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 groups. Eighteen patients (2%) were withdrawn because of severe diarrhea.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 Only 0.8% of the patients were withdrawn because of liver function changes.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.


CONCLUSIONS
Flutamide alone or in combination therapy appears to be safe and well tolerated.
Oosterlinck
W
W
Universitair Ziekenhuis, Gent, Belgium.
Casselman
J
J
Mattelaer
J
J
Van Velthoven
R
R
Kurjatkin
O
O
Schulman
C
C
D001066:Appetite / Q000187:drug effects; D003131:Combined Modality Therapy; D003967:Diarrhea / Q000139:chemically induced; D005485:Flutamide / Q000009:adverse effects / Q000627:therapeutic use*; D007987:Gonadotropin-Releasing Hormone / Q000037:antagonists & inhibitors / Q000627:therapeutic use*; D006801:Humans; D008099:Liver / Q000187:drug effects; D008297:Male; D009325:Nausea / Q000139:chemically induced; D009919:Orchiectomy; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D011788:Quality of Life
D007987:Gonadotropin-Releasing Hormone; D005485:Flutamide