C. Llorente

GreenLight HPS 120-W Laser Vaporization versus Transurethral Resection of the Prostate for the Treatment of Lower Urinary Tract Symptoms due to Benign Prostatic Hyperplasia: A Randomized Clinical Trial with 2-year Follow-up

BACKGROUND High-level evidence to support the use of photoselective vaporization of the prostate (PVP) is limited. OBJECTIVE Assess the efficacy and safety of GreenLight HPS 120-W laser PVP compared with transurethral resection of the prostate (TURP). DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial was performed with 50 patients having lower urinary tract symptoms due to benign prostatic hyperplasia in each treatment arm. INTERVENTION Random allocation to PVP or TURP. MEASUREMENTS International Prostate Symptom Score (IPSS), quality of life (QoL), and changes in maximum flow rate (Qmax) were the main end points. Patients were evaluated at a follow-up time of 2 yr. Five patients were lost to follow-up. A last observation carried forward analysis was done. RESULTS AND LIMITATIONS Both laser PVP and TURP resulted in the same IPPS reduction at 2 yr (-15.7 and -14.9, respectively; p=0.48) and in the same gain in Qmax (+14.5 ml/s and +13.1 ml/s, respectively; p=0.65). QoL was equivalent for both treatment modalities. These results were independent of prostate size, American Society of Anesthesiologists risk category, and prior indwelling catheter. No statistically significant differences were detected between arms in terms of complication rates. In the laser PVP group, three patients were readmitted to the hospital and two developed a urethral stricture. In the TURP group, two patients were readmitted, six developed a urethral stricture, and two developed bladder neck sclerosis. In-hospital stay and time to catheter removal were significantly shorter with PVP. Limitations are the potential lack of power to detect differences in the complications between groups and the lack of blindness due to the nature of the intervention. CONCLUSIONS GreenLight HPS 120-W laser PVP is as effective as TURP for symptom reduction and improvement of QoL. No differences were seen in the response of storage and voiding symptoms. Laser PVP and TURP have the same complication rate. Length of stay is shorter for laser PVP group.

Safety of Active Surveillance Program for Recurrent Nonmuscle-invasive Bladder Carcinoma

OBJECTIVES To report our experience with a select group of patients with low-risk tumors included in an observation and monitoring program after the diagnosis of recurrence. METHODS We performed a prospective cohort study in patients diagnosed with recurrent, nonmuscle-invasive bladder cancer maintained under an active surveillance protocol. The inclusion criteria were papillary tumors with negative cytology findings, previous nonmuscle-invasive tumor (Stage pTa, pT1a), grade 1-2, size <1 cm, and number of tumors <5. No symptomatic patients or those with carcinoma in situ or grade 3 tumors were included. A retrospective analysis of a control group of patients with clinical characteristics similar to those of the patients on active surveillance, but who underwent transurethral resection immediately after the recurrence was diagnosed was also performed. RESULTS The data from 64 patients (70 observation events) were analyzed. The mean patient age was 66.7 years. The median follow-up was 38.6 months. The median time patients remained in observation was 10.3 months. The tumor histologic features before observation were Stage pTa in 77.1%, Stage pT1a in 22.9%, grade 1 in 67.1%, and grade 2 in 23%. After 10.3 months, 93.5% of the patients had not progressed in stage and 83.8% had not progressed in grade. None of the patients experienced progression to muscle-invasive disease. A comparison between the rates of progression in the study and control groups showed no statistically significant difference. CONCLUSIONS Patients with recurrent, small (<1 cm), nonmuscle-invasive bladder tumors can be safely offered monitoring under an active surveillance protocol, with a minimal risk of progression in either grade or stage, thus reducing the amount of surgical intervention they might undergo throughout their life.

Long-term oncological outcomes of an active surveillance program in recurrent low grade Ta bladder cancer.

INTRODUCTION Over the last 2 decades, there has been a major increase in active surveillance (AS) as a therapeutic alternative in urological tumors regarded to be of low risk. Owing to the findings of significant clinical outcomes in our series, this report presents an update of our AS program in patients with recurrent non-muscle-invasive bladder tumor. The objective was to confirm the oncological long-term safety of this protocol and to determine possible variables associated with progression. MATERIALS AND METHODS Cohort of patients included in AS between 1999 and 2014. INCLUSION CRITERIA recurrent papillary tumors, previous pTa-pT1, G1-G2, shorter than 1cm, and fewer than 5 tumour sites. EXCLUSION CRITERIA prior G3, CIS (carcinoma in situ), or positive-result cytology. All patients underwent close monitoring with flexible cystoscopy every 3 to 4 months for the first 2 years. After this time, follow-ups were conducted every 6 months, alternating between cystoscopy and ultrasound. Urinary cytology test was performed at all visits. RESULTS In all, 252 AS periods in 186 patients were studied, with a median follow-up of 6 years. Out of all periods, 203 (80.6%) underwent active treatment. After remaining under observation, 86.4% had not progressed in stage, and 79.3% in grade. Of these patients, 4 experienced progression to T2; all of them were previously T1G2. CONCLUSIONS AS in a high-selectivity group of patients with recurrent non-muscle-invasive bladder tumor is feasible and oncologically safe in the long term. Patients with previous history of T1 should not be included in AS protocols even when very small recurrences are diagnosed.

