Danny Lascano

Validation of a frailty index in patients undergoing curative surgery for urologic malignancy and comparison with other risk stratification tools.

OBJECTIVE To retrospectively validate and compare a modified frailty index predicting adverse outcomes and other risk stratification tools among patients undergoing urologic oncological surgeries. MATERIALS AND METHODS The American College of Surgeons National Surgical Quality Improvement Program was queried from 2005 to 2013 to identify patients undergoing cystectomy, prostatectomy, nephrectomy, and nephroureterectomy. Using the Canadian Study of Health and Aging Frailty Index, 11 variables were matched to the database; 4 were also added because of their relevance in oncology patients. The incidence of mortality, Clavien-Dindo IV complications, and adverse events were assessed with patients grouped according to their modified frailty index score. RESULTS We identified 41,681 patients who were undergoing surgery for presumed urologic malignancy. Patients with a high frailty index score of >0.20 had a 3.70 odds of a Clavien-Dindo IV event (CI: 2.865-4.788, P<0.0005) and a 5.95 odds of 30-day mortality (CI: 3.72-9.51, P<0.0005) in comparison with nonfrail patients after adjusting for race, sex, age, smoking history, and procedure. Using C-statistics to compare the sensitivity and specificity of the predictive ability of different models per risk stratification tool and the Akaike information criteria to assess for the fit of the models with the data, the modified frailty index was comparable or superior to the Charlson comorbidity index but inferior to the American Society of Anesthesiologists Risk Class in predicting 30-day mortality or Clavien-Dindo IV events. When the modified frailty index was augmented with the American Society of Anesthesiologists Risk Class, the new index was superior in all aspects in comparison to other risk stratification tools. CONCLUSION Existing risk stratification tools may be improved by incorporating variables in our 15-point modified frailty index as well as other factors such as walking speed, exhaustion, and sarcopenia to fully assess frailty. This is relevant in diseases such as kidney and prostate cancer, where surveillance and other nonsurgical interventions exist as alternatives to a potentially complicated surgery. In these scenarios, our modified frailty index augmented by the American Society of Anesthesiologists Risk Class may help inform which patients have increased surgical complications that may outweigh the benefit of surgery although this index needs prospective validation.

Frailty as a marker of adverse outcomes in patients with bladder cancer undergoing radical cystectomy

OBJECTIVE To investigate the modified frailty index (mFI) as a preoperative predictor of postoperative complications following radical cystectomy (RC) in patients with bladder cancer. MATERIALS AND METHODS Patients undergoing RC were identified from the National Surgical Quality Improvement Program participant use files (2011-2013). The mFI was defined in prior studies with 11 variables based on mapping the Canadian Study of Health and Aging Frailty Index to the National Surgical Quality Improvement Program comorbidities and activities of daily livings. The mFI groups were determined by the number of risk factors per patient (0, 1, 2, and≥3). Univariable and multivariable regression were performed to determine predictors of Clavien 4 and 5 complications, and a sensitivity analysis was performed to determine the mFI value that would be a significant predictor of Clavien 4 and 5 complications. RESULTS Of the 2,679 cystectomy patients identified, 843 (31%) of patients had an mFI of 0, 1176 (44%) had an mFI of 1, 555 (21%) had an mFI of 2, and 105 (4%) had an mFI≥3. Overall, 1585 (59%) of patients experienced a Clavien complication. When stratified at a cutoff of mFI≥2, the overall complication rate was not different (61.7% vs. 58.3%, P = 0.1), but the mFI2 or greater group had a significantly higher rate of Clavien grade 4 or 5 complications (14.6% vs. 8.3%, P<0.001) and overall mortality rate (3.5% vs. 1.8%, P = 0.01) in the 30-day postoperative period. The multivariate logistic regression model showed independent predictors of Clavien grade 4 or 5 complications were age>80 years (odds ratio [OR] = 1.58 [1.11-2.27]), mFI2 (OR = 1.84 [1.28-2.64]), and mFI3 (OR = 2.58 [1.47-4.55]). CONCLUSIONS Among patients undergoing RC, the mFI can identify those patients at greatest risk for severe complications and mortality. Given that bladder cancer is increasing in prevalence particularly among the elderly, preoperative risk stratification is crucial to inform decision-making about surgical candidacy.

