© 1992 by Oxford University Press
Journal of the National Cancer Institute, Vol. 84, No. 18, 1432-1437,
September 16, 1992
© 1992 Oxford University Press
Treatment of Recurrent Gliomas With Eflornithine
Department of Neuro-oncology. The University of Texas M.D. Anderson Cancer Center Houston
Brain Tumour Research Center, University of California School of Medicine San Francisco
*Correspondence to: Victor A. Levin, M.D., Department of Neuro-oncology, Box 100, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030.
Background: Oral eflornithine in combination with intravenous mitoguazone (methylbisguanylhydrazone) has grown activity against recurrent anaplastic glimas. Eflornithine alone, however, has not been evaluated against recurrent gliomas. Purpose: This study compared the antitumour activity of oral eflonithine with that of oral eflornithine combined with intravenous mitoguazone in the treatment of patients with recurrent or progressive glioblastoma multiforme as well as nonglioblastoma anaplastic gliomas. Methods: During the 1st year of therapy with eflornithine alone, the drug was given at a dose of 3.6 g/m2 on days 1–14, 22–35, and 43–56 every 8 hours; cycles were repeated every 63 days until progression. For the 2nd year, the drug was given on days 1–14, 29–42, and 57–70, with 84 days between cycles. For the 1st and 2nd years of eflornithine-mitoguzone therapy. the same schedule. Mitoguazone was given intravenously at 200 mg/m2 on the final day of each 2-week sequence of eflornithine therapy. Response was determined by evaluating changes in the size of contrast-enhanced neuroimages. Results: Because of two cases of lethalhepatic necrosis, the initial random allocation of patients in the eflornithine-mitoguazone arm was stopped after 23 patients and been accrued. Nineety-eight patients were entered in the eflornithine arm; 80 patients (36 glioblastoma multiforme patients and 44 anaplastic glioma patients) were assessable for response. Antitumour activity (partial response, minor response, and stable disease) was seen in 45%of the patients with anaplastic glionmas, for a median of 49 weeks, but in only 17% of patients with glioblastona multiforme (median not attained). Twenty-one (20% of the patients with anaplastic glioma and 33% of the patients with glioblastoma multiforme were removed from the study before completing the first 8-week course of therapy because of neurological deterioration and tumour progression by the 5th week of treatment. Conclusion: This study suggests that efloranithine alone is an effective palliative therapy for recurrent anaplastic gliomas. Additional studies are needed to confirm our finding. (J Natl Cancer Inst 84: 1432– 1437, 1992)
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