83 results on '"Smaldone, M."'
Search Results
52. Preventing Prostate Biopsy Complications: to Augment or to Swab?
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Glick L, Vincent SA, Squadron D, Han TM, Syed K, Danella JF, Ginzburg S, Guzzo TJ, Lanchoney T, Raman JD, Smaldone M, Uzzo RG, Tomaszweski JJ, Reese A, Singer EA, Jacobs B, Trabulsi EJ, Gomella LG, and Mann MJ
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- Aged, Aged, 80 and over, Humans, Male, Rectum, Retrospective Studies, Risk Assessment, Antibiotic Prophylaxis, Bacterial Infections prevention & control, Image-Guided Biopsy adverse effects, Image-Guided Biopsy methods, Postoperative Complications etiology, Postoperative Complications prevention & control, Prostate pathology, Ultrasonography, Interventional
- Abstract
Objective: To use data from a large, prospectively- acquired regional collaborative database to compare the risk of infectious complications associated with three American Urologic Association- recommended antibiotic prophylaxis pathways, including culture-directed or augmented antibiotics, following prostate biopsy., Methods: Data on prostate biopsies and outcomes were collected from the Pennsylvania Urologic Regional Collaborative, a regional quality collaborative working to improve the diagnosis and treatment of prostate cancer. Patients were categorized as receiving one of three prophylaxis pathways: culture-directed, augmented, or provider-discretion. Infectious complications included fever, urinary tract infections or sepsis within one month of biopsy. Odds ratios of infectious complication by pathway were determined, and univariate and multivariate analyses of patient and biopsy characteristics were performed., Results: 11,940 biopsies were included, 120 of which resulted in infectious outcomes. Of the total biopsies, 3246 used "culture-directed", 1446 used "augmented" and 7207 used "provider-discretion" prophylaxis. Compared to provider-discretion, the culture-directed pathway had 84% less chance of any infectious outcome (OR= 0.159, 95% CI = [0.074, 0.344], P < 0.001). There was no difference in infectious complications between augmented and provider-discretion pathways., Conclusions: The culture-directed pathway for transrectal prostate biopsy resulted in significantly fewer infectious complications compared to other prophylaxis strategies. Tailoring antibiotics addresses antibiotic-resistant bacteria and reduces future risk of resistance. These findings make a strong case for incorporating culture-directed antibiotic prophylaxis into clinical practice guidelines to reduce infection following prostate biopsies., (Copyright © 2021. Published by Elsevier Inc.)
- Published
- 2021
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53. EDITORIAL COMMENT.
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Glick L, Vincent SA, Squadron D, Han TM, Syed K, Danella JF, Ginzburg S, Guzzo TJ, Lanchoney T, Raman JD, Smaldone M, Uzzo RG, Tomaszweski JJ, Reese A, Singer EA, Jacobs B, Trabulsi EJ, Gomella LG, and Mann MJ
- Published
- 2021
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54. Screening, Linkage to Care and Treatment of Hepatitis C Infection in Primary Care Setting in the South of Italy.
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Citarella A, Cammarota S, Bernardi FF, Coppola C, D'Antò M, Fogliasecca M, Giusto E, Masarone M, Salomone Megna A, Sellitto C, Servodio R, Smaldone M, Staiano L, Trama U, Conti V, and Persico M
- Abstract
Hepatitis C virus (HCV) infection remains a pressing public health issue. Our aim is to assess the linkage to care of patients with HCV diagnosis and to support the proactive case-finding of new HCV-infected patients in an Italian primary care setting. This was a retrospective cohort study of 44 general practitioners (GPs) who managed 63,955 inhabitants in the Campania region. Adults with already known HCV diagnosis or those with HCV high-risk profile at June 2019 were identified and reviewed by GPs to identify newly diagnosed of HCV and to assess the linkage to care and treatment for the HCV patients. Overall, 698 HCV patients were identified, 596 with already known HCV diagnosis and 102 identified by testing the high-risk group (2614 subjects). The 38.8% were already treated with direct-acting antivirals, 18.9% were referred to the specialist center and 42.3% were not sent to specialist care for treatment. Similar proportions were found for patients with an already known HCV diagnosis and those newly diagnosed. Given that the HCV infection is often silent, case-finding needs to be proactive and based on risk information. Our findings suggested that there needs to be greater outreach, awareness and education among GPs in order to enhance HCV testing, linkage to care and treatment.
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- 2020
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55. Concordance of confirmatory prostate biopsy in active surveillance with national guidelines: An analysis from the multi-institutional PURC cohort.
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Talwar R, Friel B, Mittal S, Xia L, Fonshell C, Danella J, Jacobs B, Lanchoney T, Raman J, Tomaszewski J, Trabulsi E, Reese A, Singer EA, Ginzburg S, Smaldone M, Uzzo R, Mucksavage P, Guzzo TJ, and Lee DJ
- Subjects
- Biopsy standards, Cohort Studies, Humans, Male, Prospective Studies, Guideline Adherence statistics & numerical data, Prostate pathology, Prostatic Neoplasms pathology, Watchful Waiting
- Abstract
Purpose: National Comprehensive Cancer Network (NCCN) guidelines recommend confirmatory biopsy within 12 months of active surveillance (AS) enrollment. With <10 cores on initial biopsy, re-biopsy should occur within 6 months. Our objective was to determine if patients on AS within practices in the Pennsylvania Urologic Regional Collaborative (PURC) receive guideline concordant confirmatory biopsies., Materials and Methods: Within PURC, a prospective collaborative of diverse urology practices in Pennsylvania and New Jersey, we identified men enrolled in AS after first biopsy, analyzing time to re-biopsy and factors associated with various intervals of re-biopsy., Results: In total, 1,047 patients were enrolled in AS for a minimum of 12 months after initial biopsy. Four hundred seventy-seven (45%) underwent second biopsy at 1 of the 9 PURC practices. The number of patients undergoing re-biopsy within 6 months, 6 to 12 months, 12 to 18 months, and >18 months was 71 (14%), 218 (45.7%), 134 (28%), and 54 (11%), respectively. Sixty percent underwent confirmatory biopsy within 12 months. On multivariate analysis, re-biopsy interval was associated with number of positive cores, perineural invasion, and practice ID (all P < 0.05). Adjusted multivariable regression did not identify factors predictive of re-biopsy interval., Conclusion: Of patients who underwent confirmatory biopsy at PURC practices, 60.5% were within 12 months per NCCN guidelines. This suggests area for improvement in guideline adherence after enrollment in AS. All practices that offer AS should periodically perform similar analyses to monitor their performance. In an era of value-based care, adherence to guideline based active surveillance practices may eventually comprise national quality metrics affecting provider reimbursement., (Copyright © 2020 Elsevier Inc. All rights reserved.)
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- 2020
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56. Stakeholder Perspective on Opioid Stewardship After Prostatectomy: Evaluating Barriers and Facilitators From the Pennsylvania Urology Regional Collaborative.
