Comparative study to evaluate the safety and efficacy of high dose tamoxifen and dexamethasone versus dexamethasone alone in the management of recurrent malignant gliomas

ABSTRACT

This study included 19 [15 males and 4 females] evaluable patients with recurrent malignant gliomas who failed treatment with external radiotherapy, they were randomly assigned into two arms [A and B] by a simple toss test. Arm A included ten patients [eight males and two females] treated with tamoxifen in an escalating dose to reach the target dose of 160 mg/day in the third week of treatment and dexamethasone in a dose of 12 mg/day. Arm B included nine patients [seven males and two females] treated with dexamethasone only in the same dose. In arm A, a clinical improvement was detected in three patients and radiological improvement was detected in one of them and two patients had a stable disease. The remaining five patients had a rapid progressive disease despite of treatment. In arm B, two patients had clinical improvement of a short duration and one patient had a stationary course and no radiological improvement was detected in any patients. The remaining six patients deteriorated rapidly. No major side effects were reported in both arms apart from one patient in arm A who developed deep venous thrombosis [DVT] and responded to medical treatment