Impact of prior prostate radiation on complications after radical prostatectomy.

PURPOSE: Salvage radical prostatectomy is associated with a higher complication rate than radical prostatectomy without prior radiotherapy but the magnitude of the increase is not well delineated. MATERIALS AND METHODS: A total of 3,458 consecutive patients underwent open radical prostatectomy and 98 underwent open salvage radical prostatectomy from January 1999 to June 2007. Data were collected from prospective surgical and institutional morbidity databases, and retrospectively from billing records and medical records. Medical and surgical complications were captured, graded by the modified Clavien classification and classified by time of onset. RESULTS: Median followup after salvage radical prostatectomy and radical prostatectomy was 34.5 and 45.5 months, respectively. Patients with salvage had significantly higher median age, modified Charlson comorbidity score, clinical and pathological stage, and Gleason score. They were less likely to have organ confined disease and more likely to have seminal vesicle invasion and nodal metastasis. There was no significant difference in median operative time, blood loss or transfusion rate. The salvage group had a higher adjusted probability of medical and surgical complications, including urinary tract infection, bladder neck contracture, urinary retention, urinary fistula, abscess and rectal injury. Only 1 of 4 potent patients with salvage prostatectomy who underwent bilateral nerve sparing recovered erection adequate for intercourse. The 3-year actuarial recovery of continence was 30% (95% CI 19-41). CONCLUSIONS: Medical and surgical complications of prostatectomy are significantly increased in the setting of prior radiotherapy. Understanding the magnitude of this increased risk is important for patient counseling.

Impact of previous radiotherapy for prostate cancer on clinical outcomes of patients with bladder cancer.

PURPOSE: The impact of prostate cancer radiotherapy on the biological behavior of bladder cancer remains unclear. We compared the outcomes of patients with bladder cancer previously treated for prostate cancer with radiotherapy vs other treatment modalities. MATERIALS AND METHODS: We identified 144 patients diagnosed with bladder cancer between January 1992 and June 2007 with a previous prostate cancer diagnosis. Clinicopathological data and outcomes were compared between patients with irradiated (brachytherapy and/or external beam radiation therapy 83) and nonirradiated (androgen deprivation therapy, radical prostatectomy and/or surveillance 61) disease. RESULTS: Median time between prostate and bladder cancer diagnoses was longer in the irradiated vs nonirradiated group (59 months, IQR 25 to 88, vs 24 months, IQR 2 to 87, p = 0.007). Patients in the irradiated group presented with higher tumor grade (high 92% vs 77%, p = 0.016) and had progression to higher stage disease (muscle invasive 70% vs 43%, p = 0.001) than those in the nonirradiated group. Of the patients undergoing cystectomy those previously treated with radiation had a numerically higher rate of nonorgan confined disease (75% vs 56% for nonirradiated, p = 0.1). Among all patients with bladder cancer 5-year cancer specific survival was 73% (95% CI 59-87) for irradiated vs 83% (95% CI 71-95) for nonirradiated (p = 0.07). Median followup was 53 months (IQR 24 to 75). CONCLUSIONS: More time elapsed between prostate and bladder cancer diagnoses for patients treated with radiation, and these patients also presented with more advanced disease. Future studies are needed to further establish clinical differences in bladder cancer between irradiated and nonirradiated cases, and whether biological differences exist.

Variability of treatment selection among surgeons for patients with cT1 urothelial carcinoma.

