Browsing by Subject "Urinary Bladder Neoplasms"
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Item Open Access Diet and Exercise Are not Associated with Skeletal Muscle Mass and Sarcopenia in Patients with Bladder Cancer.(European urology oncology, 2021-04) Wang, Yingqi; Chang, Andrew; Tan, Wei Phin; Fantony, Joseph J; Gopalakrishna, Ajay; Barton, Gregory J; Wischmeyer, Paul E; Gupta, Rajan T; Inman, Brant ABackground
There is limited understanding about why sarcopenia is happening in bladder cancer, and which modifiable and nonmodifiable patient-level factors affect its occurrence.Objective
The objective is to determine the extent to which nonmodifiable risk factors, modifiable lifestyle risk factors, or cancer-related factors are determining body composition changes and sarcopenia in bladder cancer survivors.Design, setting, and participants
Patients above 18 yr of age with a histologically confirmed diagnosis of bladder cancer and a history of receiving care at Duke University Medical Center between January 1, 1996 and June 30, 2017 were included in this study.Outcome measurements and statistical analysis
Bladder cancer survivors from our institution were assessed for their dietary intake patterns utilizing the Diet History Questionnaire II (DHQ-II) and physical activity utilizing the International Physical Activity Questionnaire long form (IPAQ-L) tools. Healthy Eating Index 2010 (HEI2010) scores were calculated from DHQ-II results. Body composition was evaluated using Slice-O-Matic computed tomography scan image analysis at L3 level and the skeletal muscle index (SMI) calculated by three independent raters.Results and limitations
A total of 285 patients were evaluated in the study, and the intraclass correlation for smooth muscle area was 0.97 (95% confidence interval: 0.94-0.98) between raters. The proportions of patients who met the definition of sarcopenia were 72% for men and 55% of women. Univariate linear regression analysis demonstrated that older age, male gender, and black race were highly significant predictors of SMI, whereas tumor stage and grade, chemotherapy, and surgical procedures were not predictors of SMI. Multivariate linear regression analysis demonstrated that modifiable lifestyle factors, including total physical activity (p=0.830), strenuousness (high, moderate, and low) of physical activity (p=0.874), individual nutritional components (daily calories, p=0.739; fat, p=0.259; carbohydrates, p=0.983; and protein, p=0.341), and HEI2010 diet quality (p=0.822) were not associated with SMI.Conclusions
Lifestyle factors including diet quality and physical activity are not associated with SMI and therefore appear to have limited impact on sarcopenia. Sarcopenia may largely be affected by nonmodifiable risk factors.Patient summary
In this report, we aim to determine whether lifestyle factors such as diet and physical activity were the primary drivers of body composition changes and sarcopenia in bladder cancer survivors. We found that lifestyle factors including dietary habits, individual nutritional components, and physical activity do not demonstrate an association with skeletal muscle mass, and therefore may have limited impact on sarcopenia.Item Open Access Evaluation of the Fluorescence In Situ Hybridization Test to Predict Recurrence and/or Progression of Disease after bacillus Calmette-Guérin for Primary High Grade Nonmuscle Invasive Bladder Cancer: Results from a Prospective Multicenter Trial.(The Journal of urology, 2019-11) Lotan, Yair; Inman, Brant A; Davis, Leah Gerber; Kassouf, Wassim; Messing, Edward; Daneshmand, Siamak; Canter, Daniel; Marble, H Tony; Joseph, Ajith M; Jewell, Susan; Boorjian, Stephen APURPOSE:Single center studies have shown that positive UroVysion® fluorescence in situ hybridization results were associated with recurrence of nonmuscle invasive bladder cancer treated with intravesical bacillus Calmette-Guérin. Our goal was to validate these findings. MATERIALS AND METHODS:We performed a prospective, multicenter diagnostic trial to determine whether the fluorescence in situ hybridization test could predict recurrence or progression in patients with primary high grade nonmuscle invasive bladder cancer who were scheduled to receive bacillus Calmette-Guérin. Fluorescence in situ hybridization testing was performed prior to the first bacillus Calmette-Guérin instillation, prior to the sixth instillation and at 3-month cystoscopy. The performance of fluorescence in situ hybridization was evaluated. RESULTS:A total of 150 patients were enrolled in analysis, including 68 with Ta disease, 41 with T1 disease, 26 with carcinoma in situ alone and 15 with papillary carcinoma plus carcinoma in situ. At 9 months of followup there were 46 events, including 37 recurrences and 9 progressions. For events with positive fluorescence in situ hybridization findings the HR was 2.59 (95% CI 1.42-4.73) for the baseline test, 1.94 (95% CI 1.04-3.59) for the 6-week test and 3.22 (95% CI 1.65-6.27) at 3 months. Patients with positive results at baseline, 6 weeks and 3 months had events 55% of the time and patients with negative results at each time point had no event 76% of the time. CONCLUSIONS:The study validated that a positive UroVysion fluorescence in situ hybridization test was associated with a 3.3-fold increased risk of recurrence. The test may be useful to risk stratify patients entering clinical trials in whom induction therapy fails. However, using the test to change management decisions is limited due to the discordance between results and outcomes as well as the variance of tests results with time.Item Open Access Evidence-based Assessment of Current and Emerging Bladder-sparing Therapies for Non-muscle-invasive Bladder Cancer After Bacillus Calmette-Guerin Therapy: A Systematic Review and Meta-analysis.(European urology oncology, 2020-06) Kamat, Ashish M; Lerner, Seth P; O'Donnell, Michael; Georgieva, Mihaela V; Yang, Min; Inman, Brant A; Kassouf, Wassim; Boorjian, Stephen A; Tyson, Mark D; Kulkarni, Girish S; Chang, Sam S; Konety, Badrinath R; Svatek, Robert S; Balar, Arjun; Witjes, J AlfredContext
Currently, there is no standard of care for patients with non-muscle-invasive bladder cancer (NMIBC) who recur despite bacillus Calmette-Guerin (BCG) therapy. Although radical cystectomy is recommended, many patients decline to undergo or are ineligible to receive it. Multiple agents are being investigated for use in this patient population.Objective
To systematically synthesize and describe the efficacy and safety of current and emerging treatments for NMIBC patients after treatment with BCG.Evidence acquisition
A systematic literature search of MEDLINE, Embase, and the Cochrane Controlled Register of Trials (period limited to January 2007-June 2019) was performed. Abstracts and presentations from major conference proceedings were also reviewed. Randomized controlled trials were assessed using the Cochrane risk of bias tool. Data for single-arm trials were pooled using a random-effect meta-analysis with the proportions approach. Trials were grouped based on the minimum number of prior BCG courses required before enrollment and further stratified based on the proportion of patients with carcinoma in situ (CIS).Evidence synthesis
Thirty publications were identified with data from 23 trials for meta-analysis, of which 17 were single arm. Efficacy and safety outcomes varied widely across studies. Heterogeneity across trials was reduced in subgroup analyses. The pooled 12-mo response rates were 24% (95% confidence interval [CI]: 16-32%) for trials with two or more prior BCG courses and 36% (95% CI: 25-47%) for those with one or more prior BCG courses. In a subgroup analysis, inclusion of ≥50% of patients with CIS was associated with a lower response.Conclusions
The variability in efficacy and safety outcomes highlights the need for consistent endpoint reporting and patient population definitions. With promising emerging treatments currently in development, efficacious and safe therapeutic options are urgently needed for this difficult-to-treat patient population.Patient summary
