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Mitchell C Benson - One of the best experts on this subject based on the ideXlab platform.
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phase ii trial of Intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus calmette guerin treatment failure
The Journal of Urology, 2014Co-Authors: James M Mckiernan, Lamont J Barlow, Max Kates, Dara Holder, Rashed Ghandour, Jennifer Ahn, Gina M Badalato, Arindam Roychoudhury, Joel G Decastro, Mitchell C BensonAbstract:Purpose: Response rates to current second line Intravesical therapies for recurrent nonmuscle invasive bladder cancer range between 10% and 30%. Nanoparticle albumin bound (nab-)paclitaxel has increased solubility and lower toxicity compared to other taxanes. Results of the phase I Intravesical trial of this compound demonstrated minimal toxicity during dose escalation. We now report the results of a phase II trial to assess efficacy.Materials and Methods: This study was an investigator initiated, single center, single arm, phase II trial investigating the use of nab-paclitaxel in patients with recurrent Tis, T1 and Ta urothelial carcinoma in whom at least 1 prior regimen of Intravesical bacillus Calmette-Guerin failed. Patients received 500 mg/100 ml nab-paclitaxel administered in 6 weekly Intravesical instillations. Efficacy was evaluated with cystoscopy, biopsy, cytology and imaging. If complete response was achieved, patients were treated with full dose monthly maintenance treatments for 6 months.Resu...
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predictive value of microtubule associated proteins tau and stathmin in patients with nonmuscle invasive bladder cancer receiving adjuvant Intravesical taxane therapy
The Journal of Urology, 2011Co-Authors: Matthew S Wosnitzer, James M Mckiernan, Mitchell C Benson, Josep Domingodomenech, Mireia Castillomartin, Chad R Ritch, Mahesh Mansukhani, Daniel P Petrylack, Carlos CordoncardoAbstract:Purpose: After encouraging results from 2 clinical trials performed at our institution to test Intravesical taxane based chemotherapy for bacillus Calmette-Guerin refractory, nonmuscle invasive bladder cancer we designed a study to identify molecular markers linked to the optimal response to such treatment modality.Materials and Methods: Included in the institutional review board approved study were 32 patients with nonmuscle invasive, bacillus Calmette-Guerin refractory bladder cancer who received Intravesical taxane chemotherapy, that is docetaxel or nanoparticle albumin-bound paclitaxel. Immunophenotype analysis on tissue samples obtained before Intravesical taxane therapy was done using a panel of molecular markers, including Ki-67, p53, and the microtubule associated proteins tau and stathmin.Results: Increased total tau (cytoplasmic and nuclear) and stathmin expression before Intravesical taxane therapy was significantly associated with decreased recurrence-free survival (p <0.0001 and 0.007, respec...
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a phase i trial of Intravesical nanoparticle albumin bound paclitaxel in the treatment of bacillus calmette guerin refractory nonmuscle invasive bladder cancer
The Journal of Urology, 2011Co-Authors: James M Mckiernan, Lamont J Barlow, Melissa Laudano, Mark Mann, Daniel P Petrylak, Mitchell C BensonAbstract:Purpose: Up to 50% of patients treated with Intravesical agents for high grade nonmuscle invasive bladder cancer will have disease recurrence. Response rates to current second line Intravesical therapies are low and for these high risk patients novel agents are necessary. Our previously completed phase I trial showed docetaxel was a safe agent for Intravesical use. Nanoparticle albumin-bound paclitaxel (Abraxane®, ABI-007) has been shown to have increased solubility and lower toxicity compared to docetaxel in systemic therapy. Thus, we assessed the dose limiting toxicity and maximum deliverable dose of Intravesical nanoparticle albumin-bound paclitaxel.Materials and Methods: Inclusion criteria for this institutional review board approved phase I trial were recurrent high grade Ta, T1 and Tis transitional cell carcinoma of the bladder for which at least 1 prior standard Intravesical regimen failed. Six weekly instillations of nanoparticle albumin-bound paclitaxel were administered with a modified Fibonacci...
