Medical Therapy to Facilitate the Passage of Stones: What Is the Evidence?

Related Articles Medical Therapy to Facilitate the Passage of Stones: What Is the Evidence? Eur Urol. 2009 Jun 21; Authors: Seitz C, Liatsikos E, Porpiglia F, Tiselius HG, Zwergel U CONTEXT: Medical expulsive therapy (MET) for urolithiasis has gained increasing attention in the last years. It has been suggested that the administration of alpha-adrenoreceptor antagonists (alpha-blockers) or calcium channel blockers augments stone expulsion rates and reduces colic events. OBJECTIVE: To evaluate the efficacy and safety of MET with alpha-blockers and calcium channel blockers for upper urinary tract stones with and without prior extracorporeal shock wave lithotripsy (ESWL). EVIDENCE ACQUISITION: A systematic review of the literature was performed in Medline, Embase, the Cochrane Central Register of Controlled Trials, and the Cochrane Database of Systematic Reviews searched through 31 December 2008 without time limit. Efficacy and safety end points were evaluated in 47 randomised, controlled trials assessing the role of MET. Meta-analysis was conducted using Review Manager (RevMan) v.5.0 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark). EVIDENCE SYNTHESIS: Pooling of alpha-blocker and calcium channel blocker studies demonstrated a higher and faster expulsion rate compared to a control group (risk ratio [RR]: 1.45 vs 1.49; 95% confidence interval [CI]: 1.34-1.57 vs 1.33-1.66). Similar results have been obtained after ESWL (RR: 1.29 vs 1.57; 95% CI: 1.16-1.43 vs 1.21-2.04). Additionally, lower analgesic requirements, fewer colic episodes, and fewer hospitalisations were observed within treatment groups. CONCLUSIONS: Pooled analyses suggest that MET with alpha-blockers or calcium channel blockers augments stone expulsion rates, reduces the time to stone expulsion, and lowers analgesia requirements for ureteral stones with and without ESWL for stones

The Motion: Robotic Partial Nephrectomy is Better than Open Partial Nephrectomy.

Related Articles The Motion: Robotic Partial Nephrectomy is Better than Open Partial Nephrectomy. Eur Urol. 2009 Jun 24; Authors: Rogers CG, Patard JJ PMID: 19560859 [PubMed - as supplied by publisher]

Refractory Hematuria in an Oliguric Patient After Pancreas Transplantation with Exocrine Pancreas Bladder Drainage.

Related Articles Refractory Hematuria in an Oliguric Patient After Pancreas Transplantation with Exocrine Pancreas Bladder Drainage. Eur Urol. 2009 Jun 24; Authors: Kiss B, Birkhäuser FD, Fleischmann A, Candinas D, Studer UE, Kessler TM A 52-yr-old man presented with hematuria and clot retention. He had undergone simultaneous pancreas-kidney transplantation with exocrine pancreas bladder drainage 16 yr ago. The patient suffered from progressive transplant kidney failure with gradually decreasing urine output and needed hemodialysis every other day. Gross hematuria persisted after removal of all blood clots. Cystoscopy showed multiple small, flat ulcers of the bladder mucosa. Some bled discretely and were coagulated cautiously. However, hematuria was refractory to multiple urological interventions, which eventually necessitated an enteric diversion of the exocrine pancreas. Hematuria ceased following an uneventful postoperative course. PMID: 19560858 [PubMed - as supplied by publisher]

Castration-resistant Prostate Cancer: From New Pathophysiology to New Treatment Targets.

Related Articles Castration-resistant Prostate Cancer: From New Pathophysiology to New Treatment Targets. Eur Urol. 2009 Jun 24; Authors: Chi KN, Bjartell A, Dearnaley D, Saad F, Schröder FH, Sternberg C, Tombal B, Visakorpi T CONTEXT: Castration-resistant prostate cancer (CRPC) refers to patients who no longer respond to surgical or medical castration. Standard treatment options are limited. OBJECTIVE: To review the concepts and rationale behind targeted agents currently in late-stage clinical testing for patients with CRPC. EVIDENCE ACQUISITION: Novel targeted therapies in clinical trials were identified from registries. The MEDLINE database was searched for all relevant reports published from 1996 to October 2009. Bibliographies of the retrieved articles and major international meeting abstracts were hand-searched to identify additional studies. EVIDENCE SYNTHESIS: Advances in our understanding of the molecular mechanisms underlying prostate cancer (PCa) progression has translated into a variety of treatment approaches. Agents targeting androgen receptor (AR) activation and local steroidogenesis, angiogenesis, immunotherapy, apoptosis, chaperone proteins, the insulin-like growth factor (IGF) pathway, RANK-ligand, endothelin receptors, and the Src family kinases are entering or have recently completed accrual to phase 3 trials for patients with CRPC. CONCLUSIONS: A number of new agents targeting mechanisms of PCa progression with early promising results are in clinical trials and have the potential to provide novel treatment options for CRPC in the near future. PMID: 19560857 [PubMed - as supplied by publisher]

Mechanisms of Pelvic Floor Muscle Function and the Effect on the Urethra during a Cough.

Related Articles Mechanisms of Pelvic Floor Muscle Function and the Effect on the Urethra during a Cough. Eur Urol. 2009 Jun 21; Authors: Lovegrove Jones RC, Peng Q, Stokes M, Humphrey VF, Payne C, Constantinou CE BACKGROUND: Current measurement tools have difficulty identifying the automatic physiologic processes maintaining continence, and many questions still remain about pelvic floor muscle (PFM) function during automatic events. OBJECTIVE: To perform a feasibility study to characterise the displacement, velocity, and acceleration of the PFM and the urethra during a cough. DESIGN, SETTING, AND PARTICIPANTS: A volunteer convenience sample of 23 continent women and 9 women with stress urinary incontinence (SUI) from the general community of San Francisco Bay Area was studied. MEASUREMENTS: Methods included perineal ultrasound imaging, motion tracking of the urogenital structures, and digital vaginal examination. Statistical analysis used one-tailed unpaired student t tests, and Welch's correction was applied when variances were unequal. RESULTS AND LIMITATIONS: The cough reflex activated the PFM of continent women to compress the urogenital structures towards the pubic symphysis, which was absent in women with SUI. The maximum accelerations that acted on the PFM during a cough were generally more similar than the velocities and displacements. The urethras of women with SUI were exposed to uncontrolled transverse acceleration and were displaced more than twice as far (p=0.0002), with almost twice the velocity (p=0.0015) of the urethras of continent women. Caution regarding the generalisability of this study is warranted due to the small number of women in the SUI group and the significant difference in parity between groups. CONCLUSIONS: During a cough, normal PFM function produces timely compression of the pelvic floor and additional external support to the urethra, reducing displacement, velocity, and acceleration. In women with SUI, who have weaker urethral attachments, this shortening contraction does not occur; consequently, the urethras of women with SUI move further and faster for a longer duration. PMID: 19560261 [PubMed - as supplied by publisher]

Periurethral Suspension Stitch During Robot-Assisted Laparoscopic Radical Prostatectomy: Description of the Technique and Continence Outcomes.

Related Articles Periurethral Suspension Stitch During Robot-Assisted Laparoscopic Radical Prostatectomy: Description of the Technique and Continence Outcomes. Eur Urol. 2009 Jun 16; Authors: Patel VR, Coelho RF, Palmer KJ, Rocco B BACKGROUND: Several studies have shown that robot-assisted laparoscopic radical prostatectomy (RALP) is feasible, with favorable complication rates and short hospital times. However, the early recovery of urinary continence remains a challenge to be overcome. OBJECTIVE: We describe our technique of periurethral retropubic suspension stitch during RALP and report its impact on early recovery of urinary continence. DESIGN, SETTING, AND PARTICIPANTS: We analyze prospectively 331 consecutive patients who underwent RALP, 94 without the placement of suspension stitch (group 1) and 237 with the application of the suspension stitch (group 2). SURGICAL PROCEDURE: The only difference between the groups was the placement of the puboperiurethral stitch after the ligation of the dorsal venous complex (DVC). The periurethral retropubic stitch was placed using a 12-in monofilament polyglytone suture on a CT-1 needle. The stitch was passed from right to left between the urethra and DVC, and then through the periostium on the pubic bone. The stitch was passed again through the DVC, and then through the pubic bone in a figure eight, and then tied. MEASUREMENTS: Continence rates were assessed with a self-administered validated questionnaire (Expanded Prostate Cancer Index Composite [EPIC]) at 1, 3, 6, and 12 mo after the procedure. Continence was defined as the use of no absorbent pads or no leakage of urine. RESULTS AND LIMITATIONS: In group 1, the continence rate at 1, 3, 6, and 12 mo postoperatively was 33%, 83%, 94.7%, and 95.7%, respectively; in group 2, the continence rate was 40%, 92.8%, 97.9%, and 97.9%, respectively. The suspension technique resulted in significantly greater continence rates at 3 mo after RALP (p=0.013). The median/mean interval to recovery of continence was also statistically significantly shorter in the suspension group (median: 6wk; mean: 7.338wk; 95% confidence interval [CI]: 6.387-8.288) compared to the nonsuspension group (median: 7wk; mean: 9.585wk; 95% CI: 7.558-11.612; log rank test, p=0.02). CONCLUSIONS: The suspension stitch during RALP resulted in a statistically significantly shorter interval to recovery of continence and higher continence rates at 3 mo after the procedure. PMID: 19560260 [PubMed - as supplied by publisher]

Laparoscopic versus Open Nephroureterectomy: Perioperative and Oncologic Outcomes from a Randomised Prospective Study.

Related Articles Laparoscopic versus Open Nephroureterectomy: Perioperative and Oncologic Outcomes from a Randomised Prospective Study. Eur Urol. 2009 Jun 21; Authors: Simone G, Papalia R, Guaglianone S, Ferriero M, Leonardo C, Forastiere E, Gallucci M BACKGROUND: Laparoscopic nephroureterectomy (LNU) is increasingly being used instead of open nephroureterectomy (ONU) for the treatment of urothelial carcinoma (UC) of the upper urinary tract (UUT), but the evidence of equal oncologic effectiveness is still lacking. OBJECTIVE: To present perioperative and oncologic results from a prospective randomised study comparing ONU and LNU. DESIGN, SETTING, AND PARTICIPANTS: Eighty patients with nonmetastatic UUT UC and without previous history of UC were enrolled. Of those, 40 patients (group A) randomly received ONU and 40 patients (group B) randomly received LNU. INTERVENTIONS: ONU was performed through a flank incision with a lower quadrant incision to allow excision of a bladder cuff. Transperitoneal LNU was performed with a four-trocar technique, and bladder cuff was detached with a 10-mm LigaSure device. MEASUREMENTS: Perioperative data were compared with the student t test. Bladder tumour-free survival (BTFS), metastasis-free survival (MFS), and cancer-specific survival (CSS) curves for both groups were compared with the log-rank test before and after stratifying patients for pT category and tumour grade. RESULTS AND LIMITATIONS: Operative times were comparable, while mean blood loss and mean time to discharge were significantly lower in group B (both p values <0.001). At a median follow-up of 44 mo, BTFS, CSS, and MFS were not significantly different between the two groups (log rank test; BTFS: p=0.86; CSS: p=0.2; MFS: p=0.124). When matched for pT3 and high-grade tumours, CSS and MFS were significantly different between the two groups in favour of ONU (p=0.039 and p=0.004, respectively, for pT3 tumours; p=0.078 and p=0.014, respectively, for high-grade tumours). The limitations of our study include the small sample size, the single-centre experience, the personal choice of laparoscopic technique, and not performing lymphadenectomies. Perioperative data and preliminary oncologic results were presented at 22nd Congress of the European Association of Urology, Berlin, Germany. CONCLUSIONS: In patients with organ-confined UUT UCs, LNU has the advantages of minimal invasiveness and oncologic outcomes comparable to those of ONU, while its effectiveness in patients with advanced stage diseases remains to be proven. PMID: 19560259 [PubMed - as supplied by publisher]

Long-term Survival in Patients Undergoing Radical Nephrectomy and Inferior Vena Cava Thrombectomy: Single-Center Experience.

