Published in Cancer Detection and Prevention 2000; 24(Supplement 1).

Phase I/II study of thyroid supression and high dose tamoxifen in recurrent high grade glioma -- survival significantly prolonged in patients maintaining biochemical hypothyroidism

AA Hercbergs MD, L Goyal MD, JH Suh MD, B Cohen MD, D Peereboom MD, G Stevens MD, M Gupta PhD, S Reddy MD, PG Elson DSc, G Barnett MD, C Reddy MS

Cleveland Clinic Foundation, Cleveland OH 44195, USA,

AIMS: To evaluate the efficacy of induced biochemical hypothyroidism and high-dose tamoxifen on survival in patients with recurrent high grade glioma. METHODS: 22 patients with recurrent high grade glioma were entered into the study. Biochemical hypothyrodism was induced with propylthiouracil and Lugol's soln. Tamoxifen was started when free T4 10 uU/ml was achieved , initially at 80mg and escalating to 240mg /day. RESULTS: Only 11 of 22 patients achieved and maintained biochemical hypothyroidism. Median survival for the hypothyroid group is 11.5 months[range 1.3-18] vs.3.1 [1.8-12] for those with unmaintained hypothyroid indices .[p<0.0219]. 2 patients in the hypothyroid group have demonstrated late[over 12 months on study] but significant radiographic [MRI] tumor regression at 17+ and 18+ months. No patients experienced clinically symptomatic hypothyroidism. CONCLUSIONS:Induction and maintenance of biochemical hypothyroidism and high dose tamoxifen significantly improved survival in recurrent high grade glioma patients with minimal toxicity.

KEY WORDS: Glioma, tamoxifen, biochemical hypothyroidism.

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Paper presented at the International Symposium on Impact of Biotechnology on Cancer Diagnostic & Prognostic Indicators; Geneva, Switzerland; October 28 - 31, 2000; in the section on synergistic therapies.