Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck

Jennifer E. Tseng, Bonnie S. Glisson, Fadlo R. Khuri, Dong M. Shin, Jeffrey N. Myers, Adel K. El-Naggar, Jennifer S. Roach, Lawrence E. Ginsberg, Peter F. Thall, Xuemei Wang, Stephanie Teddy, Kristie N. Lawhorn, Rebecca E. Zentgraf, Ganene D. Steinhaus, James M. Pluda, James L. Abbruzzese, Waun Ki Hong, Roy S. Herbst

Research output: Contribution to journalArticlepeer-review

Abstract

BACKGROUND. Thalidomide has been shown to have antiangiogenic effects in preclinical models as well as a significant antitumor effect in hematologic tumors such as multiple myeloma. The authors performed this Phase II study to determine the activity, toxicity profile, and antiangiogenic effect of thalidomide in patients with locoregionally recurrent or metastatic squamous cell carcinoma of the head and neck. METHODS. Twenty-one patients with recurrent or metastatic squamous cell carcinoma of the head and neck were treated with single-agent thalidomide. All patients had received radiation therapy, and most had undergone surgery (95%) and/or chemotherapy (90%). Thalidomide was initiated at 200 mgdaily and increased to a target dose of 1000 mg daily. Patients continued treatment until disease progression, unacceptable toxicity, or death occurred. RESULTS. All 21 patients eventually developed progressive disease. Median time to progression was 50 days (95% confidence interval, 28-70), with median overall survival time of 194 days (95% lower confidence boundary, 151), similar to the progression and survival times reported for this patient group with other agents. Thalidomide was generally well tolerated, with few patients experiencing Grades 3 to 4 toxicities. Serum vascular endothelial growth factor and basic fibroblast growth factor levels increased in six of seven patients, for whom paired serum samples were available and all of whom had progressive disease. CONCLUSIONS. In this heavily pretreated population of patients with advanced squamous cell carcinoma of the head and neck, thalidomide does not appear to have single-agent antitumor activity. Further evaluation of the mechanism of action of thalidomide is indicated. Potentially, future evaluations of thalidomide may be performed in combination with other antiangiogenic or cytotoxic agents in patients with earlier stage disease or in patients with minimal residual disease.

Original languageEnglish (US)
Pages (from-to)2364-2373
Number of pages10
JournalCancer
Volume92
Issue number9
DOIs
StatePublished - Nov 1 2001
Externally publishedYes

Keywords

  • Angiogenesis
  • Basic fibroblast growth factor
  • Squamous cell carcinoma of the head and neck
  • Thalidomide
  • Vascular endothelial growth factor

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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