A Phase Ib Study of Cetuximab and BYL719 (Alpelisib) Concurrent with Intensity-Modulated Radiation Therapy in Stage III-IVB Head and Neck Squamous Cell Carcinoma

This is a single-institution phase I study that evaluated the addition of BYL719, an α-specific PI3K inhibitor, to cetuximab and intensity-modulated radiation therapy (IMRT) in patients with stage III-IVB head and neck squamous cell carcinoma. The recommended phase II dose of BYL719 was found to be 250 mg/day in combination with cetuximab and IMRT. Related grade> 3 adverse events included decreased lymphocyte count, oral mucositis, dysphagia, hyperglycemia, maculopapular rash, and palmar-plantar erythrodysesthesia syndrome.

Source: International Journal of Radiation Oncology * Biology * Physics - October 30, 2019 Category: Radiology Authors: Lara A. Dunn, Nadeem Riaz, Matthew G. Fury, Sean M. McBride, Loren Michel, Nancy Y. Lee, Eric J. Sherman, Shrujal S. Baxi, Sofia S. Haque, Nora Katabi, Richard J. Wong, Han Xiao, Alan L. Ho, David G. Pfister Source Type: research