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Biomedical subjects

C Pavone

Publications and source records attributed to C Pavone.

At least 19 recordsLinked to original sources

Prospective, randomized, crossover comparison of sublingual apomorphine (3 mg) with oral sildenafil (50 mg) for male erectile dysfunction.

PURPOSE: We established the efficacy and safety of sublingual apomorphine compared with oral sildenafil in comparable groups of patients with erectile dysfunction (ED). MATERIALS AND METHODS: This prospective, randomized, crossover study included 77 heterosexual men with ED of various etiologies and severities. A total of 62 men were randomized but only 34 were evaluable for efficacy and tolerability. The study started with a run-in period of 2 to 4 weeks. The first 4 weeks of treatment were followed by a washout period of 4 weeks, after which patients changed to the alternate treatment for an additional 4-week period. The sequence of the 2 treatments was established by a randomization list in blocks in closed packets. The primary efficacy end point was the percent of attempts resulting in erection firm enough for intercourse. Additional variables were the percent of attempts resulting in intercourse and improvement in ED, as evaluated by the erectile function domain score of the International Index of Erectile Function questionnaire. RESULTS: Sildenafil was significantly more effective than apomorphine in regard to the percent of attempts resulting in erection firm enough for intercourse (85% vs 44%, p <0.0001) and actually resulting in intercourse (81% vs 43%, p <0.0001) as well as erectile function evaluated by the erectile function domain score of the International Index of Erectile Function (p <0.001). The incidence of adverse events was not significantly different for the 2 drugs. Although the number of patients was small, this study had strong statistical power due to the striking difference in results. CONCLUSIONS: Sildenafil was significantly more effective than apomorphine for ED. No statistical difference in adverse events was noted.

Administration, Oral↗

Long-term outcome of antiandrogen monotherapy in advanced prostate carcinoma: 12-year results of a phase II study.

OBJECTIVE: To present the long-term outcome of patients with locally advanced or metastatic prostate carcinoma treated by first-line antiandrogen monotherapy. PATIENTS AND METHODS: From 1983 to 1990, 41 patients with advanced prostate carcinoma were treated with flutamide monotherapy until progression or the appearance of toxicity. Twenty-five patients (61%) had T3-T4N0M0 and 16 (39%) T2-4N0-3M1 prostate carcinoma. Consensus criteria were adopted to evaluate the response. Plasma testosterone and sexual function were recorded for the first 3 years. RESULTS: Flutamide was administered for up to 147 months; seven patients (17%) interrupted the treatment because of toxicity. There was an objective response in 17 (41%) patients; 20 (49%) had stable disease while four (10%) progressed. There were objective responses, lasting up to 150 months, in 82% of those with M0 and in 18% with M1 disease (P = 0.05). The median time to progression in patients with an objective response and stable disease was 45 and 16 months, respectively (P < 0.001). Thirty-one patients (76%) died from prostate cancer and 10 (24%) from unrelated diseases. The median survival was 67 and 36 months in patients with an objective response and stable disease, respectively (P < 0.001). There was an improvement in performance status in 85% and reduction in bone pain in 83% of the patients; sexual activity was maintained in 63%. CONCLUSION: Monotherapy with flutamide is well tolerated. Objective responses are more frequent in patients with locally advanced disease. Patients with an objective response within 6 months have a prolonged progression-free and overall survival.

Administration, Oral↗

PSA and second-line therapy of hormone refractory prostate carcinoma.

The aim of the present study was to correlate PSA response with subjective response (bone pain and performance status), in patients treated for hormone refractory carcinoma of the prostate. Twenty-four patients were introduced into the study. Median PSA was 198 ng/ml. Symptom score, performance status and PSA were monitored monthly for 3 months and then 3-monthly. Sixteen patients (66%) showed a PSA response (median value 10 ng/ml). In 8 patients (33%) PSA was <4 ng/ml. Eight patients (33%) only had a subjective response. However, 75% of the patients with a PSA value <4 ng/ml had a subjective improvement. On the other hand, subjective response was 25% only in patients in whom PSA value decreased to <50% of the initial value but >4 ng/ml. In conclusion, PSA response is not always related to subjective improvement and does not always implicate a beneficial effect of the therapy for the patient.

