Publications

2014
Meskawi M, Becker A, Bianchi M, Trinh Q-D, Roghmann F, Tian Z, Graefen M, Perrotte P, Karakiewicz PI, Sun M. Partial and radical nephrectomy provide comparable long-term cancer control for T1b renal cell carcinoma. Int J Urol. 2014;21 (2) :122-8.Abstract
OBJECTIVES: To examine utilization rates of partial nephrectomy relative to radical nephrectomy for T1b renal cell carcinoma in contemporary years, to identify sociodemographic and disease characteristics associated with partial nephrectomy use, and to compare effectiveness of partial versus radical nephrectomy with respect to cancer control. METHODS: Using the Surveillance, Epidemiology, and End Results database, 16,333 patients treated with partial or radical nephrectomy for T1bN0M0 renal cell carcinoma between 1988 and 2008 were identified. Logistic regression models were carried out to identify determinants of partial nephrectomy. Subsequently, cumulative incidence rates of cancer-specific and other-cause mortality between partial and radical nephrectomy were assessed, within the matched cohort. Furthermore, competing-risks regression analyses were used for prediction of cancer-specific mortality, after adjusting for other-cause mortality, and vice versa. RESULTS: The utilization rate of partial nephrectomy increased from 1.2% in 1988 to 15.9% in 2008 (P < 0.001). Younger individuals, smaller tumors, persons of black race, as well as men, were more likely to be treated with partial nephrectomy in the current cohort (all P ≤ 0.002). In the post-propensity cohort, the 5- and 10-year cancer-specific mortality rates were 4.4 and 6.1% for partial versus 6.0 and 10.4% for radical nephrectomy, respectively (P = 0.03). Competing-risks regression analyses showed that nephrectomy type was not statistically significantly associated with cancer-specific mortality, even after adjusting for other-cause mortality (hazard ratio 0.89, P = 0.5). CONCLUSIONS: Despite providing a comparable cancer control, the use of partial over radical nephrectomy for T1b renal cell carcinoma in USA has remained limited in recent years.
Sammon JD, Zhu G, Sood A, Sukumar S, Kim SP, Sun M, Karakiewicz PI, Menon M, Trinh Q-D, Elder JS. Pediatric nephrectomy: incidence, indications and use of minimally invasive techniques. J Urol. 2014;191 (3) :764-70.Abstract
PURPOSE: There is a paucity of knowledge regarding nephrectomy in contemporary United States pediatric populations. Usage patterns, indications and demographics of children undergoing nephrectomy are unknown. Given the significant increases in the use of minimally invasive nephrectomy in adults, we hypothesized similar trends may be seen in the pediatric population. MATERIALS AND METHODS: An estimated total of 27,615 children undergoing nephrectomy between 1998 and 2010 was extracted from the Nationwide Inpatient Sample. Trends in use were analyzed with the estimated annual percent change methodology using linear regression and proportions by chi-square. Determinants of minimally invasive nephrectomy were evaluated using generalized linear models adjusted for clustering with generalized estimating equations. RESULTS: The annual incidence of pediatric nephrectomy was 2.90 per 100,000 patient-years and remained stable. Nephrectomy was most common in children 0 to 1 year old (36%) and least common in children 6 to 9 years old (14%). However, nephrectomy for malignancy was most common in children 3 to 4 years old. Minimally invasive nephrectomy usage increased from 1.1% to 11.6% during the study period (estimated annual percent change 72.82%, p = 0.007). On multivariable analysis patients with malignancy (OR 0.07, p <0.001) had a lower rate of minimally invasive nephrectomy. Increased use was associated with increasing age (OR 1.07, p <0.001), treatment at a teaching institution (OR 1.95, p = 0.008) and increasing hospital volume (OR 1.01, p = 0.001). CONCLUSIONS: While the annual incidence of nephrectomy is stable, the use of minimally invasive nephrectomy is expanding in the pediatric population. Benign pathology and increasing age as well as nephrectomy at high volume teaching institutions are independently associated with minimally invasive nephrectomy use.
Friedlander DF, Gu X, Prasad SM, Lipsitz SR, Nguyen PL, Trinh Q-D, Sun M, Hu JC. Population-based comparative effectiveness of salvage radical prostatectomy vs cryotherapy. Urology. 2014;83 (3) :653-7.Abstract
OBJECTIVE: To characterize population-based practice patterns, disease-specific and overall mortality, and cost associated with salvage cryotherapy (SCT) vs salvage radical prostatectomy (SRP). METHODS: We retrospectively identified 440 men who failed primary radiation therapy and subsequently underwent SCT (n = 341, 77.5%) or SRP (n = 99, 22.5%) between 1992 and 2009 from Surveillance, Epidemiology, and End Results-Medicare linked data. Propensity score analyses were used to compare overall and prostate cancer-specific mortality and associated Medicare expenditures for SRP vs SCT. RESULTS: Men undergoing SCT were more likely to be white (P <.001), less likely to be high school graduates (P = .008), and experienced shorter median time from diagnosis to salvage therapy (44.1 vs 60.1, P <.001) and from primary radiotherapy to salvage therapy (38.7 vs 55.8 months, P <.001). In adjusted analyses, overall mortality was higher (21.6 vs 6.1 deaths/100 person years, P <.001) for SRP vs SCT. There was a trend for higher prostate cancer-specific death rates with SRP vs SCT (6.5 vs 1.4 deaths/100 person years, P = .061). Medicare expenditures for SRP vs SCT were more than 2-fold higher ($19,543 vs $8,088, P <.001). CONCLUSION: SRP vs SCT is associated with higher overall mortality and greater health care expenditures. However, longer follow-up is needed to assess long-term functional outcomes and cancer control.
