Abstract
Background: This study assessed the maximum tolerated dose (MTD) of the PI3K inhibitor buparlisib given concurrently with cetuximab in recurrent and metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Methods: Twelve patients with R/M HNSCC were enrolled. Patients were given oral buparlisib starting day 7 and daily thereafter. The dose of buparlisib was escalated in a 3 + 3 design followed by a dose expansion cohort of 6 patients. The MTD of buparlisib per protocol was 100 mg daily with cetuximab given intravenously every 14 days starting day 0. Results: Ten patients had ≥2 previous treatment regimens (11 with prior cetuximab). There were no dose limiting toxicities observed during dose escalation. One patient achieved a partial response and 4 achieved stable disease. Conclusion: Based on this pilot study, buparlisib at 100 mg daily plus cetuximab proved to be well-tolerated. Patients previously treated with cetuximab monotherapy showed benefit from this combination.
Original language | English (US) |
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Pages (from-to) | 3842-3849 |
Number of pages | 8 |
Journal | Head and Neck |
Volume | 41 |
Issue number | 11 |
DOIs | |
State | Published - Nov 1 2019 |
Externally published | Yes |
Keywords
- PI3K inhibitor
- advanced disease
- buparlisib
- cetuximab
- head and neck squamous cell carcinoma
- metastatic disease
- recurrent disease
ASJC Scopus subject areas
- Otorhinolaryngology