OBJECTIVES: To report the heterogeneity in the treatment of patients with cT1 urothelial carcinoma by different surgeons, and to report outcomes in patients with and without bacillus Calmette-Guérin (BCG) treatment. PATIENTS AND METHODS: We retrospectively reviewed 396 patients who had undergone a re-staging transurethral resection (TUR) for cT1 bladder cancer. We assessed both differences in the treatment by surgeon, and the association of early treatment with BCG with recurrence, progression and bladder cancer-specific death. RESULTS: Muscle was captured in the re-staging TUR specimen in a median of 76% of patients (range 50-94 when stratified by surgeon). On multivariable analysis there was significant heterogeneity among surgeons in the use of early cystectomy (P < 0.001), deferred cystectomy (P < 0.001), and BCG (P= 0.014). However, there was no significant heterogeneity between surgeons in clinical outcome for recurrence (P= 0.9) and overall survival (P= 0.3). Among 288 patients placed on surveillance, the 5-year probability (95% confidence interval) of freedom from recurrence was 45 (36-54)% for those receiving and 54 (44-62)% for those not receiving early BCG. On multivariable analysis, early BCG was not significantly associated with recurrence (P= 0.14). The cumulative incidence of progression was ≈10% for both groups, and the cumulative incidence of bladder cancer-specific death was ≈7% for both groups. The cumulative incidence of deferred cystectomy before progression was 14% for those receiving and 15% for those not receiving early BCG. CONCLUSIONS: There is a significant variability among surgeons in the management of patients with T1 disease. The similar outcome for the BCG-treated and -untreated patients in our study is most likely confounded by patient selection.

The depth of the prostatic apex is an independent predictor of positive apical margins at radical prostatectomy.

OBJECTIVE: To determine the effect of a deep and narrow pelvis on apical positive surgical margins (PSM) at radical prostatectomy (RP), controlling for other clinical and pathological variables and surgical approach, i.e. open retropubic (RRP) vs laparoscopic (LRP), as apical dissection is expected to be more challenging at RP with a prostate situated deep in a narrow pelvis. PATIENTS AND METHODS: From July 2003 to January 2005, 512 consecutive patients with preoperative prostate magnetic resonance imaging (MRI) underwent RRP or LRP with no previous radio- or hormonal therapy. An additional 74 patients with preoperative MRI undergoing RP from December 2001 to June 2007 who had an apical PSM were also included, with 586 patients comprising the study population. Bony and soft-tissue pelvic dimensions, including interspinous distance (ISD), bony (BFW) and soft tissue (SW) pelvic width, apical prostate depth (AD) and symphysis pubis angle, were measured on preoperative MRI. The pelvic dimension index (PDI), bony width index (BWI) and soft-tissue width index (SWI) were defined as ISD/AD, BFW/AD and SW/AD, respectively. Multivariate logistic regression was used to assess the effect of pelvic dimensions on apical PSM, controlling for surgical approach and clinical and pathological variables. RESULTS: There was no significant difference in ISD, BFW, SW or symphysis angle between patients with and without apical PSM. The AD was significantly greater in men with an apical PSM and consequently PDI, BWI and SWI were significantly lower in men with an apical PSM. Each of PDI, AD, BWI and SWI was a significant independent predictor of apical PSM, independent of surgical approach, and other clinicopathological variables. The main limitations of the study were that it was retrospective, and the relatively few patients with apical PSM. CONCLUSIONS: Apical prostate depth is an independent risk factor for apical PSM at RP. MRI pelvimetry might allow for preoperative planning of the approach to RP.

Impact of ethnicity on surgical margins at radical prostatectomy.

OBJECTIVE: To determine if the rate of positive surgical margins (PSMs), and in particular apical PSMs, at radical prostatectomy (RP) for prostate cancer, is higher in African-American (AA) than Caucasian men, given their often narrower and deeper pelvis. PATIENTS AND METHODS: From 1999 to 2007, 3145 consecutive patients underwent RP, either open retropubic (RRP) or laparoscopic (LRP), with no previous treatment, by one of five surgeons. Multivariate logistic regression was used to determine the effect of ethnicity (AA vs Caucasian) on overall and site-specific PSMs, adjusting for age, body mass index, RP approach (RRP vs LRP), surgeon, surgeon case number, year of surgery, preoperative serum prostate-specific antigen level, specimen weight, estimated blood loss, pathological organ-confined status, and pathological Gleason score. RESULTS: In all, 205 men were AA and 2940 Caucasian; PSMs were identified in 376 (12.0%) men, 35 (17.1%) in AA and 341 (11.6%) in Caucasian men. PSMs were identified at the apex in 148 (4.7%), the bladder neck in 29 (0.9%), posteriorly in 169 (5.4%), and anteriorly in 78 (2.5%) men. For apical PSM, ethnicity was a significant predictor, with an odds ratio of 1.76 (95% confidence interval 1.01-3.04, P = 0.045) for AA vs Caucasian, independent of pathological organ-confined status and PSA level. Ethnicity was not a significant independent predictor of overall PSMs or PSMs at other sites (bladder neck, posteriorly, or anteriorly). CONCLUSIONS: The rate of apical PSMs, but not overall PSMs, at RP was higher in AA than Caucasian men, controlling for other covariates. Further investigation is necessary to determine if pelvic shape is responsible for this observation.