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Lee DJ, Talwar R, Ding J, Chandrasekar T, Syed K, Fonshell C, Danella J, Ginzburg S, Lanchoney T, Tomaszewski J, Trabulsi E, Reese A, Smaldone M, Uzzo R, Raman JD, and Guzzo TJ
- Subjects
- Clinical Competence statistics & numerical data, Humans, Male, Opioid-Related Disorders etiology, Pain Management methods, Pain, Postoperative etiology, Pennsylvania, Practice Patterns, Physicians' organization & administration, Practice Patterns, Physicians' statistics & numerical data, Quality Improvement, Stakeholder Participation, Surgeons statistics & numerical data, Surveys and Questionnaires statistics & numerical data, Urologists statistics & numerical data, Analgesics, Opioid adverse effects, Opioid-Related Disorders prevention & control, Pain, Postoperative drug therapy, Prostatectomy adverse effects, Prostatic Neoplasms surgery
- Abstract
Objective: To evaluate existing practice patterns and potential barriers to implementing opioid stewardship protocols after robot-assisted prostatectomies among providers in the Pennsylvania Urology Regional Collaborative., Methods: The Pennsylvania Urology Regional Collaborative (PURC) is a voluntary quality improvement initiative of 11 academic and community urology practices in Pennsylvania and New Jersey representing 97 urologists. PURC distributed a web-based survey of 24 questions, with 74 respondents, including 56 attendings, 11 residents, and 7 advanced practice providers., Results: More pills were prescribed if there was a default number of pills from the electronic health record (median 30) then if the number of pills was manually placed (P = .01). Only 8% discussed how to dispose of opioids with their patients, and less than a third of respondents discussed postoperative pain expectations or risks of opioid use. Patient level risk factors were often not reviewed, as 42% did not ask about previous opioid exposure., Conclusion: This study revealed extensive knowledge disparities among providers about opioid stewardship and significant gaps in the evidence-to-practice continuum of care. In the next year, PURC will be implementing targeted interventions to augment provider education, establish clear pathways for opioid disposal, improve utilization of known resources and implement opioid reduction protocols in all participating sites., (Copyright © 2020 Elsevier Inc. All rights reserved.)
- Published
- 2020
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57. Bacillus Calmette-Guérin Packaged for Percutaneous Vaccination Can Be Safely Used for Intravesical Instillation in Patients with Urothelial Carcinoma of the Bladder.
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Masic S, Srivastava A, Kloth D, Needleman R, Bloom E, Uzzo RN, Amoroso C, Lee R, Greenberg R, Smaldone M, Viterbo R, Joshi S, Chen DYT, Uzzo RG, and Kutikov A
- Abstract
Introduction: Bacillus Calmette-Guérin production is limited worldwide with stuttering shortages affecting patient access. Our institution received 50 vials of bacillus Calmette-Guérin labeled for percutaneous administration, and upon discussion with our clinical team and approval by the Pharmacy and Therapeutics Committee we used the percutaneous formulation in place of the intravesical formulation. We report our experience., Methods: Between February and April 2019 patients were treated with a third of a vial dose either with percutaneous or intravesical bacillus Calmette-Guérin. American Urological Association Symptom Score and Quality of Life survey and an additional 6-question survey (querying presence of suprapubic pain, hematuria, fevers, malaise, skin rashes, testicular/groin pain) were administered. Statistical analyses comparing the 2 groups were performed with SPSS version 22 software., Results: A total of 30 patients with 73 intravesical instillations were evaluated with 34 patients receiving intravesical and 39 percutaneous bacillus Calmette-Guérin. We found no significant differences when comparing intravesical vs percutaneous bacillus Calmette-Guérin groups in terms of American Urological Association Symptom Score (6.1 vs 6.9, p=0.177), Quality of Life score (1.3 vs 1.7, p=0.132), fevers (2.9% vs 0%, p=0.300), hematuria (14.7% vs 2.8%, p=0.075), suprapubic pain (10.1% vs 4.3%, p=0.129), skin rashes (1.4% vs 0%, p=0.307) and feeling of general fatigue and malaise (15.7% vs 8.6%, p=0.126)., Conclusions: Intravesical instillation of percutaneous bacillus Calmette-Guérin appears to be a safe alternative to intravesical bacillus Calmette-Guérin during times of shortage. Development of additional strains, use of alternative intravesical therapies and incentivizing bacillus Calmette-Guérin production through policy change and/or alternative funding may also help avoid bacillus Calmette-Guérin supply shortages in the future.
- Published
- 2020
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58. Primary small cell carcinoma of the adrenal gland: Case presentation of a rare extrapulmonary small cell carcinoma.
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Lee JY, Strauss D, Bailey K, and Smaldone M
- Abstract
Small cell carcinoma (SCC) is an aggressive histologic subtype of neuroendocrine tumor and is most commonly of bronchogenic origin. However, it can present in an extrapulmonary fashion. Primary extrapulmonary small cell carcinoma (EPSCC) is a rare disease entity, especially within the genitourinary system and furthermore of the adrenal gland. There are scarce case reports that describe management of primary adrenal SCC. We present a case of localized primary adrenal SCC diagnosed on adrenal mass biopsy and successfully treated via neoadjuvant chemotherapy and extirpative surgery., Competing Interests: None., (© 2020 The Authors.)
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- 2020
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59. The Association of Robot-assisted Versus Pure Laparoscopic Radical Nephrectomy with Perioperative Outcomes and Hospital Costs.
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Gershman B, Bukavina L, Chen Z, Konety B, Schumache F, Li L, Kutikov A, Smaldone M, Abouassaly R, and Kim SP
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- Aged, Female, Humans, Male, Middle Aged, Treatment Outcome, Hospital Costs, Laparoscopy, Nephrectomy economics, Nephrectomy methods, Robotic Surgical Procedures
- Abstract
Background: Although robot assistance can facilitate the advantages of minimally invasive surgery, it is unclear whether it offers benefits in settings in which laparoscopic surgery has been established as the standard of care., Objective: To examine the comparative effectiveness of robot-assisted laparoscopic radical nephrectomy (RALRN) and laparoscopic radical nephrectomy (LRN) using a nationwide data set., Design, Setting, and Participants: 8316 adults who underwent RALRN or LRN for non-urothelial renal cancer from the Nationwide Inpatient Sample from 2010 to 2013., Intervention: RALRN and LRN., Outcome Measurements and Statistical Analysis: The associations of surgical approach with perioperative outcomes and total hospital costs were evaluated using multivariable logistic regression., Results and Limitations: Over the study period, utilization of RALRN increased from 46% to 69%. Compared to LRN, RALRN was associated with lower rates of intraoperative (0.9% vs 1.8%; p<0.001) and postoperative complications (20.4% vs 27.2%; p<0.001), but there were no differences in perioperative blood transfusion (5.6% vs 6.2%; p=0.27) and prolonged hospitalization (7.2% vs 7.1%; p=0.81). RALRN was also significantly associated with higher total hospital costs (median $16 207 vs $15 037; p<0.001). In multivariable analyses, RALRN remained independently associated with a lower risk of intraoperative (odds ratio [OR] 0.50; p=0.001) and postoperative complications (OR 0.72; p<0.001) but not perioperative blood transfusion (OR 1.10; p=0.34), and with a higher risk of prolonged hospitalization (OR 1.29; p=0.007) and higher mean total hospital costs (+$1468; p<0.001). There was no effect modification by hospital volume., Conclusions: Although RALRN was independently associated with a reduction in perioperative complications compared to LRN, it was associated with prolonged hospitalization and higher total hospital costs. These relationships must be interpreted in light of potential differences in case mix., Patient Summary: Although robot-assisted laparoscopic radical nephrectomy was independently associated with a reduction in perioperative complications compared to laparoscopic radical nephrectomy, it was associated with prolonged hospitalization and higher total hospital costs., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)
- Published
- 2020
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60. Impact of preoperative prostate magnetic resonance imaging on the surgical management of high-risk prostate cancer.