Xylinas E, Kluth L, Passoni N, Trinh Q-D, Rieken M, Lee RK, Fajkovic H, Novara G, Margulis V, Raman JD, et al. Prediction of intravesical recurrence after radical nephroureterectomy: development of a clinical decision-making tool. Eur Urol. 2014;65 (3) :650-8.Abstract
BACKGROUND: Intravesical recurrence after radical nephroureterectomy (RNU) is a frequent event requiring intense cystoscopic surveillance. Recently, a prospective randomized clinical trial has shown that a single intravesical postoperative dose of mitomycin C (MMC) reduces the absolute risk of intravesical recurrence after RNU. OBJECTIVE: The aim of the current study was to identify predictors of intravesical recurrence and to develop a tool to allow a risk-stratified approach supporting patient counseling for cystoscopic surveillance and postoperative intravesical MMC administration. DESIGN, SETTING, AND PARTICIPANTS: We performed a retrospective analysis of 1839 patients with upper tract urothelial carcinoma (UTUC). The data set was split into a development cohort of 1261 patients from North America and a validation cohort of 578 patients from Europe. INTERVENTIONS: RNU with bladder cuff excision was performed. The surgical approach was open in 1424 patients (77.4%) and laparoscopic in 415 patients (22.6%). OUTCOME MEASUREMENTS AND STATISTICAL ANALYSES: Univariable and multivariable Cox regression models addressed time to intravesical recurrence after RNU. We developed a nomogram for prediction of the probability of intravesical recurrence at 3, 6, 9, 12, 18, 24, and 36 mo. Predictive accuracy was quantified using the concordance index. Decision curve analysis was performed to evaluate the clinical benefit associated with the use of our nomograms. RESULTS AND LIMITATIONS: With a median follow-up of 45 mo, intravesical recurrence occurred in 577 patients (31%). The probability of intravesical recurrence-free survival at 6, 12, 24, and 36 mo was 85% ± 1%, 78% ± 1%, 68% ± 1%, and 47% ± 2%, respectively. In multivariable Cox regression analysis, advanced age, male gender, ureteral tumor location, laparoscopic surgical technique, endoscopic distal ureteral management, previous bladder cancer, higher tumor stage, concomitant carcinoma in situ, and lymph node involvement were all significantly associated with intravesical recurrence (p values ≤ 0.04). The nomograms were highly accurate for predicting intravesical recurrence in the external validation cohort (concordance index of 67.8% and 69.0% for the reduced model and the full model, respectively), and calibration plots revealed only minor overestimation beyond 24 mo. If one decided to perform postoperative instillation based on the risk of intravesical recurrence of 15% at 24 mo, one would spare 23% of the patients while not preventing only 0.3% of intravesical recurrences. The lack of information on the stage and grade of the intravesical recurrences is the main limitation of the study. CONCLUSIONS: Intravesical recurrence after RNU is a common event in patients with UTUC. We developed nomograms that predict intravesical recurrence after RNU with reasonable accuracy. Such nomograms could improve the clinical decision-making process with regard to cystoscopic surveillance scheduling and postoperative intravesical instillations of MMC after RNU.
Roghmann F, Trinh Q-D, Braun K, von Bodman C, Brock M, Noldus J, Palisaar J. Standardized assessment of complications in a contemporary series of European patients undergoing radical cystectomy. Int J Urol. 2014;21 (2) :143-9.Abstract
OBJECTIVES: To examine postoperative complications in a contemporary series of patients after radical cystectomy using a standardized reporting system, and to identify readily available preoperative risk factors. METHODS: Using the modified Clavien-Dindo classification, we assessed the 90-day postoperative clinical course of 535 bladder cancer patients who underwent radical cystectomy and urinary diversion (ileal conduit n = 349, ileal neobladder n = 186) between June 2003 and February 2012 at a single institution. All Martin criteria for standardized reporting of complications were met. Uni- and multivariable analyses for prediction of complications were carried out; covariates included body mass index, Charlson Comorbidity Index, age, sex, American Society of Anesthesiologists Score, neoadjuvant chemotherapy, prior abdominal or pelvic surgery, localized tumor and urinary diversion type. RESULTS: The 90-day rates for overall (Clavien-Dindo classification I-V) and high-grade complications (Clavien-Dindo classification III-V), as well as mortality (Clavien-Dindo classification V), were 56.4, 18.7 and 3.9%, respectively. Infections (16.4%), bleeding (14.2%) and gastrointestinal complications (10.7%) were the most common adverse outcomes. Independent risk factors for overall complications were body mass index (odds ratio 1.08) and Charlson Comorbidity Index ≥3 (odds ratio 1.93). Risk factors for high-grade complications were Charlson Comorbidity Index ≥3 (odds ratio 1.86), American Society of Anesthesiologists Score ≥3 (odds ratio 1.92) and body mass index (odds ratio 1.07, all P < 0.03). CONCLUSIONS: Radical cystectomy is associated with significant morbidity; nevertheless, the majority of complications are minor. Charlson Comorbidity Index, American Society of Anesthesiologists Score and body mass index might help to identify patients at risk for high-grade complications after radical cystectomy.