Biochemical recurrence rate in patients with positive surgical margins at radical prostatectomy with further negative resected tissue.

OBJECTIVE: To determine the biochemical recurrence (BCR) rate in patients with positive surgical margins (PSMs) on the prostate specimen who have additional negative tissue resected from that site (M+ -), compared to patients with negative margins (M-) and those with persistent PSM (M+), as those with PSM at radical prostatectomy (RP) are at greater risk of BCR, and in some instances where suspicious tissue is noted in the prostate bed or when frozen-section analysis shows PSM, additional tissue is resected from the suspect site of the PSM. PATIENTS AND METHODS: Between January 1999 and June 2007, 4217 consecutive patients underwent open or laparoscopic RP with no previous radiotherapy or hormonal therapy. The median (interquartile range) follow-up was 37.4 (21.1-60.7) months. RESULTS: Pathological organ-confined (OC) cancer was present in 2901 men, of whom 2659 had M-, 216 had M+, and 26 had M+-. Extracapsular extension (ECE) alone with no seminal vesicle or lymph node involvement was present in 843 men, of whom 657 had M-, 174 had M+ and 12 had M+-. For patients with OC cancer, the 36-month actuarial BCR-free probability was 97.9% (95% confidence interval 97.3-98.5) for M-, vs 89.0 (84.1-93.9)% for M+ vs 100% for M+-. For patients with ECE, the 36-month actuarial BCR-free probability was 83.7 (80.0-87.4)% for M- vs 73.7 (66.1-81.3)% for M+ vs 90.0 (71.4-100)% for M+-. The main limitation of the study was its retrospective nature, with the reason for resection of additional tissue not always well documented. CONCLUSIONS: While the few patients with PSMs and further negative resected tissue limited the statistical analysis, it would appear that in these patients the disease behaves as in those with negative margins.

Age-adjusted Charlson comorbidity score is associated with treatment decisions and clinical outcomes for patients undergoing radical cystectomy for bladder cancer.

BACKGROUND: By using the age-adjusted Charlson comorbidity index (ACCI), the authors characterized the impact of age and comorbidity on disease progression and overall survival after radical cystectomy (RC) for transitional cell carcinoma of the bladder. Also evaluated was whether ACCI was associated with clinicopathologic and treatment characteristics. METHODS: The authors evaluated 1121 patients treated by RC for transitional cell carcinoma of the bladder at a single institution (1990-2004). Logistic regression was used to determine the relation between ACCI and clinical features. They evaluated the association between ACCI and overall and progression-free survival by using multivariate survival-time models with pathologic stage and nodal status as covariates. RESULTS: ACCI scores increased during the study period (P = .009). Extravesical disease was present in 43% of patients with ACCI 5 (P = .051). Despite their higher prevalence of extravesical disease, patients with higher ACCI were less likely to have lymph-node dissection (odds ratio, 0.55 and 0.35, respectively, for ACCI 3-5 and >5 vs 5 vs

An analysis of the effect of statin use on the efficacy of bacillus calmette-guerin treatment for transitional cell carcinoma of the bladder.