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Baack Kukreja J, Bathala TK, Reichard CA, Troncoso P, Delacroix S, Davies B, Eggener S, Smaldone M, Minhaj Siddiqui M, Tollefson M, and Chapin BF
- Subjects
- Clinical Decision-Making, Disease Management, Humans, Male, Multiparametric Magnetic Resonance Imaging, Neoplasm Staging, Prognosis, Prostatectomy methods, Prostatic Neoplasms surgery, Risk Assessment, Magnetic Resonance Imaging methods, Preoperative Care, Prostatic Neoplasms diagnostic imaging, Prostatic Neoplasms pathology
- Abstract
Objective: To evaluate the effect of adding multiparametric magnetic resonance imaging (mpMRI) to pre-surgical planning on surgical decision making for the management of high-risk prostate cancer (HRPC)., Patients and Methods: A survey was designed to query multiple centers on surgical decisions of 41 consecutive HRPC cases seen from 2012 to 2015. HRPC was defined by the National Comprehensive Cancer Center Network guidelines. Six fellowship-trained urologic oncologists were asked for their surgical plan in regards to the degree of planned nerve-sparing and lymph node dissection. Two rounds of surveys were administered to six external urologic oncologists. The first survey included the case description only and the second included case description with mpMRI images and report. The correct surgical plan was analyzed by correlation of the degree of planned surgical excision and consistency with the final pathologic evaluation. A priori, an effect size of 20% change was used to determine statistical significance, at p < 0.05., Results: All cases had at least one change to surgical planning after mpMRI review. Forty (98%) patients had a change in the degree of planned nerve sparing: wider excision in 32% and increased nerve sparing in 24%. After mpMRI the correct surgical plan change was made in 49% for the right and left 51%, decreasing the potential for positive margins. Lymph node dissection was altered from standard to extended lymph node dissection in 17%., Conclusions: Although mpMRI is not integrated in guidelines for preoperative planning in HRPC, its use may impact surgical planning, cancer control, and quality of life.
- Published
- 2020
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61. Active Surveillance as Initial Management of Newly Diagnosed Prostate Cancer: Data from the PURC.
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Botejue M, Abbott D, Danella J, Fonshell C, Ginzburg S, Guzzo TJ, Lanchoney T, Marlowe B, Raman JD, Smaldone M, Tomaszewski JJ, Trabulsi EJ, Uzzo RG, and Reese AC
- Subjects
- Aged, Biopsy, Needle, Disease Progression, Humans, Immunohistochemistry, Male, Middle Aged, Neoplasm Invasiveness pathology, Neoplasm Staging, New Jersey, Pennsylvania, Practice Patterns, Physicians', Prognosis, Prostate-Specific Antigen blood, Prostatic Neoplasms therapy, Survival Analysis, Early Detection of Cancer, Prostatic Neoplasms diagnosis, Prostatic Neoplasms mortality, Registries, Watchful Waiting methods
- Abstract
Purpose: We describe contemporary active surveillance utilization and variation in a regional prostate cancer collaborative. We identified demographic and disease specific factors associated with active surveillance in men with newly diagnosed prostate cancer., Materials and Methods: We analyzed data from the PURC (Pennsylvania Urologic Regional Collaborative), a cooperative effort of urology practices in southeastern Pennsylvania and New Jersey. We determined the rates of active surveillance among men with newly diagnosed NCCN® (National Comprehensive Cancer Network®) very low, low or intermediate prostate cancer and compared the rates among participating practices and providers. Univariate and multivariable analyses were used to identify factors associated with active surveillance utilization., Results: A total of 1,880 men met inclusion criteria. Of the men with NCCN very low or low risk prostate cancer 57.4% underwent active surveillance as the initial management strategy. Increasing age was significantly associated with active surveillance (p <0.001) while adverse clinicopathological variables were associated with decreased active surveillance use. Substantial variation in active surveillance utilization was observed among practices and providers., Conclusions: More than 50% of men with low risk disease in the PURC collaborative were treated with active surveillance. However, substantial variation in active surveillance rates were observed among practices and providers in academic and community settings. Advanced age and favorable clinicopathological factors were strongly associated with active surveillance. Analysis of regional collaboratives such as the PURC may allow for the development of strategies to better standardize treatment in men with prostate cancer and offer active surveillance in a more uniform and systematic fashion.
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- 2019
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62. Comparative Effectiveness of Local and Systemic Therapy for T4 Prostate Cancer.
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Kim AH, Konety B, Chen Z, Schumacher F, Kutikov A, Smaldone M, Abouassaly R, Khanna A, and Kim SP
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- Academic Medical Centers statistics & numerical data, Adult, Age Factors, Aged, Aged, 80 and over, Androgen Antagonists therapeutic use, Antineoplastic Agents therapeutic use, Comorbidity, Databases, Factual, Humans, Male, Medically Uninsured statistics & numerical data, Middle Aged, Multivariate Analysis, Proportional Hazards Models, Prostatectomy, Race Factors, Racial Groups statistics & numerical data, Radiotherapy, Adjuvant, Retrospective Studies, Rural Health Services statistics & numerical data, Survival Analysis, United States epidemiology, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Prostatic Neoplasms therapy
- Abstract
Objective: To evaluate the comparative effectiveness of local vs systemic therapy among patients diagnosed with nonmetastatic clinical T4 prostate cancer., Methods: Using the National Cancer Database men with clinical T4N0-1M0 prostate cancer from 2004 to 2013 were identified. Local therapy was defined as radiation (RT with androgen deprivation therapy [ADT]), surgery (radical prostatectomy with ADT), or combined radiation plus surgery (radical prostatectomy plus RT with ADT). Systemic therapy was defined as ADT or chemotherapy alone. The primary outcome of overall survival was estimated using the Kaplan-Meier method. Factors associated with overall survival were determined by Cox proportional hazards models., Results: A total of 1914 patients were included in our analysis, 1559 received local therapy and 355 received systemic therapy. Median 5-year survival for local vs systemic therapy was 41.5 and 28.2 months, respectively. On multivariable analysis, local therapy was associated with increased overall survival compared to systemic therapy (hazard ratio [HR] = 0.52; 95% confidence interval [CI] 0.44-0.62, P < .001). Comparing local therapy treatment modalities, both radiation (HR = 0.44; 95% CI 0.36-0.53, P < .001) and surgery (HR = 0.67; 95% CI 0.55-0.82, P < .001) were associated with increased overall survival compared to systemic therapy. Among those receiving local therapy, more patients were treated with radiation (n = 709/1559 or 45.5%) compared to surgery (n = 560/1559 or 35.9%) or combined radiation plus surgery (n = 290/1559 or 18.6%) with 5-year overall survival by treatment type being 61%, 51.4%, and 62.2%, respectively., Conclusion: Local therapy for clinical T4 prostate cancer is associated with improved overall survival. Due to the retrospective, nonrandomized nature of the study design, a clinical trial is needed to better define the efficacy of local therapy in this high-risk patient population., (Copyright © 2018. Published by Elsevier Inc.)
- Published
- 2018
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63. Functional Parenchymal Volume-based Spectrum Score Is Able to Quantify Ischemic Injury After Partial Nephrectomy.
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Lee Z, Uzzo R, Asghar A, Parkansky P, Botejue M, Li T, Viterbo R, Chen DYT, Smaldone M, and Kutikov A
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- Acute Kidney Injury etiology, Aged, Creatinine blood, Female, Glomerular Filtration Rate, Humans, Kidney Neoplasms surgery, Male, Middle Aged, Nephrectomy methods, Organ Size, Retrospective Studies, Acute Kidney Injury diagnosis, Kidney pathology, Models, Statistical, Nephrectomy adverse effects, Warm Ischemia adverse effects
- Abstract
Objective: To externally validate the Spectrum Score (SS) using a modified calculation based on functional parenchymal volumes (FPVs) instead of renal scans. The SS quantifies acute ischemic injury in the ipsilateral kidney after partial nephrectomy. However, this metric requires renal split function assessment via renal scans, which may be unavailable in routine practice., Methods: We retrospectively reviewed patients with a solitary renal mass and contralateral kidney who underwent partial nephrectomy at our institution between 2015 and 2017. FPVs were calculated using cylindrical volume approximation and used to quantitate relative renal function. Based on renal split function and parenchyma preserved, we determined creatinine
ideal , assuming no ipsilateral kidney ischemic injury, and creatinineworst-case , assuming temporary ipsilateral kidney nonfunction. FPV-based SS was defined as follows: (observed peak creatinine-creatinineideal )/(creatinineworst-case -creatinineideal ). Functional recovery was defined as follows: (% function saved)/(% parenchyma preserved). Factors associated with FPV-based SS and functional recovery were assessed using linear regression., Results: We assessed 174 patients with a median renal mass size of 2.7 cm (IQR 2.0-3.6), warm ischemia time of 26.0 minutes (IQR 19.0-34.3), and parenchyma preservation of 92.6% (IQR 80.8-100). Preoperative ipsilateral kidney % split function (P = .003), preoperative ipsilateral kidney glomerular filtration rate (P = .045), and warm ischemia time (P = .005) were independently associated with FPV-based SS. Only FPV-based SS (P<.001) was independently associated with functional recovery., Conclusion: The FPV-based SS, which does not require renal scans, quantifies acute ipsilateral renal dysfunction and predicts functional recovery after partial nephrectomy., (Copyright © 2018 Elsevier Inc. All rights reserved.)- Published
- 2018
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64. Neoadjuvant Dose-dense Gemcitabine and Cisplatin in Muscle-invasive Bladder Cancer: Results of a Phase 2 Trial.
