Factores de riesgo de enfermedad residual en la re-RTU en una gran cohorte de pacientes con enfermedad T1G3 / Risk factors for residual disease at re-TUR in a large cohort of T1G3 patients

Introducción y objetivos: Los objetivos de la resección transuretral (RTU) del tumor vesical son la resección completa de las lesiones y la realización de un diagnóstico correcto con el objetivo de estadificar adecuadamente al paciente. Es bien sabido que la presencia de músculo detrusor en el espécimen es un requisito previo para minimizar el riesgo de infraestadificación.La persistencia de enfermedad tras la resección de los tumores vesicales no es infrecuente, y es la razón por la que las guías europeas recomiendan una re-resección transuretral (re-RTU) para todos los tumores T1. Recientemente se ha publicado que, en los casos con inclusión de músculo en el espécimen, la re-RTU no afecta la progresión ni la supervivencia específica del cáncer.Presentamos aquí los factores relacionados con el paciente y el tumor que pueden influir en la presencia de enfermedad residual en la re-RTU.Material y métodosDe nuestra cohorte retrospectiva de 2.451 pacientes con tumores T1G3 primarios tratados inicialmente con bacilo de Calnette-Guérin (BCG), están disponibles los resultados patológicos de 934 pacientes (38,1%) que se sometieron a una re-RTU. El 74% tenía tumores multifocales, el 20% de los tumores tenía más de 3 cm de diámetro y el 26% tenía carcinoma in situ (CIS) concomitante. En este subgrupo de pacientes que se sometieron a una segunda RTU, no hubo enfermedad residual en 267 pacientes (29%) y se presentó enfermedad residual en 667 pacientes (71%): Ta en 378 (40%) y T1 en 289 (31%) pacientes. Se analizaron la edad, el sexo, el estado del tumor (primario/recurrente), la terapia intravesical previa, el tamaño del tumor, la multifocalidad del tumor, la presencia de CIS concomitante y la inclusión de músculo en el espécimen para evaluar los factores de riesgo de enfermedad residual en la re-RTU, tanto en los análisis univariantes, como en las regresiones logísticas multivariantes. (AU)

Introduction and objectives: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis in order to adequately stage the patient. It is well known that the presence of detrusor muscle in the specimen is a prerequisite to minimize the risk of under staging.Persistent disease after resection of bladder tumors is not uncommon and is the reason why the European Guidelines recommended a re-TUR for all T1 tumors. It was recently published that when there is muscle in the specimen, re-TUR does not influence progression or cancer specific survival.We present here the patient and tumor factors that may influence the presence of residual disease at re-TUR.Material and methodsIn our retrospective cohort of 2451 primary T1G3 patients initially treated with BCG, pathology results for 934 patients (38.1%) who underwent re-TUR are available. 74% had multifocal tumors, 20% of tumors were more than 3 cm in diameter and 26% had concomitant CIS.In this subgroup of patients who underwent re-TUR, there was no residual disease in 267 patients (29%) and residual disease in 667 patients (71%): Ta in 378 (40%) and T1 in 289 (31%) patients. Age, gender, tumor status (primary/recurrent), previous intravesical therapy, tumor size, tumor multi-focality, presence of concomitant CIS, and muscle in the specimen were analyzed in order to evaluate risk factors of residual disease at re-TUR, both in univariate analyses and multivariate logistic regressions. (AU)

Risk factors for residual disease at re-TUR in a large cohort of T1G3 patients.

