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Survival and oncologic outcomes of complete transurethral resection of bladder tumor prior to neoadjuvant chemotherapy for muscle-invasive bladder cancer

Pak, Jamie S; Haas, Christopher R; Anderson, Christopher B; DeCastro, G Joel; Benson, Mitchell C; McKiernan, James M
OBJECTIVES/OBJECTIVE:Prior studies have shown that pathologic complete response at radical cystectomy, a significant prognostic factor, can be attributed to both neoadjuvant chemotherapy (NAC) and high-quality transurethral resections (TURBT) prior to NAC. It remains unclear whether the visual completeness of TURBT prior to NAC plays an important role in subsequent outcomes. We sought to assess the association of completeness of TURBT prior to NAC with response and survival outcomes. METHODS AND MATERIALS/METHODS:We retrospectively reviewed all patients with clinically localized muscle-invasive bladder cancer at our institution who received NAC from 2000 to 2017. Complete TURBT was defined as resection of all visible tumor in entirety, resection to normal-appearing muscle, and/or repeat pre-NAC TURBT revealing cT0. Patients who were restaged as cT0 after NAC and refused cystectomy were placed on an active surveillance/delayed intervention (ASDI) protocol. The primary endpoints were overall and cancer-specific survival. The secondary endpoints were recurrence-free and muscle-invasive recurrence-free survival. RESULTS:Of 93 patients, 62 (67%) underwent complete TURBT prior to chemotherapy. Compared to patients with incomplete TURBT, those with complete TURBT had lower rates of variant histology (13% vs. 32%) and hydronephrosis (15% vs. 39%). Also, 36% of patients with incomplete TURBT had ≥cT3 disease prior to NAC, compared to none in the complete TURBT cohort. Patients with complete TURBT were more likely to defer RC and pursue ASDI (61% vs. 32%). Those with complete TURBT had lower rates of pT2 or higher disease at cystectomy (48% vs. 75%), with a lower rate of N+ disease trending towards significance (17% vs. 37%). Patients with complete TURBT had higher 5-year overall (77% vs. 46%, P = 0.003) and cancer-specific (85% vs. 50%, P = 0.001) survival. On Cox regression analysis, complete TURBT was significantly associated with superior cancer-specific, recurrence-free, and muscle-invasive recurrence-free survival. CONCLUSIONS:A complete TURBT prior to NAC is associated with improved survival and oncologic outcomes in this cohort with muscle-invasive bladder cancer. The extent to which complete TURBT simply represents a proxy for less aggressive disease or is actually a beneficial therapeutic intervention which improves response to chemotherapy is difficult to define retrospectively.
PMID: 33865688
ISSN: 1873-2496
CID: 5122212

Diagnostic yield of repeat evaluation for asymptomatic microscopic hematuria after negative initial workup

Pak, Jamie S; Wang, Elizabeth Y; Lee, Kevin; Pina, Luis A; McKiernan, James M; Anderson, Christopher B
PURPOSE:The American Urological Association guideline for asymptomatic microhematuria recommends in patients with a negative initial workup, repeat workup should be considered for those with persistent/recurrent microhematuria. However, there is little data on the yield of repeat evaluation. Our hypothesis was that repeat workup yields a low detection rate of urologic malignancy. MATERIALS AND METHODS:We retrospectively reviewed all patients at our institution who underwent microhematuria workup with cystoscopy and upper tract imaging from May 2010 to June 2016. Microhematuria was defined as ≥3 RBCs/HPF on a properly collected specimen in the absence of a benign cause. Demographics, age, smoking history, history of radiation, and findings on repeat cystoscopy and imaging were collected. Our primary endpoint was a new diagnosis of urologic malignancy. RESULTS:Our initial cohort included 1,332 patients, of whom 21 were diagnosed with urothelial carcinoma and 7 with suspicious renal masses on initial workup. A total of 637 patients with negative initial workup had persistent/recurrent microhematuria. Repeat cystoscopy was performed in 161 (25%) patients at a median of 39 months, and repeat upper tract imaging was performed in 317 (50%) patients at a median of 39 months. Overall, repeat cystoscopy revealed new bladder cancer in 2 (1.2%) patients and repeat imaging revealed new suspicious renal mass in 4 (1.3%) patients. CONCLUSIONS:We observed a low number of newly diagnosed malignancies among patients with persistent/recurrent asymptomatic microhematuria who had a prior negative workup. Additional research is required to determine the utility of a repeat AMH workup.
PMID: 33339726
ISSN: 1873-2496
CID: 5122202