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Anari F, O'Neill J, Choi W, Chen DYT, Haseebuddin M, Kutikov A, Dulaimi E, Alpaugh RK, Devarajan K, Greenberg RE, Bilusic M, Wong YN, Viterbo R, Hoffman-Censits JH, Lallas CD, Trabulsi EJ, Smaldone M, Geynisman DM, Zibelman M, Lin J, Kelly WK, Uzzo R, McConkey D, and Plimack ER
- Abstract
Background: Accelerated (also termed dose-dense, DD) chemotherapy regimens such as accelerated methotrexate, vinblastine, doxorubicin, and cisplatin have shown better efficacy and tolerability in the metastatic setting, and shortened the time to surgery in the neoadjuvant setting compared to standard-schedule regimens. We hypothesized that a DD schedule of gemcitabine and cisplatin (GC) would shorten the time to surgery and yield similar pathologic complete response rates (pT0) in patients with muscle-invasive bladder cancer (MIBC) compared with historical controls with standard GC., Objective: To determine the safety and efficacy of neoadjuvant DDGC in MIBC., Design Setting and Participants: Patients with cT2-4a, N0-1, M0 MIBC were eligible and received three 14-d cycles of DDGC with pegfilgrastim support followed by radical cystectomy with lymph node dissection. The primary end point was the pT0 rate. Molecular subtypes were assigned and correlated with survival., Results and Limitations: Thirty-one patients were evaluable for toxicity and response, of whom 58% had baseline clinical stage >T2N0M0; the median age was 69 yr. Ten patients (32%, 95% confidence interval [CI] 16-49%) achieved ypT0N0 status at cystectomy. Another four patients (13%, 95% CI 1-25%) were downstaged to non-muscle-invasive (
- Published
- 2018
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65. Defining Novel and Practical Metrics to Assess the Deliverables of Multiparametric Magnetic Resonance Imaging/Ultrasound Fusion Prostate Biopsy.
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Ristau BT, Chen DYT, Ellis J, Malhotra A, DeMora L, Parsons RB, Milestone B, Brody M, Viterbo R, Greenberg R, Smaldone M, Uzzo R, Anaokar J, and Kutikov A
- Subjects
- Aged, Humans, Image-Guided Biopsy methods, Male, Middle Aged, Prospective Studies, Prostate diagnostic imaging, Prostatic Neoplasms diagnostic imaging, Evaluation Studies as Topic, Magnetic Resonance Imaging, Interventional methods, Prostate pathology, Prostatic Neoplasms pathology, Ultrasonography, Interventional methods
- Abstract
Purpose: Multiparametric magnetic resonance/ultrasound targeted prostate biopsy is touted as a tool to improve prostate cancer care and yet its true clinical usefulness over transrectal ultrasound guided prostate biopsy has not been systematically analyzed. We introduce 2 metrics to better quantify and report the deliverables of targeted biopsy., Materials and Methods: We reviewed our prospective database of patients who underwent simultaneous multiparametric magnetic resonance/ultrasound targeted prostate biopsy and transrectal ultrasound guided prostate biopsy. Actionable intelligence metric was defined as the proportion of patients in whom targeted biopsy provided actionable information over transrectal ultrasound guided prostate biopsy. Reduction metric was defined as the proportion of men in whom transrectal ultrasound guided prostate biopsy could have been omitted. We compared metrics in our cohort with those in prior reports., Results: A total of 371 men were included in study. The actionable intelligence and reduction metrics were 22.2% and 83.6% in biopsy naïve cases, 26.7% and 84.2% in prior negative transrectal ultrasound guided prostate biopsy cases, and 24% and 77.5%, respectively, in active surveillance cases. No significant differences were observed among the groups in the actionable intelligence metric and the reduction metric (p = 0.89 and 0.27, respectively). The actionable intelligence metric was 25.0% for PI-RADS™ (Prostate Imaging Reporting and Data System) 3, 27.5% for PI-RADS 4 and 21.7% for PI-RADS 5 lesions (p = 0.73). Transrectal ultrasound guided prostate biopsy could have been avoided in more patients with PI-RADS 3 compared to PI-RADS 4/5 lesions (reduction metric 92.0% vs 76.7%, p <0.01). Our results compare favorably to those of other reported series., Conclusions: The actionable intelligence metric and the reduction metric are novel, clinically relevant quantification metrics to standardize the reporting of multiparametric magnetic resonance/ultrasound targeted prostate biopsy deliverables. Targeted biopsy provides actionable information in about 25% of men. Reduction metric assessment highlights that transrectal ultrasound guided prostate biopsy may only be omitted after carefully considering the risk of missing clinically significant cancers., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2018
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66. Assessing the relative influence of hospital and surgeon volume on short-term mortality after radical cystectomy.
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Waingankar N, Mallin K, Smaldone M, Egleston BL, Higgins A, Winchester DP, Uzzo RG, and Kutikov A
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- Adolescent, Adult, Aged, Aged, 80 and over, Female, Hospital Mortality, Humans, Male, Middle Aged, Propensity Score, Proportional Hazards Models, Registries, Young Adult, Clinical Competence, Cystectomy mortality, Cystectomy statistics & numerical data, Hospitals, High-Volume statistics & numerical data, Surgeons statistics & numerical data, Urinary Bladder Neoplasms mortality, Urinary Bladder Neoplasms surgery
- Abstract
Objectives: To assess the relationship between surgeon (SV) and hospital volume (HV) on mortality after radical cystectomy (RC)., Patients and Methods: We queried the National Cancer Database (NCDB) for adult patients undergoing RC between 2010 and 2013. We calculated average volume for each surgeon and hospital. Using propensity-scored weights for combined volume groups with a proportional hazards regression model, we compared the associations between HV and SV with 90-day survival after RC., Results: A total of 19 346 RCs were performed at 927 hospitals by 2 927 surgeons in the period 2010-2013. The median (interquartile range) HV and SV were 12.3 (5.0-35.5) and 4.3 (1.3-12.3) cases, respectively. For HV, 90-day unadjusted mortality was 8.5% in centres with <5 cases/year (95% confidence interval [CI] 7.7-9.3) and 5.6% in those with >30 cases/year (95% CI 5.0-6.2). For SV, 90-day mortality was 8.1% for surgeons with <5 cases/year (95% CI 7.6-8.6) and 4.0% for those with >30 cases/year (95% CI 2.8-5.2; all P < 0.05). The 30-day mortality rate was lowest for the combined HV-SV groups with HV >30, ranging from 1.6% to 2.1%., Conclusions: In hospitals reporting to the NCDB, volume was associated with improved mortality after RC. These associations appear to be driven by hospital- rather than surgeon-level effects. An elevated SV had a beneficial effect on mortality at the highest-volume hospitals. These findings inform efforts to regionalize complex surgical care and improve quality at community and safety net hospitals., (© 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.)
- Published
- 2017
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67. Diffusion volume (DV) measurement in endometrial and cervical cancer: A new MRI parameter in the evaluation of the tumor grading and the risk classification.