Adenocarcinoma↗

Correlation between chronic prostatitis syndrome and pelvic venous disease: a survey of 2,554 urologic outpatients.

OBJECTIVES: In this study we evaluated the association between chronic prostatitis syndrome (CPS), varicocele and hemorrhoids as manifestations of a pelvic venous disease. METHODS: Our retrospective study was based upon 2,554 patients treated in two general urology clinics over the past 10 years. We have assessed the incidence of CPS among urological patients. RESULTS: We found 483 patients with CPS, representing 18.9% of the total number of visits at the outpatient clinic. In this group the percentage of varicocele and hemorrhoids was 14.69 and 8.48%, whereas in a control group these figures were 5.02 and 5.84%, respectively (p<0.001 and 0.1054). Such a difference is statistically significant and suggests a higher prevalence of varicocele in the CPS group, but this may be due to a methodological error of the retrospective study. CONCLUSION: Only a prospective study, which is of importance due to the frequency of the disease, can give a precise answer to this question.

Case-Control Studies↗

The fate of patients with locally advanced bladder cancer treated conservatively with neoadjuvant chemotherapy, extensive transurethral resection and radiotherapy: 10-year experience.

PURPOSE: We assess the results of bladder preservation for infiltrating bladder cancer. The potential for neoadjuvant chemotherapy followed by extensive transurethral resection and radiotherapy was evaluated in 40 patients with T2-T4a G2-G3 bladder carcinoma. MATERIALS AND METHODS: From 1983 to 1995, 40 patients with bladder cancer underwent bladder sparing treatment, consisting of neoadjuvant chemotherapy, extensive transurethral resection and radiotherapy. Most patients had T3G3 cancer. A deep transurethral resection biopsy was performed before and after chemotherapy, and an extensive transurethral resection was repeated at the end of radiotherapy. Of the patients 30 received cisplatin and methotrexate and 10 also received vinblastine. Total dose of radiotherapy was 60 to 65 Gy. Recurrent superficial tumors were treated transurethrally. Radical cystectomy was considered for persistent or recurrent invasive disease. RESULTS: Complete response occurred in 19 patients (47.5%) after chemotherapy, and in 8 patients after transurethral resection and radiotherapy (67.5%). Within 10 years 8 responding patients (30%) had local recurrences and 3 underwent cystectomy. Of the patients 14 (35%) are alive, including 13 with no evidence of disease (mean survival 65 months), 5 died of unrelated disease and 21 (52.5%) died of distant metastases (mean survival 28 months). Of the 21 patients 14 had residual tumor after radiotherapy, 3 presented with distant metastases after vesical infiltrating recurrence and 4 had distant metastases in the absence of locoregional recurrence. In 22 patients (55%) the bladder was salvaged. Patients with complete response to chemotherapy had a low risk for recurrent infiltrating tumors and metastases. CONCLUSIONS: Complete tumor control was maintained at 5 years in more than 50% of the patients treated conservatively. Bladder salvage is feasible in select patients.

Adult↗

[Conservative treatment of locally advanced bladder carcinoma: neoadjuvant chemotherapy, TUR and radiotherapy. Results in 40 patients].

