Clinical trial NCT05941676: Prognostic Immune Biomarkers in HNSCC
Official title: Evaluation of the Prognostic Potential of New Immune Biomarkers in Non-metastatic Squamous Cell Carcinoma of the Head and Neck
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Squamous Cell Carcinoma
Keywords: immune biomarkers
tumor-infiltrating lymphocytes
PD-L1 (programmed death ligand-1) expression
prognosis
head and neck cancer
head and neck squamous cell carcinoma (HNSCC)
radiotherapy
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2023-07-12
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stage I-IVb HNSCC indicated for radical treatment - radiotherapy or radiochemotherapy

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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival (OS)
timeFrame: 24 months
Secondary outcomes:
measure: Disease-specific survival (DSS)
timeFrame: 24 months
measure: Disease-free survival (DFS)
timeFrame: 24 months
measure: Locoregional-free survival (LRFS)
timeFrame: 24 months
measure: Distant metastatic-free survival (DMFS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
References:
citation: Blazek T, Petras M, Knybel L, Cvek J, Soumarova R. Programmed Cell Death Ligand 1 Expression on Immune Cells and Survival in Patients With Nonmetastatic Head and Neck Cancer: A Systematic Review and Meta-analysis. JAMA Netw Open. 2023 Mar 1;6(3):e236324. doi: 10.1001/jamanetworkopen.2023.6324.