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Phase I Trial of Intravesical Docetaxel in the Management of Superficial Bladder Cancer Refractory to Standard Intravesical Therapy
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006Co-Authors: James M Mckiernan, Daniel P Petrylak, Puneet Masson, Alana M. Murphy, Manlio A. Goetzl, Carl A. Olsson, Manisha Desai, Mitchell C BensonAbstract:Purpose Up to 50% of patients treated with Intravesical agents for superficial bladder cancer will experience recurrence. Response rates to second-line Intravesical therapies range from 20% to 40%. For these high-risk patients, novel agents are necessary to prevent recurrence. Docetaxel is a microtubule depolymerization inhibitor with unique physiochemical properties, making it an excellent candidate for investigation as an Intravesical agent. Patients and Methods This phase I trial included patients with recurrent Ta, T1, and Tis transitional cell carcinoma who experienced treatment failure with at least one prior Intravesical treatment. Docetaxel was administered as six weekly instillations at a starting dose of 5 mg, with a dose-escalation model used until a maximum tolerated dose (MTD) was achieved. Primary end points were dose-limiting toxicity (DLT) and MTD. Efficacy was evaluated by cystoscopy with biopsy, cytology, and computed tomography imaging. Results Eighteen patients (100%) completed the trial, and the distribution of stages included six patients with Tis, seven with Ta, and five with T1 disease. No grade 3 or 4 DLTs occurred in 108 infusions, and no patient had systemic absorption of docetaxel. Eight (44%) of 18 patients experienced grade 1 or 2 toxicities, with dysuria being the most common. Ten (56%) of 18 patients had no evidence of disease at their post-treatment cystoscopy and biopsy. None of the patients who experienced relapse had disease progression. Conclusion Intravesical docetaxel exhibited minimal toxicity and no systemic absorption in the first human Intravesical clinical trial. This suggests that docetaxel is a safe agent for further evaluation of efficacy in a phase II trial.
James M Mckiernan - One of the best experts on this subject based on the ideXlab platform.
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phase ii trial of Intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus calmette guerin treatment failure
The Journal of Urology, 2014Co-Authors: James M Mckiernan, Lamont J Barlow, Max Kates, Dara Holder, Rashed Ghandour, Jennifer Ahn, Gina M Badalato, Arindam Roychoudhury, Joel G Decastro, Mitchell C BensonAbstract:Purpose: Response rates to current second line Intravesical therapies for recurrent nonmuscle invasive bladder cancer range between 10% and 30%. Nanoparticle albumin bound (nab-)paclitaxel has increased solubility and lower toxicity compared to other taxanes. Results of the phase I Intravesical trial of this compound demonstrated minimal toxicity during dose escalation. We now report the results of a phase II trial to assess efficacy.Materials and Methods: This study was an investigator initiated, single center, single arm, phase II trial investigating the use of nab-paclitaxel in patients with recurrent Tis, T1 and Ta urothelial carcinoma in whom at least 1 prior regimen of Intravesical bacillus Calmette-Guerin failed. Patients received 500 mg/100 ml nab-paclitaxel administered in 6 weekly Intravesical instillations. Efficacy was evaluated with cystoscopy, biopsy, cytology and imaging. If complete response was achieved, patients were treated with full dose monthly maintenance treatments for 6 months.Resu...
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predictive value of microtubule associated proteins tau and stathmin in patients with nonmuscle invasive bladder cancer receiving adjuvant Intravesical taxane therapy
The Journal of Urology, 2011Co-Authors: Matthew S Wosnitzer, James M Mckiernan, Mitchell C Benson, Josep Domingodomenech, Mireia Castillomartin, Chad R Ritch, Mahesh Mansukhani, Daniel P Petrylack, Carlos CordoncardoAbstract:Purpose: After encouraging results from 2 clinical trials performed at our institution to test Intravesical taxane based chemotherapy for bacillus Calmette-Guerin refractory, nonmuscle invasive bladder cancer we designed a study to identify molecular markers linked to the optimal response to such treatment modality.Materials and Methods: Included in the institutional review board approved study were 32 patients with nonmuscle invasive, bacillus Calmette-Guerin refractory bladder cancer who received Intravesical taxane chemotherapy, that is docetaxel or nanoparticle albumin-bound paclitaxel. Immunophenotype analysis on tissue samples obtained before Intravesical taxane therapy was done using a panel of molecular markers, including Ki-67, p53, and the microtubule associated proteins tau and stathmin.Results: Increased total tau (cytoplasmic and nuclear) and stathmin expression before Intravesical taxane therapy was significantly associated with decreased recurrence-free survival (p <0.0001 and 0.007, respec...