PURPOSE: to assess the results of bladder preservation in infiltrating bladder cancer. The potential for neoadjuvant chemotherapy followed by extensive TUR and radiotherapy was investigated in 40 patients with T2-T4a G2-G3 bladder carcinoma. MATERIALS AND METHODS: from 1983 to 1995, 40 patients were submitted to bladder-sparing treatment consisting of neoadjuvant chemotherapy, extensive, TUR and radiotherapy. Most patients had T3G3 cancer. Cystectomy was not performed due to patient" choice in 29 cases (72.5%), for severe pulmonary or cardiovascular disease in disease in 9 patients (22.5) and age over 80 in 2 (5%) patients. A deep TUR-biopsy was performed before and after chemotherapy and an extensive TUR was repeated at the end of radiotherapy. In the first 30 patients chemotherapy consisted of 2-4 cycles of 70 mg/m2 cisplatin on fay 1, and 40 mg/m2 methotrexate on days 8 and 15. In the last 10 patients chemotherapy consisted of 3 cycles of CMV (100 mg/m2 cisplatin on day 2, 30 mg/m2 of vinblastine on days 1 and 8). Total dose of radiotherapy was 60-65 Gy. Recurrent superficial tumors were treated transurethrally. Radical cystectomy, when feasible, was considered for persistent or recurrent invasive disease. RESULTS: after chemotherapy, a clinical objective response was obtained in 27 patients (67.5%), 19 (47.5%) of whom showed a complete response. Thirteen (32.5%) patients showed no response and 5 (12.5%) progressed during chemotherapy. After extensive TUR of any residual mass and radiotherapy, a complete response was achieved in 6 patients who initially showed a partial response and in other 2 patients and stable disease after chemotherapy. Altogether, 27 patients (67.5%) presented had local recurrences, 3 patients underwent cystectomy. Fourteen patients (35%) are alive and 13 NED (65 months mean survival). Five patients died of unrelated disease. Twenty-one patients (52.5%) died of distant metastases (mean survival 28 months). Four patients presented distant metastases after vesical infiltrating recurrence and 4 patients had distant metastases in the absence of loco-regional recurrence. Twenty-two patients (55%) maintained an intact bladder. Patients with complete response to chemotherapy showed a low risk for developing recurrent infiltrating tumors and metastases. CONCLUSIONS: A complete tumor was maintained at 5 years in over 50% of the patients conservatively treated. Bladder salvage is feasible in selected patients.

Adult↗

Results of conservative treatment (transurethral resection plus adjuvant intravesical chemotherapy) in patients with primary T1, G3 transitional cell carcinoma of the bladder.

OBJECTIVES: To evaluate a selected population of 50 consecutive patients with primary T1, G3 bladder transitional cell carcinoma in the absence of carcinoma in situ (Tis) treated with a bladder-sparing approach. METHODS: Between January 1983 and December 1992, all patients were treated by transurethral resection (TUR) plus adjuvant intravesical chemotherapy over 1 year. In most cases, doxorubicin, epirubicin, and mitomycin were used alone or in combination. RESULTS: At a mean follow-up period of 52 months (range, 18 to 126), 16 of 50 patients (32%) showed a recurrent superficial tumor. The recurrent lesion was of Stage T1 in 11 (22%) cases, but was a T1, G3 tumor only in 5 cases (10%). In 2 additional patients (4%) a Tis developed during the observation period after TUR. The mean interval between TUR and first recurrence was 14.6 months (range, 3 to 38). At a mean time of 17 months after the initial TUR, 3 patients (6%) underwent a radical cystectomy due to a progression in T category and 3 additional patients (6%) developed distant metastases at a mean time of 23 months after TUR. In brief, 84% of the patients are alive and tumor-free. Five patients (10%) died of bladder cancer with a mean follow-up of 52 months. CONCLUSIONS: If no concomitant Tis exist, a conservative approach is a legitimate option as an initial treatment of patients with primary T1, G3 bladder tumors.

Administration, Intravesical↗

Is there a role for recombinant tumor necrosis factor alpha in the intravesical treatment of superficial bladder tumors?--a phase II study.

Clinical use of recombinant tumor necrosis factor-alpha is strongly limited by its severe toxicity, mainly cardiovascular, when systemically administered. Recent studies suggest that topical (intrapleural, intraperitoneal, intratumoral) administration is free of significant toxicity. Human recombinant tumor necrosis factor-alpha was administered intravesically, at a dose of 500 mg dissolved in 30 ml of phosphate buffer (pH 7.6-7.8) plus 0.25% human albumin, weekly for two months to 18 patients with papillary transitional cell carcinoma of the bladder. Of the 15 evaluable patients, four (26%) achieved a complete response. Systemic and local tolerability were excellent.

