A pilot study of the pan-class I PI3K inhibitor buparlisib in combination with cetuximab in patients with recurrent or metastatic head and neck cancer

Ryan J. Brisson, Sara Kochanny, Saba Arshad, Allison Dekker, Jonas A. DeSouza, Vassiliki Saloura, Everett E. Vokes, Tanguy Y. Seiwert

Research output: Contribution to journalArticlepeer-review

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 languageEnglish (US)
Pages (from-to)3842-3849
Number of pages8
JournalHead and Neck
Volume41
Issue number11
DOIs
StatePublished - Nov 1 2019
Externally publishedYes

Keywords

  • PI3K inhibitor
  • advanced disease
  • buparlisib
  • cetuximab
  • head and neck squamous cell carcinoma
  • metastatic disease
  • recurrent disease

ASJC Scopus subject areas

  • Otorhinolaryngology

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