Vigilancia activa en cáncer de próstata de bajo riesgo. Aceptación por el paciente y resultados

OBJECTIVES To evaluate the acceptance of active monitoring by patients treated in our healthcare community and to report the clinical results of an active surveillance program in patients with low-risk prostate cancer. MATERIAL AND METHODS Prospective study of patients enrolled in an active surveillance programme at our centre between 2004 and 2012. The inclusion criteria were PSA <10 ng/ml, Gleason score ≤6, clinical stage T1c/T2a, ≤2 positive cores, and no more than 50% of the core being affected. Curative treatment was proposed when faced with pathological progression over the course of the monitoring. RESULTS In 2011, only 17% of the total number of potential candidate patients rejected their inclusion in a surveillance programme and were treated actively. We analysed a series of 144 patients included in our active surveillance protocol. The mean follow-up time was 3.22 years (SD 2.08). A total of 110 patients (76.3%) remained under active monitoring, with an estimated median treatment-free survival after diagnosis of 6.9 years (95% CI: 6.2-7.6). The percentage of patients who remained free of treatment at 2 and 5 years was 96.3% (95% CI: 92.8%-99.8%) and 70.9% (95% CI: 59.3%-85.5%), respectively. Thirty four patients (23.6%) required curative treatment. The mean time to treatment was 4.6 years (SD 2.3). CONCLUSIONS Active surveillance of highly selected patients with low-risk prostate cancer is a valid alternative therapy that is accepted by patients in our community.

Resultados oncológicos en pacientes potencialmente candidatos a vigilancia activa sometidos a prostatectomía radical

OBJECTIVE To determine whether there are differences in the oncological outcomes after radical prostatectomy (adverse pathology and biochemical recurrence) based on clinical selection criteria used in two active surveillance (AS) protocols. MATERIAL AND METHODS 442 patients diagnosed with localized prostate cancer (CP) underwent radical prostatectomy at our institution between August 2003 and December 2009. We selected patients with low-risk CP, which could have been included in an AS program. Patients were divided into two groups: group i, those who met the most strict surveillance criteria described by Epstein (PSAD<.15; T1/T2a;<2 positive core, Gleason≤6,<50% involvement of the core) and group ii, those meeting the more open criteria described by Klotz (PSA≤10 or<15 at age 70, Gleason≤6 or<7 [3+4] in over 70 years). We compared both groups to determine differences in pathological stage, positive surgical margins and biochemical recurrence after radical prostatectomy. RESULTS Of the 442 patients 48% (213 patients) had low-risk PC, and become potential candidates for an AS program. Of the patients operated on 17% (76 patients) met the criteria for AS as of Epsteins and 48% (213 patients) according to Klotz. Comparing patients in both groups there were no statistically significant differences in the presence of pT3 (7.9% vs 10.8%) P=.55, positive margins (22.4% vs. 28.3%) P=.41, nor in biochemical recurrence at 3 years (5.3% vs 5.6%) P=.86. CONCLUSIONS In our series of patients theoretically candidates for inclusion in a program of active surveillance, we found no differences in the percentage of patients with pathological stage pT3, positive margins and biochemical recurrence according to clinical inclusion criteria currently used.

Optimización de un programa de alta precoz tras prostatectomía radical laparoscópica

OBJECTIVE To assess the safety of hospital discharge 24 hours after laparoscopic radical prostatectomy and to identify possible factors associated with longer hospital stays. MATERIAL AND METHODS Retrospective study of patients diagnosed with localized prostate cancer underwent to laparoscopic radical prostatectomy consecutively between May of 2007 and December of 2010. Those patients who met the following requirements were discharged in less than 24 hours: absence of complications, drainage debit minor than 50 cc, normal oral tolerance, no significant bladder haematuria and good functional recovery. Logistic regression analysis was conducted in order to assess the possible associated variables with longer hospital stays. RESULTS A total of 266 patients were analysed. The follow-up median was 34 months. Eighty patients (30.1%) were discharged in less than 24 hours. Average stay (SD) of all series was 2.9 days (3.08). Solely HTA, neurovascular bundles sparing and the development of lymphadenectomy were statistically significant between both groups in univariate analysis (discharge<24 hours vs. discharge>24 hours). In multivariate analysis, only HTA (OR=1.98 [CI 95%:1.13-3.47], P=.016) and lymphadenectomy performance (OR=2.56 [CI 95%:1.18-5.56] P=.017) were independent predictive variables of hospital stays longer than 24 hours. CONCLUSIONS Early hospital discharge of patients underwent to LRP is feasible and safe. In our series, the lymphadenectomy performance and the HTA were associated factors to longer hospital stay.