INTRODUCTION AND OBJECTIVES: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis in order to adequately stage the patient. It is well known that the presence of detrusor muscle in the specimen is a prerequisite to minimize the risk of under staging. Persistent disease after resection of bladder tumors is not uncommon and is the reason why the European Guidelines recommended a re-TUR for all T1 tumors. It was recently published that when there is muscle in the specimen, re-TUR does not influence progression or cancer specific survival. We present here the patient and tumor factors that may influence the presence of residual disease at re-TUR. MATERIAL AND METHODS: In our retrospective cohort of 2451 primary T1G3 patients initially treated with BCG, pathology results for 934 patients (38.1%) who underwent re-TUR are available. 74% had multifocal tumors, 20% of tumors were more than 3 cm in diameter and 26% had concomitant CIS. In this subgroup of patients who underwent re-TUR, there was no residual disease in 267 patients (29%) and residual disease in 667 patients (71%): Ta in 378 (40%) and T1 in 289 (31%) patients. Age, gender, tumor status (primary/recurrent), previous intravesical therapy, tumor size, tumor multi-focality, presence of concomitant CIS, and muscle in the specimen were analyzed in order to evaluate risk factors of residual disease at re-TUR, both in univariate analyses and multivariate logistic regressions. RESULTS: The following were not risk factors for residual disease: age, gender, tumor status and previous intravesical chemotherapy. The following were univariate risk factors for presence of residual disease: no muscle in TUR, multiple tumors, tumors > 3 cm, and presence of concomitant CIS. Due to the correlation between tumor multi-focality and tumor size, the multivariate model retained either the number of tumors or the tumor diameter (but not both), p < 0.001. The presence of muscle in the specimen was no longer significant, while the presence of CIS only remained significant in the model with tumor size, p < 0.001. CONCLUSIONS: The most significant factors for a higher risk of residual disease at re-TUR in T1G3 patients are multifocal tumors and tumors more than 3 cm. Patients with concomitant CIS and those without muscle in the specimen also have a higher risk of residual disease.

Moderate hypofractionated helical tomotherapy for prostate cancer in a cohort of older patients: a mono-institutional report of toxicity and clinical outcomes.

PURPOSE OR OBJECTIVE: To evaluate toxicity and outcomes of moderately hypofractionated helical tomotherapy for the curative treatment of a cohort of patients aged ≥ 75 years with localized prostate cancer (PC). MATERIALS AND METHODS: From January 2013 to February 2017, 95 patients with median age 77 years (range 75-88) were treated for PC. 39% were low risk, 33% intermediate risk (IR), 28% high risk (HR). Median iPSA was 9.42 ng/ml (1.6-107). Androgen deprivation was prescribed according to NCCN recommendations. All patients received 70 Gy in 28 fractions to the prostate; 61.6 Gy were delivered to the seminal vesicles for IR; whole pelvis irradiation with a total dose of 50.4 Gy was added in the HR group. Toxicity evaluation was based on CTCAE V4.0 criteria, biochemical failure was defined following Phoenix criteria. Quality of Life was assessed with the EPIC-26 index. Overall survival and biochemical failure-free survival were analysed with Kaplan-Meier method. RESULTS: With a median follow-up of 36 months (range 24-73), acute and late toxicity were acceptable. No correlation between toxicity patterns and clinical or dosimetric parameter was registered. EPIC-26 showed a negligible difference in urinary and bowel function post-treatment that did not reach statistical significance. The 2- and 3-years OS were 93% and 87% with cancer specific survival of 97.9% and 96.2%. CONCLUSION: Moderate hypofractionated RT reported excellent outcomes in our cohort of older patients. Shorter schedules may be proposed regardless of chronological age facilitating the treatment compliance in the older population.

Predictors of oncological outcomes in T1G3 patients treated with BCG who undergo radical cystectomy.

PURPOSE: To evaluate the oncological impact of postponing radical cystectomy (RC) to allow further conservative therapies prior to progression in a large multicentre retrospective cohort of T1-HG/G3 patients initially treated with BCG. METHODS: According to the time of RC, the population was divided into 3 groups: patients who did not progress to muscle-invasive disease, patients who progressed before radical cystectomy and patients who experienced progression at the time of radical cystectomy. Clinical and pathological outcomes were compared across the three groups. RESULTS: Of 2451 patients, 509 (20.8%) underwent RC. Patients with tumors > 3 cm or with CIS had earlier cystectomies (HR = 1.79, p = 0.001 and HR = 1.53, p = 0.02, respectively). Patients with tumors > 3 cm, multiple tumors or CIS had earlier T3/T4 or N + cystectomies. In patients who progressed, the timing of cystectomy did not affect the risk of T3/T4 or N + disease at RC. Patients with T3/T4 or N + disease at RC had a shorter disease-specific survival (HR = 4.38, p < 0.001), as did patients with CIS at cystectomy (HR = 2.39, p < 0.001). Patients who progressed prior to cystectomy had a shorter disease-specific survival than patients for whom progression was only detected at cystectomy (HR = 0.58, p = 0.024) CONCLUSIONS: Patients treated with RC before experiencing progression to muscle-invasive disease harbor better oncological and survival outcomes compared to those who progressed before RC and to those upstaged at surgery. Tumor size and concomitant CIS at diagnosis are the main predictors of surgical treatment while tumor size, CIS and tumor multiplicity are associated with extravesical disease at surgery.

