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

Jessica L. Geiger, Julie E. Bauman, Michael K. Gibson, William E. Gooding, Prakash Varadarajan, Athanasios Kotsakis, Daniel Martin, Jorge Silvio Gutkind, Matthew L. Hedberg, Jennifer R. Grandis, Athanassios Argiris

Research output: Contribution to journalArticle

25 Scopus citations

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: 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.

Original languageEnglish (US)
Pages (from-to)1759-1764
Number of pages6
JournalHead and Neck
Volume38
Issue number12
DOIs
StatePublished - Dec 1 2016

Keywords

  • PIK3CA mutations
  • clinical trial
  • everolimus
  • head and neck squamous cell carcinoma (HNSCC)
  • mammalian target of rapamycin (mTOR) inhibitors

ASJC Scopus subject areas

  • Otorhinolaryngology

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  • Cite this

    Geiger, J. L., Bauman, J. E., Gibson, M. K., Gooding, W. E., Varadarajan, P., Kotsakis, A., Martin, D., Gutkind, J. S., Hedberg, M. L., Grandis, J. R., & Argiris, A. (2016). Phase II trial of everolimus in patients with previously treated recurrent or metastatic head and neck squamous cell carcinoma. Head and Neck, 38(12), 1759-1764. https://doi.org/10.1002/hed.24501