We examined the efficacy and safety outcomes of treatments for non-muscle-invasive bladder cancer after bacillus Calmette-Guerin therapy. Outcomes varied across studies and patient populations, but emerging treatments currently in development show promising efficacy.Item Open Access Heated Intravesical Chemotherapy: Biology and Clinical Utility.(The Urologic clinics of North America, 2020-02) Tan, Wei Phin; Longo, Thomas A; Inman, Brant ANon-muscle-invasive bladder cancer can be a challenging disease to manage. In recent years, hyperthermia therapy in conjunction with intravesical therapy has been gaining traction as a treatment option for bladder cancer, especially if Bacillus Calmette-Guerin might not be available. Trials of intravesical chemotherapy with heat are few and there has been considerable heterogeneity between studies. However, multiple new trials have accrued and high-quality data are forthcoming. In this review, we discuss the role of combined intravesical hyperthermia and chemotherapy as a novel approach for the treatment of bladder cancer.Item Open Access Longitudinal patterns of cost and utilization of medicare beneficiaries with bladder cancer.(Urologic oncology, 2020-02) Sloan, Frank A; Yashkin, Arseniy P; Akushevich, Igor; Inman, Brant ABackground
Bladder cancer (BC) is highly prevalent and costly. This study documented cost and use of services for BC care and for other (non-BC) care received over a 15-year follow-up period by a cohort of Medicare beneficiaries diagnosed with BC in 1998.Methods
Data came from the Surveillance, Epidemiology and End Results Program linked to Medicare claims. Medicare claims provided data on diagnoses, services provided, and Medicare Parts A and B payments. Cost was actual Medicare payments to providers inflated to 2018 US$. Cost and utilization were BC-related if the claim contained a BC diagnosis code. Otherwise, costs were for "other care." For utilization, we grouped Part B-covered services into 6 mutually-exclusive categories. Utilization rates were ratios of the count of claims in a particular category during a follow-up year divided by the number of beneficiaries with BC surviving to year-end.Results
Cumulatively over 15-years, for all stages combined, total BC-related cost per BC beneficiary was $42,011 (95% Confidence Interval (CI): $42,405-$43,417); other care cost was about twice this number. Cumulative total BC-related cost of 15-year BC survivors for all stages was $43,770 (CI: $39,068-$48,522), intensity of BC-related care was highest during the first year following BC diagnosis, falling substantially thereafter. After follow-up year 5, there were few statistically significant changes in BC-related utilization. Utilization of other care remained constant during follow-up or increased.Conclusions
Substantial costs were incurred for non-BC care. While increasing BC survivorship is an important objective, non-BC care would remain a burden to Medicare.Item Open Access Partitioning of time trends in prevalence and mortality of bladder cancer in the United States.(Annals of epidemiology, 2020-07) Akushevich, Igor; Yashkin, Arseniy P; Inman, Brant A; Sloan, FrankPurpose
The aim of the study was to evaluate the relative contributions of incidence, stage-specific relative survival, and stage ascertainment to changes in bladder cancer (BC) prevalence and incidence-based mortality.Methods
Partitioning of prevalence and incidence-based mortality trends into their epidemiologic components.Results
BC prevalence estimated from our model increased but at monotonically decreasing rates until 2007, after which it decreased again. The main forces underlying observed trends in BC prevalence were relative BC survival, which improved throughout the period, and BC incidence, which increased at a decreasing rate until 2005 and declined thereafter. Mortality of persons ever diagnosed with BC increased at an increasing rate until 1997, increased at a decreasing rate from 1997 to 2005, and decreased thereafter. The primary forces accounting for mortality trends were changes in mortality in the general population, which improved at an increasing rate during most of 1992-2010, the most important factor, and changes in incidence. Stage ascertainment did not improve during 1992-2010.Conclusions
Although mortality rates improved, these gains largely reflected improvements in U.S. population survival rather than from improvements in BC-specific outcomes.Item Open Access Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography (FDG-PET)/Magnetic Resonance Imaging (MRI) for Staging of Muscle-invasive Bladder Cancer (MIBC).(Clinical genitourinary cancer, 2020-10) Eulitt, Patrick J; Altun, Ersan; Sheikh, Arif; Wong, Terence Z; Woods, Michael E; Rose, Tracy L; Wallen, Eric M; Pruthi, Raj S; Smith, Angela B; Nielsen, Matthew E; Whang, Young E; Kim, William Y; Godley, Paul A; Basch, Ethan M; David, Grace U; Ramirez, Juanita; Deal, Allison M; Rathmell, W Kimryn; Chen, Ronald C; Bjurlin, Marc A; Lin, Weili; Lee, Joseph K; Milowsky, Matthew IIntroduction
