Phase II trial of sorafenib in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or nasopharyngeal carcinoma

Christine Elser, Lillian L. Siu, Eric Winquist, Mark Agulnik, Gregory R. Pond, Soo F. Chin, Peggy Francis, Robin Cheiken, James Elting, Angela McNabola, Dean Wilkie, Oana Petrenciuc, Eric X. Chen*

*Corresponding author for this work

Research output: Contribution to journalArticle

175 Scopus citations

Abstract

Purpose: To determine the efficacy and safety of single-agent sorafenib in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) and nasopharyngeal carcinoma (NPC). Patients and Methods: In this single-arm phase II trial, oral continuous sorafenib was administered in 28-day cycles. Patients had ≤ one line of chemotherapy for recurrent and/or metastatic disease, Eastern Cooperative Oncology Group performance status of ≤ 2, and adequate organ function. At the end of stage 1, efficacy criteria for further accrual were not met, but the study was amended to enroll an additional five patients for paired tumor biopsies. Results: Twenty-seven and 26 patients were eligible for toxicity and efficacy evaluations, respectively. One patient (3.7%; 95% CI, 0.1% to 19.0%) achieved a partial response. Disease stabilization was maintained in 10 patients (37.0%; 95% CI, 22.4% to 61.2%). The median time to progression was 1.8 months (95% CI, 1.6 to 3.4 months), and median overall survival time was 4.2 months (95% CI, 3.6 to 8.7 months). Sorafenib was well tolerated with few grade 3 and no grade 4 toxicities. Biomarker analysis of paired tumor samples before and after treatment with sorafenib revealed a decrease of pERK in all five patients, with a decrease in Ki67 in four patients, consistent with a disruption of ERK signaling. The antiapoptotic protein Mcl-1 was downregulated in four patients, and there was also evidence of antiangiogenic activity. Conclusion: Sorafenib was well tolerated and had modest anticancer activity comparable to monotherapy with other targeted agents in this group of patients. Further development in combination with radiation or other agents may be warranted.

Original languageEnglish (US)
Pages (from-to)3766-3773
Number of pages8
JournalJournal of Clinical Oncology
Volume25
Issue number24
DOIs
StatePublished - Aug 20 2007

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Elser, C., Siu, L. L., Winquist, E., Agulnik, M., Pond, G. R., Chin, S. F., Francis, P., Cheiken, R., Elting, J., McNabola, A., Wilkie, D., Petrenciuc, O., & Chen, E. X. (2007). Phase II trial of sorafenib in patients with recurrent or metastatic squamous cell carcinoma of the head and neck or nasopharyngeal carcinoma. Journal of Clinical Oncology, 25(24), 3766-3773. https://doi.org/10.1200/JCO.2006.10.2871