Antonio Galfano

A systematic review and meta-analysis of randomized controlled trials with antimuscarinic drugs for overactive bladder

CONTEXT Anticholinergic drugs are commonly used in patients with overactive bladder (OAB) who do not achieve symptom relief and quality of life improvement with conservative management. Several drugs, with different doses, formulations, and routes of administration are currently available, making the choice quite difficult. OBJECTIVE To evaluate efficacy and safety of different doses, formulations, and route of administration of the available anticholinergic drugs. EVIDENCE ACQUISITION A systematic review of the literature was performed in August 2007 using Medline, Embase, and Web of Science. Efficacy (micturitions per 24h, volume voided per micturition, urgency urinary incontinence episodes per 24h, incontinence episodes per 24h) and safety (mainly, adverse events and withdrawal rates) end points were evaluated in the randomized control trials (RCTs) assessing the role of anticholinergic drugs in non-neurogenic OAB. Meta-analysis of RCTs was conducted using the Review Manager software 4.2 (Cochrane Collaboration). EVIDENCE SYNTHESIS Our systematic search identified 50 RCTs and three pooled analyses. Tolterodine immediate release (IR) had a more favorable profile of adverse events than oxybutynin IR. Regarding different dosages of IR formulations, dose escalation might yield some limited improvements in the efficacy but at the cost of significant increase in the rate of adverse events. In the comparisons between IR and extended-release (ER) formulations, the latter showed some advantages, both in terms of efficacy and safety. With regard to the route of administration, use if a transdermal route of administration does not provide significant advantage over an oral one. CONCLUSION Many of the available RCTs have good methodological quality. ER formulations should be preferred to the IR ones. With regard to IR formulations, dose escalation might yield some improvements in the efficacy with significant increase in the AE. More clinical studies are needed to indicate which of the drugs should be used as first-, second-, or third-line treatment.

Independent predictors of cancer-specific survival in transitional cell carcinoma of the upper urinary tract: multi-institutional dataset from 3 European centers.

The objective of the current study was to identify variables that were predictive of cancer‐specific survival in patients with nonmetastatic transitional cell carcinoma of the upper urinary tract (UUT‐TCC).

Prognostic factors in squamous cell carcinoma of the penis.

Squamous cell carcinoma (SCC) of the penis is an uncommon disease in the US and Europe. Without treatment, patients with penile SCC usually die within 2 years after diagnosis of the primary lesion, because of uncontrollable locoregional disease or from distant metastases. The spread of the tumor to the locoregional lymph nodes (lymph-node positivity) is the most relevant prognostic factor. With the available treatments, 5-year cancer-specific survival probabilities are between 75% and 93% for those patients with clinically node-negative disease, and progressively lower for those with increasingly extensive node-positive disease. Similarly, patients with pathologically proven negative nodes have 5-year cancer-specific survival probabilities ranging from 85% to 100%. While patients with a single positive superficial lymph node on pathology have very good cancer-related outcomes, patients with multiple involved lymph nodes have significantly less favorable outcomes. This article focuses on the most important issues that surround the prognosis of squamous cell carcinoma of the penis, with special attention to the prognostic nomograms for penile cancer patients published in 2006.

Independent predictors of metachronous bladder transitional cell carcinoma (TCC) after nephroureterectomy for TCC of the upper urinary tract

To identify the prognostic factors predictive of metachronous bladder transitional cell carcinoma (TCC) in a multi‐institutional dataset of patients who had undergone nephroureterectomy (NU) for nonmetastatic upper urinary tract (UUT) TCC.

Beyond the Learning Curve of the Retzius-sparing Approach for Robot-assisted Laparoscopic Radical Prostatectomy: Oncologic and Functional Results of the First 200 Patients with ≥1 Year of Follow-up

