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| ID | Type | Description | Link |
|---|---|---|---|
| RVO-FNOs/2021 | Other Grant/Funding Number | University Hospital Ostrava |
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Evaluation of the prognostic potential of tumor-infiltrating lymphocytes and PD-L1 expression in non-metastatic squamous cell carcinoma of the head and neck
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Head and neck carcinoma patients | Head and neck carcinoma patients will be enrolled in this study group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumour immunoprofile evaluation | Diagnostic Test | Tumour immunoprofile evaluation will be performed in patients with head and neck cancer. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival measured in months - calculated from the date of initiation of radiotherapy to the date of death from any cause or the date of the last follow-up visit. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-specific survival (DSS) | Disease-specific survival calculated from the date of initiation of radiotherapy to the date of cancer death, or date of the last follow-up visit. Patients who died from causes other than HNSCC are censored at the time of death. | 24 months |
| Disease-free survival (DFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage I-IVb HNSCC indicated for radical treatment - radiotherapy or radiochemotherapy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Ostrava | Ostrava | Moravian-Silesian Region | 70852 | Czechia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37000447 | Result | 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. | |
| 38638854 | Derived |
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There is no plan to make individual participant data available to other researchers.
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D002294 | Carcinoma, Squamous Cell |
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
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Biopsy specimen from the primary tumour in head and neck, before curative radiotherapy/radiochemotherapy
Disease-free survival calculated from the date of initiation of radiotherapy to the date of detection of any recurrence, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence are censored at the last follow-up contact. |
| 24 months |
| Locoregional-free survival (LRFS) | Locoregional-free survival calculated from the date of initiation of radiotherapy to the date of detection of clinical, radiological and/or pathological evidence of recurrence or tumor progression at the primary site or in the regional nodal area, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence are censored at the last follow-up contact. | 24 months |
| Distant metastatic-free survival (DMFS) | Distant metastatic-free survival calculated from the date of initiation of radiotherapy to the date of detection of distant metastasis of the tumor, or date of death from any cause or date of the last follow-up visit. Patients without tumor recurrence were censored at the last follow-up contact. | 24 months |
| Blazek T, Petras M, Hurnik P, Matousek P, Knybel L, Cermakova ZZ, Stembirek J, Cvek J, Soumarova R. High PD-L1 expression on immune cells along with increased density of tumor-infiltrating lymphocytes predicts a favorable survival outcome for patients with loco-regionally advanced head and neck cancer: early results from a prospective study. Front Oncol. 2024 Apr 4;14:1346793. doi: 10.3389/fonc.2024.1346793. eCollection 2024. |
| D009370 |
| Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |