Bruno Frea

Morbidity and Quality of Life in Elderly Patients Receiving Ileal Conduit or Orthotopic Neobladder After Radical Cystectomy for Invasive Bladder Cancer

OBJECTIVES The objectives of the study were to evaluate morbidity, survival, and quality of life (QoL) in elderly patients with invasive bladder cancer who received an orthotopic neobladder or an ileal conduit. METHODS The charts of 85 patients, aged 75 or older (median age 78), who had received an ileal conduit (n = 53) or an orthotopic neobladder (n = 32) after radical cystectomy at 3 Italian institutions in the period January 2000 to September 2004 were retrospectively reviewed. Perioperative and postoperative complications were recorded, as well as survival data at last follow-up. QoL was evaluated in 34 of 37 patients who were alive at the time of analysis by using the European Organisation for Research and Treatment of Cancer (EORTC) instruments quality of life questionnaire C30 (QLQ-C30) and QLQ-muscle-invasive bladder cancer module (QLQ-BLM). RESULTS Multiple regression analysis showed that stage significantly affected survival whereas the type of urinary diversion did not. Global Health Status (GHS) scores in the neobladder group were higher than in the ileal conduit group but the difference was not statistically significant. The scores of all the QLQ multi-item scales and single-item measures were comparable in the 2 groups. Overall, 56% and 25% daytime and nighttime complete continence rates were observed in patients with an orthotopic neobladder. CONCLUSIONS The results of our retrospective analysis suggest that an orthotopic neobladder can be suitable for elderly patients with no additional morbidity compared with an ileal conduit. Both types of diversion seem to result in acceptable scores for most aspects of QoL, including urinary symptoms and continence rate. These figures may be helpful in the preoperative counselling of elderly patients with bladder cancer.

Identifying the Best Candidate for Radical Prostatectomy Among Patients with High-Risk Prostate Cancer

BACKGROUND The current role of radical prostatectomy (RP) in patients with high-risk disease remains controversial. OBJECTIVE To identify which high-risk prostate cancer (PCa) patients might have favorable pathologic outcomes when surgically treated. DESIGN, SETTING, AND PARTICIPANTS We evaluated 1366 patients with high-risk PCa (ie, at least one of the following risk factors: prostate-specific antigen [PSA]>20 ng/ml, cT3, biopsy Gleason 8-10) treated with RP and pelvic lymph node dissection (PLND) at eight European centers between 1987 and 2009. A favorable pathologic outcome was defined as specimen-confined (SC) disease-namely, pT2-pT3a, node negative PCa with negative surgical margins. INTERVENTION All patients underwent radical retropubic prostatectomy and PLND. MEASUREMENTS Univariable and multivariable logistic regression models tested the association between predictors and SC disease. A logistic regression coefficient-based nomogram was developed and internally validated using 200 bootstrap resamples. The Kaplan-Meier method was used to depict biochemical recurrence (BCR) and cancer-specific survival (CSS) rates. RESULTS AND LIMITATIONS Overall, 505 of 1366 patients (37%) had SC disease at RP. All preoperative variables (ie, age and PSA at surgery, clinical stage, and biopsy Gleason sum) were independent predictors of SC PCa at RP (all p≤0.04). Patients with SC disease had significantly higher 10-yr BCR-free survival and CSS rates than patients without SC disease at RP (66% vs 47% and 98 vs 88%, respectively; all p<0.001). A nomogram including PSA, age, clinical stage, and biopsy Gleason sum demonstrated 72% accuracy in predicting SC PCa. This study is limited by its retrospective design and by the lack of an external validation of the nomogram. CONCLUSIONS Roughly 40% of patients with high-risk PCa have SC disease at final pathology. These patients showed excellent long-term outcomes when surgically treated, thus representing the ideal candidates for RP as the primary treatment for PCa. Prediction of such patients is possible using a nomogram based on routinely available clinical parameters.