Related Articles Long-term Survival in Patients Undergoing Radical Nephrectomy and Inferior Vena Cava Thrombectomy: Single-Center Experience. Eur Urol. 2009 Jun 21; Authors: Ciancio G, Manoharan M, Katkoori D, De Los Santos R, Soloway MS BACKGROUND: Renal cell carcinoma (RCC) with a tumor thrombus extension into the inferior vena cava (IVC) demands aggressive surgical management. OBJECTIVE: To evaluate the long-term survival in patients undergoing radical nephrectomy and IVC thrombectomy. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective analysis of 87 patients undergoing surgery between 1997 and 2008. The patients were grouped according to the extent of tumor thrombus, with level I involving the IVC at the level of the renal vein, level II being infrahepatic IVC, level III being intrahepatic IVC, and level IV being suprahepatic IVC or right atrium. Relevant clinical and pathologic data were analyzed. MEASUREMENTS: Disease-free survival (DFS) and disease-specific survival (DSS) were studied. RESULTS AND LIMITATIONS: The median follow-up was 22 mo, and 19, 14, 40, and 14 patients had level I, II, III, and IV IVC thrombus, respectively. Among patients with M0 disease, 22 developed metastases. The 5-yr DFS was 64% for all levels and 74%, 69.5%, 59.5%, and 58% for levels I, II, III, and IV, respectively. Of the level I group, 16% of patients died of disease compared to 57% of the level IV group. The 5-yr DSS for all levels was 46% and 71%, 48%, 40%, and 35% for levels I, II, III, and IV, respectively. Patients with level IV thrombus had a significantly lower 5-yr DSS compared to level I (p=0.03). However, when analyzed in two groups-supradiaphragmatic and infradiaphragmatic-there was no significant difference in DSS (P=0.14). On univariate analysis, metastasis at presentation, non-clear-cell histology, lymph node metastases, and higher nuclear grade were statistically significant prognostic factors influencing DSS. Only higher nuclear grade (p=0.03), metastasis at presentation (p<0.01), and non-clear-cell histology (p=0.03) were independent prognostic factors on multivariate analysis. CONCLUSIONS: Radical nephrectomy and IVC thrombectomy offer reasonable long-term survival. The level of tumor thrombus is not an independent prognostic factor. Distant metastasis at presentation, higher nuclear grade, and non-clear-clear cell histology are significant prognostic factors influencing DSS. PMID: 19560258 [PubMed - as supplied by publisher]

Single Postoperative Instillation of Gemcitabine in Patients with Non-muscle-invasive Transitional Cell Carcinoma of the Bladder: A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Study.

Related Articles Single Postoperative Instillation of Gemcitabine in Patients with Non-muscle-invasive Transitional Cell Carcinoma of the Bladder: A Randomised, Double-blind, Placebo-controlled Phase III Multicentre Study. Eur Urol. 2009 Jun 21; Authors: Böhle A, Leyh H, Frei C, Kühn M, Tschada R, Pottek T, Wagner W, Knispel HH, von Pokrzywnitzki W, Zorlu F, Helsberg K, Lübben B, Soldatenkova V, Stoffregen C, Büttner H, BACKGROUND: Recurrence prophylaxis with intravesical gemcitabine (GEM) was effective and safe in patients with non-muscle-invasive bladder cancer (NMIBC); efficacy as single-shot instillation remains to be proved. OBJECTIVE: To compare the efficacy of a single GEM instillation versus placebo (PBO) immediately after transurethral resection (TUR) of tumour in patients with histologically confirmed NMIBC (pTa/pT1,G1-3). DESIGN, SETTING, AND PARTICIPANTS: This was a double-blind, randomised, PBO-controlled study in patients with clinical evidence of primary or recurrent NMIBC (Ta/T1,G1-3). Of 355 patients randomised at 24 urologic centres, 328 underwent TUR and received instillation (92.4%; GEM/PBO: 166/162). In case of nonmalignancy, carcinoma in situ (CIS), >/=pT2 disease, or intraoperative complications, patients were discontinued. INTERVENTION: We used a single, postoperative 30-40-min instillation of GEM (2000mg/100ml of saline) or PBO (100ml of saline) followed by continuous bladder irrigation for >/=20h. A second TUR (no instillation) and adjuvant bacillus Calmette-Guérin (BCG) instillations were allowed. MEASUREMENTS: Primary outcome was recurrence-free survival (RFS). Secondary outcomes included type of recurrence and adverse events. To detect a difference in RFS, 191 recurrences were required (80% power, log-rank-test, alpha=0.050). RESULTS AND LIMITATIONS: Two hundred forty-eight patients (69.9%, GEM, PBO: 124, 124) had histologically confirmed pTa/pT1 G1-3 Gx tumour and were eligible for efficacy (GEM: 76.6% male; median age: 65 yr; PBO: 83.1% male; median age: 67 yr). Treatment groups were balanced (pTa: 75.0%, 71.0%; G1-G2: 85.5%, 87.9%; recurrent tumour: 24.2%, 21.0%; BCG: 10.5%, 16.9%). After a median follow-up of 24 mo, there were only 94 recurrences and 11 deaths. The study was terminated early based on predefined decision criteria. RFS was high in both groups (12-mo RFS [95% confidence interval (CI)]: GEM: 77.7% [68.8-84.3]; PBO: 75.3% [66.3-82.3]). There was no significant group difference (hazard ratio [HR]: 0.946 [0.64-1.39], log-rank test, p=0.777). CONCLUSIONS: In this study of NMIBC, the immediate single instillation of GEM 2000mg/100ml of saline after TUR was not superior to PBO in terms of RFS. Rigid continuous irrigation and improved TUR/cystoscopy techniques may have contributed to the high RFS in both groups. PMID: 19560257 [PubMed - as supplied by publisher]

Editorial Comment on: A Comparison of Postoperative Complications in Open versus Robotic Cystectomy.