Computed tomography (CT) has limited diagnostic accuracy for staging of muscle-invasive bladder cancer (MIBC). [18F] Fluorodeoxyglucose positron emission tomography (FDG-PET)/magnetic resonance imaging (MRI) is a novel imaging modality incorporating functional imaging with improved soft tissue characterization. This pilot study evaluated the use of preoperative FDG-PET/MRI for staging of MIBC.Patients and methods
Twenty-one patients with MIBC with planned radical cystectomy were enrolled. Two teams of radiologists reviewed FDG-PET/MRI scans to determine: (1) presence of primary bladder tumor; and (2) lymph node involvement and distant metastases. FDG-PET/MRI was compared with cystectomy pathology and computed tomography (CT).Results
Eighteen patients were included in the final analysis, most (72.2%) of whom received neoadjuvant chemotherapy. Final pathology revealed 10 (56%) patients with muscle invasion and only 3 (17%) patients with lymph node involvement. Clustered analysis of FDG-PET/MRI radiology team reads revealed a sensitivity of 0.80 and a specificity of 0.56 for detection of the primary tumor with a sensitivity of 0 and a specificity of 1.00 for detection of lymph node involvement when compared with cystectomy pathology. CT imaging demonstrated similar rates in evaluation of the primary tumor (sensitivity, 0.91; specificity, 0.43) and lymph node involvement (sensitivity, 0; specificity, 0.93) when compared with pathology.Conclusions
This pilot single-institution experience of FDG-PET/MRI for preoperative staging of MIBC performed similar to CT for the detection of the primary tumor; however, the determination of lymph node status was limited by few patients with true pathologic lymph node involvement. Further studies are needed to evaluate the potential role for FDG-PET/MRI in the staging of MIBC.Item Open Access Retrospective analysis of the efficacy and safety of neoadjuvant gemcitabine and cisplatin in muscle-invasive bladder cancer.(Journal of oncology pharmacy practice : official publication of the International Society of Oncology Pharmacy Practitioners, 2020-03) Meleis, Laura; Moore, Russell; Inman, Brant A; Harrison, Michael RBackground
Neoadjuvant cisplatin-based combination chemotherapy for muscle-invasive bladder cancer (MIBC) improves overall and disease-free survival. However, there is much debate over the optimal neoadjuvant regimen. Gemcitabine plus cisplatin (GC) has been the neoadjuvant regimen of choice for many institutions for patients with MIBC based on data extrapolated from the metastatic setting. Based on recent data, many institutions are transitioning to variations of methotrexate, vinblastine, doxorubicin, and cisplatin (MVAC) as the neoadjuvant regimen of choice.Objective
To assess the effectiveness and safety of neoadjuvant chemotherapy with gemcitabine plus cisplatin in patients with muscle-invasive bladder cancer prior to cystectomy.Methods
This is a single-center, retrospective, cohort study at Duke University Hospital (DUH). Patients included had MIBC and received gemcitabine plus cisplatin chemotherapy prior to a cystectomy. The primary endpoint was to assess the pathologic complete response (pCR) rate in MIBC after treatment with gemcitabine and cisplatin. Patients were split into two groups, those who received their chemotherapy at DUH, and those who received their chemotherapy at an outside facility.Results
Overall pCR rate for all patients (n = 36) was 14%. The pCR rates for patients in the Duke Chemotherapy Group (n = 17) and in the Community Chemotherapy Group (n = 19) were 24% and 5%, respectively. GC was overall well tolerated in most patients with few adverse events ≥ grade 3.Conclusions
