Economic evaluation of different hormonal therapies for prostate cancer. Final results from the Quality of Life Antiandrogen Blockade Italian Observational Study (QuABIOS).

OBJECTIVE: The paper compares costs and Quality-Adjusted Life Years (QALYs) of different hormonal therapies (HTs) administered to 275 out of 471 patients with prostate cancer (PC) enrolled in the Quality of Life Antiandrogen Blockade Italian Observational Study (QuABIOS), who did not change HT during the study period. METHODS: QALYs and costs related to monoHT witk cyproterone acetate (CYP) (42 patients); bicalutamide (BIC) (41 patients); LHRH-a (96 patients) and complete androgenic blockade (CAB) with: CYP (CYP CAB) (50 patients); BIC (BIC CAB) (46 patients) were compared via a cost-utility analysis (CUA) adopting the Italian National Healthcare Service (INHS) viewpoint. RESULTS: As no statistical significant difference among the mean QALYs gained with the different HTs was detected (p = 0.116), CUA was replaced by a cost minimization analysis (CMA). However, the lowest and the highest mean QALYs gained per patient were registered for BIC CAB (0.59; 95% CI: 0.50; 0.68) and for for CYP (0.75; 95% CI: 0.68; 0.82), respectively. CYP was the least costly HT, reaching the lowest and the highest savings when compared to LHRH-a (-Euros 974.99; 95% CI: -Euros 1066.86; -Euros 883.12; p<0.0001) and to monoHT with BIC (-Euros 5887.81; 95% CI: -Euros 6143.99; -Euros 5631.64; p<0.0001). A nonparametric bootstrap sensitivity analysis confirmed the robustness of the base case CMA. CONCLUSION: CYP is an interesting option for curbing the INHS drug expenditure for PC patients, with a trend towards increasing the mean number of QALYs gained.

Quality of life evaluation by the EORTC QLQ-C30 questionnaire in patients treated with hormonal treatment in Italy. A QuABIOS group study.

OBJECTIVES: An observational study was planned by the QuABIOS group, to survey the hormonal treatment administered to prostate cancer patients in Italy within a time window of 12 months. We report here a prospective quality of life (QOL) evaluation over time and by hormonal treatment modalities. METHODS: Patients with diagnosis of prostate cancer and treated with hormonal therapy were eligible for this study. The EORTC QLQ-C30 v.3 questionnaire was administered at enrolment, after 6 months and after 12 months from enrolment. RESULTS: 587 patients were enrolled by 33 urological centers. When 1518 visits were considered together independently of time, antiandrogen monotherapy was associated with a significantly better QOL than LHRH-analogue containing treatment modalities in almost all functional scales; cyproterone acetate demonstrated a better physical function and general health status than bicalutamide. When QOL was analyzed in a prospective 12-month window, a worsening of physical function and general health status was observed, notwithstanding, antiandrogens remained significantly associated to a better QOL than LHRH-analogue therapies also over time: a favourable physical function and general health status appeared again to be related to cyproterone acetate than bicalutamide. CONCLUSIONS: Androgen deprivation therapy is associated with decline in QOL, particularly in the domains of physical function, energy, and general health status. This survey demonstrated that antiandrogens had a better QOL profile than LHRH-analogue containing therapies;furthermore, a more favourable tolerability for cyproterone acetate as compared to bicalutamide is suggested.

Hormonal treatment for prostate cancer in Italy. Preliminary data from a survey of the QUABIOS Group.

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. MATERIAL AND 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.

Open prostatectomy for benign prostatic enlargement in southern Europe in the late 1990s: a contemporary series of 1800 interventions.

OBJECTIVES: Contemporary series of open prostatectomies from Western countries are rare. Frequently, the analysis of the outcome of open prostatectomy refers to old experiences or to series from developing countries. Any comparison with transurethral resection of the prostate can be invalidated by complications of open surgery because of the lack of an adequate healthcare system and technology. METHODS: The Sicilian-Calabrian Society of Urology performed a retrospective study to assess the surgical management of benign prostatic hyperplasia in Sicily and Calabria in 1997 and 1998. A three-page questionnaire was sent to the 36 urologic units of these two Italian regions with more than 7.5 million inhabitants. RESULTS: Twenty-six units (72.3%) replied. Of 31,558 patients treated for symptomatic benign prostatic hyperplasia, 5636 underwent surgery. Open prostatectomy (n = 1804) accounted for 32% of all surgical treatment. The median prostate volume was 75 cm(3) and the median serum prostate-specific antigen level was 3.7 ng/mL. The postoperative median hospitalization time was 7 days. Concomitant low urinary tract disease was present in 25% of the patients. Severe bleeding occurred in 11.6% of open prostatectomies. Blood transfusions were given in 8.2% of cases. Sepsis was reported in 8.6% of the patients. Reinterventions, within 2 years, mainly due to bladder neck stenosis, were reported in 3.6% of cases. CONCLUSIONS: The results of the present survey provide a current picture of open prostatectomy. This procedure, even if performed nowadays and in Western countries, shows the same significant rate of early and late complications reported in the past or in less-developed countries.

Management of symptomatic benign prostatic hyperplasia in southern Italy: a retrospective analysis of the Sicilian-Calabrian Society of Urology (SSCU) of 32,000 patients.

INTRODUCTION: The availability of new pharmacological and surgical options is responsible for important changes in the management of symptomatic benign prostate hyperplasia (BPH). The Sicilian-Calabrian Society of Urology performed a retrospective survey to assess the management of BPH in southern Italy in 1997 and 1998. PATIENTS AND METHODS: A 3-page questionnaire was sent to the 36 urological units of these two regions. The real number of patients treated was required. The numbers were checked with data obtained from the Health Regional Offices. RESULTS: Twenty-six urological units (72.3%) replied. Almost all patients underwent urinalysis, determination of serum prostate-specific antigen and creatinine levels, and renal and postvoid vesical echography. Uroflowmetry was performed in 69% and transrectal ultrasound in 56% of the patients. International Prostate Symptom Score or other symptom scores were used in 36% of the cases. Out of 31,558 patients with symptomatic BPH, 5,636 were surgically treated. Admission was due to acute urinary retention in 1,324 cases (23.5%). Transurethral resection of the prostate was the commonest procedure, accounting for 59.5% of the interventions. Open prostatectomy was performed in 1,804 patients (32%). Minimally invasive therapies accounted for less than 9% of the treatments. CONCLUSIONS: The present survey provides a picture of the current surgical practice in BPH in southern Italy in the late 1990s. Symptom scores are not routinely adopted. The low rate of transurethral prostate resections is in keeping with the worldwide decline. On the contrary, a high rate of open prostatectomies has been detected.