PURPOSE: Bacillus Calmette-Guerin is an effective immunotherapy for carcinoma in situ of the bladder and it reduces recurrence from resected papillary transitional cell carcinoma of the bladder. Many patients receiving bacillus Calmette-Guerin therapy are concurrently taking statin agents, which have known immunomodulatory properties and may alter the performance of bacillus Calmette-Guerin. Some data have suggested that patients taking a statin while on bacillus Calmette-Guerin therapy experience reduced clinical efficacy. MATERIALS AND METHODS: We conducted a retrospective review of 952 consecutive patients from 1978 through 2006. Time to recurrence and progression to surgery were compared between those taking and those not taking a statin by Kaplan-Meier methods and multivariable Cox regression controlling for stage and grade. RESULTS: There were 245 (26%) patients taking a statin before bacillus Calmette-Guerin therapy and 707 not on statin therapy (74%). A total of 796 patients had recurrence overall with 214 in the statin group and 582 in the other group. Median time to recurrence was similar between those who did and those who did not use a statin. On multivariable analysis statin use was not significantly associated with recurrence (hazard ratio 1.04; 95% CI 0.81, 1.34; p = 0.7) or progression to surgery (hazard ratio 0.77; 95% CI 0.52, 1.13; p = 0.17) after bacillus Calmette-Guerin therapy. CONCLUSIONS: This retrospective study in a large cohort of patients showed no statistically significant association between statin use and recurrence or progression to open surgery in patients treated with bacillus Calmette-Guerin for transitional cell carcinoma of the bladder. Based on these data patients should not be discouraged from taking statins while undergoing bacillus Calmette-Guerin treatment.

Pathological upgrading and up staging with immediate repeat biopsy in patients eligible for active surveillance.

PURPOSE: Active surveillance with selective delayed intervention is a treatment regimen used in patients with low risk prostate cancer. Decision making is based on pretreatment prostate specific antigen, clinical stage and prostate biopsy results. We reviewed our experience with immediate repeat biopsy in patients eligible for active surveillance with selective delayed intervention. MATERIALS AND METHODS: A retrospective review was done of the records of consecutive patients who underwent repeat biopsy within 3 months of a first positive biopsy from March 2002 to June 2007. Patients were considered eligible if they had prostate specific antigen less than 10 ng/ml, clinical stage T2a or less, Gleason pattern 3 or less, 3 or fewer positive cores and no single core with 50% or greater cancer involvement. RESULTS: A total of 104 patients met eligibility criteria. Of the 104 repeat biopsies performed 27 (26%) were negative, 59 (57%) had a Gleason score of 6 or less and 17 (16%) had a Gleason score of 7. One patient had a Gleason score of 9, while 10 of 104 (10%) had greater than 3 cores involved on repeat biopsy and 12 (12%) had 50% or greater involvement of at least 1 core. Of 104 cases (27%) 28 were upgraded and/or up staged. Treated cases that were upgraded and/or up staged were more likely to show higher pathological stage and grade at radical prostatectomy than those that were not (p = 0.003 and p = 0.001, respectively). CONCLUSIONS: Immediate repeat biopsy in cases of active surveillance with selective delayed intervention resulted in 27% being upgraded or up staged and those were more likely to show higher grade and stage disease at radical prostatectomy. We recommend repeat biopsy because it improved our discrimination of who are the best candidates for active surveillance with selective delayed intervention.

A case of Castleman's disease that presented as a retroperitoneal mass.

BACKGROUND: A 35-year -old man presented to a local emergency room with acute left-flank pain and a medical history of nephrolithiasis. There were no aggravating or relieving factors for the left-flank pain and no other presenting symptoms, and the physical examination was unremarkable. INVESTIGATIONS: Complete blood count, urinalysis, serum tumor markers, scrotal ultrasonography, CT scan of the abdomen (with and without contrast), MRI of the abdomen. DIAGNOSIS: Unicentric Castleman's disease (hyaline-vascular type). MANAGEMENT: Surgical exploration and excision. Pathologic and immunohistochemical work-up confirmed the diagnosis. CT scan after 7 months was normal with no evidence of recurrence.

Simultaneous gingival squamous cell carcinoma in an oral lichen planus patient.