A Phase I Trial of Intravesical Cabazitaxel, Gemcitabine and Cisplatin for the Treatment of Nonmuscle Invasive bacillus Calmette-Guérin Unresponsive or Recurrent/Relapsing Urothelial Carcinoma of the Bladder

DeCastro, Guarionex J; Sui, Wilson; Pak, Jamie S; Lee, Shing M; Holder, Dara; Kates, Max M; Virk, Renu K; Drake, Charles G; Anderson, Christopher B; James, Bridget; Abate-Shen, Cory T; McKiernan, James M
PURPOSE/OBJECTIVE:For patients with bacillus Calmette-Guérin unresponsive or recurrent/relapsing nonmuscle invasive bladder cancer, multi-agent intravesical trials have been limited. In this study we investigate the safety of intravesical cabazitaxel, gemcitabine and cisplatin in the salvage setting. MATERIALS AND METHODS/METHODS:This was a dose escalation, drug escalation trial for patients with bacillus Calmette-Guérin unresponsive or recurrent/relapsing nonmuscle invasive bladder cancer who declined or were ineligible for radical cystectomy. All patients underwent a 6-week induction regimen of sequentially administered cabazitaxel, gemcitabine and cisplatin. Complete response was defined as no cancer on post-induction transurethral bladder tumor resection and negative urine cytology, while partial response allowed for positive cytology. Responders continued with maintenance cabazitaxel and gemcitabine monthly for the first year and bimonthly for the second year. RESULTS:A total of 18 patients were enrolled. Mean age was 71 years, median followup was 27.8 months (range 16.3 to 46.9) and mean number of previous rounds of intravesical therapies before trial enrollment was 3.7. Nine patients (50%) had received intravesical chemotherapy after bacillus Calmette-Guérin and 7 (39%) were previously treated in a phase I clinical trial setting. At enrollment 6 (33%) subjects had T1 disease and 13 (72%) had carcinoma in situ. There were no dose limiting toxicities. Initial partial and complete response rates were 94% and 89%, respectively. At 1 year recurrence-free survival was 0.83 (range 0.57 to 0.94) and at 2 years estimated recurrence-free survival was 0.64 (0.32 to 0.84). CONCLUSIONS:In this high risk and highly pretreated cohort of bacillus Calmette-Guérin unresponsive or recurrent/relapsing nonmuscle invasive bladder cancer cases combination intravesical cabazitaxel, gemcitabine and cisplatin was a well tolerated and potentially effective regimen.
PMID: 32118506
ISSN: 1527-3792
CID: 5122172

Bladder Preservation for Patients With Bladder Paragangliomas: Case Series and Review of the Literature

Wang, Elizabeth Y; Pak, Jamie S; Virk, Renu K; Anderson, Christopher B; Healy, Kelly A; Lee, James A; Benson, Mitchell C; McKiernan, James M
Bladder paragangliomas are rare tumors, with no prospective studies or guidelines on the management of this disease. We present a case series of 6 patients managed with bladder preservation over a median follow-up period of 124 months. We also present a review of the recent literature on bladder paragangliomas. We aim to provide a timely synthesis of the recent evidence on bladder paragangliomas as changing paradigms necessitate individualized treatment.
PMID: 32437773
ISSN: 1527-9995
CID: 5122192

Oncologic Outcomes of Definitive Treatments for Low- and Intermediate-Risk Prostate Cancer After a Period of Active Surveillance