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Mainenti PP, Pizzuti LM, Segreto S, Comerci M, Fronzo S, Romano F, Crisci V, Smaldone M, Laccetti E, Storto G, Alfano B, Maurea S, Salvatore M, and Pace L
- Subjects
- Adult, Aged, Analysis of Variance, Female, Humans, Image Interpretation, Computer-Assisted, Middle Aged, Neoplasm Grading, Observer Variation, Risk, Sensitivity and Specificity, Tumor Burden, Diffusion Magnetic Resonance Imaging methods, Endometrial Neoplasms pathology, Uterine Cervical Neoplasms pathology
- Abstract
Purpose: A new MRI parameter representative of active tumor burden is proposed: diffusion volume (DV), defined as the sum of all the voxels within a tumor with apparent diffusion coefficient (ADC) values within a specific range. The aims of the study were: (a) to calculate DV on ADC maps in patients with cervical/endometrial cancer; (b) to correlate DV with histological grade (G) and risk classification; (c) to evaluate intra/inter-observer agreement of DV calculation., Materials and Methods: Fifty-three patients with endometrial (n=28) and cervical (n=25) cancers underwent pelvic MRI with DWI sequences. Both endometrial and cervical tumors were classified on the basis of G (G1/G2/G3) and FIGO staging (low/medium/high-risk). A semi-automated segmentation procedure was used to calculate the DV. A freehand closed ROI outlined the whole visible tumor on the most representative slice of ADC maps defined as the slice with the maximum diameter of the solid neoplastic component. Successively, two thresholds were generated on the basis of the mean and standard deviation (SD) of the ADC values: lower threshold (LT="mean minus three SD") and higher threshold (HT="mean plus one SD"). The closed ROI was expanded in 3D, including all the contiguous voxels with ADC values in the range LT-HT × 10-3mm(2)/s. A Kruskal-Wallis test was used to assess the differences in DV among G and risk groups. Intra-/inter-observer variability for DV measurement was analyzed according to the method of Bland and Altman and the intraclass-correlation-coefficient (ICC)., Results: DV values were significantly different among G and risk groups in both endometrial (p<0.05) and cervical cancers (p ≤ 0.01). For endometrial cancer, DV of G1 (mean ± sd: 2.81 ± 3.21 cc) neoplasms were significantly lower than G2 (9.44 ± 9.58 cc) and G3 (11.96 ± 8.0 cc) ones; moreover, DV of low risk cancers (5.23 ± 8.0 cc) were significantly lower than medium (7.28 ± 4.3 cc) and high risk (14.7 ± 9.9 cc) ones. For cervical cancer, DV of G1 (0.31 ± 0.13 cc) neoplasms was significantly lower than G3 (40.68 ± 45.65 cc) ones; moreover, DV of low risk neoplasms (6.98 ± 8.08 cc) was significantly lower than medium (21.7 ± 17.13 cc) and high risk (62.9 ± 51.12 cc) ones and DV of medium risk neoplasms was significantly lower than high risk ones. The intra-/inter-observer variability for DV measurement showed an excellent correlation for both cancers (ICC ≥ 0.86)., Conclusions: DV is an accurate index for the assessment of G and risk classification of cervical/endometrial cancers with low intra-/inter-observer variability., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2016
- Full Text
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68. Dose-Escalated Irradiation and Overall Survival in Men With Nonmetastatic Prostate Cancer.
- Author
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Kalbasi A, Li J, Berman A, Swisher-McClure S, Smaldone M, Uzzo RG, Small DS, Mitra N, and Bekelman JE
- Subjects
- Comparative Effectiveness Research, Databases, Factual, Dose-Response Relationship, Radiation, Humans, Male, Multivariate Analysis, Propensity Score, Proportional Hazards Models, Prostatic Neoplasms mortality, Prostatic Neoplasms pathology, Radiotherapy, Intensity-Modulated adverse effects, Radiotherapy, Intensity-Modulated mortality, Retrospective Studies, Risk Assessment, Risk Factors, Time Factors, Treatment Outcome, Prostatic Neoplasms radiotherapy, Radiotherapy Dosage, Radiotherapy, Intensity-Modulated methods
- Abstract
Importance: In 5 published randomized clinical trials, dose-escalated external-beam radiation therapy (EBRT) for prostate cancer resulted in improved biochemical and local control. However, scarce evidence addresses whether dose escalation improves overall survival., Objective: To examine the association between dose-escalated EBRT and overall survival among men with nonmetastatic prostate cancer., Design, Setting, and Participants: We conducted a retrospective, nonrandomized comparative effectiveness study of dose-escalated vs standard-dose EBRT for prostate cancer diagnosed from 2004 to 2006 using the National Cancer Database (NCDB), which includes data from patients treated at Commission on Cancer-accredited community, academic, and comprehensive cancer facilities. Three cohorts were evaluated: men with low-risk (n = 12,229), intermediate-risk (n = 16,714), or high-risk (n = 13,538) prostate cancer., Exposures: We categorized patients in each risk cohort into 2 treatment groups: standard-dose (from 68.4 Gy to <75.6 Gy) or dose-escalated (≥75.6 Gy to 90 Gy) EBRT (1 Gy = 100 rad)., Main Outcomes and Measures: We compared overall survival between treatment groups in each analytic cohort using Cox proportional hazard models with an inverse probability weighted propensity score (IPW-PS) approach. In secondary analyses, we evaluated dose response for survival., Results: Dose-escalated EBRT was associated with improved survival in the intermediate-risk (IPW-PS adjusted hazard ratio [HR], 0.84; 95% CI, 0.80-0.88; P < .001) and high-risk groups (HR, 0.82; 95% CI, 0.78-0.85; P < .001) but not the low-risk group (HR, 0.98; 95% CI, 0.92-1.05; P = .54). For every incremental increase of about 2 Gy in dose, there was a 7.8% (95% CI, 5.4%-10.2%; P < .001) and 6.3% (95% CI, 3.3%-9.1%; P < .001) reduction in the hazard of death for intermediate- and high-risk patients, respectively., Conclusions and Relevance: Dose-escalated EBRT is associated with improved overall survival in men with intermediate- and high-risk prostate cancer but not low-risk prostate cancer. These results add to the evidence questioning aggressive local treatment strategies in men with low-risk prostate cancer but supporting such treatment in men with greater disease severity.
- Published
- 2015
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69. Increasing use of dose-escalated external beam radiation therapy for men with nonmetastatic prostate cancer.
- Author
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Swisher-McClure S, Mitra N, Woo K, Smaldone M, Uzzo R, and Bekelman JE
- Subjects
- Adult, Aged, Aged, 80 and over, Databases, Factual statistics & numerical data, Humans, Logistic Models, Male, Middle Aged, Neoplasm Grading, Prostate-Specific Antigen blood, Prostatic Neoplasms blood, Prostatic Neoplasms pathology, Radiotherapy, Intensity-Modulated statistics & numerical data, Registries statistics & numerical data, Retrospective Studies, Risk, Time Factors, United States, Prostatic Neoplasms radiotherapy, Radiotherapy Dosage
- Abstract
Purpose: To examine recent practice patterns, using a large national cancer registry, to understand the extent to which dose-escalated external beam radiation therapy (EBRT) has been incorporated into routine clinical practice for men with prostate cancer., Methods and Materials: We conducted a retrospective observational cohort study using the National Cancer Data Base, a nationwide oncology outcomes database in the United States. We identified 98,755 men diagnosed with nonmetastatic prostate cancer between 2006 and 2011 who received definitive EBRT and classified patients into National Comprehensive Cancer Network (NCCN) risk groups. We defined dose-escalated EBRT as total prescribed dose of ≥75.6 Gy. Using multivariable logistic regression, we examined the association of patient, clinical, and demographic characteristics with the use of dose-escalated EBRT., Results: Overall, 81.6% of men received dose-escalated EBRT during the study period. The use of dose-escalated EBRT did not vary substantially by NCCN risk group. Use of dose-escalated EBRT increased from 70.7% of patients receiving treatment in 2006 to 89.8% of patients receiving treatment in 2011. On multivariable analysis, year of diagnosis and use of intensity modulated radiation therapy were significantly associated with receipt of dose-escalated EBRT., Conclusions: Our study results indicate that dose-escalated EBRT has been widely adopted by radiation oncologists treating prostate cancer in the United States. The proportion of patients receiving dose-escalated EBRT increased nearly 20% between 2006 and 2011. We observed high utilization rates of dose-escalated EBRT within all disease risk groups. Adoption of intensity modulated radiation therapy was strongly associated with use of dose-escalated treatment., (Copyright © 2014 Elsevier Inc. All rights reserved.)
