FLUTAMIDE-ASSOCIATED LIVER TOXICITY DURING TREATMENT WITH TOTAL ANDROGEN SUPPRESSION AND RADIATION-THERAPY FOR PROSTATE-CANCER

PURPOSE: To examine the frequency and severity of toxicity associated with flutamide in patients treated with total androgen suppression bef ore and during pelvic radiation therapy (RT) for prostate cancer. MATE RIALS AND METHODS: Sixty-five patients with T2b-T4 prostate cancer rec eived flutamide and goserelin acetate for 4 months, with RT beginning at the 3rd month. Treatment records including liver function test (LFT ) results at baseline and during treatment were reviewed and toxicitie s noted. RESULTS: In 30 (46%) of 65 patients, flutamide was discontinu ed prematurely. Primary reasons included elevation in LFT levels (n = 14); gastrointestinal toxicity (n = 9); decreased hemoglobin level (n = 2); patient refusal (n = 2); and arthralgia, rash, and malaise (n = 1 each). Hepatotoxicity generally was manifest as asymptomatic transam inase level elevation. Grade 3-4 hepatotoxicity was noted in four of 6 5 patients. Mean aspartase aminotransferase increased from 23 (baselin e) to 67 U/L (during flutamide treatment) (P < .02); mean alanine amin otransferase level increased from 26 (baseline) to 94 U/L (during flut amide treatment) (P < .005). CONCLUSION: Flutamide toxicity was common . LFTs should be monitored during flutamide therapy. The role of fluta mide in this treatment regimen may need to be reevaluated.