BACKGROUND Robot-assisted laparoscopic radical prostatectomy (RARP) has become the main surgical option for localized prostate cancer. We recently developed a new approach for RARP, passing through the pouch of Douglas and avoiding all the Retzius structures involved in continence and potency preservation. OBJECTIVE To report the functional and oncologic results of our first 200 patients operated on using this new approach. DESIGN, SETTING, AND PARTICIPANTS This was a prospective, noncontrolled case series including the first 200 consecutive patients undergoing this kind of surgery (January the 1st, 2010 to December the 31st, 2011). SURGICAL PROCEDURE Retzius-sparing RARP. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS All perioperative, oncologic, and functional data were prospectively recorded. Potency was defined as an International Index of Erectile Function-5 questionnaire score >17; continence was defined as use of no pad or of one safety liner. Oncologic results were reported as positive surgical margins (PSM) and 1-yr biochemical disease-free survival (1y-bDFS). Recurrence was defined as a repeated prostate-specific antigen >0.2 ng/ml. Complications were graded according to the Clavien-Dindo system. The first 100 patients (group 1) were compared with the second 100 (group 2) to evaluate the learning curve effects. RESULTS AND LIMITATIONS The median patient age was 65 yr. Comparing the two groups, transfusions were needed in 8% versus 4% of cases in groups 1 and 2, respectively (p=0.02). There was one Clavien-Dindo grade 3b in group 1 versus one grade 3a complication in group 2. In patients with pT2 disease, PSMs were recorded in 22.4% of those in group 1 versus 10.1% in group 2 (p=0.045). 1y-bDFS was 89% in group 1 versus 92% in group 2. For groups 1 and 2, respectively, immediate continence was reached in 92% versus 90% of patients, and the 1-yr continence rate was 96% versus 96%. Considering the 77 potent patients aged <65 yr who underwent bilateral intrafascial nerve-sparing surgery, 40.4% of those in group 1 versus 40% of those in group 2 reached their first intercourse within 1 mo; at 1 yr of follow-up, these figures had increased to 81% versus 71%, respectively (p=0.162). The main limitation of this study is its noncontrolled nature. CONCLUSIONS We demonstrated Retzius-sparing RARP to be oncologically safe and to result in high early continence and potency rates. Long-term, prospective, comparative, and possibly randomized studies are needed.

Is robotically assisted laparoscopic radical prostatectomy less invasive than retropubic radical prostatectomy? Results from a prospective, unrandomized, comparative study

To evaluate whether robotically assisted laparoscopic prostatectomy (RALP) is less invasive than radical retropubic prostatectomy (RRP), as experimental studies suggest that the acute phase reaction is proportional to surgery‐induced tissue damage.

TNM staging system for renal-cell carcinoma: current status and future perspectives.

The Tumour, Nodes, and Metastasis (TNM) staging system is a method of stratifying patients with cancer and is based on data obtained from large multicentre studies that involved large numbers of patients, and have a good level of evidence. However, despite continual revisions to the methodology to incorporate evidence from new clinical studies, the optimum stratification of patients with renal-cell carcinoma (RCC) using the TNM staging system remains controversial and further revisions, in our opinion, are needed. Revision of the TNM staging system for renal-cell cancer could also result in the simultaneous update of the integrated prognostic systems that are currently used along side this traditional method of staging. These integrated systems could become key instruments for guiding patient counselling, for appropriate follow up strategies, for patient selection for clinical trials, and for appropriate assessment of results if the perception that they are complex is overcome. This perception is driven by the presence of more than one system, the heterogeneity of clinical and pathological variables included in the methodology, and the need for robust comparative studies between the various systems. Therefore, in everyday clinical practice, the TNM system is regarded as a more reliable method of staging. In this Essay, we aim to highlight the problems associated with the current version of the TNM staging system and highlight areas in which this grading instrument can be improved in future to become a more refined and standardised method of communication between all clinicians involved in clinical management of RCC.

The 'Stage, Size, Grade and Necrosis' score is more accurate than the University of California Los Angeles Integrated Staging System for predicting cancer-specific survival in patients with clear cell renal cell carcinoma

To compare the prognostic accuracy of the two most used integrated staging systems to predict the outcome of patients with clear cell renal cell carcinoma (RCC).

A New Anatomic Approach for Robot-Assisted Laparoscopic Prostatectomy: A Feasibility Study for Completely Intrafascial Surgery

Robot-assisted laparoscopic prostatectomy (RALP) has been disseminated widely, changing the knowledge of surgical anatomy of the prostate. The aim of our study is to demonstrate the feasibility of a new, purely intrafascial approach. The Bocciardi approach for RALP passes through the Douglas space, following a completely intrafascial plane without any dissection of the anterior compartment, which contains neurovascular bundles, Aphrodites veil, endopelvic fascia, the Santorini plexus, pubourethral ligaments, and all of the structures thought to play a role in maintenance of continence and potency. In this case series, we present our first five patients undergoing the Bocciardi approach for RALP. We report the results of our technique in three patients following two unsuccessful attempts. No perioperative major complication was recorded. Pathologic stage was pT2c in two patients and pT2a in one patient, with no positive surgical margin. The day after removing the catheter, two of the three patients reported use of a single, small safety pad, and one patient was discharged without any pad. One patient reported an erection the day after removing the catheter. The anatomic rationale for better results compared with traditional RALP is strong, but well-designed studies are needed to evaluate the advantages of our technique.

Independent predictors of contralateral metachronous upper urinary tract transitional cell carcinoma after nephroureterectomy: Multi‐institutional dataset from three European centers

Objectives:  To identify the variables predictive of contralateral metachronous upper urinary tract transitional cell carcinoma (UUT‐TCC) after nephroureterectomy (NFU) for non‐metastatic UUT‐TCC.