Related Articles Editorial Comment on: A Comparison of Postoperative Complications in Open versus Robotic Cystectomy. Eur Urol. 2009 Jun 10; Authors: Gakis G, Stenzl A PMID: 19560256 [PubMed - as supplied by publisher]

A Comparison of Postoperative Complications in Open versus Robotic Cystectomy.

Related Articles A Comparison of Postoperative Complications in Open versus Robotic Cystectomy. Eur Urol. 2009 Jun 10; Authors: Ng CK, Kauffman EC, Lee MM, Otto BJ, Portnoff A, Ehrlich JR, Schwartz MJ, Wang GJ, Scherr DS BACKGROUND: Robotic cystectomy is an emerging alternative for treatment of invasive bladder cancer (BCa). However, reduction in postoperative morbidity relative to the open approach has not been demonstrated. OBJECTIVE: To compare complication rates in patients undergoing robotic versus open radical cystectomy (RC). DESIGN, SETTING, AND PARTICIPANTS: A prospective cohort study of 187 consecutive patients undergoing RC at our institution-104 open RC, 83 robotic RC. INTERVENTION: Open or robotic RC with urinary diversion. MEASUREMENTS: Demographic, perioperative, and complication data were recorded prospectively. Thirty-day and 90-d complication rates were assessed using the modified Clavien complication scale. Data were evaluated using chi(2) and multivariate logistic regression analyses. RESULTS AND LIMITATIONS: At 30 d, the open group demonstrated a higher overall complication rate (59% vs 41%; p=0.04) as well as more major complications (30% vs 10%; p=0.007). At 90 d, the overall complication rate was greater in the open group, but this was not statistically significant (62% vs 48%; p=0.07). However, there was a significantly higher major complication rate in the open cohort (31% vs 17%; p=0.03). When subjected to logistic regression analysis, robotic cystectomy was an independent predictor of fewer overall and major complications at 30 and 90 d. High American Society of Anesthesiologists (ASA) score (3-4) and longer surgical time were independent predictors of major complications. Though this is one of the largest published RC series, the sample size is relatively small. Moreover, despite the two patient cohorts being similarly matched, the study was not performed in a randomized fashion. CONCLUSIONS: Patients undergoing robotic cystectomy experienced fewer postoperative complications than those undergoing open cystectomy. Robotic cystectomy is an independent predictor of fewer overall and major complications. Until long-term oncologic results are available, robotic cystectomy should still be considered investigational. PMID: 19560255 [PubMed - as supplied by publisher]

Therapeutic Potential of Mdm2 Inhibition in Malignant Germ Cell Tumours.

Related Articles Therapeutic Potential of Mdm2 Inhibition in Malignant Germ Cell Tumours. Eur Urol. 2009 Jun 21; Authors: Bauer S, Mühlenberg T, Leahy M, Hoiczyk M, Gauler T, Schuler M, Looijenga L BACKGROUND: Inadequate response to cisplatin-based chemotherapy is associated with poor prognosis in patients with advanced malignant testicular germ cell tumours (TGCTs), especially of the nonseminomatous type. Novel chemotherapeutic agents have failed so far to significantly improve the outcome of such patients. The majority of these tumours express low levels of p53, and TP53 mutations are rarely observed. Murine double minute 2 (Mdm2) inhibitors enhance apoptosis in tumours harbouring wild-type p53. OBJECTIVE: We sought to investigate the potential therapeutic value of Mdm2 in TGCT-derived cell lines with the histology of nonseminoma. DESIGN, SETTING, AND PARTICIPANTS: The Mdm2 inhibitor nutlin-3 was evaluated alone and in combination with cisplatin in a panel of germ cell tumour (GCT)-derived cell lines (embryonal carcinomas, being the nonseminomatous stem-cell component) with wild-type (NT2 and 2102EP cells) and mutant (NCCIT cells) p53 status. MEASUREMENTS: Biological consequences of Mdm2 inhibition were determined by analysis of the p53 pathway, cell proliferation, and apoptosis. RESULTS AND LIMITATIONS: Nutlin-3 exhibited significant activity (IC50 2.8muM) in NT2 and 2102EP (wild-type p53) but not in p53-mutant NCCIT cells (<10% inhibition at 10muM). At concentrations beyond 500nM, additive effects were seen for the combination of nutlin-3 and cisplatin in NT2 and 2102EP cells but not in NCCIT cells. This correlated with the induction of p53 and its target p21, suggesting an on-target effect of nutlin-3. Moreover, nutlin-3 (5muM) and cisplatin (0.5muM) additively induced caspase cleavage and apoptosis in NT2 cells and 2102-EP cells but not in p53-mutant NCCIT cells. CONCLUSIONS: These results provide strong evidence for further development of pharmacologic Mdm2 inhibition for the treatment of patients suffering from high-risk nonseminomatous TGCT with wild-type p53 status. PMID: 19560254 [PubMed - as supplied by publisher]