OBJECTIVE: To describe a case of bilateral simultaneous squamous cell carcinoma of the gingiva affecting the mandible in a lichen planus patient and discuss the pertinent literature. METHOD AND MATERIALS: We present a case of a 50-year-old woman with a history of oral lichen planus who was diagnosed with a primary and a second primary squamous cell carcinoma originating from the mandibular gingiva. A literature review did not disclose cases of gingival carcinoma arising simultaneously and bilaterally in the mandible. RESULTS: Presentation of two simultaneous clinically distinct squamous cell carcinoma of gingiva, invading underlying mandible, is rare. Second primary tumor refers to a concomitant malignancy that is independent from the primary tumor. Second primary tumor is an independent prognostic factor since the surgical procedure is highly influenced by the extent of bony invasion. CONCLUSION: The general practitioner should be aware of the possibility of multiple independent lesions at different sites of the oral cavity. A thorough oral examination of sites remote from the obvious main lesion should be performed. The presence of simultaneous primary oral cancerous lesions may indicate a greater morbidity and a grave outcome for the patient.

Development and validation of preoperative nomogram for disease recurrence within 5 years after laparoscopic radical prostatectomy for prostate cancer.

OBJECTIVES: To develop a nomogram that allows the prediction of disease recurrence using preoperative clinical factors for patients with clinically localized prostate cancer who are candidates for laparoscopic radical prostatectomy. Few published studies have combined the clinical prognostic factors into risk profiles that can be used to predict the likelihood of recurrence or metastatic progression after laparoscopic radical prostatectomy for prostate cancer. METHODS: Using Cox proportional hazards regression analysis, we modeled the clinical data and disease follow-up data for 2272 men with clinically localized prostate cancer who had undergone laparoscopic radical prostatectomy. The clinical data included the pretreatment serum prostate-specific antigen level, biopsy Gleason grade, clinical stage, number of positive cores, and number of negative cores. Treatment failure was recorded when clinical evidence of disease recurrence was present, the serum prostate-specific antigen level had increased (2 measurements of ≥0.1 ng/mL and increasing), or the initiation of adjuvant therapy. Validation was also performed on an external data set of 1151 men. RESULTS: Treatment failure was noted in 229 of the 2272 men. The group without failure had a median follow-up of 16.7 months (range 0-120.6). The concordance index, when the nomogram was applied to the validation data set, was 0.77. The calibration in this data set was adequate. The predictions from this nomogram were more accurate than those using an open prostatectomy nomogram. CONCLUSIONS: We have externally validated a nomogram that predicts the 5-year probability of treatment failure among men with clinically localized prostate cancer treated with laparoscopic radical prostatectomy.

Comprehensive standardized report of complications of retropubic and laparoscopic radical prostatectomy.

BACKGROUND: The lack of standardized reporting of the complications of radical prostatectomy in the literature has made it difficult to compare incidences across institutions and across different surgical approaches. OBJECTIVE: To define comprehensively the incidence, severity, and timing of onset of medical and surgical complications of open retropubic prostatectomy (RP) and laparoscopic radical prostatectomy (LP) using a standardized reporting methodology to facilitate comparison. DESIGN, SETTING, AND PARTICIPANTS: Between January 1999 and June 2007, 4592 consecutive patients underwent RP or LP without prior radiation or hormonal therapy. Median follow-up was 36.9 mo (interquartile range: 20.3-60.6). INTERVENTION: Open or laparoscopic radical prostatectomy. MEASUREMENTS: All medical and surgical complications of radical prostatectomy were captured and graded according to the modified Clavien classification and classified by timing of onset. RESULTS AND LIMITATIONS: There were 612 medical complications in 467 patients (10.2%) and 1426 surgical complications in 925 patients (20.1%). The overall incidences of early minor and major medical and surgical complications for RP were 8.5% and 1.5% for medical and 11.4% and 4.9% for surgical complications, respectively. The overall incidences of early minor and major medical and surgical complications for LP were 14.2% and 2.3% for medical and 23.1% and 6.6% for surgical complications, respectively. On multivariate analysis, LP approach was associated with a higher incidence of any grade medical and surgical complications but a lower incidence of major surgical complications than RP. Six hundred fifty-two men (14.2%) visited the emergency department, and 240 men (5.2%) required readmission. The main limitation is the retrospective nature. CONCLUSIONS: With standardized reporting, the incidence of some complications is higher than recognized in the literature. Although most complications are minor in severity, medical and surgical complications are observed in approximately 10% and 20% of patients, respectively. Accurate reporting of complications through a standardized methodology is essential for counseling patients regarding risk of complications, for identifying modifiable risk factors, and for facilitating comparison across institutions and approaches.

