Fresh or archived pretreatment tumor specimens were obtained after the last therapy and before trial entry from 90.6% of the patients. For patients with oropharyngeal cancer, tumor HPV status, assessed by means of p16 immunohistochemical testing, was required to be documented by local or central analysis and was defined as positive if diffuse staining was present in at least 70% of the tumor cells.15 (link) Immunochemical testing for p16 was not performed for nonoropharyngeal cancers because of the low prevalence of HPV-positive tumors and poor specificity for HPV status at these anatomical sites.16 Tumor PD-L1 membrane expression was evaluated centrally by means of immunohistochemical testing (Dako North America) with the use of a rabbit antihuman PD-L1 antibody (clone 28–8, Epitomics) and was scored at prespecified expression levels, including levels of 1% or more, 5% or more, and 10% or more in a minimum of 100 tumor cells that could be evaluated.17
Protocol detail
Comprehensive Biomarker Profiling in Cancer Trials
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Anatomical sites
Antibody
Cancers
Cells
Clone
Membrane
Oropharyngeal cancer
Patients
Pd l1
Rabbit
Therapy
Tumor
Corresponding Organization :
Other organizations : Cancer Institute (WIA), University of Pittsburgh Medical Center, The University of Texas MD Anderson Cancer Center, Centre Léon Bérard, Centre Antoine Lacassagne, Cancer Prevention Institute of California, Fondazione IRCCS Istituto Nazionale dei Tumori, National Institute for Health Research, Essen University Hospital, University of Chicago, Institut Gustave Roussy, University of Michigan–Ann Arbor, Emory University, Hospital Universitario 12 De Octubre, Dana-Farber Cancer Institute, University Hospital of Zurich, Kobe University Hospital, National Cancer Center Hospital East, Bristol-Myers Squibb (United States), The Ohio State University
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Variable analysis
independent variables
- Tumor HPV status, assessed by means of p16 immunohistochemical testing
- Tumor PD-L1 membrane expression, evaluated centrally by means of immunohistochemical testing
- Not explicitly mentioned
- Fresh or archived pretreatment tumor specimens were obtained after the last therapy and before trial entry from 90.6% of the patients
- For patients with oropharyngeal cancer, tumor HPV status was required to be documented by local or central analysis and was defined as positive if diffuse staining was present in at least 70% of the tumor cells
- Immunochemical testing for p16 was not performed for nonoropharyngeal cancers because of the low prevalence of HPV-positive tumors and poor specificity for HPV status at these anatomical sites
- Tumor PD-L1 membrane expression was scored at prespecified expression levels, including levels of 1% or more, 5% or more, and 10% or more in a minimum of 100 tumor cells that could be evaluated
- Positive control: Not mentioned
- Negative control: Not mentioned
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