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Phase I/II study of cisplatin, 5-fluorouracil and α-interferon for recurrent carcinoma of the head and neck

  • Phase II Studies
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Summary

Current chemotherapy regimens have failed to demonstrate a significant impact on the overall survival of patients with recurrent head and neck cancer; therefore, new agents or combinations of agents are necessary to improve outcome. Alpha-interferon potentiates the activity in vitro of both agents of one of the most active regimens currently available, cisplatin and 5-fluorouracil. The purpose of the current study was to evaluate the feasibility and efficacy in patients with recurrent head and neck cancer of adding α-interferon to cisplatin 14 mg/m2 daily and 5-fluorouracil 700 mg/m2 daily for 5 days. No significant toxicity occurred with α-interferon at dose level 0,1 × 106 units/m2 daily for five days. Of four patients treated at dose level +1, α-interferon 3 × 106 units/m2, two developed prolonged grade III neutropenic following the fourth course. One of three patients developed grade IV thrombocytopenia and 6 of 13 courses at this dose level resulted in grade III neutropenia. A phase II study was performed in 19 patients with cisplatin 17 mg/m2/ day, 5-fluoruracil 700 mg/m2/day and a-interferon 3 × 106 units/m2/day. During the phase II study grade III neutropenia occurred in 6 patients and grade IV neutropenia in another patient during at least one course. Grade III and IV thrombocytopenia occurred in one patient each during the phase II study. Overall, major responses occurred in 7 or 23 patients (30%): 5 in phase I and 2 in phase II.

In conclusion, the addition of α-interferon to cisplatin and 5-fluorouracil is feasible, but does not appear to increase response rates in recurrent head and neck cancer.

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Authors and Affiliations

  1. Department of Thoracic/Head & Neck Medical Oncology, The University of Texas, M.D. Anderson Cancer Center, Houston, Texas, USA

    Martin H. Huber, Mihran Shirinian, Scott M. Lippman, Isaiah W. Dimery & Waun Ki Hong

  2. Department of Head and Neck Surgery, The University of Texas, M.D. Anderson Cancer Center, Houston, Texas, USA

    Robert A. Frankenthaler

Authors
  1. Martin H. Huber
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  2. Mihran Shirinian
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  3. Scott M. Lippman
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  4. Isaiah W. Dimery
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  5. Robert A. Frankenthaler
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  6. Waun Ki Hong
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Huber, M.H., Shirinian, M., Lippman, S.M. et al. Phase I/II study of cisplatin, 5-fluorouracil and α-interferon for recurrent carcinoma of the head and neck. Invest New Drugs 12, 223–229 (1994). https://doi.org/10.1007/BF00873963

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