Whalen, Michael J; Pak, Jamie S; Lascano, Danny; Ahlborn, David; Matulay, Justin T; McKiernan, James M; Benson, Mitchell C; Wenske, Sven
BACKGROUND:To compare oncologic outcomes of different definitive treatment (DT) modalities in a cohort of patients with prostate cancer (PCa) after active surveillance (AS). METHODS:We identified 237 patients with National Comprehensive Cancer Network (NCCN) low- and intermediate-risk prostate cancer diagnosed from 1990 to 2012 who did not undergo immediate DT within 12 months of diagnosis (ie, AS patients as well as watchful waiting and those refusing DT). Charts were examined for clinical/pathologic data and type of DT: surgery (RP), radiation including brachytherapy (XRT), cryotherapy, and androgen deprivation therapy monotherapy (ADT). The impact of DT on oncologic outcomes of biochemical recurrence (BCR), metastasis, disease-specific (DSS), and overall survival (OS) was examined with the Cox proportional hazards model, along with the Kaplan-Meier method and log-rank test. RESULTS:After median time on AS of 63.4 months, 40% of patients underwent DT: 47% XRT, 28% RP, 14% ADT, and 11% cryotherapy. On multivariable analysis, the use of XRT predicted higher BCR (hazard ratio [HR] 6.1, P = .001) and worse overall mortality (HR 2.1, P = .03) compared with other treatments, controlling for age, Charlson Comorbidity Index (CCI), stage, Gleason score, and NCCN risk category. Median follow-up was 71.7 months. On Kaplan-Meier analysis, 10-year OS was superior for RP versus XRT among patients with prostatic specific antigen (PSA) velocity >2.0 ng/mL/y. CONCLUSIONS:Low- and intermediate-risk patients with PCa who progress to DT after AS may be inadequately treated with radiation therapy compared with other DT modalities, especially when pretreatment PSA velocity is > 2 ng/mL/y.
PMID: 29113772
ISSN: 1938-0682
CID: 5122162

Utilization trends and outcomes up to 3 months of open, laparoscopic, and robotic partial nephrectomy

Pak, Jamie S; Lee, Jason J; Bilal, Khawaja; Finkelstein, Mark; Palese, Michael A
The aim of the study was to compare the utilization trends and short-term outcomes of open, laparoscopic, and robotic partial nephrectomy in New York State since the introduction of the robotic modifier in October 2008. The Statewide Planning and Research Cooperative System database is an all-payer, administrative database covering all hospital discharges within New York State. All patients who underwent partial nephrectomy (ICD-9 55.4) for kidney cancer (189.0) from October 2008 to December 2012 were identified. Patients with a minimally invasive modifier (54.21, 54.51) without the robotic modifier (17.4x) were categorized in the laparoscopic cohort. Logistic regression was performed to assess outcomes by surgical approach. Of the 5107 patients, 57.9% (2959/5107) underwent open, 12.1% (617/5107) laparoscopic, and 30.0% (1531/5107) robotic partial nephrectomy. From 2009 to 2012, the percentage of robotic cases increased from 17.7 to 39.8%. In comparison to open patients, those undergoing laparoscopic and robotic approaches, respectively, were less likely to receive blood transfusion (OR 0.54, p < 0.0005 and OR 0.45, p < 0.0005) and to experience a prolonged length of stay (OR 0.52, p < 0.0005 and OR 0.30, p < 0.0005). Patients undergoing robotic approach were also less likely to have an inpatient complication (OR 0.74, p = 0.004) and be readmitted within one (OR 0.73, p = 0.005) and 3 months (OR 0.69, p < 0.0005), but were at higher risk of excess hospital charges (OR 1.216, p = 0.01). Robotic partial nephrectomy is the predominant minimally invasive approach in New York State. Minimally invasive partial nephrectomy has multiple short-term advantages over open, with the costlier robotic approach having additional advantages with less inpatient complication and readmission risk.
PMID: 27804062
ISSN: 1863-2491
CID: 5122132

Utilization Trends and Short-term Outcomes of Robotic Versus Open Radical Cystectomy for Bladder Cancer