- Published
- 2014
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70. Coexisting hybrid malignancy in a solitary sporadic solid benign renal mass: implications for treating patients following renal biopsy.
- Author
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Ginzburg S, Uzzo R, Al-Saleem T, Dulaimi E, Walton J, Corcoran A, Plimack E, Mehrazin R, Tomaszewski J, Viterbo R, Chen DY, Greenberg R, Smaldone M, and Kutikov A
- Subjects
- Adenoma, Oxyphilic metabolism, Adenoma, Oxyphilic surgery, Aged, Angiomyolipoma metabolism, Angiomyolipoma surgery, Female, Humans, Immunohistochemistry, Kidney Neoplasms metabolism, Male, Middle Aged, Retrospective Studies, Adenoma, Oxyphilic pathology, Angiomyolipoma pathology, Kidney Neoplasms pathology, Kidney Neoplasms surgery
- Abstract
Purpose: Concern regarding coexisting malignant pathology in benign renal tumors deters renal biopsy and questions its validity. We examined the rates of coexisting malignant and high grade pathology in resected benign solid solitary renal tumors., Materials and Methods: Using our prospectively maintained database we identified 1,829 patients with a solitary solid renal tumor who underwent surgical resection between 1994 and 2012. Lesions containing elements of renal oncocytoma, angiomyolipoma or another benign pathology formed the basis for this analysis. Patients with an oncocytic malignancy without classic oncocytoma and those with known hereditary syndromes were excluded from study., Results: We identified 147 patients with pathologically proven elements of renal oncocytoma (96), angiomyolipoma (44) or another solid benign pathology (7). Median tumor size was 3.0 cm (IQR 2.2-4.5). As quantified by the R.E.N.A.L. (radius, exophytic/endophytic, nearness to collecting system or sinus, anterior/posterior and location relative to polar lines) nephrometry score, tumor anatomical complexity was low in 28% of cases, moderate in 56% and high in 16%. Only 4 patients (2.7%) were documented as having hybrid malignant pathology, all involving chromophobe renal cell carcinoma in the setting of renal oncocytoma. At a median followup of 44 months (IQR 33-55) no patient with a hybrid tumor experienced regional or metastatic progression., Conclusions: In our cohort of patients with a solitary, sporadic, solid benign renal mass fewer than 3% of tumors showed coexisting hybrid malignancy. Importantly, no patient harbored coexisting high grade pathology. These data suggest that uncertainty regarding hybrid malignant pathology coexisting with benign pathological components should not deter renal biopsy, especially in the elderly and comorbid populations., (Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2014
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71. Renal cell carcinoma metastasis to a contralateral oncocytoma in a patient presenting with bilateral synchronous renal tumors.
- Author
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Mehrazin R, Wong YN, Wu H, Al-Saleem T, and Smaldone M
- Subjects
- Biopsy, Carcinoma, Renal Cell surgery, Humans, Kidney Neoplasms pathology, Kidney Neoplasms secondary, Kidney Neoplasms surgery, Male, Middle Aged, Adenoma, Oxyphilic secondary, Carcinoma, Renal Cell pathology
- Published
- 2013
- Full Text
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72. Differential use of partial nephrectomy for intermediate and high complexity tumors may explain variability in reported utilization rates.
- Author
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Lane BR, Golan S, Eggener S, Tobert CM, Kahnoski RJ, Kutikov A, Smaldone M, Whelan CM, Shalhav A, and Uzzo RG
- Subjects
- Aged, Analysis of Variance, Biopsy, Needle, Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell pathology, Cohort Studies, Confidence Intervals, Female, Humans, Immunohistochemistry, Incidence, Kidney Neoplasms mortality, Kidney Neoplasms pathology, Male, Middle Aged, Minimally Invasive Surgical Procedures methods, Minimally Invasive Surgical Procedures statistics & numerical data, Multivariate Analysis, Neoplasm Invasiveness pathology, Neoplasm Staging, Patient Selection, Practice Patterns, Physicians' trends, Prognosis, Retrospective Studies, Risk Assessment, Robotics statistics & numerical data, Survival Rate, Treatment Outcome, Carcinoma, Renal Cell surgery, Kidney Neoplasms surgery, Nephrectomy methods, Nephrectomy statistics & numerical data, Robotics methods
- Abstract
Purpose: Partial nephrectomy has become a reference standard for tumors amenable to a kidney sparing approach but reported utilization rates vary widely. The R.E.N.A.L. (radius, exophytic/endophytic, nearness of tumor to collecting system or sinus, anterior/posterior, location relative to polar lines and hilar tumor touching main renal artery or vein) nephrometry score was developed to standardize the reporting of tumor complexity with applicability in academic and community based settings. We hypothesized that tumor and surgeon factors account for variable use of partial nephrectomy., Materials and Methods: Clinical and R.E.N.A.L. nephrometry score data were analyzed on 1,433 cases performed between 2004 and 2011 by a total of 19 surgeons with varying partial nephrectomy utilization rates (0% to 100%) who practiced at a total of 2 academic centers and 1 community based health system., Results: Partial nephrectomy use increased during the study period from 36% before 2007 to 73% for 2010 to 2012 (p <0.0001). Increasing proportions of intermediate and high R.E.N.A.L. nephrometry score tumors were treated with partial nephrectomy during this time (35% to 86% and 11% to 36%, respectively, p <0.0001). Partial nephrectomy use was stable for low complexity tumors at 91% overall. Individual surgeons performed partial nephrectomy for 0% to 100% of intermediate complexity and 0% to 45% of high complexity tumors. On multivariable analysis surgery year, tumor size, each R.E.N.A.L. nephrometry score component, surgeon and annual surgeon volume predicted partial vs radical nephrectomy (each p <0.05). On multivariable analysis several surgeon factors, including surgeon volume, setting, fellowship training, and proportional use of minimally invasive and robotic partial nephrectomy, were associated with higher partial nephrectomy use (each p <0.002)., Conclusions: Surgeon and tumor factors contribute significantly to the choice of partial nephrectomy. The significant variation in partial nephrectomy use by individual surgeons appears to be caused by differential treatment for intermediate and high complexity tumors. This may be due to surgical volume, training, setting and the use of minimally invasive techniques., (Copyright © 2013 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)
- Published
- 2013
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73. [Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in patients undergoing surgery].
- Author
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Chiari P, Giorgi S, Ugolini D, Montanari M, Giudanella P, Gramantieri A, Collesi F, Pau M, Smaldone M, Matarasso M, Mazzini C, Russo F, Gazineo D, Fontana M, and Taddia P
- Subjects
- Administration, Cutaneous, Algorithms, Bandages, Beds, Case-Control Studies, Female, Humans, Italy, Male, Middle Aged, Pressure Ulcer diagnosis, Pressure Ulcer therapy, Severity of Illness Index, Surgery Department, Hospital, Time Factors, Dermatologic Agents administration & dosage, Glycerides administration & dosage, Pressure Ulcer nursing, Pressure Ulcer prevention & control, Wound Healing
- Abstract
Unlabelled: Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in surgical patients., Introduction: The risk of pressure sores in surgical patients is widely recognised. The Corpitolinol 60 (Sanyréne®) applied on compressed areas seems to reduce the risk of pressure sores., Aim: To assess the efficacy of Corpitolinol 60 in preventing pressure sores in the operatory theatre., Methods: The open label randomized clinical trial was conducted in 5 operating theatres of Northen Italy. Patients were randomized to receive Corpitolinol 60 in areas undergoing compression. Experimental group and controls were treated with usual measures for preventing pressure sores. The lesions were staged according to NPUAP up to 24 hours after surgery., Results: Three-hundred-one patients were randomized (155 in the Sanyréne® group and 143 controls). The main variables predictive of pressure sores risk (ASA class, sex, age, duration of the surgery, and BMI) were comparable across groups. At the end of the surgery 71 patients (23.8%) in the experimental group and 47 controls (30.8%) had a pressure sore (p 0.006; RR 1.81 IC95% 1.17-2.79). Twelve and 24 hours after surgery the differences between groups were not significant., Conclusions: The aim of reducing pressure sores was not reached for patients treated with Corpitolinol 60.
