Biomedical subjects

V Serretta

Publications and source records attributed to V Serretta.

At least 19 recordsLinked to original sources

PubMed2006

Preliminary report of a multicentric study on environmental risk factors in Ta-T1 transitional cell carcinoma of the bladder. A study from Gruppo Studi Tumori Urologici Foundation.

OBJECTIVE: The distribution of potential environmental risk factors among patients affected by superficial transitional cell carcinoma of the bladder (TCCB) has been analyzed. METHODS: Patients affected by superficial TCCB underwent TUR and early intravesical chemotherapy. Detailed data about age, sex, residence, employment, active and passive cigarette smoking, water resource and hair dye use were centralized. Analysis has been conducted on 474 patients affected by Ta-T1 G1-2 TCCB at medium risk for recurrence. Patients with primary single Ta G1-2, Tis or T1G3 tumors were excluded from the present analysis. RESULTS: Over 80% of the patients lived in urban areas, 22% were employed in industries presumed at risk for bladder cancer, 8% used hair dye and 75% were smokers. Bottled water was the only water resource in 42% of the patients. Employment in industry at risk (p = 0.01) and cigarette smoking (p = 0.04) resulted in being statistically related to tumor multiplicity. Moreover, the period of cigarette smoking was significantly longer in patients with recurrent tumors (p = 0.026). The municipal water supply represented the main water source in never-smokers (p = 0.01) rather than in smokers and in patients harboring T1 rather than Ta tumors (p = 0.03). CONCLUSIONS: Employment in industry at risk and cigarette smoking resulted in being related to tumor multiplicity. The length of exposure to cigarette smoking was related to the natural history of the tumor. A drinkable water source emerged as a risk factor in absence of cigarette smoking.

Adult↗

PubMed2004

Randomized Phase II trial assessing estramustine and vinblastine combination chemotherapy vs estramustine alone in patients with progressive hormone-escaped metastatic prostate cancer.

Based on the results of combined data from three North American Phase II studies, a randomised Phase II study in the same patient population was performed, using combination chemotherapy with estramustine phosphate (EMP) and vinblastine (VBL) in hormone refractory prostate cancer patients. In all, 92 patients were randomised into a Phase II study of oral EMP (10 mg kg day continuously) or oral EMP in combination with intravenous VBL (4 mg m(2) week for 6 weeks, followed by 2 weeks rest). The end points were toxicity and PSA response in both groups, with the option to continue the trial as a Phase III study with time to progression and survival as end points, if sufficient responses were observed. Toxicity was unexpectedly high in both treatment arms and led to treatment withdrawal or refusal in 49% of all patients, predominantly already during the first treatment cycle. The mean treatment duration was 10 and 14 weeks, median time to PSA progression was 27.2 and 30.8 weeks, median survival time was 44 and 50.9 weeks, and PSA response rate was only 24.6 and 28.9% in the EMP/VBL and EMP arms, respectively. There was no correlation between PSA response and survival. While the PSA response in the patients tested was less than half that recorded in the North American studies, the toxicity of EMP monotherapy or in combination with VBL was much higher than expected. Further research on more effective and less toxic treatment strategies for hormone refractory prostate cancer is mandatory.

Administration, Oral↗

PubMed2004

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↗

PubMed2003

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↗

PubMed2001

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↗

PubMed2000

Pure squamous cell carcinoma of the bladder in western countries. Report on 19 consecutive cases.

INTRODUCTION: Pure squamous carcinoma (SCC) is a rare entity in western regions. The management of SCC still remains similar to that of transitional carcinoma, although it is a different entity. A retrospective review can be helpful in understanding the biological behavior of this uncommon vesical tumour. MATERIAL AND METHODS: Nineteen consecutive cases of pure SCC of the bladder, not related to bilharziasis or spinal cord injury, are herein reported. Fifteen patients were submitted to radical cystectomy, combined with emasculation in 1 case and unilateral nephroureterectomy in another. Partial cystectomy was performed in 1 patient and transurethral resection followed by radiotherapy in 3 more cases. Involvement of prostatic urethra and upper urinary tract was evident in 9 (47.3%) and 5 patients (26.3%), respectively. Four patients were submitted to neoadjuvant chemotherapy and 1 to presurgical radiotherapy without any objective response. Adjuvant chemotherapy was performed in 3 patients. At a mean follow-up of 52 months, 6 patients (31.5%) are alive without any evidence of disease. SCC antigen was monitored in 5 patients. The possible role of this marker in bladder SCC is discussed. CONCLUSIONS: Invasion of the upper urinary tract and prostatic urethra seems more common in SCC than in transitional cell carcinoma. Distant metastases are rare. Most patients die after attempts of locoregional control of the tumor have failed. Extensive surgery is recommended. Preoperative radiotherapy should be considered since pelvic recurrences are the leading cause of progression in squamous cell carcinoma.

Aged↗

PubMed2000

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↗

PubMed2000

Urinary BTA-stat, BTA-trak and NMP22 in surveillance after TUR of recurrent superficial transitional cell carcinoma of the bladder.

OBJECTIVES: To evaluate NMP22, BTA-Stat and BTA-Trak tests in monitoring recurrent transitional cell carcinoma of the bladder. METHODS: The tests were performed in 179 selected patients being followed up for recurrent superficial bladder tumors: 55 patients had bladder recurrence and 124 patients were recurrence free. The NMP22 test was obtained in all patients; BTA-Stat and BTA-Trak in the last 96 and 74 patients, respectively. Sixty-four patients (51.6%) were undergoing adjuvant intravesical chemotherapy. RESULTS: Sensitivity was 74, 57 and 62% and specificity was 55, 62 and 79% for NMP22, BTA-Stat and BTA-Trak, respectively. A high percentage of patients submitted to intravesical chemotherapy had false-positive tests. Positive predictive values of the NMP22, BTA-Stat and BTA-Trak tests were 42.2, 40 and 45.4%, and negative predictive values were 82.9, 76.9 and 88.4%, respectively. CONCLUSIONS: NMP22, BTA-Stat and BTA-Trak tests cannot replace cystoscopy and cannot be adopted as routine tools in surveillance after TUR in patients with superficial bladder cancer.