This retrospective study demonstrates a consistent pCR rate (24% in Duke Chemotherapy Group) for neoadjuvant GC in MIBC compared with other literature. The overall pCR rate for all patients was 14%.Item Open Access Safety and efficacy of intravesical chemotherapy and hyperthermia in the bladder: results of a porcine study.(International journal of hyperthermia : the official journal of European Society for Hyperthermic Oncology, North American Hyperthermia Group, 2020-01) Tan, Wei Phin; Chang, Andrew; Brousell, Steven C; Grimberg, Dominic C; Fantony, Joseph J; Longo, Thomas A; Etienne, Wiguins; Spasojevic, Ivan; Maccarini, Paolo; Inman, Brant ABackground
Hyperthermia (heating to 43 °C) activates the innate immune system and improves bladder cancer chemosensitivity.Objective
To evaluate the tissue penetration and safety of convective hyperthermia combined with intravesical mitomycin C (MMC) pharmacokinetics in live porcine bladder models using the Combat bladder recirculation system (BRS).Methods
Forty 60 kg-female swine were anesthetized and catheterized with a 3-way, 16 F catheter. The Combat device was used to heat the bladders to a target temperature of 43 °C with recirculating intravesical MMC at doses of 40, 80, and 120 mg. Dwell-heat time varied from 30-180 min. Rapid necropsy with immediate flash freezing of tissues, blood and urine occurred. MMC concentrations were measured by liquid chromatography tandem-mass spectrometry.Results
The Combat BRS system was able to achieve target range temperature (42-44 °C) in 12 mins, and this temperature was maintained as long as the device was running. Two factors increased tissue penetration of MMC in the bladder: drug concentration, and the presence of heat. In the hyperthermia arm, MMC penetration saturated at 80 mg, suggesting that with heating, drug absorption may saturate and not require higher doses to achieve the maximal biological effect. Convective hyperthermia did not increase the MMC concentration in the liver, heart, kidney, spleen, lung, and lymph node tissue even at the 120 mg dose.Conclusions
Convective bladder hyperthermia using the Combat BRS device is safe and the temperature can be maintained at 43 °C. Hyperthermia therapy may increase MMC penetration into the bladder wall but does not result in an increase of MMC levels in other organs.Item Open Access Small cell bladder cancer: should we consider prophylactic cranial irradiation?(International braz j urol : official journal of the Brazilian Society of Urology, 2019-03) Morgan, Tara Nikonow; Turner, Robert M; Baptiste, Julian; Lyon, Timothy D; Maranchie, Jodi K; Hrebinko, Ronald L; Davies, Benjamin J; Gingrich, Jeffrey R; Jacobs, Bruce LPurpose
To describe the clinical characteristics, treatment patterns, and outcomes in patients with small cell bladder cancer at our institution, including those who received prophylactic cranial irradiation (PCI) for the prevention of intracranial recurrence.Materials and methods
Patients with small cell bladder cancer treated at a single institution between January 1990 and August 2015 were identified and analyzed retrospectively for demographics, tumor stage, treatment, and overall survival.Results
Of 44 patients diagnosed with small cell bladder cancer, 11 (25%) had metastatic disease at the time of presentation. Treatment included systemic chemotherapy (70%), radical surgery (59%), and local radiation (39%). Six patients (14%) received PCI. Median overall survival was 10 months (IQR 4 - 41). Patients with extensive disease had worse overall survival than those with organ confined disease (8 months vs. 36 months, respectively, p = 0.04). Among those who received PCI, 33% achieved 5 - year survival.Conclusion
Outcomes for patients with small cell bladder cancer remain poor. Further research is indicated to determine if PCI increases overall survival in small call bladder cancer patients, especially those with extensive disease who respond to chemotherapy.Item Open Access Synergistic Immuno Photothermal Nanotherapy (SYMPHONY) for the Treatment of Unresectable and Metastatic Cancers.