Germline BRCA mutations denote a clinicopathologic subset of prostate cancer.

PURPOSE: Increased prostate cancer risk has been reported for BRCA mutation carriers, but BRCA-associated clinicopathologic features have not been clearly defined. EXPERIMENTAL DESIGN: We determined BRCA mutation prevalence in 832 Ashkenazi Jewish men diagnosed with localized prostate cancer between 1988 and 2007 and 454 Ashkenazi Jewish controls and compared clinical outcome measures among 26 BRCA mutation carriers and 806 noncarriers. Kruskal-Wallis tests were used to compare age of diagnosis and Gleason score, and logistic regression models were used to determine associations between carrier status, prostate cancer risk, and Gleason score. Hazard ratios (HR) for clinical end points were estimated using Cox proportional hazards models. RESULTS: BRCA2 mutations were associated with a 3-fold risk of prostate cancer [odds ratio, 3.18; 95% confidence interval (95% CI), 1.52-6.66; P = 0.002] and presented with more poorly differentiated (Gleason score > or =7) tumors (85% versus 57%; P = 0.0002) compared with non-BRCA-associated prostate cancer. BRCA1 mutations conferred no increased risk. After 7,254 person-years of follow-up, and adjusting for clinical stage, prostate-specific antigen, Gleason score, and treatment, BRCA2 and BRCA1 mutation carriers had a higher risk of recurrence [HR (95% CI), 2.41 (1.23-4.75) and 4.32 (1.31-13.62), respectively] and prostate cancer-specific death [HR (95% CI), 5.48 (2.03-14.79) and 5.16 (1.09-24.53), respectively] than noncarriers. CONCLUSIONS: BRCA2 mutation carriers had an increased risk of prostate cancer and a higher histologic grade, and BRCA1 or BRCA2 mutations were associated with a more aggressive clinical course. These results may have implications for tailoring clinical management of this subset of hereditary prostate cancer.

Clinical outcome in a contemporary series of restaged patients with clinical T1 bladder cancer.

OBJECTIVES: To evaluate the indications for early and deferred cystectomy and to report the impact of this tailored approach on survival. DESIGN, SETTING, AND PARTICIPANTS: We retrospectively studied 523 patients seen at our institution who were initially diagnosed with T1 disease between 1990 and 2007. MEASUREMENTS: Variables analyzed included age, gender, multifocality, multifocal T1 disease, carcinoma in situ, grade, recurrence rate, and restaging status. End points were overall and disease-specific survival. RESULTS AND LIMITATIONS: A restaging transurethral resection (TUR) was performed in 523 patients. Of the patients who underwent restaging, 106 (20%) were upstaged to muscle-invasive disease and 417 patients were considered true clinical T1 (cT1); 84 of the latter group underwent immediate cystectomy. The median follow-up for survivors was 4.3 yr. The cumulative incidence of disease-specific death at 5 yr was 8% (95% confidence interval [CI], 5-13%), 10% (95% CI, 5-17%), and 44% (95% CI, 35-56%) for those restaged with lower than T1, T1, and T2 disease, respectively. Immediate cystectomy was more likely in patients with cT1 disease at restaging than in those with disease lower than cT1, but there were no other obvious differences in clinical characteristics between those with and without immediate cystectomy. Survival was not statistically different for patients who underwent an immediate cystectomy versus those who were maintained on surveillance with deferred cystectomy if deemed appropriate. Of 333 patients who did not undergo immediate cystectomy, 59 had a deferred cystectomy, and the likelihood of deferred cystectomy was greater in those with T1 disease on restaging TUR (hazard ratio: 2.40; 95% CI, 1.43-4.01; p=0.001). CONCLUSIONS: Restaging TUR should be performed in patients diagnosed with cT1 bladder cancer to improve staging accuracy. Patients with T1 disease on restaging are at higher risk of progression and should be considered for early cystectomy.

Oncologic outcome after laparoscopic radical prostatectomy: 10 years of experience.