Gandaglia G, Bianchi M, Trinh Q-D, Becker A, Larouche A, Abdollah F, Roghmann F, Tian Z, Shariat SF, Briganti A, et al. Survival after nephroureterectomy for upper tract urothelial carcinoma: a population-based competing-risks analysis. Int J Urol. 2014;21 (3) :249-56.Abstract
OBJECTIVES: To examine the rates of cancer-specific mortality, other-cause and bladder cancer mortality in patients with upper-tract urothelial carcinoma undergoing radical nephroureterectomy. METHODS: Relying on the Surveillance, Epidemiology, and End Results database, 9899 patients treated with radical nephroureterectomy were identified. A 20-strata graphical aid was constructed using age (<60, 60-69, 70-79, >79 years) and American Joint Committee on Cancer/TNM stage (pT₁N₀/x , pT₂N₀/x , pT₃N₀/x , pT₄N₀/x , pTany pN₁₋₃) as stratifying variables. The 5-year cancer-specific mortality, other-cause and bladder cancer mortality rates were generated through competing-risks Poisson regression methodologies. Multivariable competing-risks regression models were used to test the effect of age and stage on three different end-points: cancer-specific mortality, other-cause and bladder cancer mortality. RESULTS: Overall, 1797 (18.1%), 891 (9.1%) and 3090 (31.2%) patients died of cancer-specific mortality, other-cause and bladder cancer mortality, respectively. Following stratification according to age and stage, the proportion of patients who succumbed to cancer-specific mortality (11.7-21.9%) and other-cause mortality (8.9-30.4%) increased with age. In contrast, with increasing stage, the proportion of patients who died of cancer-specific mortality increased (7.2-37.5%), whereas the proportion of other-cause mortality remained stable (18.9-22.0%). The rate of bladder cancer mortality increased with advancing stage. At multivariable competing-risk regression model, besides age and stage, women, type of surgery, grade and location were associated with higher cancer-specific mortality. Furthermore, ureteral location, stage and grade were associated with bladder cancer mortality. CONCLUSIONS: The developed graphical aid for prediction of cancer-specific mortality, other-cause, and bladder cancer mortality according to age and stage in patients with upper-tract urothelial carcinoma undergoing radical nephroureterectomy can be useful for physicians and patients during clinical counseling.
Li H, Sammon J, Roghmann F, Sood A, Ehlert M, Sun M, Menon M, Atiemo H, Trinh Q-D. Utilization and perioperative outcomes of robotic vaginal vault suspension compared to abdominal or vaginal approaches for pelvic organ prolapse. Can Urol Assoc J. 2014;8 (3-4) :100-6.Abstract
OBJECTIVES: Robot-assisted vaginal vault suspension (RAVVS) for pelvic organ prolapse (POP) represents a minimally-invasive alternative to abdominal sacrocolpopexy. We measured perioperative outcomes and utilization rates of RAVVS. METHODS: RAVVS (n = 2381) and open VVS (OVVS, n = 11080) data were extracted from the 2009-2010 Nationwide Inpatient Sample. Propensity score-matched analysis compared patients undergoing RAVVS or OVVS for complications, mortality, prolonged length-of-stay, and elevated hospital charges. RESULTS: Use of RAVVS for POP increased from 2009 to 2010 (16.3% to 19.2%). Patients undergoing RAVVS were more likely to be white (77.2% vs. 69.6%), to carry private insurance (52.8% vs. 46.0%) and to have fewer comorbidities (Charlson Comorbidity Index [CCI] ≥1 = 17.5% vs. 26.6%). They were more likely to undergo surgery at urban (98.2% vs. 93.7%) and academic centres (75.7% vs. 56.7%). Patients undergoing RAVVS were less likely to receive a blood-transfusion (0.7% vs. 1.8%, p < 0.001) or experience prolonged length-of-stay (9.3% vs. 25.1%, p < 0.001). They had more intraoperative complications (6.0% vs. 4.2%, p < 0.001), and higher median hospital charges ($32 402 vs. $24 136, p < 0.001). Overall postoperative complications were equivalent (17.9%, p = 1.0), though there were differences in wound (0.4% vs. 1.3%, p < 0.001), genitourinary (4.9% vs. 6.5%, p = 0.009), and surgical (6.6% vs. 4.9%, p = 0.007) complications. CONCLUSIONS: The increasing use of RAVVS from 2009 to 2010 suggests a growth in the adoption of robotics to manage POP. We show that RAVVS is associated with decreased length of stay, fewer blood transfusions, as well as lower postoperative wound, genitourinary and vascular complications. The benefits of RAVVS are mitigated by higher hospital charges and higher rates of intra-operative complications.
