Impact of HPV-related head and neck cancer in clinical trials: opportunity to translate scientific insight into personalized care.

Patients with human papillomavirus (HPV)-positive squamous cell carcinoma of the oropharynx (SCCOP) enjoy better treatment outcomes than patients suffering from HPV-negative head and neck cancer. To maintain the integrity and utility of future clinical trials, HPV-positive SCCOP must be studied as a distinct entity. The discovery of HPV-positive disease has (1) convoluted comparison of current phase II trial data to historical controls, (2) made formal stratification for HPV infection status an imperative for future phase III trial design, and (3) drawn focus toward opportunities for personalization of treatment intensity. This review discusses these research issues.