- Published
- 2012
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74. Partial nephrectomy for renal masses ≥ 7 cm: technical, oncological and functional outcomes.
- Author
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Long CJ, Canter DJ, Kutikov A, Li T, Simhan J, Smaldone M, Teper E, Viterbo R, Boorjian SA, Chen DY, Greenberg RE, and Uzzo RG
- Subjects
- Adult, Aged, Aged, 80 and over, Carcinoma, Renal Cell mortality, Carcinoma, Renal Cell physiopathology, Disease-Free Survival, Female, Follow-Up Studies, Humans, Incidence, Kidney Neoplasms mortality, Kidney Neoplasms physiopathology, Male, Middle Aged, Neoplasm Staging, Pennsylvania epidemiology, Postoperative Complications epidemiology, Prospective Studies, Survival Rate trends, Time Factors, Treatment Outcome, Young Adult, Carcinoma, Renal Cell surgery, Glomerular Filtration Rate, Kidney Neoplasms surgery, Nephrectomy methods
- Abstract
Unlabelled: What's known on the subject? and What does the study add? Partial nephrectomy for the pT1 renal mass has demonstrated acceptable oncological outcomes in addition to improved overall long-term survival when compared with radical nephrectomy. Previous reports for lesions ≥ 7 cm have shown mixed data concerning oncological outcomes and technological success. We demonstrate that partial nephrectomy for renal masses ≥ 7 cm has acceptable oncological, technical, and functional outcomes. As such, partial nephrectomy should be a surgical option when feasible regardless of tumour size. Study Type - Therapy (case series) Level of Evidence 4., Objective: To present outcomes for patients with renal masses ≥ 7 cm in size who are treated with partial nephrectomy (PN) at our institution and to summarize the cumulative published experience., Patients and Methods: We reviewed our prospectively maintained institutional kidney cancer database and identified patients undergoing PN for tumours >7 cm in size. Technical, oncological and renal functional data were analyzed and compared with the existing published experience of PNs for tumours >7 cm in size., Results: In total, 46 patients with 49 renal tumours >7 cm in size who underwent PN were identified. With a median (range) follow-up of 13.1 (0.2-170.0) months, there were 16 complications, including four (8.2%) blood transfusions and six (12.2%) urinary fistulae. The 5- and 10-year overall and renal cell carcinoma (RCC)-specific survivals were 94.5% and 70.9%. There were five (10.9%) patients who had an upward migration in their chronic kidney disease status after PN. There were six previous series totalling 280 tumours encompassing the published experience of PN for tumours >7 cm in size. The incidence of urinary fistulae and postoperative haemorrhage, respectively, was in the range 3.3-18.8% and 0-3%. Although oncological outcomes showed cancer-specific survival in the range 66-97.0%, series matching PN and RN in patients with T2 RCC show equivalency in RCC-specific and overall survivals. When reported, PN for tumours >7 cm in size was associated with better renal functional preservation., Conclusion: The findings of the present study show that PN can safely be performed in tumours ≥ 7 cm in size with acceptable technical, oncological and functional outcomes. Further studies are warranted., (© 2012 THE AUTHORS. BJU INTERNATIONAL © 2012 BJU INTERNATIONAL.)
- Published
- 2012
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75. Utility of the R.E.N.A.L. nephrometry scoring system in objectifying treatment decision-making of the enhancing renal mass.
- Author
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Canter D, Kutikov A, Manley B, Egleston B, Simhan J, Smaldone M, Teper E, Viterbo R, Chen DY, Greenberg RE, and Uzzo RG
- Subjects
- Adult, Aged, Aged, 80 and over, Humans, Middle Aged, Organ Size, Prospective Studies, Kidney Neoplasms pathology, Kidney Neoplasms surgery, Nephrectomy
- Abstract
Objective: To evaluate the treatment patterns of solid renal masses according to the quantifiable anatomic features using nephrometry. The treatment of localized renal cell carcinoma remains overly subjective. The R.E.N.A.L. (radius, exophytic/endophytic properties, nearness of tumor to the collecting system or sinus in millimeters, anterior/posterior, location relative to polar lines) nephrometry score quantifies the salient characteristics of renal mass anatomy in an objective and reproducible manner., Methods: Nephrometry scores were available in 615 patients in our prospective kidney tumor database (2000-2010). The nephrometry score sum and its individual component scores were analyzed to determine their relationship to treatment approach., Results: The median age, age-adjusted Charlson co-morbidity index, and estimated glomerular filtration rate was 60 years (range 25-89), 2 (range 0-10), and 80.5 mL/min (range 5.1-120.0), respectively. Increasing tumor complexity, as measured by a greater overall nephrometry score was associated with both radical nephrectomy and open partial nephrectomy (P < .0001). Compared with patients who underwent partial nephrectomy, the patients treated with radical nephrectomy had a significantly greater size (R), central proximity (N), and location (L) component scores (P < .001). Furthermore, tumors treated with radical nephrectomy were more often hilar (P < .001). Similarly, compared with minimally invasive partial nephrectomy (laparoscopic or robotic), open partial nephrectomy was associated with an increasing individual component score for size, endophytic, and central proximity to the collecting system (P < .001) and nonpolar location (P = .016)., Conclusion: The R.E.N.A.L nephrometry score standardizes the reporting of solid renal masses and appears to effectively stratify by treatment type. Although only 1 part of the treatment decision-making process, nephrometry aids in objectifying previously subjective measures., (Copyright © 2011 Elsevier Inc. All rights reserved.)
- Published
- 2011
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76. A forensic approach to fatal dog attacks. A case study and review of the literature.
- Author
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Santoro V, Smaldone G, Lozito P, Smaldone M, and Introna F
- Subjects
- Animals, Forensic Dentistry, Humans, Male, Middle Aged, Muscle, Skeletal injuries, Muscle, Skeletal pathology, Skin injuries, Skin pathology, Subcutaneous Tissue injuries, Subcutaneous Tissue pathology, Bites and Stings pathology, Dogs, Models, Dental
- Abstract
The authors present a case of a 45-year-old man who was found dead on the grounds of an abandoned military base. His body was discovered lying face down in a large pool of partially desiccated blood with signs of having been dragged. On-site examination revealed severe injuries to the face, neck and head, the result of having been attacked by a pack of dogs. A multi-disciplinary approach, including autopsy findings, histological examination, and bite mark analysis was performed. Photos of the injuries were taken using the specific photographic recommendations of the American Board of Forensic Odontology (ABFO). Comparisons between dental casts obtained from the dogs, and the inflicted wounds were made, resulting in positive correlations of injuries and the dental casts of three of the five dogs involved, suggesting that these dogs were probably the more active participants in the attack. This paper also highlights the ever-growing problems posed by stray dogs which tend to live under certain conditions: hunger; thirst; compromised health status; possible feelings of being threatened. At times they are also feral. This situation poses a threat to humans who come into contact with them., (Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2011
- Full Text
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77. Immunotherapeutic agents for the management of BCG refractory non-muscle invasive bladder cancer.