Gandaglia G, Abdollah F, Schiffmann J, Trudeau V, Shariat SF, Kim SP, Perrotte P, Montorsi F, Briganti A, Trinh Q-D, et al. Distribution of metastatic sites in patients with prostate cancer: A population-based analysis. Prostate. 2014;74 (2) :210-6.Abstract
BACKGROUND: There is few data on what constitutes the distribution of metastatic sites in prostate cancer (PCa). The aim of our study was to systematically describe the most common sites of metastases in a contemporary cohort of PCa patients. METHODS: Patients with metastatic PCa were abstracted from the Nationwide Inpatient Sample (1998-2010). Most common metastatic sites within the entire population were described. Stratification was performed according to the presence of single or multiple (≥ 2 sites) metastases. Additionally, we evaluated the distribution of metastatic sites amongst patients with and without bone metastases. RESULTS: Overall, 74,826 patients with metastatic PCa were identified. The most common metastatic sites were bone (84%), distant lymph nodes (10.6%), liver (10.2%), and thorax (9.1%). Overall, 18.4% of patients had multiple metastatic sites involved. When stratifying patients according to the site of metastases, only 19.4% of men with bone metastases had multiple sites involved. Conversely, among patients with lymph nodes, liver, thorax, brain, digestive system, retroperitoneum, and kidney and adrenal gland metastases the proportion of men with multiple sites involved was 43.4%, 76.0%, 76.7%, 73.0%, 52.2%, 60.9%, and 76.4%, respectively. When focusing exclusively on patients with bone metastases, the most common sites of secondary metastases were liver (39.1%), thorax (35.2%), distant lymph nodes (24.6%), and brain (12.4%). CONCLUSIONS: Although the majority of patients with metastatic PCa experience bone location, the proportion of patients with atypical metastases is not negligible. These findings might be helpful when planning diagnostic imaging procedures in patients with advanced PCa.
Ghani KR, Roghmann F, Sammon JD, Trudeau V, Sukumar S, Rahbar H, Kumar R, Karakiewicz PI, Peabody JO, Menon M, et al. Emergency department visits in the United States for upper urinary tract stones: trends in hospitalization and charges. J Urol. 2014;191 (1) :90-6.Abstract
PURPOSE: Using the Nationwide Emergency Department Sample (NEDS) we examined trends in visits, hospitalization and charges for patients with upper urinary tract stones who presented to the emergency department in the United States. MATERIALS AND METHODS: All visits with a primary diagnosis of kidney calculus (ICD-9-CM code 592.0), ureter calculus (592.1) or urinary calculus unspecified (592.9) were extracted from NEDS between 2006 and 2009. A weighted sample was used to calculate incidence rates. Temporal trends were quantified by the estimated annual percent change. Patient and hospital characteristics associated with hospitalization were evaluated using logistic regression models adjusted for clustering. RESULTS: Between 2006 and 2009 there were 3,635,054 emergency department visits for upper urinary tract stones. The incidence increased from 289 to 306/100,000 individuals. More men visited than women but women showed significant increases in visits (estimated annual percent change 2.85%, p = 0.018). Total monthly emergency department visits ranged from 5.8% in February to 8.4% in August. Overall 12.0% of patients were hospitalized and the hospitalization rate remained stable (estimated annual percent change -1.02%, p = 0.634). Patients were more likely to be hospitalized if they were female, more ill, seen at an urban teaching or low volume hospital, or had Medicaid or Medicare (each p <0.001). Sepsis was associated with the highest likelihood of hospital admission (OR 69.64, p <0.001). In 2009 charges for emergency department visits increased to $5 billion (estimated annual percent change 10.06%, p = 0.003). CONCLUSIONS: Women showed significant annual increases in emergency department visits for upper urinary tract stones. While emergency department charges increased substantially, hospitalization rates remained stable. Greater use of computerized tomography and medical expulsive therapy could be the reasons for this observation, which warrants further study.
Sun M, Trinh Q-D, Bianchi M, Hansen J, Abdollah F, Tian Z, Shariat SF, Montorsi F, Perrotte P, Karakiewicz PI. Extent of lymphadenectomy does not improve the survival of patients with renal cell carcinoma and nodal metastases: biases associated with the handling of missing data. BJU Int. 2014;113 (1) :36-42.Abstract
UNLABELLED: WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: A recent population-based analysis suggested a potential survival benefit with respect to performing lymph node dissection at nephrectomy in node-positive patients with RCC. The findings of the present study failed to corroborate the association of a survival benefit with the performance of lymph node dissection at nephrectomy. OBJECTIVE: Previous studies showed no survival benefit with respect to performing lymph node dissection (LND) at nephrectomy, whereas a recent population-based analysis suggested otherwise, although the latter relied on imputation. To reconcile the findings of that study by critically evaluating the handling of missing data. PATIENTS AND METHODS: Study participants comprised patients diagnosed with non-metastatic renal cell carcinoma (RCC) of all stages who underwent LND at nephrectomy (n = 10 596). Multivariable Cox regression models were performed to predict cancer-specific mortality (CSM), where the primary variable of interest was the extent of LND. To examine differences in approaches with respect to handling missing data, separate analyses were performed: (i) imputed population; (ii) exclusion of patients with missing data; and (iii) inclusion of patients with missing data as a sub-category. RESULTS: Overall, 2916 (28%) patients had missing tumour grade. In multivariable analyses, our findings showed that increasing the extent of LND was associated with a significant protective effect on CSM in patients with pN1 after imputation (hazard ratio [HR], 0.82; P = 0.04). By contrast, the extent of LND was no longer significantly associated with a lower risk of CSM after excluding patients with a missing tumour grade (HR, 0.83; P = 0.1) or when including patients with missing tumour grade as a sub-category (HR, 0.82; P = 0.05). CONCLUSIONS: The findings of the present study failed to corroborate the association of a survival benefit with increasing extent of LND at nephrectomy. The different methodologies employed to account for missing data may introduce important biases. Such considerations are non-negligible with respect to the interpretation of results for investigators who rely on administrative cohorts.