Cambios en el grado de Gleason en las biopsias de seguimiento de pacientes con cáncer de próstata en programa de vigilancia activa

INTRODUCTION Active surveillance for prostate cancer has grown systematically in the recent years with more robust mid-term outcomes. However, changes in Gleason score during serial biopsies are not detailed in many of these reports. OBJECTIVES To evaluate changes in Gleason score on follow-up biopsies in low-risk prostate cancer in patients undergoing AS program in our center. MATERIAL AND METHODS Series of patients diagnosed of prostate cancer between 2004 and 2013 have been analyzed. The inclusion criteria were: PSA ≤ 10 ng/ml + Gleason ≤ 6 + T1c/T2a + ≤ 2 positive cores, and no more than 50% of affected core. The pathology of each of the biopsies was analyzed. RESULTS We studied a series of 175 patients undergoing AS. Mean follow-up was 3.96 years (SD 2.4). Follow-up biopsies with Gleason scores ≥ 7 were: 5.72% in the first biopsy, 7.39% and 7.41% in subsequent biopsies. By contrast, in 42.03% of cases did not show evident tumor involvement in the first biopsy, 40.74% and 51.85% in the second and third biopsies respectively. Median stay in the AS program was: 90.99 months (95% CI: 53.53-128.46) in patients with first positive biopsy vs. 96.66 months (95% CI: 63.19-130.13) in those without evidence of tumor. CONCLUSIONS In our series the pathological data of the first 3 biopsies remain stable in terms of the positive biopsy rate, Gleason score, or indication of active treatment proportions. Those patients who do not show evidence of malignancy in the first follow-up biopsy are less likely to need active treatment than the other patients in the series.

1037 EXTERNAL VALIDATION AND APPLICABILITY OF THE EORTC RISK TABLES FOR NON MUSCLE-INVASIVE BLADDER CANCER

Purpose To perform an external validation of the EORTC risk tables and to evaluate their applicability in the patients of our institution by comparing the actual risk of recurrence and progression in our series to those obtained through the application of the EORTC tables.

Application of self-expanding stents in prostate cancer with rectal involvement. Report of two cases and review of the literature

OBJECTIVES Rectal involvement due to local spread from prostate cancer is an uncommon finding. When this condition occurs, prognosis is ominous. Our objective is to report our experience in the use of self-expanding endorectal stents in the management of rectal invasion from prostate cancer. Two cases are presented and a review of the literature is carried out. METHODS AND RESULTS In both cases, self-expanding Wallstent devices were placed (under fluoroscopic control), in order to solve their episodes of bowel obstruction. It was successfully performed in both patients. Therefore, an open surgery procedure was avoided. CONCLUSIONS When facing the evidence of a tumor that invades the rectal wall, it is important to rule out the existence of prostate cancer (the surgical option in these patients carries an ominous prognosis). Therefore, we propose this new procedure whose results could be very satisfactory in certain settings.

Influencia de la localización y del número de metástasis en la supervivencia de los pacientes con cáncer de próstata metastásico

INTRODUCTION The prognosis of patients diagnosed with metastatic prostate cancer seems to be modulated by factors such as the number and site of metastases. Our objective is to evaluate survival outcomes according to the number and site of metastases in our series of metastatic patients over the last 15 years. MATERIALS AND METHODS A retrospective analysis was performed on patients diagnosed between 1998 and 2014. We analyzed overall survival and progression-free survival, depending on the number and location of metastases on patients with newly diagnosed metastatic prostate cancer. Other potential prognostic factors were also evaluated: age, clinical stage, PSA at diagnosis, Gleason, PSA nadir, time till PSA nadir and first-line or second-line treatment after progression. RESULTS We analyzed a series of 162 patients. The mean age was 72.7yr (SD: 8.5). The estimated median overall survival was 3.9 yr (95% CI 2.6-5.2). The overall survival in patients with only lymph node metastases was 7 yr (95% CI 4.1-9.7), 3.9 (95%CI 2.3-5.5) in patients with only bone metastases, 2.5 yr (95% CI 2-2.3) in lymph nodes and bone metastases, and 2.2 yr (95% CI 1.4-3) in patients with visceral metastases (P<.001). In multivariate analysis, the location of metastasesis significantly associated with overall survival and progression-free survival. The number of metastases showed no association with survival. CONCLUSIONS The site of metastases has a clear impact on both overall survival and progression-free survival. Patients with only lymph node involvement had a better prognosis. The number of metastases showed no significant impact on survival in our series.