Tolerability and safety of flutamide in monotherapy, with orchiectomy or with LHRH-a in advanced prostate cancer patients : A Belgian Multicenter Study of 905 patients

Objective : In a multicenter study, 905 patients with newly diagnosed advanced prostate cancer treated with flutamide were followed for safety and side effects. Methods : Flutamide was administered in monotherapy (75 patients (8%)) or as part of total androgen blockade (TAB groups) : the latter group had orchiectomy (196 patients (22%)) or an LHRH (634 patients (70%)). Results : The incidence of gastrointestinal complaints such as loss of appetite, vomiting/nausea and diarrhea (± 15%) was similar in the TAB and the monotherapy goups. Eighteen patients (2%) were withdrawn because of severe diarrhea. Hot flushes was the most frequently reported adverse event in TAB groups (40% of patients), leading to withdrawal in 4 patients (0.4%). Breast tenderness occurred most frequently in the monotherapy group (49%) and was reported as severe in 7% of the patients. Only 0.8% of the patients were withdrawn because of liver function changes. No unexpected potentially dangerous adverse events were reported. Conclusion : Flutamide alone or in combination therapy appears to be safe and well tolerated.