BACKGROUND: While the published short-term oncologic outcomes after laparoscopic radical prostatectomy (LRP) are encouraging, intermediate and long-term data are lacking. OBJECTIVE: We analyzed the oncologic outcome after LRP based on 10 yr of experience. DESIGN, SETTING, AND PARTICIPANTS: This retrospective analysis of data prospectively collected from 1998 to 2007 studies 1564 consecutive patients with clinically localized prostate cancer (cT1c-cT3a) who underwent LRP. INTERVENTION: LRP was performed by two surgeons at either L'Institut Mutualiste Montsouris (IMM) in Paris, France, or Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City, USA. MEASUREMENTS: Progression of disease was defined as a prostate-specific antigen (PSA) of >or=0.1 ng/ml with confirmatory rise or initiation of secondary therapy. Patients were stratified as low, intermediate, or high risk based on the pretreatment prostate cancer nomogram progression-free probability of >90%, 89-71%, and <70%, respectively. RESULTS AND LIMITATIONS: The overall 5-yr and 8-yr probability of freedom from progression (PFP) was 78% (95% confidence interval [CI], 74-82%) and 71% (95% CI, 63-78%), respectively. For low-, intermediate-, and high-risk cancer, the 5-yr PFP was 91% (95% CI, 85-95%), 77% (95% CI, 71-82%), and 53% (95% CI, 40-65%), respectively. Surgical margins (SMs) were positive in 13% of the cases. Nodal metastases were detected in 3% of the patients after limited pelvic lymph node dissection (PLND) and in 10% after a standard PLND (p<0.001). The 3-yr PFP for node-positive patients was 49%. There were 22 overall deaths and 2 deaths from prostate cancer. CONCLUSIONS: LRP provided 5- and 8-yr cancer control in 78% and 71% of patients, respectively, with clinically localized prostate cancer and in 53% of those with high-risk cancer at 5 yr. A PLND limited to the external iliac nodal group is inadequate for detecting nodal metastases.

Defining early morbidity of radical cystectomy for patients with bladder cancer using a standardized reporting methodology.

BACKGROUND: Reporting methodology is highly variable and nonstandardized, yet surgical outcomes are utilized in clinical trial design and evaluation of healthcare provider performance. OBJECTIVE: We sought to define the type, incidence, and severity of early postoperative morbidities following radical cystectomy (RC) using a standardized reporting methodology. DESIGN, SETTING, AND PARTICIPANTS: Between 1995 and 2005, 1142 consecutive RCs were entered into a prospective complication database and retrospectively reviewed for accuracy. All patients underwent RC/urinary diversion by high-volume fellowship-trained urologic oncologists. MEASUREMENTS: All complications within 90 d of surgery were analyzed and graded according to the Memorial Sloan-Kettering Cancer Center complication grading system. Complications were defined and stratified into 11 specific categories. Univariate and multivariate regression models were used to define predictors of complications. RESULTS AND LIMITATIONS: Sixty-four percent (735/1142) of patients experienced a complication within 90 d of surgery. Among patients experiencing a complication, 67% experienced a complication during the operative hospital admission and 58% following discharge. Overall, the highest grade of complication was grade 0 in 36% (n=407), grade 1-2 in 51% (n=582), and grade 3-5 in 13% (n=153). Gastrointestinal complications were most common (29%), followed by infectious complications (25%) and wound-related complications (15%). The 30-d mortality rate was 1.5%. CONCLUSIONS: Surgical morbidity following RC is significant and, when strict reporting guidelines are incorporated, higher than previously published. Accurate reporting of postoperative complications after RC is essential for counseling patients, combined modality treatment planning, clinical trial design, and assessment of surgical success.

Postoperative nomogram predicting risk of recurrence after radical cystectomy for bladder cancer.

