OBJECTIVE

An observational study was planned by the QUABIOS group, to survey the hormonal modalities administered to prostate cancer patients in Italy within a time window of 12 months. We report here a summary of treatment schedules and related adverse effects, as recorded at the first visit.

METHODS

Patients with diagnosis of prostate cancer and under hormonal therapy (LHRH-a and/or antiandrogen, previous orchidectomy) were eligible for this study. Adverse events were reported (graduated according to NCI-CTC v2.0, when pertaining) only in patients having received at least three months of hormonal treatment.

RESULTS

560 patients were enrolled from February to December, 2004 by 33 urological centers in Italy. A moderate to severe impairment of sexual function subsequent to the hormonal treatment was observed in 18.3% of patients treated with antiandrogen monotherapy, in 48.1% of patients treated with LHRH-a, and in 59.9% of patients treated with the combined approach. 24.7% patients referred a gastrointestinal toxicity (nausea/vomiting and diarrhea), without clear differences between treatment modalities. An asthenia subsequent to the hormonal treatment was moderate to severe in 3.5% of patients treated with antiandrogen monotherapy, as compared to 14.5% for LHRH-a and 12.9% for the combined approach, respectively. A gynecomastia / breast pain was present in 27.8% of antiandrogen monotherapy patients, as compared to 13.9% for LHRH-a and 13.8% for the combined approach, respectively. As compared to cyproterone acetate, bicalutamide had more sexual function impairment, more gastrointestinal toxicity, (slightly) more asthenia and more gynecomastia / breast pain.

CONCLUSIONS

In our series antiandrogens were obviously associated with less sexual function impairment and less asthenia than LHRH-a containing schedules; on the other hand gynecomastia mainly affected patients receiving antiandrogen monotherapy. Within antiandrogens, cyproterone acetate generally appeared to be better tolerated than bicalutamide, with less severe impairment of sexual function, less gastrointestinal toxicity and negligible gynecomastia.