Trinh Q-D, Sun M, Kim SP, Sammon J, Kowalczyk KJ, Friedman AA, Sukumar S, Ravi P, Muhletaler F, Agarwal PK, et al. The impact of hospital volume, residency, and fellowship training on perioperative outcomes after radical prostatectomy. Urol Oncol. 2014;32 (1) :29.e13-20.Abstract
OBJECTIVES: Although high-volume hospitals have been associated with improved outcomes for radical prostatectomy (RP), the association of residency or fellowship teaching institutions or both and this volume-outcome relationship remains poorly described. We examine the effect of teaching status and hospital volume on perioperative RP outcomes. METHODS AND MATERIALS: Within the Nationwide Inpatient Sample, we focused on RPs performed between 2003 and 2007. We tested the rates of prolonged length of stay beyond the median of 3 days, in-hospital mortality, and intraoperative and postoperative complications, stratified according to teaching status. Multivariable logistic regression analyses further adjusted for confounding factors. RESULTS: Overall, 47,100 eligible RPs were identified. Of these, 19,193 cases were performed at non-teaching institutions, 24,006 at residency teaching institutions, and 3,901 at fellowship teaching institutions. Relative to patients treated at non-teaching institutions, patients treated at fellowship teaching institutions were healthier and more likely to hold private insurance. In multivariable analyses, patients treated at residency (OR = 0.92, P = 0.015) and fellowship (OR = 0.82, P = 0.011) teaching institutions were less likely to experience a postoperative complication than patients treated at non-teaching institutions. Patients treated at residency (OR = 0.73, P<0.001) and fellowship (OR = 0.91, P = 0.045) teaching institutions were less likely to experience a prolonged length of stay. CONCLUSIONS: More favorable postoperative complication profile and shorter length of stay should be expected at residency and fellowship teaching institutions following RP. Moreover, postoperative complication rates were lower at fellowship teaching than at residency teaching institutions, despite adjustment for potential confounders.
Gandaglia G, Becker A, Trinh Q-D, Abdollah F, Schiffmann J, Roghmann F, Tian Z, Montorsi F, Briganti A, Karakiewicz PI, et al. Long-term survival in patients with germ cell testicular cancer: a population-based competing-risks regression analysis. Eur J Surg Oncol. 2014;40 (1) :103-12.Abstract
BACKGROUNDS: Incidence of secondary malignancies and cardiovascular diseases among testicular germ cell tumor (TGCT) survivors is higher compared to the general population. We sought to describe the rates of other-cancer (OCM), non-cancer related (NCRM), and cancer-specific mortality (CSM) among men with TGCT. METHODS: Using the Surveillance, Epidemiology, and End Results (SEER) database, 31,330 patients with a primary diagnosis of TGCT between 1973 and 2009 were identified. The primary endpoints comprised of 15-year CSM, OCM, and NCRM rates. Survival rates were stratified according to histology (seminoma vs. non-seminoma), median age (<34 vs. ≥34 years old), and disease stage (localized vs. regional vs. distant). Competing-risks Poisson regression methodologies were performed. RESULTS: For seminoma patients, the rates of CSM at 15 years increased with advancing stage (0.4-12.6%; P < 0.001), but varies little with age. In contrast, the rates of OCM (0.4-7.9%) and NCRM (2.9-8.9%) at 15 years increased with advancing stage and age (all P < 0.001). For non-seminoma patients, the 15-year CSM rates increased with advancing stage and age (1.9-24.4%; all P < 0.001). For the same time point, the rates of OCM (0.3-11.4%) and NCRM (2.4-8.0%) also increased with age and stage (all P ≤ 0.001). CONCLUSIONS: The risk of dying from secondary malignancies or other causes significantly increases with advancing stage and age at diagnosis among TGCT survivors. Such information can help provide patients and physicians with better screening strategies, follow-up protocols, and mental preparedness for such undesirable effects.