Editorial Comment on: The Extent of Lymphadenectomy Seems to Be Associated with Better Survival in Patients with Nonmetastatic Upper-Tract Urothelial Carcinoma: How Many Lymph Nodes Should Be Removed?

Related Articles Editorial Comment on: The Extent of Lymphadenectomy Seems to Be Associated with Better Survival in Patients with Nonmetastatic Upper-Tract Urothelial Carcinoma: How Many Lymph Nodes Should Be Removed? Eur Urol. 2009 Jun 18; Authors: Dalbagni G PMID: 19559519 [PubMed - as supplied by publisher]

The Extent of Lymphadenectomy Seems to Be Associated with Better Survival in Patients with Nonmetastatic Upper-Tract Urothelial Carcinoma: How Many Lymph Nodes Should Be Removed?

Related Articles The Extent of Lymphadenectomy Seems to Be Associated with Better Survival in Patients with Nonmetastatic Upper-Tract Urothelial Carcinoma: How Many Lymph Nodes Should Be Removed? Eur Urol. 2009 Jun 18; Authors: Roscigno M, Shariat SF, Margulis V, Karakiewicz P, Remzi M, Kikuchi E, Zigeuner R, Weizer A, Sagalowsky A, Bensalah K, Raman JD, Bolenz C, Kassou W, Koppie TM, Wood CG, Wheat J, Langner C, Ng CK, Capitanio U, Bertini R, Fernández MI, Mikami S, Isida M, Ströbel P, Montorsi F BACKGROUND: The role and extent of lymphadenectomy in patients with upper-tract urothelial carcinoma (UTUC) is debated. OBJECTIVE: To establish whether the number of lymph nodes (LNs) removed might be associated with better cause-specific survival in patients with UTUC. DESIGN, SETTING, AND PARTICIPANTS: The study included 552 consecutive patients who underwent radical nephroureterectomy (RNU) and lymphadenectomy between 1992 and 2006. INTERVENTION: Patients were treated with RNU and lymphadenectomy. MEASUREMENTS: Univariable and multivariable Cox proportional hazards regression models addressed the association between the number of LNs removed and cause-specific mortality (CSM). The number of LNs removed was coded as a cubic spline to allow for nonlinear effects. Finally, the most informative cut-off for the number of removed LNs was identified. RESULTS AND LIMITATIONS: In the entire population, the number of LNs removed was not associated with CSM in univariable (hazard ratio [HR]: 0.99; p=0.16) or in multivariable (HR: 0.97; p=0.12) analyses. In contrast, in the subgroup of pN0 patients (n=412), the number of LNs removed achieved the independent predictor status of CSM (HR: 0.93; p=0.02). Eight LNs removed was the most informative cut-off in predicting CSM (HR: 0.42; p=0.004). The inclusion of the variable defining dichotomously the number of removed LNs (<8 vs >/=8) in the base model (age, Eastern Cooperative Oncology Group performance status, pathologic stage, grade, architecture, and lymphovascular invasion) significantly increased the accuracy in predicting CSM (+1.7%; p<0.001). CONCLUSIONS: The extension of the lymphadenectomy in pN0 UTUC patients seems to be associated with CSM. Longer survival was observed in patients in whom at least eight LNs had been removed. PMID: 19559518 [PubMed - as supplied by publisher]

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Hurdles in Modern Trial Management: As Overbureaucracy and Commercialization of Clinical Trials Suffocate Independent Academic Research, It's Time for a Change.