Phase II trial of 13-cis-retinoic acid plus interferon-α in recurrent head and neck cancer

Narin Voravud, Scott M. Lippman, Randal S. Weber, Gladys I. Rodriquez, Douglas Yee, Isaiah W. Dimery, Charles L. Earley, Daniel D. Von Hoff, Waun Ki Hong

Research output: Contribution to journalArticlepeer-review

29 Scopus citations

Abstract

13-cis-retinoic acid (isotretinoin) and interferon-α have limited activity as single agents in advanced cancer. Preclinical data indicate that these agents have different mechanisms of action and, in combination have greater activity (that is, the ability to modulate growth and differentiation) in a number of malignant cell types than either agent alone. In clinical trials, the new biological regimen of 13-cis-retinoic acid and interferon-α was shown to have major activity in advanced squamous cell carcinoma of the skin and cervix. We conducted a phase II trial of this regimen in recurrent squamous cell carcinoma of the head and neck. Of the 21 evaluable patients, none had a complete response, and only one had a partial response (5%). Two patients had minor responses, four had stable disease, and 14 experienced disease progression. Five patients developed grade 3 toxic effects, including skin toxicity, fatigue, headache, and anorexia/weight loss. The median survival duration was 25.5 weeks (range, 4-95). The combination of 13-cis- retinoic acid and interferon-α at this dose and schedule is ineffective for the treatment of recurrent squamous cell carcinoma of the head and neck.

Original languageEnglish (US)
Pages (from-to)57-60
Number of pages4
JournalInvestigational New Drugs
Volume11
Issue number1
DOIs
StatePublished - Feb 1 1993

Keywords

  • head and neck neoplasms
  • interferon-α
  • retinoic acid

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