Sun M, Becker A, Tian Z, Roghmann F, Abdollah F, Larouche A, Karakiewicz PI, Trinh Q-D. Management of localized kidney cancer: calculating cancer-specific mortality and competing risks of death for surgery and nonsurgical management. Eur Urol. 2014;65 (1) :235-41.Abstract
BACKGROUND: For elderly individuals with localized renal cell carcinoma (RCC), surgical intervention remains the primary treatment option but may not benefit patients with limited life expectancy. OBJECTIVE: To calculate the trade-offs between surgical excision and nonsurgical management (NSM) with respect to competing causes of mortality. DESIGN, SETTING, AND PARTICIPANTS: Relying on a cohort of Medicare beneficiaries, all patients with nonmetastatic node-negative T1 RCC between 1988 and 2005 were abstracted. INTERVENTION: All patients were treated with partial nephrectomy (PN), radical nephrectomy (RN), or NSM. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Cancer-specific mortality (CSM) and other-cause mortality (OCM) rates were modeled through competing-risks regression methodologies. Instrumental variable analysis was used to account for the potential biases associated with measured and unmeasured confounders. RESULTS AND LIMITATIONS: A total of 10 595 patients were identified. In instrumental variable analysis, patients treated with PN (hazard ratio [HR]: 0.45; 95% confidence interval [CI], 0.24-0.83; p=0.01) or RN (HR: 0.58; 95% CI, 0.35-0.96; p=0.03) had a significantly lower risk of CSM than those treated with NSM. In subanalyses restricted to patients ≥ 75 yr, the instrumental variable analysis failed to detect any statistically significant difference between PN (HR: 0.48; p=0.1) or RN (HR: 0.57; p=0.1) relative to NSM with respect to CSM. Similar trends were observed in T1a RCC only. CONCLUSIONS: PN or RN is associated with a reduction of CSM among older patients diagnosed with localized RCC, compared with NSM. The same benefit failed to reach statistical significance among patients ≥ 75 yr. The harms of surgery need to be weighed against the marginal survival benefit for some patients.
Bianchi M, Gandaglia G, Trinh Q-D, Hansen J, Becker A, Abdollah F, Tian Z, Lughezzani G, Roghmann F, Briganti A, et al. A population-based competing-risks analysis of survival after nephrectomy for renal cell carcinoma. Urol Oncol. 2014;32 (1) :46.e1-7.Abstract
OBJECTIVES: Variability in survival after surgical treatment is observed in patients with renal cell carcinoma (RCC), thereby affirming the heterogeneity of the disease. The aim of our study was to provide a clinically relevant and detailed assessment of survival following surgical excision in patients with RCC of all stages according to age, stage, and grade. MATERIALS AND METHODS: A retrospective population-based analysis of 42,090 patients in the United States who were treated with partial nephrectomy (PN) or radical nephrectomy (RN) for RCC of all stages between the years 1988 and 2008 was performed. Competing-risks Poisson regression analyses focusing on cancer-specific mortality (CSM) or other-cause mortality (OCM) were executed. Stratification was performed according to age groups (≤ 59, 60-69, 70-79, and ≥ 80 y), the American Joint Committee on Cancer stage (I, II, III, and IV), and the Fuhrman grade (I-II and III-IV). RESULTS: Increasing stage was associated with higher CSM rates (from 2%-9% to 54%-79% for stage I and IV), regardless of age. Similarly, high tumor grade was associated with higher CSM rates (from 2%-64% to 6%-79% for low and high grade). However, OCM was nonnegligible amongst persons aged 70 to 79 years (11%-24%) and ≥ 80 years (17%-44%), regardless of stage and grade. In subanalyses focusing on stage I RCC, CSM (3%-10%) rates were slightly higher for RN-treated patients, regardless of age and grade. However, in individuals aged 70 to 79 years with high-grade RCC, OCM rates were slightly higher for PN relative to RN (25.5% vs. 23.5%). In those aged ≥ 80 years, OCM rates were higher for PN compared with RN, both for low-grade (39.4% vs. 32.7%) and high-grade disease (52.0% vs. 42.8%). CONCLUSIONS: Tumor grade and American Joint Committee on Cancer stage represent important prognostic factors for the prediction of CSM, despite adjustment for patient age. However, OCM rates were nonnegligible in elderly individuals (≥ 70 y) with low-grade and stage I to III RCC.
Roghmann F, Sukumar S, Ravi P, Trinh VQ, Meskawi M, Ghani KR, Sammon JD, Friedman AA, Peabody JO, Menon M, et al. Radical cystectomy in the elderly: national trends and disparities in perioperative outcomes and quality of care. Urol Int. 2014;92 (1) :27-34.Abstract
INTRODUCTION: To examine national trends of radical cystectomy (RC) for urothelial carcinoma of urinary bladder in octogenarian patients and to assess the rates of adverse outcomes. MATERIALS AND METHODS: Within the Nationwide Inpatient Sample (NIS), we focused on RCs performed between 1998 and 2007. Age was stratified as <80 versus ≥80 years. Propensity-based matched analyses were used to account for treatment selection biases. Generalized linear regression analyses were fitted to predict adverse perioperative events according to age. RESULTS: Of 12,274 RC patients, 1,605 were ≥80 years (13.1%). The RC rates in octogenarians increased significantly from 9.9% in 1998 to 13.7% in 2007. Most elderly patients were treated at low-/intermediate-volume hospitals (81.7%) and nonacademic centers (60.6%). After propensity score matching, the inpatient mortality rate was higher in octogenarians (4.6 vs. 2.6%, p < 0.001). In multivariable analyses, octogenarians were at increased risk of blood transfusions (OR: 1.30) and postoperative complications (OR: 1.22). CONCLUSIONS: Most octogenarians undergoing RC are treated at low-/intermediate-volume hospitals and at nonacademic centers. The inpatient hospital mortality is about twice as high in these patients, and adverse perioperative outcomes are more frequent. Such patients may benefit from RC at high-volume and/or academic centers to maximally reduce adverse perioperative outcomes.