Impact of Age and Comorbidities on Long-term Survival of Patients with High-risk Prostate Cancer Treated with Radical Prostatectomy: A Multi-institutional Competing-risks Analysis.

BACKGROUND Survival after surgical treatment using competing-risk analysis has been previously examined in patients with prostate cancer (PCa). However, the combined effect of age and comorbidities has not been assessed in patients with high-risk PCa who might have heterogeneous rates of competing mortality despite the presence of aggressive disease. OBJECTIVE To examine the risk of 10-yr cancer-specific mortality (CSM) and other-cause mortality (OCM) according to clinical and pathologic characteristics of patients treated with radical prostatectomy (RP) for high-risk PCa. DESIGN, SETTING, AND PARTICIPANTS Within a multi-institutional cohort, 3828 men treated with RP for high-risk PCa (defined as the presence of at least one of these risk factors: prostate-specific antigen >20 ng/ml, biopsy Gleason score 8-10, clinical stage ≥ T3) were identified. INTERVENTION All patients underwent RP and pelvic lymph node dissection. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Competing-risk Poisson regression analyses were performed to simultaneously assess the 10-yr CSM and OCM rates after RP. The same analyses were also conducted after stratification of patients according to age at surgery, comorbidity status assessed by the Charlson Comorbidity Index (CCI), and number of risk factors (one vs two or more). RESULTS AND LIMITATIONS Overall, 229 patients (5.9%) died from PCa; 549 (14.3%) died from other causes. The 10-yr CSM and OCM rates ranged from 5.1% to 12.8% and from 4.3% to 37.4%, respectively. Age and CCI were the major determinants of OCM; their impact on CSM was minimal. OCM was the leading cause of death in all patient groups except in young men (≤ 59 yr) with no comorbidities, regardless of the number of risk factors (10-yr CSM and OCM 6.9-12.8% and 5.5-6.3%, respectively). The main limitation was the lack of patients managed conservatively. CONCLUSIONS Even in the context of high-risk PCa, long-term CSM after RP is modest and represents the leading cause of death only in young, healthy patients. Conversely, older and sicker patients with multiple risk factors are at the highest risk of dying from OCM while sharing very low CSM rates.

Prognostic factors and risk groups in T1G3 non-muscle-invasive bladder cancer patients initially treated with Bacillus Calmette-Guerin: results of a retrospective multicenter study of 2451 patients

BACKGROUND The impact of prognostic factors in T1G3 non-muscle-invasive bladder cancer (BCa) patients is critical for proper treatment decision making. OBJECTIVE To assess prognostic factors in patients who received bacillus Calmette-Guérin (BCG) as initial intravesical treatment of T1G3 tumors and to identify a subgroup of high-risk patients who should be considered for more aggressive treatment. DESIGN, SETTING, AND PARTICIPANTS Individual patient data were collected for 2451 T1G3 patients from 23 centers who received BCG between 1990 and 2011. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Using Cox multivariable regression, the prognostic importance of several clinical variables was assessed for time to recurrence, progression, BCa-specific survival, and overall survival (OS). RESULTS AND LIMITATIONS With a median follow-up of 5.2 yr, 465 patients (19%) progressed, 509 (21%) underwent cystectomy, and 221 (9%) died because of BCa. In multivariable analyses, the most important prognostic factors for progression were age, tumor size, and concomitant carcinoma in situ (CIS); the most important prognostic factors for BCa-specific survival and OS were age and tumor size. Patients were divided into four risk groups for progression according to the number of adverse factors among age ≥ 70 yr, size ≥ 3 cm, and presence of CIS. Progression rates at 10 yr ranged from 17% to 52%. BCa-specific death rates at 10 yr were 32% in patients ≥ 70 yr with tumor size ≥ 3 cm and 13% otherwise. CONCLUSIONS T1G3 patients ≥ 70 yr with tumors ≥ 3 cm and concomitant CIS should be treated more aggressively because of the high risk of progression. PATIENT SUMMARY Although the majority of T1G3 patients can be safely treated with intravesical bacillus Calmette-Guérin, there is a subgroup of T1G3 patients with age ≥ 70 yr, tumor size ≥ 3 cm, and concomitant CIS who have a high risk of progression and thus require aggressive treatment.