Patterns of care for readmission after radical cystectomy in New York State and the effect of care fragmentation

OBJECTIVE To determine if readmission after radical cystectomy (RC) to the original hospital of the procedure (OrH) vs. readmission to a different hospital (DiffH) has an effect on outcomes. METHODS The New York Statewide Planning and Research Cooperative System database was queried for discharges between January 1, 2009 and November 31, 2012 after RC in New York State. Primary outcome was mortality within 30 and 90 days. Secondary outcomes included length of stay for readmission, rate of transfers/subsequent readmissions, hospital charges per readmission, and, if applicable, length of intensive care unit stays. Multivariate linear regression analyses were performed to adjust for confounding factors in predicting mortality. RESULTS During the study period, 2,338 patients were discharged from 100 New York State hospitals after RC. Overall rate of readmission was 28.5% and 39.7% within 30 and 90 days, respectively. Of all readmitted patients, 80.4% and 77.1% were first readmitted to OrH within 30 and 90 days, respectively. Patients readmitted to OrH were younger (P<0.0005) and had a lower All Patient Refined Severity of Illness (P = 0.004). Patients readmitted to DiffH had shorter length of stay (P<0.0005) and lower hospital charges per readmission (P<0.0005), but higher rates of transfers/subsequent readmissions (P = 0.007) and intensive care unit stays (P = 0.002) at 90 days. Patients initially readmitted to DiffH also had a higher rate of mortality (30d, 7.8% vs. 2.3%, P = 0.002; 90d, 5.2% vs. 2.5%, P = 0.05), but initial readmission status was not significant for mortality when controlling for other variables of interest. CONCLUSION Initial readmission to DiffH vs. OrH after RC was associated with higher rates of mortality, likely owing to underlying differences in the populations.

Renal functional outcomes after surgery for renal cortical tumors

Historically, radical nephrectomy represented the gold standard for the treatment of small (≤ 4cm) as well as larger renal masses. Recently, for small renal masses, the risk of ensuing chronic kidney disease and end stage renal disease has largely favored nephron-sparing surgical techniques, mainly partial nephrectomy. In this review, we surveyed the literature on renal functional outcomes after partial nephrectomy for renal tumors. The largest randomized control trial comparing radical and partial nephrectomy failed to show a survival benefit for partial nephrectomy. With regards to overall survival, surgically induced chronic kidney disease (GFR < 60 ml/min/ 1.73m2) caused by nephrectomy might not be as deleterious as medically induced chronic kidney disease. In evaluating patients who underwent donor nephrectomy, transplant literature further validates that surgically induced reductions in GFR may not affect patient survival, unlike medically induced GFR declines. Yet, because patients who present with a renal mass tend to be elderly with multiple comorbidities, many develop a mixed picture of medically, and surgically-induced renal disease after extirpative renal surgery. In this population, we believe that nephron sparing surgery optimizes oncological control while protecting renal function.

Is participation in a clinical trial associated with a survival benefit in patients with bladder cancer

Bladder cancer that is unresponsive to intravesical therapies is difficult to treat. Patients with this disease usually have to try salvage therapies, partial cystectomy, or radical cystectomy. Unfortunately, the population afflicted by bladder cancer is older and frailer than those afflicted by other cancers with mortality approaching 1.5% and readmission rates approaching 64%. �怀ese patients are le�耀 with no other options aside from participating in a clinical trial to delay or avoid surgery. We hypothesized that participation in a clinical trial provides survival bene�耀ts when controlling for tumor stage and pathology in the case of non-muscle invasive bladder cancer that is refractory to intravesical Bacillus Calmette-Guerin (BCG). Using our Institutional Review Board (IRB) approved Columbia Urologic Oncology Database, 55 patients with BCG-refractory NMIBC (29 clinical trial patients, 26 non-clinical trial patients) were identi�耀ed between 2008 and 2012. Clinical characteristics, demographics, and outcomes were obtained from the medical records. Non-clinical trial patients had fewer mean BCG instillations than their clinical trial counterparts (7.8 versus 11.5 doses, p < .01). Kaplan Meier (KP) curves for Overall Survival (OS) and Cancer Speci�耀c Survival (CSS) indicate an increased survival bene�耀t for patients enrolled in a clinical trial (OS: χ² = 8.802, p< 0.01, median of 6.68 years versus 3.15 years; CSS: χ² = 10.205, p < 0.01, mean 5.6 years versus 2.65 years). �怀e data support the notion that there may be an inherent survival bene�耀t gained by virtue of being included in a clinical trial. �怀e drivers of this survival bene�耀t may include more interactions with the hospitals and clinics, greater patient involvement in their health care, and increased surveillance by clinicians.