Administration, Intravesical↗

Intravesical mitoxantrone in superficial bladder tumours (Ta-T1).

36 patients with histologically proven grade G1-G2, Ta-T1 transitional cell carcinoma of the bladder were introduced, after transurethral resection (TUR), into a study of intravesical chemoprophylaxis with mitoxantrone (20 mg diluted in 50 ml). After a mean follow-up of 23 months, 16 (50%) patients showed a superficial recurrence with a mean recurrence rate of 0.56 per year. In 19 patients with recurring tumours the mean recurrence rate decreased from 1.65 to 0.58 per year. 9 patients (25.7%) suffered from a chemical cystitis that in 2 cases (5.7%) required treatment interruption.

Administration, Intravesical↗

Current views on intravesical treatment and chemoprophylaxis of superficial bladder cancer. The present role of epirubicin and doxorubicin.

Since 1972, a large number of studies have shown that intravesical treatment with doxorubicin (adriamycin) is effective against carcinoma in situ and multiple papillary tumors. Furthermore, it significantly reduces the recurrence rate after transurethral resection. Its efficacy has been compared with that of Bacillus Calmette-Guerin (BCG), which is the only treatment accepted by the US Food and Drug Administration for therapy of carcinoma in situ (Tis). In more recent years, a few studies have been performed using intravesical epirubicin in the hope that different properties of the molecule might enhance the activity of the anthracyclines, but produce fewer and milder side-effects. After weekly instillations of epirubicin (50 mg in 50 ml of sterile water) a complete response is achieved in 47% of patients with a histologically proven papillary marker lesion. The prophylactic efficacy of even a single instillation of epirubicin within 6 hours after transurethral resection (TUR) was proved in a randomized study (30863) of the EORTC (European Organization for Research on Therapy of Cancer) Urological Group. A randomized Italian trial (Blinst 4) of chemoprophylaxis after TUR investigated the efficacy of different intravesical administration schedules of epirubicin (50 mg in 50 ml of sterile water). All treatment regimens were more effective than no treatment. The sequential intravesical combination of epirubicin and interferon-alpha-2b has shown, in our personal experience, encouraging clinical results and our laboratory data suggest the synergic activation of the local immune response.

Administration, Intravesical↗

The flexible cystoscope.

We have been using the flexible cystoscope since 1987. Detailed information is given concerning the technique of flexible cystoscopy, its indications, advantages and disadvantages. A comparison is made with the results obtained using the rigid cystoscope in an initial series of 100 patients, yielding false negative results in only 8% of cases during the learning period. The flexible scope can be successfully employed for Neodymium YAG laser coagulation of superficial bladder tumours. The conclusion is reached that once the urologist has learned how to use it, he will consider the flexible cystoscope as a fundamental tool in his diagnostic armamentarium and false negative results will decrease almost to zero, especially if additional investigations, namely cytology, are routinely adopted.

Cystoscopes↗

A pilot study comparing different dose levels and administration schedules of interferon-alpha 2b combined with epirubicin for prevention of recurrence in bladder cancer.

A pilot study in 62 patients has been carried out to evaluate the combination of epirubicin and interferon (IFN)-alpha 2b using different doses and schedules of intravesical administration in the prevention of recurrence of bladder cancer. Preliminary results show greater prophylactic efficacy not only when higher doses of epirubicin and IFN-alpha 2b are used but also when a larger interval between instillation of the compounds was used.

Administration, Intravesical↗

Study of cellular DNA content by flow cytometry in primary bladder carcinomas. Significance of monoclonal and multiclonal varieties of DNA aneuploidy.

