SUPREME-HN: a retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
SUPREME-HN: a retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.
- 2019
Available online through MWHC library: 2003 - present
BACKGROUND: Programmed cell death ligand-1 (PD-L1) expression on tumor cells (TCs) is associated with improved survival in patients with head and neck squamous cell carcinoma (HNSCC) treated with immunotherapy, although its role as a prognostic factor is controversial. This study investigates whether tumoral expression of PD-L1 is a prognostic marker in patients with recurrent and/or metastatic (R/M) HNSCC treated with standard chemotherapy. CONCLUSIONS: PD-L1 expression, assessed using the VENTANA PD-L1 (SP263) Assay, was not prognostic of OS in patients with R/M HNSCC treated with standard of care chemotherapies. Trial registration ClinicalTrials.gov, NCT02543476. Registered September 4, 2015. METHODS: This retrospective, multicenter, noninterventional study assessed PD-L1 expression on archival R/M HNSCC tissue samples using the VENTANA PD-L1 (SP263) Assay. PD-L1 high was defined as PD-L1 staining of >= 25% TC, with exploratory scoring at TC >= 10% and TC >= 50%. The primary objective of this study was to estimate the prognostic value of PD-L1 status in terms of overall survival (OS) in patients with R/M HNSCC. RESULTS: 412 patients (median age, 62.0 years; 79.9% male; 88.2% Caucasian) were included from 19 sites in seven countries. 132 patients (32.0%) had TC >= 25% PD-L1 expression; 199 patients (48.3%) and 85 patients (20.6%) had TC >= 10% and >= 50%, respectively. OS did not differ significantly across PD-L1 expression (at TC >= 25% cutoff median OS: 8.2 months vs TC < 25%, 10.1 months, P = 0.55) or the >= 10% and >= 50% cutoffs (at TC >= 10%, median OS: 9.6 months vs TC < 10%, 9.4 months, P = 0.32, and at TC >= 50%, median OS 7.9 vs TC < 50%, 10.0 months, P = 0.39, respectively).
English
1479-5876
10.1186/s12967-019-02182-1 [doi] 10.1186/s12967-019-02182-1 [pii] PMC6933901 [pmc]
*B7-H1 Antigen/me [Metabolism]
*Biomarkers, Tumor/me [Metabolism]
*Neoplasm Recurrence, Local/me [Metabolism]
*Squamous Cell Carcinoma of Head and Neck/me [Metabolism]
*Squamous Cell Carcinoma of Head and Neck/pa [Pathology]
Adult
Aged
Aged, 80 and over
Disease-Free Survival
Female
Humans
Male
Middle Aged
Multivariate Analysis
Neoplasm Metastasis
Prognosis
Retrospective Studies
Risk Factors
Treatment Outcome
MedStar Health Research Institute
Journal Article
Available online through MWHC library: 2003 - present
BACKGROUND: Programmed cell death ligand-1 (PD-L1) expression on tumor cells (TCs) is associated with improved survival in patients with head and neck squamous cell carcinoma (HNSCC) treated with immunotherapy, although its role as a prognostic factor is controversial. This study investigates whether tumoral expression of PD-L1 is a prognostic marker in patients with recurrent and/or metastatic (R/M) HNSCC treated with standard chemotherapy. CONCLUSIONS: PD-L1 expression, assessed using the VENTANA PD-L1 (SP263) Assay, was not prognostic of OS in patients with R/M HNSCC treated with standard of care chemotherapies. Trial registration ClinicalTrials.gov, NCT02543476. Registered September 4, 2015. METHODS: This retrospective, multicenter, noninterventional study assessed PD-L1 expression on archival R/M HNSCC tissue samples using the VENTANA PD-L1 (SP263) Assay. PD-L1 high was defined as PD-L1 staining of >= 25% TC, with exploratory scoring at TC >= 10% and TC >= 50%. The primary objective of this study was to estimate the prognostic value of PD-L1 status in terms of overall survival (OS) in patients with R/M HNSCC. RESULTS: 412 patients (median age, 62.0 years; 79.9% male; 88.2% Caucasian) were included from 19 sites in seven countries. 132 patients (32.0%) had TC >= 25% PD-L1 expression; 199 patients (48.3%) and 85 patients (20.6%) had TC >= 10% and >= 50%, respectively. OS did not differ significantly across PD-L1 expression (at TC >= 25% cutoff median OS: 8.2 months vs TC < 25%, 10.1 months, P = 0.55) or the >= 10% and >= 50% cutoffs (at TC >= 10%, median OS: 9.6 months vs TC < 10%, 9.4 months, P = 0.32, and at TC >= 50%, median OS 7.9 vs TC < 50%, 10.0 months, P = 0.39, respectively).
English
1479-5876
10.1186/s12967-019-02182-1 [doi] 10.1186/s12967-019-02182-1 [pii] PMC6933901 [pmc]
*B7-H1 Antigen/me [Metabolism]
*Biomarkers, Tumor/me [Metabolism]
*Neoplasm Recurrence, Local/me [Metabolism]
*Squamous Cell Carcinoma of Head and Neck/me [Metabolism]
*Squamous Cell Carcinoma of Head and Neck/pa [Pathology]
Adult
Aged
Aged, 80 and over
Disease-Free Survival
Female
Humans
Male
Middle Aged
Multivariate Analysis
Neoplasm Metastasis
Prognosis
Retrospective Studies
Risk Factors
Treatment Outcome
MedStar Health Research Institute
Journal Article