Partial Cystectomy for Primary Bladder Tumors in Contemporary Patients with Diverse Tumor Locations

Introduction: Partial cystectomy use has historically been limited by stringent selection criteria. We compared outcomes following partial cystectomy at our institution with those in other contemporary series. Also, we specifically characterized outcomes in patients with tumors in bladder locations traditionally considered unamenable to partial cystectomy. Methods: Patients who underwent partial cystectomy for primary bladder cancer from 1990 to 2012 were identified from our database. Clinical and pathological data were reviewed. Survival analyses were performed using Kaplan‐Meier methods. Cox regression was done to identify factors associated with survival and recurrence. Results: A total of 55 patients were included in analysis. Five‐year overall, disease specific and recurrence‐free survival was 70.3%, 77.0% and 39.4%, respectively. When controlling for clinical and pathological covariates, lymphovascular invasion predicted decreased recurrence‐free survival (HR 10.6, p = 0.025). Perioperative morbidity and mortality rates were 4% and 5%, respectively. In 8 patients (15%) trigone tumors required ureteral reimplantation. Two of the 8 patients (25%) experienced complications, including hydronephrosis and bladder neck contracture, which were treated conservatively. Cancer recurred in 2 of the 8 patients (25%) and both were treated successfully. None of the 8 patients died of bladder cancer. Conclusions: Patients treated with partial cystectomy for primary bladder cancer had satisfactory cancer control and favorable perioperative morbidity consistent with other contemporary reports. Patients with tumors in the bladder trigone, historically considered poor candidates for partial cystectomy, also had good oncologic outcomes without significant complications related to reimplantation. Our data further support partial cystectomy in select patients with bladder cancer.

MP72-09 ADJUVANT CISPLATIN LEADS TO A LARGER DECLINE IN GFR THAN NEOADJUVANT CISPLATIN IN RADICAL CYSTECTOMY PATIENTS

RESULTS: No significant difference was noted in 5-year CSS between GC NAC (58%) and non-NAC cohorts (61%). The median followup was 19.6 months for GC NAC and 106.5 months for non-NAC. Patients with residual non-muscle-invasive disease (pTis, pTa, pT1) after GC NAC exhibit similar 5-year CSS relative to patients with no residual carcinoma (pT0), p1⁄40.99. NAC pathologic responders ( T1, n1⁄480) demonstrated improved 5-year CSS rates of 90.6% vs. 27.1% (p<0.01) and decreased nodal positivity rates of 0% vs. 41.3% (p<0.01) compared to NAC pathologic non-responders ( pT2). Clinical and pathologic outcomes were inferior in NAC pathologic non-responders compared to the entire RC only treated cohort (pT2-T4). A significantly lower pathologic non-response rate was seen in those able to tolerate sufficient dosing of NAC when patients were stratified by the JHH-DI (p1⁄40.049) which is congruent with NCCN guidelines. A multivariate decision tree model demonstrated age 60 years and clinical stage cT2 as significant of response to NAC (p<0.05). CONCLUSIONS: Pathologic non-responders fare worse than patients proceeding directly to RC alone, suggesting the need to identify clinical features predictive of poor response prior to the initiation of chemotherapy. To this effect, multiple predictive models incorporating clinical, histopathologic, and molecular features are currently being developed to identify patients, prior to the initiation of therapy, that are most likely to benefit or not benefit from GC NAC.

