TY - JOUR
T1 - Phase II trial of everolimus in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma
AU - Geiger, Jessica L.
AU - Bauman, Julie E.
AU - Gibson, Michael K.
AU - Gooding, William E.
AU - Varadarajan, Prakash
AU - Kotsakis, Athanasios
AU - Martin, Daniel
AU - Gutkind, Jorge Silvio
AU - Hedberg, Matthew L.
AU - Grandis, Jennifer R.
AU - Argiris, Athanassios
N1 - Publisher Copyright:
© 2016 Wiley Periodicals, Inc.
PY - 2016/12/1
Y1 - 2016/12/1
N2 - 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.
AB - 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.
KW - PIK3CA mutations
KW - clinical trial
KW - everolimus
KW - head and neck squamous cell carcinoma (HNSCC)
KW - mammalian target of rapamycin (mTOR) inhibitors
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U2 - 10.1002/hed.24501
DO - 10.1002/hed.24501
M3 - Article
C2 - 27232378
AN - SCOPUS:84971229215
VL - 38
SP - 1759
EP - 1764
JO - Head and Neck Surgery
JF - Head and Neck Surgery
SN - 1043-3074
IS - 12
ER -