Evaluation of the impact of tumor HPV status on outcome in patients with locally advanced unresectable head and neck squamous cell carcinoma (HNSCC) receiving cisplatin, 5-Fluorouracil with or without docetaxel: retrospective analysis of EORTC24971 study

6061 Background: EORTC 24971 was phase III trial demonstrating superiority of induction regimen TPF over PF, in terms of progression-free (PFS) and overall survival (OS) in locally advanced unresectable HNSCC. We conducted prospective-retrospective analysis with the aim to evaluate whether only HPV negative patients(pts) derive benefit from adding docetaxel to PF, in which case de-intensifying induction treatment in HPV+ patients could be considered. Methods: HNSCC specimens were collected from 1999 until 2002. Pre-therapy tumor biopsies (blocks or slides) were assessed for high risk (HR) HPV by p16 immunohistochemistry, PCR and quantitative PCR (qPCR). HPV DNA+ and/or p16+ tumors were subjected to in situ hybridization (ISH) and HPV E6/7 oncogene expression analysis by quantitative reverse transcriptase. The primary and secondary objectives were to evaluate the value of HPV/p16 status as predictive factor of treatment benefit in terms of PFS and OS, respectively. The predictive effect was analyzed based ...