Adjustable Continence Therapy for the treatment of male stress urinary incontinence : A single-centre study

Objective. To evaluate the Adjustable Continence Therapy (ProACT™) device, a new device for the treatment of male stress urinary incontinence resulting from compromised sphincteric function. Material and methods. A total of 64 males with post-prostatectomy incontinence underwent ProACT implantation. Efficacy was assessed by means of a daily pad count, a direct visual stress test, administration of the Incontinence Quality of Life (IQOL) and patient global impression (PGI) questionnaires and use of a visual analogue scale (VAS) to assess improvement in incontinence. These assessments were performed at baseline, 1, 3, 6 and 12 months after the procedure and annually thereafter. Results. The pad count declined from a median of 5.2 at baseline to 2 at 6 months and to 1.54 at 12 months. The median baseline IQOL score was 31.7, and this improved to 62.5 at 6 months and to 71.1 at 12 months. In terms of postoperative daily pad usage, 43 patients (67%) were considered to be dry, 10 (15%) improved and 11 (17%) unchanged. In terms of the post operative PGI score, 42 patients (66%) considered themselves to have improved greatly, 10 (16%) to have improved quite a lot, 6 (9%) to have improved slightly and 6 (9%) to be unchanged. The average improvement based on the VAS was 80%. The average number of postoperative adjustments was three (range zero to nine). Complications included infection (2/64; 3%), erosion of balloons (5/64; 7.6%), migration (2/64; 3%) and balloon deflation (2/64; 3%). Device removal was required in 9/64 patients (14%) but was easily achieved using local anaesthesia, and this thus permitted further therapeutic intervention. New balloons were implanted following endoscopic confirmation of urethral healing. Conclusion. The ProACT device represents an efficacious treatment modality, which has an acceptable complication rate for a difficult group of patients.

Analysis of radical cystectomy and urinary diversion complications with the Clavien classification system in an Italian real life cohort

INTRODUCTION Standardized methods of reporting complications after radical cystectomy (RC) and urinary diversions (UD) are necessary to evaluate the morbidity associated with this operation to evaluate the modified Clavien classification system (CCS) in grading perioperative complications of RC and UD in a real life cohort of patients with bladder cancer. MATERIALS AND METHODS A consecutive series of patients treated with RC and UD from April 2011 to March 2012 at 19 centers in Italy was evaluated. Complications were recorded according to the modified CCS. Results were presented as complication rates per grade. Univariate and binary logistic regression analysis were used for statistical analysis. RESULTS RESULTS AND LIMITATIONS 467 patients were enrolled. Median age was 70 years (range 35-89). UD consisted in orthotopic neobladder in 112 patients, ileal conduit in 217 patients and cutaneous ureterostomy in 138 patients. 415 complications were observed in 302 patients and were classified as Clavien type I (109 patients) or II (220 patients); Clavien type IIIa (45 patients), IIIb (22 patients); IV (11 patients) and V (8 patients). Patients with cutaneous ureterostomy presented a lower rate (8%) of CCS type ≥IIIa (p = 0.03). A longer operative time was an independent risk factor of CCS ≥III (OR: 1.005; CI: 1.002-1.007 per minute; p = 0.0001). CONCLUSIONS In our study, RC is associated with a significant morbidity (65%) and a reduced mortality (1.7%) when compared to previous experiences. The modified CCS represents an easily applicable tool to classify the complications of RC and UD in a more objective and detailed way.

