Abstract
The results in 362 postmenopausal women with advanced breast cancer treated with delta-1-testololactone according to the protocol of the Cooperative Breast Cancer Group are reported. Delta-1-testololactone is 17a-oxa-d-homo-14-androstadine-317-dione (Teslac NSC 23759) a hormonally inactive testosterone derivative. It does not produce masculinization in women nor significant metabolic changes in test animals. Regression of metastatic breast cancer with this agent has been reported in 12.5-30% of cases. In this study the drug was administered at levels of 200 mg 1000 mg and 2000 mg per day. Treatment was stopped in 11 patients because of toxicity 14 refused to continue and 2 were lost to followup. A total of 33 untoward effects involving 29 of the 362 patients were reported mostly gastrointestinal. No deaths resulted from toxicity of the drug. Few of the reactions were severe. With the 200 mg dose there were 4.2% remissions; with 1000 mg 14.6%; and with 2000 mg 12.4%. Side-effects were lowest with the 1000 mg dose. The difference between 200 mg and 1000 mg doses in remission rates was significant at the p<.01 level between the 200 and 2000 mg level at the p<.05 level. Those responding clearly lived longer than those not responding; 91% with objective regressions were alive 12 months after starting treatment. With visceral metastases the 2000 mg dose is recommended for those not responding to the 1000 mg dose.
Published Version
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