Phase II trial of everolimus in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma.

ABSTRACT:

Background

Patients with recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) demonstrate aberrant activation of the phosphotidylinositol-3-kinase (PI3K)/Akt/mammalian target of rapamycin (mTOR) pathway. We examined the efficacy of everolimus, an mTOR inhibitor, in patients with recurrent or metastatic HNSCC.

Methods

This single-arm phase II study enrolled biomarker-unselected patients with recurrent or metastatic HNSCC who failed at least 1 prior therapy. Everolimus was administered until progressive disease or unacceptable toxicity. Primary endpoint was clinical benefit rate (CBR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), and evaluation of tissue and serum biomarkers related to the PIK3CA pathway.

Results

Sev

SUBMITTER: Geiger JL 

PROVIDER: S-EPMC6820341 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature