CYPROTERONE-ACETATE IN THE TREATMENT OF ADVANCED PROSTATIC-CANCER - RETROSPECTIVE ANALYSIS OF LIVER TOXICITY IN THE LONG-TERM FOLLOW-UP OF 89 PATIENTS

Cyproterone acetate (CPA) was the first steroidal antiandrogen used fo r the treatment of prostatic cancer. In recent studies CPA has been li nked with DNA adduct formation and increased DNA repair synthesis in v itro, suggesting an increased risk for the development of hepatic mali gnancies. To assess liver-toxic and carcinogenic effects, 89 patients who received CPA 50 mg/day p.o. over 4 (range 2-152 months) years for prostatic cancer treatment were retrospectively evaluated. 22 patients (28.2%) showed elevated liver enzyme concentrations. In none of the 8 9 patients a-fetoprotein serum levels were elevated. In no case hepato cellular carcinoma has been observed, and in no case CPA administratio n was discontinued due to side effects. Considering the life expectanc y of patients with advanced prostatic cancer and the long-term and hig h-dose exposure to CPA necessary to possibly induce liver tumors, it a ppears highly unlikely that CPA treatment may account for a substantia l number of Liver carcinomas in such patients.