infection and tumors with a “classic” etiology associated with smoking, age, alcohol consumption, and other oncogenic factors. A tumor is considered HPV-associated if the expression of p16 is determined in the tumor tissue. According to available data, HPV-associated tumors are more sensitive to systemic treatment and have a more favorable prognosis. 

Aim. To assess the impact of p16 expression on drug-induced pathomorphosis (DIP) in head and neck squamous cell carcinoma (HNSCC) and their impact on relapse-free (RFS) and overall survival (OS).
Material and methods. The study included 45 patients with HNSCC who underwent complex treatment in the Department of Combined Treatment Methods at the University Clinical Hospital No. 1 of the Sechenov First Moscow State Medical University from 2016 to 2018. The expression of p16 was assessed by IHC, the grade of drug-induced pathomorphosis was assessed using the G.A. Lavnikova scale. All patients underwent induction chemotherapy according to the TPF scheme (docetaxel+cisplatin+5-fluorouracil) and, depending on the clinical stage, either surgical treatment followed by radiation therapy or radiation therapy alone. 

Results. For high-grade DIP, median RFS reached 30.2 months (95% CI 25.5–34.9), and for low-grade DIP, median RFS was 17.3 months (95% CI 10.1–24.5), p=0.007. Three-year OS was also assessed for low-grade (I–II) and high-grade (III–IV) DIP. For grade I–II DIP, 3-y OS was 51%, the mean survival time was 24.6±3.1 months (95% CI 18.4–30.8), for grade III–IV DIP, 3-y OS was 82%, the mean time was 31.7±2.0 months (95% CI 27.7–35.8), p=0.051. For p16+ tumors, three-year OS was 83%, the mean survival time was 32.0±1.9 months (95% CI 28.2–35.9), for p16- tumors, OS was 53%, the mean survival time was 25.1±2.8 months (95% CI 19.6–30.6), p=0.038. Expression of p16 correlated with the tumor DIP grade (p=0.043). Out of 20 patients with grade IV DIP, 14 (73.7%) had p16+ status. Conclusions. Expression of p16 is a predictor of pathologic complete response to systemic treatment and a high- grade drug-induced pathomorphosis, which are associated with a better prognosis. 

Ключевые слова: head and neck squamous cell carcinoma, human papillomavirus, HPV-associated cancer, drug-induced pathomorphosis, TPF protocol 

Conflicts of interest. The authors have no conflicts of interest to declare.
Funding. There was no funding for this study

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