Sun M, Sammon JD, Becker A, Roghmann F, Tian Z, Kim SP, Larouche A, Abdollah F, Hu JC, Karakiewicz PI, et al. Radical prostatectomy vs radiotherapy vs observation among older patients with clinically localized prostate cancer: a comparative effectiveness evaluation. BJU Int. 2014;113 (2) :200-8.Abstract
OBJECTIVE: To compare efficacy between radical prostatectomy (RP), radiotherapy and observation with respect to overall survival (OS) in patients with clinically localized prostate cancer (PCa). METHODS: Using data (1988-2005) from the Surveillance, Epidemiology, and End Results-Medicare linked database, 67 087 men with localized PCa were identified. The prevalence of the initial treatment strategy was quantified according to patients' life expectancy ([LE] <10 vs ≥10 years) at initial diagnosis and according to tumour stage. To reduce the unmeasured bias associated with treatment, we performed an instrumental variable analysis. Stratified (by stage and LE) Cox regression and competing-risks regression analyses were generated for the prediction of OS and cancer-specific mortality, respectively. RESULTS: Among patients with <10 years of LE, most were treated with radiotherapy (49%) or observation (47%). Among patients with ≥10 years of LE, most received radiotherapy (49%), followed by RP (26%). In men with <10 years of LE, RP and radiotherapy were not different with respect to OS (hazard ratio [HR]: 0.81, 95% confidence interval [CI]: 0.45-1.48, P = 0.499). Conversely, in men with ≥10 years of LE, RP was associated with an improved OS compared with observation (HR: 0.59, 95% CI: 0.49-0.71, P < 0.001) and radiotherapy (HR: 0.66, 95% CI: 0.56-0.79, P < 0.001). Similar results were recorded in competing-risks regression analyses. CONCLUSION: In patients with an estimated LE ≥10 years at initial diagnosis, RP was associated with improved survival compared with radiotherapy and observation, regardless of disease stage.
Sun M, Ravi P, Karakiewicz PI, Sukumar S, Sammon J, Bianchi M, Shariat SF, Jeong W, Ghani KR, Hansen J, et al. Is there a relationship between leapfrog volume thresholds and perioperative outcomes after radical cystectomy?. Urol Oncol. 2014;32 (1) :27.e7-13.Abstract
OBJECTIVE: Threshold levels for hospital volume (HV), defined by the Leapfrog Group for Patient Safety, advocate the concentration of high-risk medical care to high-volume hospitals in order to avail of these outcome benefits. We explored the effect of Leapfrog volume thresholds (LVT) on 5 short-term radical cystectomy (RC) outcomes. MATERIALS AND METHODS: Within the Health Care Utilization Project Nationwide Inpatient Sample, we focused on RCs performed between 2001 and 2007. We tested the rates of in-hospital mortality, intraoperative and postoperative complications, blood transfusions, as well as length of stay, stratified according to the number of LVT met. Multivariable regression analyses further adjusted for potential confounders. RESULTS: Overall, 28.6%, 17.1%, 18.8%, 17.0%, 15.4%, and 3.1% of cases were performed at institutions reaching 0, 1, 2, 3, 4, and 5 LVT, respectively. Patients treated at institutions reaching 5 LVT had fewer comorbidities, were younger, and more likely to hold private insurance, relative to patients treated at institutions reaching 0 LVT. In adjusted analyses, after accounting for patient characteristics and HV, LVT status was inversely related to mortality (P = 0.030), intraoperative (P = 0.042) and postoperative (P = 0.041) complications, as well as the likelihood of blood transfusion (P<0.001). CONCLUSIONS: LVT is an important determinant of the risk of mortality, complications, and blood transfusions after RC, independent of HV. These findings hint at intrinsic structural and procedural elements available within hospitals that meet LVT, which enable them to manage complications, and prevent mortality, in a more optimal manner.
Becker A, Roghmann F, Ravi P, Tian Z, Kluth LA, Gandaglia G, Noldus J, Dahlem R, Schlomm T, Graefen M, et al. Delay in nephrectomy and cancer control outcomes in elderly patients with small renal masses. Urol Int. 2014;92 (4) :455-61.Abstract
OBJECTIVE: To examine the impact of nephrectomy delay on the survival of patients with small renal masses. METHODS: Relying on the Surveillance, Epidemiology, and End Results Medicare-linked database, 6,237 patients with pT1a renal cell carcinoma who underwent radical or partial nephrectomy were identified (1988-2005). Nephrectomy delay was dichotomized as ≤3 vs. >3 months. Uni- and multivariate Cox regression analyses tested the effect of delayed nephrectomy on cancer-specific mortality (CSM). In sub-analyses, various other time from diagnosis to nephrectomy cut-offs were modelled: (a) ≤1 vs. >1 month, (b) ≤2 vs. >2 months, (c) ≤4 vs. >4 months, (d) ≤6 vs. >6 months, (e) ≤12 vs. >12 months or (f) continuously coded. RESULTS: In univariate analyses, nephrectomy delay >3 months was associated with a higher risk of CSM (hazard ratio [HR]: 2.07; 95% confidence interval [CI]: 1.58-2.72; p < 0.001). However, after multivariate adjustment, a nephrectomy delay >3 months was not significantly associated with a higher risk of CSM (HR: 1.33; 95% CI: 0.96-1.86; p = 0.09). The lack of a relationship between nephrectomy delay and CSM after multivariate adjustment persisted even in various sub-analyses of other categorizations for nephrectomy delay. CONCLUSIONS: In the case of eventual nephrectomy delay among patients with small renal masses, CSM is unaffected.