MP64-07 SIMPLIFIED FRAILTY INDEX PREDICTS ADVERSE OUTCOMES IN RADICAL CYSTECTOMY: AN ANALYSIS OF THE ACS- NSQIP DATABASE

INTRODUCTION AND OBJECTIVES: Preoperative malnutrition is a concern for patients undergoing radical cystectomy and may influence both medical and surgical complications post operatively. We seek to identify specific complications related to preoperative nutritional deficiency. METHODS: The American College of Surgeons-National Surgical Quality Improvement Program (ACS-NSQIP) 2005-2012 database was reviewed for all patients undergoing a radical cystectomy based on Current Procedural Terminology (CPT) codes (51570, 51575, 51580, 51585, 51590, 51595, 51596, 51597). Patients with missing data on albumin, height, weight, gender and American Society of Anesthesiology (ASA) class were removed. Patients who had an albumin 10% weight loss were considered “nutritionally deficient” (ND). All other patients had “normal nutritional status” (NNS). We also stratified post-operative complication by Clavien grade and summed up patients’ comorbidites to create a “comorbidity count” variable that was entered into multivariate logistic regression. RESULTS: After all exclusions, 1,513 patients underwent a radical cystectomy. Of this cohort, 21.5% (n1⁄4325) were nutritionally deficient while 78.5% had normal nutritional status. Specifically, 18% had an albumin 10% weight loss. The ND group displayed higher rates of any complication (71.1% vs 58.7%, p1⁄4<0.001), Clavien grade 2 (66.8% versus 54.5%, p1⁄4<0.001), and Clavien grade 4 (9.5% vs 6.2%, p1⁄40.037) complications. On multivariate regression, after controlling for age, inpatient status, ASA class, total relative value unit (RVU), operation time and comorbidity count, preoperative nutritional deficiency increased risk of any complication (OR 1.788, 95% CI 1.357-2.356, p1⁄4<0.001) and Clavien grade 2 complications (OR 1.735, 95% CI 1.328-2.267, p<0.001). CONCLUSIONS: Pre-operative nutritional status increases risk of post-operative complications.

PD30-04 COMPARING ONCOLOGIC OUTCOMES OF DIFFERENT DEFINITIVE TREATMENTS FOR PROSTATE CANCER AFTER A PERIOD OF ACTIVE SURVEILLANCE

INTRODUCTION AND OBJECTIVES: Most current guidelines recommend active surveillance (AS) as a valid treatment option for clinically localized, low-risk prostate cancer (PCa) to reduce overtreatment. However, a considerable proportion of AS candidates harbors unfavorable PCa at final pathology when surgically treated. The aim of this study was to identify predictors of unfavorable PCa in AS candidates that were treated surgically. METHODS: We relied on the 2010e2011 Surveillance Epidemiology and End Results (SEER) database. We identified 3,300 patients treated with radical prostatectomy who could have been selected for AS according to the UCSF criteria: prostate-specific antigen (PSA) <10 ng/ml, biopsy Gleason score 6 with no pattern 4 or 5, clinical stage T1/T2a, and percentage of positive cores <33%. All patients had complete demographic, clinical, and pathologic data. The main outcome was unfavorable PCa, defined as pathologic Gleason score 4þ3 and/ or pathologic stage pT3b. We performed a sensitivity analysis defining unfavorable PCa as pathologic Gleason score 7 and/or pathologic stage pT3a. Multivariable logistic regression analysis tested the relationship between unfavorable PCa and age, race (White vs African American vs Hispanic vs Other), marital status (not married vs married), annual family income, insurance status (insured vs Medicaid covered vs uninsured), total PSA, clinical stage (T1 vs T2a), and percentage of positive cores. RESULTS: Overall, 195 patients (5.9%) harbored unfavorable PCa at final pathology. On the other hand, 1,309 patients (40%) showed unfavorable PCa when pathologic Gleason score 7 and/or pathologic stage pT3a were considered. At multivariable analysis, patient age (odds ratio [OR]: 1.03; 95% confidence interval [CI]: 1.01, 1.05; p1⁄40.006), African American patients (OR: 1.82; 95% CI: 1.19, 2.78; p1⁄40.016), Hispanic patients (OR: 1.63; 95% CI: 1.04, 2.57; p1⁄40.033), and total PSA (OR: 1.15; 95% CI: 1.07, 1.25; p<0.0004) were significantly associated with higher probability of harboring unfavorable PCa. These results were confirmed when unfavorable PCa was defined as pathologic Gleason score 7 and/or pathologic stage pT3a. CONCLUSIONS: A significant proportion of AS candidates harbors unfavorable PCa at final pathology, even considering stringent criteria as adverse cancer features (namely, pathologic Gleason 4þ3 or pathologic stage pT3b). Patient age, race, and total PSA are significant predictors of unfavorable PCa. These results should be taken into account when counseling AS candidates.

MP24-19 PATTERNS OF CARE FOR READMISSION FOLLOWING RADICAL CYSTECTOMY IN NEW YORK STATE: DOES THE HOSPITAL MATTER?

CONCLUSIONS: Hospital readmissions within 90 days of major urologic cancer surgery are associated with a low FTR rate; however, patients readmitted to a SH experienced higher FTR than those readmitted to their original hospital. These findings may inform clinical decision-making around hospital transfers and aid future quality improvement initiatives to reduce the morbidity associated with complex urologic oncology surgeries.