A prospective evaluation of efficacy and compliance with a multistep treatment approach for erectile dysfunction in patients after non-nerve sparing radical prostatectomy

Associate Editor

Survival and impact of clinical prognostic factors in surgically treated metastatic renal cell carcinoma.

BACKGROUND The survival impact of metastasectomy for metastatic renal cell carcinoma (mRCC) is still an active research field, particularly in the multimodal/targeted therapy era. OBJECTIVE To determine the survival impact of clinical prognostic factors and their application to stratification of patients according to their prognosis so clinicians may be aided in their management of mRCC. DESIGN, SETTING, AND PARTICIPANTS Retrospective, bi-institutional cohort study of 109 consecutive patients (71 male and 38 female; median age: 62 yr (range: 25-82 yr) with renal cell carcinoma (RCC) who underwent partial or radical nephrectomy and at least one metastasectomy for mRCC. INTERVENTION Metastasis resection from various anatomic sites with the aim of completely removing detected lesions. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS Univariable and multivariable Cox regression models were used to analyse the impact of clinical prognostic factors on cancer-specific survival (CSS). Kaplan-Meier analysis with the log-rank test was used to compare CSS. Receiver operating characteristic (ROC) analysis was performed to test accuracy of prognostic groups. The α error for statistical significance was set at 0.05. RESULTS AND LIMITATIONS Multivariable analysis revealed that primary tumour T stage ≥ 3 (hazard ratio [HR]: 2.8; p<0.01), primary tumour Fuhrman grade ≥ 3 (HR: 2.3; p<0.03), nonpulmonary metastases (HR: 3.1; p<0.03), disease-free interval ≤ 12 mo (HR: 2.3; p<0.058), and multiorgan metastases (HR: 2.5; p<0.04) were independent pretreatment prognostic factors. Leuven-Udine (LU) prognostic groups based on these covariates were created and analysed with Kaplan-Meier and log-rank tests. The 2- and 5-yr CSS were significantly different; the respective group A CSS rates were 95.8% and 83.1%; group B, 89.9% and 56.4%; group C, 65.6% and 32.6%; and group D, 24.7% and 0% (p<0.0001). ROC analysis on the accuracy of prognostic grouping revealed respective areas under the curve of 0.87 and 0.88 at 2 and 5 yr. Main limitations to present study are the retrospective design and the presence of different metastasis sites. CONCLUSIONS LU prognostic groups could be considered an accurate clinical tool to stratify patients according to prognosis and aid clinicians in the management of mRCC.

Adjustable continence therapy for treatment of recurrent female urinary incontinence.

PURPOSE The Adjustable Continence Therapy (ACT) device has been developed for the treatment of recurrent stress urinary incontinence resulting from intrinsic sphincter deficiency (ISD) by increasing urethral coaptation. We critically evaluated the technique and its results. METHODS The ACT device consists of two balloons each attached to an injectable port placed in the labia majora. The port enables postoperative adjustment in balloon coaptation pressure. All 49 patients had previously failed anti-incontinence surgery. Each patient was implanted with the ACT device and assessed by preoperative and postoperative overall impression, incontinence quality of life questionnaire, and visual analog scale; 38 of the 49 subjects had a minimum of 1 year of data collected, including pad use, number of adjustments needed, and complications. RESULTS Mean operative time was 20.3 minutes (range 10-30 minutes), with 88% of implantations performed using local or regional anesthesia. Balloon adjustments were needed in 62%; 68% of patients reported being dry and 16% improved. Complications included migration (12%), balloon failure (3.6%), and erosion (4%). CONCLUSION The ACT device provided significant improvement in at last 70% of patients with recurrent stress urinary incontinence.

Adjustable continence therapy (ProACT) and bone anchored male sling: Comparison of two new treatments of post prostatectomy incontinence.

Objectives:  To compare the efficacy of two surgical treatments for male urinary stress incontinence: adjustable continence therapy (ProACT) and bone anchored male sling (BAMS).