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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.

Authors :
Brisson RJ
Kochanny S
Arshad S
Dekker A
DeSouza JA
Saloura V
Vokes EE
Seiwert TY
Source :
Head & neck [Head Neck] 2019 Nov; Vol. 41 (11), pp. 3842-3849. Date of Electronic Publication: 2019 Sep 04.
Publication Year :
2019

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).<br />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.<br />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.<br />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.<br /> (© 2019 Wiley Periodicals, Inc.)

Details

Language :
English
ISSN :
1097-0347
Volume :
41
Issue :
11
Database :
MEDLINE
Journal :
Head & neck
Publication Type :
Academic Journal
Accession number :
31486207
Full Text :
https://doi.org/10.1002/hed.25910