Rieken M, Xylinas E, Kluth L, Trinh Q-D, Lee RK, Fajkovic H, Novara G, Margulis V, Lotan Y, Martinez-Salamanca JI, et al. Diabetes mellitus without metformin intake is associated with worse oncologic outcomes after radical nephroureterectomy for upper tract urothelial carcinoma. Eur J Surg Oncol. 2014;40 (1) :113-20.Abstract
AIMS: Evidence suggests a detrimental effect of diabetes mellitus (DM) on cancer incidence and outcomes. To date, the effect of DM and its treatment on prognosis in upper tract urothelial carcinoma (UTUC) remains uninvestigated. We tested the hypothesis that DM and metformin use impact oncologic outcomes of patients treated with radical nephroureterectomy (RNU) for UTUC. METHODS: Retrospective analysis of 2492 patients with UTUC treated at 23 institutions with RNU without neoadjuvant therapy. Cox regression models addressed the association of DM and metformin use with disease recurrence, cancer-specific mortality and any-cause mortality. RESULTS: A total of 365 (14.3%) patients had DM and 194 (7.8%) patients used metformin. Within a median follow-up of 36 months, 663 (26.6%) patients experienced disease recurrence, 545 patients (21.9%) died of UTUC and 884 (35.5%) patients died from any cause. Diabetic patients who did not use metformin were at significantly higher risk of disease recurrence and cancer-specific death compared to non-diabetic patients and diabetic patients who used metformin. In multivariable Cox regression analyses, DM treated without metformin was associated with worse recurrence-free survival (HR: 1.44, 95% CI 1.10-1.90, p = 0.009) and cancer-specific mortality (HR: 1.49, 95% CI 1.11-2.00, p = 0.008). CONCLUSIONS: Diabetic UTUC patients without metformin use have significantly worse oncologic outcomes than diabetics who used metformin and non-diabetics. The possible mechanism behind the impact of DM on UTUC biology and the potentially protective effect of metformin need further elucidation.
Xylinas E, Rink M, Cha EK, Clozel T, Lee RK, Fajkovic H, Comploj E, Novara G, Margulis V, Raman JD, et al. Impact of distal ureter management on oncologic outcomes following radical nephroureterectomy for upper tract urothelial carcinoma. Eur Urol. 2014;65 (1) :210-7.Abstract
BACKGROUND: There is a lack of consensus regarding the optimal approach to the bladder cuff during radical nephroureterectomy (RNU) for upper tract urothelial carcinoma (UTUC). OBJECTIVES: To compare the oncologic outcomes following RNU using three different methods of bladder cuff management. DESIGN, SETTING, AND PARTICIPANTS: Retrospective analysis of 2681 patients treated with RNU for UTUC at 24 international institutions from 1987 to 2007. INTERVENTION: Three methods of bladder cuff excision were performed: transvesical, extravesical, and endoscopic. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Univariable and multivariable models tested the effect of distal ureter management on intravesical recurrence, recurrence-free survival (RFS), cancer-specific survival (CSS), and overall survival (OS). RESULTS AND LIMITATIONS: Of the 2681 patients, 1811 (67.5%) underwent the transvesical approach; 785 (29.3%), the extravesical approach; and 85 (3.2%), the endoscopic approach. There was no difference in terms of RFS, CSS, and OS among the three distal ureteral management approaches. Patients who underwent the endoscopic approach were at significantly higher risk of intravesical recurrence compared with those who underwent the transvesical (p=0.02) or extravesical approaches (p=0.02); the latter two groups did not differ from each other (p=0.40). Actuarial intravesical RFS estimates at 2 and 5 yr after RNU were 69% and 58%, 69% and 51%, and 61% and 42% for the transvesical, extravesical, and endoscopic approaches, respectively. In multivariate analyses, distal ureteral management (p=0.01), surgical technique (open vs laparoscopic; p=0.02), previous bladder cancer (p<0.001), higher tumor stage (trend; p=0.01), concomitant carcinoma in situ (CIS) (p<0.001), and lymph node involvement (trend; p<0.001) were all associated with intravesical recurrence. Excluding patients with history of previous bladder cancer, all variables remained independent predictors of intravesical recurrence. CONCLUSIONS: The endoscopic approach was associated with higher intravesical recurrence rates. Interestingly, concomitant CIS in the upper tract is a strong predictor of intravesical recurrence after RNU. The association of laparoscopic RNU with intravesical recurrence needs to be further investigated.

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