A prospective study of cellular DNA content by flow cytometry was performed on a nonconsecutive series of 67 patients undergoing diagnostic and/or therapeutic transurethral resection for primary urothelial bladder carcinoma. DNA-aneuploidy was present in 82% of the cases (55/67), while multiclonality was found in 45% of the DNA-aneuploid cases (25/55). DNA-ploidy was much more strictly correlated with histological grading (p less than 0.005) than with papillary or non-papillary growth pattern (p less than 0.05) or T staging (p less than 0.05). Of 26 patients with a minimum follow-up of 24 months, 100% (6/6) of cases with DNA-diploid neoplasias showed no signs of disease relapse, versus 10% (2/20) of those with DNA-aneuploid neoplasias (p less than 0.001). Furthermore, tumoral progression occurred in 10 of 20 cases (50%) with aneuploid DNA content. In this latter group of 10 cases a multiclonal DNA-aneuploid pattern was found, with a significant difference (p less than 0.001).

Aged↗

Prostatitis, prostatosis and prostalgia. Psychogenic or organic disease?

The term 'chronic prostatitis syndrome' (C.P.S) encompasses chronic bacterial prostatitis, chlamydia or ureaplasma-associated disease, chronic 'abacterial' prostatitis, and patients with prostatosis or prostatosis or prostalgia. Interesting observations emerged from the evaluation of the clinical material indicating that the patients with abacterial prostatitis and those with prostatosis or prostaglia group have frequent sperm abnormalities and ultrasonographic changes suggesting a more complex pathogenesis than mere congestion and neurosis. Treatment in 144 evaluable patients treated with a long-acting sulphur-trimethoprim combination was almost uniformly well tolerated; Chlamydia was eradicated in all 10 treated patients and 77.4% of patients with bacterial C.P.S. were rendered free of bacteria. Sperm abnormalities were almost invariably resistant to the treatment. Only 44.4% of patients showed a partial improvement, limited to one or more parameters. Results did not differ significantly in the various subgroup. An overall evaluation of results showed that disappearance of every presenting symptom and sign was obtained in 24.3% and a significant improvement in another 25% of patients, including those in the prostatosis-prostalgia group. These results suggest that antibacterial treatment may be followed by favourable clinical results even in patients in whom no bacteria or other aetiological agents could be isolated.

Adult↗

Carcinoma of the prostate. Guidelines for treatment: the role of antiandrogens.

Our preliminary experience shows that flutamide is effective in patients with stage C or D prostate cancer. Local and distant response rates are comparable to those obtained with "classic" hormone therapy. Libido and sexual potency generally are unaffected. Palliation of symptoms, which is frequent, is usually accompanied by improved performance status and quality of life. Side effects are slight or moderate, but elevated transaminase levels in patients with borderline liver insufficiency are possible.

Androgen Antagonists↗

Is there a role for pure antiandrogens in the treatment of advanced prostatic cancer?

Our preliminary experience shows that flutamide is an effective treatment in patients with stage C and D prostate cancer. Local and distant response rates appear to be comparable with those obtained by "classic" hormone therapy. Libido and sexual potency are generally not affected. Palliation of symptoms is frequent and is usually accompanied by improvement of performance status and quality of life. The side effects are slight or moderate, but an elevation of transaminases in patients with borderline liver insufficiency is possible.

Aged↗

Interactive computerized morphometric analysis for the differential diagnosis between dysplasia and well differentiated adenocarcinoma of the prostate.

To distinguish prostatic dysplasia (or adenosis) from well differentiated adenocarcinoma on transrectal needle biopsy, a morphometric study was conducted on 20 cases of adenosis and 20 cases of well differentiated adenocarcinoma of the prostate. About 100 cells for each patient were analyzed by means of a computerized image analyzer, and mean nuclear diameter, mean nuclear area, mean form factor and number of cells in eight classes of nuclear diameter were studied. The best predictors of malignancy (evaluated by means of Receiver Operating Characteristics curves) were mean nuclear area greater than 28 mu2, presence of more than 5% of cells with nuclear diameter greater than 6.15 mu, and mean nuclear diameter greater than 5 mu. Using these diagnostic criteria the probability of malignancy for a positive specimen rises from 14% (pre-test) to 75% (post-test).

Adenocarcinoma↗