PURPOSE: Radical cystectomy and pelvic lymphadenectomy (PLND) remains the standard treatment for localized and regionally advanced invasive bladder cancers. We have constructed an international bladder cancer database from centers of excellence in the management of bladder cancer consisting of patients treated with radical cystectomy and PLND. The goal of this study was the development of a prognostic outcomes nomogram to predict the 5-year disease recurrence risk after radical cystectomy. PATIENTS AND METHODS: Institutional radical cystectomy databases containing detailed information on bladder cancer patients were obtained from 12 centers of excellence worldwide. Data were collected on more than 9,000 postoperative patients and combined into a relational database formatted with patient characteristics, pathologic details of the pre- and postcystectomy specimens, and recurrence and survival status. Patients with available information for all selected study criteria were included in the formation of the final prognostic nomogram designed to predict 5-year progression-free probability. RESULTS: The final nomogram included information on patient age, sex, time from diagnosis to surgery, pathologic tumor stage and grade, tumor histologic subtype, and regional lymph node status. The predictive accuracy of the constructed international nomogram (concordance index, 0.75) was significantly better than standard American Joint Committee on Cancer TNM (concordance index, 0.68; P < .001) or standard pathologic subgroupings (concordance index, 0.62; P < .001). CONCLUSION: We have developed an international bladder cancer nomogram predicting recurrence risk after radical cystectomy for bladder cancer. The nomogram outperformed prognostic models that use standard pathologic subgroupings and should improve our ability to provide accurate risk assessments to patients after the surgical management of bladder cancer.

Standardization of pelvic lymphadenectomy performed at radical cystectomy: can we establish a minimum number of lymph nodes that should be removed?

BACKGROUND: The number of lymph nodes (LNs) removed during radical cystectomy (RC) for transitional cell carcinoma (TCC) of the bladder affects overall and disease-specific survival, but no consensus exists regarding the minimum number of LNs that should be removed. The goal of the current study was to determine if a threshold number of nodes exists, above which taking additional LNs has no clinical benefit. METHODS: A total of 1121 patients were identified who underwent RC for clinically localized TCC of the bladder between January 1990 and April 2004. To determine the relation of LNs removal and overall survival, a Cox proportional hazards model was used with pathologic stage, age, and comorbidity as covariates. A dose-response curve, adjusted for covariates, was modeled to assess the impact of an increasing number of LNs removed on overall survival. RESULTS: A median of 9 LNs were removed (range, 0-53 LNs). In multivariable analysis, all covariates (number of LNs removed, age, stage of disease, and comorbidity) were found to be predictive of survival. The dose-response curve for number of LNs versus survival revealed that, when adjusted for covariates, the probability of survival did not plateau but instead continued to rise as the number of LNs removed increased. CONCLUSIONS: No evidence was found that a minimum number of LNs is sufficient for optimizing bladder cancer outcomes when a limited or extended pelvic LN dissection is performed during RC. Instead, the probability of survival continues to rise as the number of LNs removed increases. This study supports a more extended LN dissection at the time of RC, and highlights the challenges of interpreting retrospective LN dissection data.

Multicenter, randomized, controlled trial of virtual-reality simulator training in acquisition of competency in colonoscopy.

BACKGROUND: The GI Mentor is a virtual reality simulator that uses force feedback technology to create a realistic training experience. OBJECTIVE: To define the benefit of training on the GI Mentor on competency acquisition in colonoscopy. DESIGN: Randomized, controlled, blinded, multicenter trial. SETTING: Academic medical centers with accredited gastroenterology training programs. PATIENTS: First-year GI fellows. INTERVENTIONS: Subjects were randomized to receive 10 hours of unsupervised training on the GI Mentor or no simulator experience during the first 8 weeks of fellowship. After this period, both groups began performing real colonoscopies. The first 200 colonoscopies performed by each fellow were graded by proctors to measure technical and cognitive success, and patient comfort level during the procedure. MAIN OUTCOME MEASUREMENTS: A mixed-effects model comparison between the 2 groups of objective and subjective competency scores and patient discomfort in the performance of real colonoscopies over time. RESULTS: Forty-five fellows were randomized from 16 hospitals over 2 years. Fellows in the simulator group had significantly higher objective competency rates during the first 100 cases. A mixed-effects model demonstrated a higher objective competence overall in the simulator group (P < .0001), with the difference between groups being significantly greater during the first 80 cases performed. The median number of cases needed to reach 90% competency was 160 in both groups. The patient comfort level was similar. CONCLUSIONS: Fellows who underwent GI Mentor training performed significantly better during the early phase of real colonoscopy training.