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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.
- 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.)
- Subjects :
- Aged
Drug Therapy, Combination
Female
Head and Neck Neoplasms mortality
Head and Neck Neoplasms pathology
Humans
Male
Middle Aged
Neoplasm Recurrence, Local mortality
Neoplasm Recurrence, Local pathology
Pilot Projects
Squamous Cell Carcinoma of Head and Neck mortality
Squamous Cell Carcinoma of Head and Neck pathology
Treatment Outcome
Aminopyridines administration & dosage
Antineoplastic Agents, Immunological administration & dosage
Cetuximab administration & dosage
Head and Neck Neoplasms drug therapy
Morpholines administration & dosage
Neoplasm Recurrence, Local drug therapy
Squamous Cell Carcinoma of Head and Neck drug therapy
Subjects
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