Recurrence, progression and cancer-specific mortality according to stage at re-TUR in T1G3 bladder cancer patients treated with BCG: not as bad as previously thought.

PURPOSE: The goals of transurethral resection of a bladder tumor (TUR) are to completely resect the lesions and to make a correct diagnosis to adequately stage and treat the patient. Persistent disease after TUR is not uncommon and is why re-TUR is recommended in T1G3 patients. When there is T1 tumor in the re-TUR specimen, very high risks of progression (82%) have been reported. We analyze the risks of recurrence, progression to muscle-invasive disease and cancer-specific mortality (CSM) according to tumor stage at re-TUR in T1G3 patients treated with BCG. METHODS: In our retrospective cohort of 2451 T1G3 patients, 934 patients (38.1%) underwent re-TUR. 667 patients had residual disease (71.4%): Ta in 378 (40.5%), T1 in 289 (30.9%) patients. Times to recurrence, progression and CSM in the three groups were estimated using cumulative incidence functions and compared using the Cox regression model. RESULTS: During a median follow-up of 5.2 years, 512 patients recurred. The recurrence rate was significantly higher in patients with a T1 at re-TUR (P < 0.001). Progression rates differed according to the pathology at re-TUR, 25.3% in T1, 14.6% in Ta and 14.2% in case of no residual tumor (P < 0.001). Similar trends were seen in both patients with and without muscle in the original TUR specimen. CONCLUSIONS: Patients with T1G3 tumors and no residual disease or Ta at re-TUR have better recurrence, progression and CSM rates than previously reported, with a CSM rate of 13.1 and a 25.3% progression rate in re-TUR T1 disease.

The clinical use of statistical permutation test methodology: a tool for identifying predictive variables of outcome.

OBJECTIVES: To identify the predictive variables affecting the outcome after radical surgery for bladder cancer by a newer statistical methodology, i.e. nonparametric combination (NPC). METHODS: A multicenter study enrolled 1,312 patients who had undergone radical cystectomy for bladder cancer in 11 Italian oncological centers from January 1982 to December 2002. A statistical analysis of their medical history and diagnostic, pathological and postoperative variables was performed using a NPC test. The patients were included in a comprehensive database with medical history and clinical and pathological data. Five-year survival was used as the dependent variable, and p values were corrected for multiplicity using a closed testing procedure. The newer nonparametric approach was used to evaluate the prognostic importance of the variables. All of the analyses were performed using routines developed in MATLAB© and the significance level was set at α = 0.05. RESULTS: A significant prognostic predictive value (p < 0.01) for tumor clinical staging, hydronephrosis, tumor pathological staging, grading, presence of concomitant carcinoma in situ, regional lymph node involvement, corpora cavernosa invasion, microvascular invasion, lymphatic invasion and prostatic stroma involvement was found. CONCLUSIONS: The NPC test could handle any type of variable (categorical and quantitative) and take into account the multivariate relation among variables. This newer methodology offers a significant contribution in biomedical studies with several endpoints and is recommended in presence of non-normal data and missing values, as well as solving high-dimensional data and problems relating to small sample sizes.

[Antibiotic prophylaxis in prostate biopsy]. / La profilassi antibiotica nell'agobiopsia prostatica.

INTRODUCTION: Prostate biopsy is nowadays one of the most frequent diagnostic procedures in urology. The incidence of bacteraemia, bacteriuria and infective complications is higher after the transrectal procedure than after the transperineal one. A survey demonstrated that 98% of the urologists in USA use antibiotics to prevent infective complications. The transrectal prostate biopsy is the only diagnostic intervention procedure in urology for which an antibiotic prophylaxis is recommended, also for low-risk patients, by the guidelines of the European Association of Urology. If the perineal route is adopted, the antibiotic prophylaxis is recommended only in high-risk patients. MATERIALS AND METHODS: The patient should preferably receive an evacuative enema to achieve a rectal cleansing and to ameliorate the diagnostic accuracy of transrectal ultrasound. A survey in the US demonstrated that an evacuative enema with saline solution is adopted by more than 80% of urologists. Criteria for antibiotics choice. The majority of bacteraemias are transitory, asymptomatic and self-limiting. On the other side, bacteriuria can persist for several days. Antibiotics must achieve high drug concentrations not only in plasma and tissue but also in urine. Symptomatic infections are generally caused by E. Coli and less frequently by the Streptococcus faecalis. Nevertheless, other agents as Klebsiella and Chlostridium, although rare, might cause severe infections. Thus, prophylaxis needs antibiotics at large spectrum and a single agent may not be enough for high-risk patients. Risk determination and drug schedules. It is essential to point out the infective risk of the patient. The choice of the drug, the timing and schedule of antibiotic prophylaxis are still object of debate. Several randomized studies have been conducted with contradictory results. RESULTS: The antibiotic prophylaxis should be tailored according to patients? infective risk and to the procedure adopted. It is able to reduce infections rate after transrectal biopsy below 5%. The adoption of periprostatic anesthesia and the number of cores can influence the incidence of infective complications. Commonly, one-three days oral administration of fluoroquinolone is adopted. A single-dose prophylaxis can be also used with favorable results. Tolerability and route of administration should be taken into account, and also costs should be considered. CONCLUSIONS: Considering the low cost of antibiotics adopted as short-term prophylaxis and the high cost of the treatment of infective complications, it seems reasonable to provide antibiotics prophylaxis for all patients at high risk for infective complications and for all cases submitted to transrectal prostate biopsy.

