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Phase II trial of everolimus in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma
Author(s) -
Geiger Jessica L.,
Bauman Julie E.,
Gibson Michael K.,
Gooding William E.,
Varadarajan Prakash,
Kotsakis Athanasios,
Martin Daniel,
Gutkind Jorge Silvio,
Hedberg Matthew L.,
Grandis Jennifer R.,
Argiris Athanassios
Publication year - 2016
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.24501
Subject(s) - everolimus , medicine , head and neck squamous cell carcinoma , clinical endpoint , oncology , pi3k/akt/mtor pathway , phases of clinical research , toxicity , head and neck cancer , clinical trial , radiation therapy , biology , signal transduction , biochemistry
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 Seven of 9 patients treated in the first stage were evaluable. No objective responses were seen; CBR was 28%. Three patients discontinued everolimus because of toxicity. Median PFS and OS were 1.5 and 4.5 months, respectively. No activating PI3K mutations were identified in available tumor tissue. Conclusion Everolimus was not active as monotherapy in unselected patients with recurrent/metastatic HNSCC. © 2016 Wiley Periodicals, Inc. Head Neck 38: 1759–1764, 2016