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

Publication ,  Journal Article
Tseng, JE; Glisson, BS; Khuri, FR; Shin, DM; Myers, JN; El-Naggar, AK; Roach, JS; Ginsberg, LE; Thall, PF; Wang, X; Teddy, S; Lawhorn, KN ...
Published in: Cancer
November 1, 2001

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 mg;3>daily 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.

Duke Scholars

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

November 1, 2001

Volume

92

Issue

9

Start / End Page

2364 / 2373

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thalidomide
  • Survival Analysis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Humans
  • Head and Neck Neoplasms
  • Female
 

Citation

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Tseng, J. E., Glisson, B. S., Khuri, F. R., Shin, D. M., Myers, J. N., El-Naggar, A. K., … Herbst, R. S. (2001). Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck. Cancer, 92(9), 2364–2373. https://doi.org/10.1002/1097-0142(20011101)92:9<2364::aid-cncr1584>3.0.co;2-p
Tseng, J. E., B. S. Glisson, F. R. Khuri, D. M. Shin, J. N. Myers, A. K. El-Naggar, J. S. Roach, et al. “Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck.Cancer 92, no. 9 (November 1, 2001): 2364–73. https://doi.org/10.1002/1097-0142(20011101)92:9<2364::aid-cncr1584>3.0.co;2-p.
Tseng JE, Glisson BS, Khuri FR, Shin DM, Myers JN, El-Naggar AK, et al. Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck. Cancer. 2001 Nov 1;92(9):2364–73.
Tseng, J. E., et al. “Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck.Cancer, vol. 92, no. 9, Nov. 2001, pp. 2364–73. Pubmed, doi:10.1002/1097-0142(20011101)92:9<2364::aid-cncr1584>3.0.co;2-p.
Tseng JE, Glisson BS, Khuri FR, Shin DM, Myers JN, El-Naggar AK, Roach JS, Ginsberg LE, Thall PF, Wang X, Teddy S, Lawhorn KN, Zentgraf RE, Steinhaus GD, Pluda JM, Abbruzzese JL, Hong WK, Herbst RS. Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck. Cancer. 2001 Nov 1;92(9):2364–2373.
Journal cover image

Published In

Cancer

DOI

ISSN

0008-543X

Publication Date

November 1, 2001

Volume

92

Issue

9

Start / End Page

2364 / 2373

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Thalidomide
  • Survival Analysis
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Humans
  • Head and Neck Neoplasms
  • Female