(Scientific reports, 2017-08-17) Liu, Yang; Maccarini, Paolo; Palmer, Gregory M; Etienne, Wiguins; Zhao, Yulin; Lee, Chen-Ting; Ma, Xiumei; Inman, Brant A; Vo-Dinh, TuanMetastatic spread is the mechanism in more than 90 percent of cancer deaths and current therapeutic options, such as systemic chemotherapy, are often ineffective. Here we provide a proof of principle for a novel two-pronged modality referred to as Synergistic Immuno Photothermal Nanotherapy (SYMPHONY) having the potential to safely eradicate both primary tumors and distant metastatic foci. Using a combination of immune-checkpoint inhibition and plasmonic gold nanostar (GNS)-mediated photothermal therapy, we were able to achieve complete eradication of primary treated tumors and distant untreated tumors in some mice implanted with the MB49 bladder cancer cells. Delayed rechallenge with MB49 cancer cells injection in mice that appeared cured by SYMPHONY did not lead to new tumor formation after 60 days observation, indicating that SYMPHONY treatment induced effective long-lasting immunity against MB49 cancer cells.Item Open Access The Cost to Medicare of Bladder Cancer Care.(European urology oncology, 2020-08) Sloan, Frank A; Yashkin, Arseniy P; Akushevich, Igor; Inman, Brant ABackground
Bladder cancer care is costly, including cost to Medicare, but the medical cost associated with bladder cancer patients relative to identical persons without bladder cancer is unknown.Objective
To determine incremental bladder cancer cost to Medicare and the impact of diagnosis stage and bladder cancer survival on cost.Design, setting, and participants
A case-control study was conducted using 1998-2013 Surveillance, Epidemiology and End Results-Medicare data. Controls were propensity score matched for diagnosis year, age, gender, race, and 31 Elixhauser Comorbidity Index values. Three incident cohorts, 1998 (n=3136), 2003 (n=7000), and 2008 (n=7002), were compared.Outcome measurements and statistical analysis
Survival following diagnosis and Medicare payments (in 2018 dollars) were tabulated, and compared between cases and controls.Results and limitations
From 1998 to 2008, bladder cancer patients became older and had more comorbidities at diagnosis, although no stage migration or change in survival occurred. Incremental costs (above those associated with controls) were highest during the 1st year after diagnosis and were higher for distant ($47533) than for regional ($42403) or localized ($14304) cancer. Bladder cancer survival was highly stage dependent. After an initial spike in costs lasting 1-2yrs, monthly costs dropped in survivors but remained higher than for controls. Long-term survivors in the full sample accrued cumulative Medicare costs of $172426 over 16yrs-46% higher than for controls. Limitations include omission of indirect costs and reliance on traditional Medicare.Conclusions
While a bladder cancer diagnosis incurs initial high Medicare cost, particularly in patients with advanced cancers, the cumulative costs of bladder cancer in long-term survivors are higher still. Bladder cancer prevention saves Medicare money. However, while early detection, better therapies, and life extension of bladder cancer patients are worthwhile goals, they come at the cost of higher Medicare outlays.Patient summary
The lifetime cost of bladder cancer, reflecting surveillance, treatment, and management of complications, is substantial. Since care is ongoing, cost increases with the length of life after diagnosis as well as the severity of initial diagnosis.Item Open Access Thromboembolism and bleeding in bladder cancer.(Oncology (Williston Park), 2014-10) Fantony, Joseph J; Inman, Brant ABladder cancer is a unique disease process in that clinically significant hemorrhage can occur simultaneously with equally significant aberrant clotting. With hematuria the key presenting symptom of bladder cancer, hemorrhage is generally thought to be a component of the natural history of the disease, and to commonly occur during its treatment. However, as those who regularly treat bladder cancer know, the need to address a predisposition to clotting is also very much part of the treatment paradigm. Physicians must be cognizant of the biochemical changes that confer a propensity for both significant bleeding and clotting occurring simultaneously in their patients. Both of these entities remain important issues, and further study is needed to find ways to mitigate and balance the associated risks. Here, we performed a review of the literature, focusing on the concomitant issues of bleeding and venous thromboembolism in both the pre- and post-operative periods in patients with bladder cancer. We formulated a general management approach with respect to these two processes, and we provide direction for further investigation.