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Treatment of advanced squamous cell carcinoma of the head and neck with isotretinoin: a phase II randomized trial

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Summary

Retinoids, the analogs of vitamin A, are active in vitro and in vivo against squamous cell carcinoma in animals and against certain epithelial precancers and cancers in humans. These data led us to design a prospective, multi-institutional, randomized phase II trial of isotretinoin in advanced head and neck squamous cell carcinoma. We randomly assigned 40 patients to receive isotretinoin or methotrexate, the best-studied and most active single agent for this disease. Overall, the study patients had extremely poor prognoses, i.e., low performance statuses and recurring disease after surgery and/or irradiation. Three objective responses (16%), including one complete response, occurred in the 19 evaluable isotretinoin-treated patients. Only one minor response (5%) occurred in the methotrexate-treated group. Toxicity occurred with both drugs, but was manageable and never life threatening in the retinoid group. These results and the established activity of retinoids in oral leukoplakia (a precursor of head and neck cancer) indicate the need for further study of this class of drugs in head and neck cancer.

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Author information

Author notes

  1. John F. Kassler

    Present address: David Grant Medical Center (USAF), Travis AFB, CA, USA

Authors and Affiliations

  1. The Sections of Hematology and Medical Oncology, The University of Arizona Cancer Center, USA

    Scott M. Lippman, John F. Kassler, David S. Alberts, Lois Loescher & Frank L. Meyskens Jr.

  2. Medical Oncology, Wayne State University, USA

    Muhyi Al-Sarraf

  3. Department of Clinical Research, Hoffmann-LaRoche, Nutley, NJ, USA

    Loretta M. Itri

  4. Department of Surgery, University of Texas, San Antonio, USA

    Douglas Mattox

  5. Department of Medicine, University of Texas, San Antonio, USA

    Daniel D. Von Hoff

  6. Department of Otolaryngology, Head and Neck Surgery, The Johns Hopkins Hospital, Baltimore, MD, USA

    Douglas Mattox

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  1. Scott M. Lippman
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  9. Frank L. Meyskens Jr.
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Lippman, S.M., Kassler, J.F., Al-Sarraf, M. et al. Treatment of advanced squamous cell carcinoma of the head and neck with isotretinoin: a phase II randomized trial. Invest New Drugs 6, 51–56 (1988). https://doi.org/10.1007/BF00170781

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