- Author
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Smaldone MC and Gingrich JR
- Subjects
- Adjuvants, Immunologic therapeutic use, BCG Vaccine therapeutic use, Humans, Neoplasm Invasiveness, Treatment Failure, Urinary Bladder Neoplasms pathology, Immunologic Factors therapeutic use, Urinary Bladder Neoplasms drug therapy
- Published
- 2010
78. Strategies to enhance the efficacy of intravescical therapy for non-muscle invasive bladder cancer.
- Author
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Smaldone MC, Gayed BA, Tomaszewski JJ, and Gingrich JR
- Subjects
- Adjuvants, Immunologic administration & dosage, Administration, Intravesical, Antineoplastic Combined Chemotherapy Protocols administration & dosage, BCG Vaccine administration & dosage, Carcinoma, Transitional Cell pathology, Clinical Trials as Topic, Clinical Trials, Phase I as Topic, Disease Progression, Humans, Photochemotherapy methods, Treatment Outcome, Urinary Bladder Neoplasms pathology, Adjuvants, Immunologic therapeutic use, Antineoplastic Combined Chemotherapy Protocols therapeutic use, BCG Vaccine therapeutic use, Carcinoma, Transitional Cell therapy, Urinary Bladder Neoplasms therapy
- Abstract
Transitional cell carcinoma (TCC) is the second most common urologic malignancy, and 70% of patients present with superficial, or non-muscle invasive disease (NMIBC). Bacillus Calmette-Guerin (BCG), currently the most effective intravesical agent at preventing disease recurrence, is the only therapy shown to inhibit disease progression. Unfortunately, approximately 20% of patients discontinue BCG due to local and systemic toxicity and more than 30% show evidence of recurrence; this has led to increased interest in alternate chemotherapeutic agents. Induction intravesical chemotherapy has shown comparable efficacy to BCG in select patients and the immediate perioperative instillation of chemotherapeutic agents has become standard of care. Clinical trial evidence demonstrating the efficacy of BCG plus interferon 2B, gemcitabine and anthracyclines (doxorubicin, epirubicin, valrubicin) in patients refractory or intolerant to BCG is accumulating. Phase I trials investigating alternative agents such as apaziquone, taxanes (docetaxel, paclitaxel), and suramin are reporting promising data. Current efforts are also being directed towards optimizing the administration of existing chemotherapeutic regimens, including the use of novel modalities including hyperthermia, photodynamic therapy, magnetically targeted carriers, and liposomes. Despite recent enthusiasm for new intravesical agents, radical cystectomy remains the treatment of choice for patients with NMIBC who have failed intravesical therapy and select patients with naive T1 tumors and aggressive features. Our aim in this report is to provide a comprehensive review of contemporary intravesical therapy options for NMIBC with an emphasis on emerging agents and novel treatment modalities.
- Published
- 2009
79. Stem cell therapy for urethral sphincter regeneration.
- Author
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Smaldone MC, Chen ML, and Chancellor MB
- Subjects
- Adipocytes transplantation, Adult, Animals, Humans, Myoblasts, Skeletal transplantation, Treatment Outcome, Urethra pathology, Urinary Incontinence, Stress pathology, Urologic Surgical Procedures, Adult Stem Cells transplantation, Regeneration, Stem Cell Transplantation methods, Urethra surgery, Urinary Incontinence, Stress surgery
- Abstract
In anatomical and functional studies of the human and animal urethra, the middle urethral contained rhabdosphincter is critical for maintaining continence. Transplanted stem cells may have the ability to undergo self renewal and multipotent differentiation, leading to sphincter regeneration. In addition, such cells may release, or be engineered to release, neurotrophins with subsequent paracrine recruitment of endogenous host cells to concomitantly promote a regenerative response of nerve-integrated muscle. Cell-based therapies are most often associated with the use of autologous multipotent stem cells, such as the bone marrow stromal cells. However, harvesting bone marrow stromal stem cells is difficult, painful, and may yield low numbers of stem cells upon processing. In contrast, alternative autologous adult stem cells such as muscle derived stem cells (MDSCs) and adipose-derived stem cells (ADSCs) can be easily obtained in large quantities and with minimal discomfort. This chapter aims to discuss the neurophysiology of stress urinary incontinence (highlighting the importance of the middle urethra); current injectable cell sources for endoscopic treatment; and the potential of MDSCs for the delivery of neurotrophic factors.
- Published
- 2009
80. Subcutaneous reservoir placement during penile prosthesis implantation.
- Author
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Smaldone MC, Cannon GM Jr, and Benoit RM
- Subjects
- Abdominal Wall surgery, Adult, Erectile Dysfunction etiology, Humans, Male, Obesity, Morbid, Pelvis injuries, Subcutaneous Tissue surgery, Erectile Dysfunction surgery, Penile Implantation methods, Surgically-Created Structures
- Abstract
Currently, the prosthesis of choice for patients undergoing penile prosthesis surgery is a three piece inflatable device, as this provides optimal inflation and deflation when compared to a one or two piece prosthesis. However, prior pelvic surgery or radiation therapy can obliterate the retropubic space and make placement of the reservoir required for a three piece prosthesis difficult. We report a novel location for reservoir placement in a man who had undergone multiple pelvic surgeries after suffering a severe pelvic crush injury.
- Published
- 2006
81. Multiple foreign bodies in the anterior and posterior urethra.
- Author
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Sukkarieh T, Smaldone M, and Shah B
- Subjects
- Humans, Male, Middle Aged, Foreign Bodies therapy, Urethra
- Abstract
Foreign bodies of the urethra and bladder are seen with iatrogenic injury, self-insertion, and rarely migration from adjacent sites. Treatment is focused on foreign body extraction, diagnosing complications, and avoiding compromise of erectile function. With advances in endourology, the majority of cases can now be managed endoscopically. We present a case of a man with multiple foreign bodies located both above and below the urogenital diaphragm. Advancing the posterior objects intravesically and extracting with a stone basket accomplished successful removal.
- Published
- 2004
- Full Text
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82. Testicular ischemia following open prostatectomy.
- Author
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Brison DI, Smaldone MC, Sukkarieh TZ, and Lipke MC
- Subjects
- Humans, Male, Middle Aged, Ischemia etiology, Prostatectomy adverse effects, Testis blood supply
- Published
- 2004
- Full Text
- View/download PDF
83. Female gender exacerbates respiratory depression in leptin-deficient obesity.
- Author
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Polotsky VY, Wilson JA, Smaldone MC, Haines AS, Hurn PD, Tankersley CG, Smith PL, Schwartz AR, and O'Donnell CP
- Subjects
- Animals, Carbon Dioxide, Female, Male, Mice, Mice, Inbred C57BL, Mice, Mutant Strains, Obesity metabolism, Obesity physiopathology, Respiratory Insufficiency physiopathology, Severity of Illness Index, Sex Factors, Leptin deficiency, Obesity complications, Respiratory Insufficiency etiology
- Abstract
Obese females are less predisposed to sleep-disordered breathing and have higher serum leptin levels than males of comparable body weight. Because leptin is a powerful respiratory stimulant, especially during sleep, we hypothesized that the elevated leptin level is necessary to maintain normal ventilatory control in obese females. We examined ventilatory control during sleep and wakefulness in male and female leptin-deficient obese C57BL/6J-Lep(ob) mice, wild-type C57BL/6J mice with dietary-induced obesity and high serum leptin levels, and normal weight wild-type C57BL/6J mice. Both male and female C57BL/6J-Lep(ob) mice had depressed hypercapnic ventilatory response (HCVR) in comparison with wild-type animals. In comparison with male C57BL/6J-Lep(ob) mice, female C57BL/6J-Lep(ob) mice had reduced HCVR and respiratory drive (a ratio of tidal volume to inspiratory time) both during non-rapid eye movement (NREM) sleep and wakefulness. In contrast, the HCVR did not differ between sexes in wild-type mice during NREM sleep and wakefulness, but was lower in females during REM sleep. Thus, leptin deficiency in female obesity is even more detrimental to hypercapnic ventilatory control during wakefulness and NREM sleep than in obese, leptin-deficient males.
- Published
- 2001
- Full Text
- View/download PDF
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