[Management, and prevention, of intravesical therapy complications].

The urologist must prevent, identify and properly treat the complications of intravesical chemotherapy and immunotherapy. Both local and systemic toxicity of adjuvant intravesical therapy is herein analyzed. Topical toxicity is mainly due to the inflammation induced by the contact between the instilled agent and the bladder mucosa. MATERIAL AND METHODS. The factors predisposing to topical toxicity must be identified and removed before starting the treatment. The choice of the agent, its dose, concentration and dosage must be tailored, whenever possible, to the presence of the above mentioned factors. Mitomycin and BCG can rarely provoke chronic cystitis, severely compromising bladder function. RESULTS. The most dangerous complication of early intravesical chemotherapy is the instillation in presence of an unrecognized bladder perforation. Flu-like syndrome, fever, chills, arthralgia are reported in almost 20% of patients receiving BCG. If fever persists for more than 48 hours or exceeds 38.5 °C, isoniazid must be administered and BCG stopped until complete remission. BCG sepsis is a rare but severe complication that must be promptly recognized and treated. If not, a life-threatening multi-organ failure syndrome can arise. Isoniazid and rifampicin, adding ethambutol when required, must be administered for a prolonged period until complete remission. CONCLUSIONS. Granulomatous lesions represent the main other rare systemic complications of BCG therapy. Systemic toxicity of intravesical chemotherapy is rare, due to the high molecular weight of the drugs, limiting systemic absorption.

[a-blockers in benign prostatic hyperplasia: the problem of "floppy iris syndrome". Results of a case-control study to evaluate the surgical risk through the meausurement of pupil diameter].

OBJECTIVES. α-blockers are a group of α-adrenoceptor antagonists used by urologists to treat lower urinary tract symptoms suggestive of benign prostatic hyperplasia. Recent studies have suggested that these drugs - tamsulosin in particular - are involved in the development of iris complications during phacoemulsification. The objective of this study is to investigate the effects of α-blockers - especially tamsulosin - on pupil diameter. MATERIALS AND METHODS. We measured the photopic, mesopic and post-dilatation pupil diameters in both eyes of 24 patients (46 eyes in total), 16 of them treated with α-blockers and 8 of them (16 eyes in total) not treated with any drugs (controls). RESULTS. All patients treated with tamsulosin showed minor photopic, mesopic and post-dilatation diameters compared to controls. Patients treated with other α-blockers did not show any difference compared to controls. CONCLUSIONS. Even if a small number of eyes was evaluated, our study shows that tamsulosin - through its selective effect on α1A receptors - is the most involved drug in the Intraoperative Floppy Iris Syndrome.

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.

PSA reduction (after antibiotics) permits to avoid or postpone prostate biopsy in selected patients.

Microscopic foci of prostatitis may induce prostate-specific antigen (PSA) increase. PSA reduction after antibiotics might identify those patients in whom biopsy can be avoided. Ninety-nine patients received ciprofloxacin for 3 weeks, of whom 59 showed PSA reduction. Histology detected small foci of prostatitis in 65% of cases. Carcinoma was found in 40 and 20.3% of patients with unchanged or decreased PSA, respectively (P=0.03). No cancer was detected if PSA decreased below 4 ng/ml or more than 70%. Biopsy can be postponed, with a low risk of missing a cancer, if PSA decreases more than 70% or below 4 ng/ml.

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.

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.

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.

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.

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.

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.