Immunohistochemistry for p16 and p53 Provides Substantial Agreement With Molecular Tests in Penile Cancer.

A key negative prognostic marker is TP53 mutation.

Analyzing invasive SCC from 209 patients, we assessed concordance between p16 immunohistochemistry and HPV status (n = 132) determined by quantitative PCR, obtaining Cohen's kappa Κ = 0.62 (p < 0.0001).

For p53 immunohistochemistry versus TP53 status by NGS (n = 145), Cohen's kappa reached Κ = 0.693 (p < 0.0001).

Both HPV status and p53 profile can be reliably assessed by immunohistochemistry with substantial agreement.