Prognostic Immune Biomarkers in HNSCC

University Hospital Ostrava

Status: Completed

Conditions: Squamous Cell Carcinoma; Head and Neck Cancer

Treatments: Diagnostic Test: Tumour immunoprofile evaluation

Study type: Observational

Funder types: Other

Identifiers

NCT05941676

RVO-FNOs/2021 (Other Grant/Funding Number)

ONKOL-01-Head and neck

Details and patient eligibility

About

Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck

Full description

The role of the immune system in the process of tumor growth and progression in head and neck (HaN) cancer has become of increasing importance. In the last years, the concept of tumor immune microenvironment (TIME) with the presence of tumor cells (TC) and infiltrating immune cells (IC) has been intensively studied. The results of available clinical studies suggest a positive impact of tumor-infiltrating lymphocytes (TILs) on the prognosis of HNSCC patients and their overall (OS) and cancer specific survivals. Beside TILs, an integral component of TIME is the immunosuppressive activity represented by inhibitory signalling molecules expressed on tumor cells (TCs) and immune cells (ICs).

One of these molecules is programmed death-ligand 1 (PD-L1), which inhibits the cytotoxic immune response mediated by T-lymphocytes.

The aim of this observational cohort study is to assess the prognostic potential of novel immune biomarkers in patients with HNSCC tumors stage I-IVb treated with radical radiotherapy and radiochemotherapy. Specifically, the association between high and low TILs infiltration and OS and cancer specific survival parameters will be investigated. As well as the association between high and low PD-L1 expression and OS and cancer specific survival parameters will be investigated.

This is a non-interventional study conducted in one institution - Department of oncology, University hospital Ostrava. The tumor immunoprofile defined by the presence of immune biomarkers (TIL, PD-L1) will be evaluated in each patient from biopsy specimens in representative hematoxylin and eosin stained sections by immuno-histochemistry. The Cox proportional risk model will be used to estimate the prognostic potential of each of the biomarker.

Enrollment: 55 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with non-metastatic squamous-cell head and neck cancer (HNSCC) stage I-IVb indicated for curative/radical treatment
• Histologically verified squamous cell carcinoma including HPV-positive carcinomas
• Tumor site: oropharynx, larynx, hypopharynx, oral cavity, nasal cavity
• Treatment modality - radiotherapy or radiochemotherapy
• Presence of immune biomarkers in the tissue - tumor-infiltrating lymphocytes (TILs) and/or PD-L1 expression
• Sufficient data on patient follow-up

Exclusion criteria

• Histological type other than squamous cell carcinoma
• Paranasal sinus tumors, thyroid and nasopharyngeal carcinomas, salivary gland tumors, mucosal melanoma, skin carcinoma, lymphomas, and occult primary tumors
• Synchronous malignancies or recurrent disease
• The previous use of radiotherapy
• The presence of distant metastatic disease
• Missing or inadequate follow-up data
• The inability to evaluate biomarkers (TILs or PD-L1) in a histological tissue sample.

Trial design

55 participants in 1 patient group

Head and neck carcinoma patients

Description:

Head and neck carcinoma patients will be enrolled in this study group.

Treatment:

Diagnostic Test: Tumour immunoprofile evaluation