Adult↗

PubMed1999

Endoprosthesis implantation in the treatment of recurrent urethral stricture: a multicenter study. Sicilian-Calabrian Urology Society.

PURPOSE: This study was conducted by nine urology departments in southern Italy to assess the efficacy of and tolerance to treatment of recurrent urethral stricture using a permanent prosthesis. PATIENTS AND METHODS: Since 1992, 99 prostheses have been implanted to treat inflammatory and iatrogenic (seven departments) or all types (two departments) of urethral strictures. The Urolume Wallstent was used in 94 cases. Three centers implanted more than one prosthesis when this was indicated. Local anesthesia was used by six centers, spinal anesthesia by two, and local or general by one. At three centers, urethrotomy was performed immediately prior to implantation; two centers used dilation to 30F, and two centers performed urethrotomy 24 or 36 hours before implantation. The median follow-up is 29.1 months (range 3-53 months). RESULTS: The results were good in 52%, fair in 34%, and poor in 14% of patients. The maximum flow rate increased >75% in 82% of patients. All departments reported complete reepithelialization of the urethra by 6 months. The short-term complications (7-28 days) were perineal discomfort (86%) and dribbling (14%). The long-term complications were painful erection (44%), mucous hyperplasia (44%), recurring stricture (29%), and incontinence (14%). All departments performed resection for hyperplasia in many cases. CONCLUSION: Permanent urethral endoprostheses can produce excellent results in patients with recurrent urethral strictures.

Adult↗

PubMed1998

Urinary NMP22 for the detection of recurrence after transurethral resection of transitional cell carcinoma of the bladder: experience on 137 patients.

OBJECTIVES: To evaluate the nuclear matrix protein 22 (NMP22) test in the management of patients after transurethral resection (TUR) of recurrent transitional cell carcinoma of the bladder. METHODS: The NMP22 test was performed in 137 patients: in 42 patients, a bladder recurrence was detected by cystoscopy and histologically confirmed; 95 patients were recurrence-free at cytology and cystoscopy performed at least 3 months after TUR. RESULTS: In patients with tumoral recurrence, the mean NMP22 value was 54.8 U/mL. The false-negative rate was 28.5%. In recurrence-free patients, the mean NMP22 value was 22.8 U/mL. The specificity of the NMP22 test was 61%. Higher NMP22 mean values (29.6 versus 15.8 U/mL) were found in patients who underwent intravesical chemotherapy or immunotherapy. CONCLUSIONS: Despite its good sensitivity, the NMP22 test cannot be adopted as a routine tool in the surveillance after TUR of patients with superficial bladder cancer because of its low specificity.

Adult↗

PubMed1998

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↗

PubMed1998

[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↗

PubMed1997

[The Urologic Cooperative Group of the EORTC. Structure, scope, research, results].

The European Organization for Research and Treatment of Cancer (EORTC) was founded in 1962. The first urological group was French-speaking and concentrated particularly on testicular tumours. Shortly after, an English-speaking group started its activities in Yorkshire, with main emphasis on prostate cancer, and a "bladder cancer group" attracted many urologists from Belgium and other European countries. In 1976 all these groups were fused into a one new urological group of which M. Pavone-Macaluso from Palermo, Italy, secretary of the French-speaking group, was chosen as secretary and then chairman of the unified group, whereas Ph. Smith from Leeds, UK, chairman of the English-speaking group, was elected as chairman and later as secretary of the new group. The two "founding fathers" celebrated the 10th and 20th anniversaries of the foundation of the group respectively in Leeds in 1986 and in Palermo in 1996. Later chairman were L. Denis, Belgium; F. Schröder, The Netherlands; D. Newling, UK; F. Debruyne, The Netherlands and R. Hall, UK. A. van der Meijden, The Netherlands, will take over in 1997. The present secretary is A.V. Bono from Varese, Italy. The present structure of the group consists of a variety of working parties (disease-orientated groups), with special interest in a given pathology (such as prostate cancer, superficial or advanced bladder cancer, etc.) and of other committees (chemotherapy, quality of life, quality control). All the activities are coordinated by a Data Centre in Brussels, that is responsible for the statistical support. In its 20 years of activity the group has made many contributions of significance which have coincided with a number of changes in the urological oncology and have obtained international recognition. The paper analyses in detail the most significant of the group's achievements in the various fields of urological oncology.

Europe↗

PubMed1996

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↗

PubMed1995

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↗

PubMed1993

Correlation between clinical response and urinary interleukin levels using different doses and intravesical administration schedules of interferon-alpha-2b combined with epirubicin: a pilot study.

A total of 62 patients at high risk for recurrence of superficial bladder cancer were selected for a study designed to compare the prophylactic efficacy of different doses and schedules of sequential intravesical instillations of epirubicin and interferon-alpha-2b and to evaluate which sequence could enhance the release of cytokines in the urine. Our investigations showed a significant increase in urinary concentrations of interleukins in patients who received the sequential intravesical administration of epirubicin and interferon-alpha-2b. Higher urinary concentrations of interleukins and a lower recurrence rate were detected in patients who received interferon-alpha-2b 24h after epirubicin instillation.

Administration, Intravesical↗

PubMed1993

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↗

PubMed1993

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↗