Pak, Jamie S; Lee, Jason J; Bilal, Khawaja; Finkelstein, Mark; Palese, Michael A
OBJECTIVE:To compare utilization trends and short-term outcomes of robotic versus open radical cystectomy for bladder cancer since the introduction of the robotic modifier (ICD-9 17.4x). MATERIALS AND METHODS:Using the Statewide Planning and Research Cooperative System database, an all-payer administrative system on all hospital discharges in New York State, we identified patients undergoing radical cystectomy (57.71) with a diagnosis of bladder cancer (188.0-188.9, 233.7, 236.7) from October 2008 to December 2012. Primary outcomes were inpatient complications and mortality at index stay. RESULTS:Of the 2525 patients, 24.2% (610 of 2525) underwent robotic and 75.8% (1915 of 2525) underwent open radical cystectomy. The proportion of robotic cases increased from 19.9% (119 of 597) in 2009 to 28.9% (173 of 598) in 2012 (P < .05). From 2009 to 2012, the number of open surgeons decreased from 117 to 109, and that of robotic increased from 56 to 66. Robotic patients had lower approach-specific surgeon and hospital volume, and more likely underwent lymph node dissection, ileal conduit diversion, blood transfusion, and prolonged length of stay. On multivariate analysis, robotic approach conferred a reduced risk of blood transfusion (odds ratio: 0.600, 95% confidence interval: 0.492-0.732, P < .0005) but had no association with prolonged length of stay. There were no significant differences in inpatient complications or mortality at index stay, parenteral nutrition, length of stay, hospital charges, readmission rates up to 90 days, or mortality up to 90 days between the surgical approaches. CONCLUSION:Despite the rapid dissemination and more recent experience of robotic radical cystectomy, we report lower rates of blood transfusion and otherwise similar short-term outcomes with open radical cystectomy.
PMID: 28189553
ISSN: 1527-9995
CID: 5122142

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

Pak, Jamie S; Lascano, Danny; Kabat, Daniel H; Finkelstein, Julia B; RoyChoudhury, Arindam; DeCastro, G Joel; Gold, William; McKiernan, James M
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/CONCLUSIONS:Initial readmission to DiffH vs. OrH after RC was associated with higher rates of mortality, likely owing to underlying differences in the populations.
PMID: 26162487
ISSN: 1873-2496
CID: 5122112

Editorial Comment [Comment]

Thakker, Sameer; Pak, Jamie S
PMID: 38598657
ISSN: 1527-3792
CID: 5657322

Interaction of patient age and high-grade prostate cancer on targeted biopsies of MRI suspicious lesions

Pak, Jamie S; Huang, Richard; Huang, William C; Lepor, Herbert; Wysock, James S; Taneja, Samir S
OBJECTIVES/OBJECTIVE:To evaluate the interaction of patient age and Prostate Imaging-Reporting and Data System (PI-RADS) score in determining the grade of prostate cancer (PCa) identified on magnetic resonance imaging (MRI)-targeted biopsy in older men. PATIENTS AND METHODS/METHODS:From a prospectively accrued Institutional Review Board-approved comparative study of MRI-targeted and systematic biopsy between June 2012 and December 2022, men with at least one PI-RADS ≥3 lesion on pre-biopsy MRI and no prior history of PCa were selected. Ordinal and binomial logistic regression analyses were performed. RESULTS:A total of 2677 men met study criteria. The highest PI-RADS score was 3 in 1220 men (46%), 4 in 950 men (36%), and 5 in 507 men (19%). The median (interquartile range [IQR]) patient age was 66.7 (60.8-71.8) years, median (IQR) prostate-specific antigen (PSA) level was 6.1 (4.6-9.0) ng/mL, median (IQR) prostate volume was 48 (34-68) mL, and median (IQR) PSA density was 0.13 (0.08-0.20) ng/mL/mL. Clinically significant (cs)PCa and high-risk PCa were identified on targeted biopsy in 1264 (47%) and 321 (12%) men, respectively. Prevalence of csPCa and high-risk PCa were significantly higher in the older age groups. On multivariable analyses, patient age was significantly associated with csPCa but not high-risk PCa; PI-RADS score and the interaction of age and PI-RADS score were significantly associated with high-risk PCa but not csPCa. CONCLUSION/CONCLUSIONS:In our cohort, the substantial rate of high-risk PCa on MRI-ultrasound fusion targeted biopsies in older men, and its significant association with MRI findings, supports the value of pre-biopsy MRI to localise disease that could cause cancer mortality even in older men.
PMID: 38533536
ISSN: 1464-410x
CID: 5644852