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a phase i trial of Intravesical nanoparticle albumin bound paclitaxel in the treatment of bacillus calmette guerin refractory nonmuscle invasive bladder cancer
The Journal of Urology, 2011Co-Authors: James M Mckiernan, Lamont J Barlow, Melissa Laudano, Mark Mann, Daniel P Petrylak, Mitchell C BensonAbstract:Purpose: Up to 50% of patients treated with Intravesical agents for high grade nonmuscle invasive bladder cancer will have disease recurrence. Response rates to current second line Intravesical therapies are low and for these high risk patients novel agents are necessary. Our previously completed phase I trial showed docetaxel was a safe agent for Intravesical use. Nanoparticle albumin-bound paclitaxel (Abraxane®, ABI-007) has been shown to have increased solubility and lower toxicity compared to docetaxel in systemic therapy. Thus, we assessed the dose limiting toxicity and maximum deliverable dose of Intravesical nanoparticle albumin-bound paclitaxel.Materials and Methods: Inclusion criteria for this institutional review board approved phase I trial were recurrent high grade Ta, T1 and Tis transitional cell carcinoma of the bladder for which at least 1 prior standard Intravesical regimen failed. Six weekly instillations of nanoparticle albumin-bound paclitaxel were administered with a modified Fibonacci...
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Phase I Trial of Intravesical Docetaxel in the Management of Superficial Bladder Cancer Refractory to Standard Intravesical Therapy
Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2006Co-Authors: James M Mckiernan, Daniel P Petrylak, Puneet Masson, Alana M. Murphy, Manlio A. Goetzl, Carl A. Olsson, Manisha Desai, Mitchell C BensonAbstract:Purpose Up to 50% of patients treated with Intravesical agents for superficial bladder cancer will experience recurrence. Response rates to second-line Intravesical therapies range from 20% to 40%. For these high-risk patients, novel agents are necessary to prevent recurrence. Docetaxel is a microtubule depolymerization inhibitor with unique physiochemical properties, making it an excellent candidate for investigation as an Intravesical agent. Patients and Methods This phase I trial included patients with recurrent Ta, T1, and Tis transitional cell carcinoma who experienced treatment failure with at least one prior Intravesical treatment. Docetaxel was administered as six weekly instillations at a starting dose of 5 mg, with a dose-escalation model used until a maximum tolerated dose (MTD) was achieved. Primary end points were dose-limiting toxicity (DLT) and MTD. Efficacy was evaluated by cystoscopy with biopsy, cytology, and computed tomography imaging. Results Eighteen patients (100%) completed the trial, and the distribution of stages included six patients with Tis, seven with Ta, and five with T1 disease. No grade 3 or 4 DLTs occurred in 108 infusions, and no patient had systemic absorption of docetaxel. Eight (44%) of 18 patients experienced grade 1 or 2 toxicities, with dysuria being the most common. Ten (56%) of 18 patients had no evidence of disease at their post-treatment cystoscopy and biopsy. None of the patients who experienced relapse had disease progression. Conclusion Intravesical docetaxel exhibited minimal toxicity and no systemic absorption in the first human Intravesical clinical trial. This suggests that docetaxel is a safe agent for further evaluation of efficacy in a phase II trial.
Masato Fujisawa - One of the best experts on this subject based on the ideXlab platform.
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expression profile of e cadherin and n cadherin in non muscle invasive bladder cancer as a novel predictor of Intravesical recurrence following transurethral resection
Urologic Oncology-seminars and Original Investigations, 2012Co-Authors: Mototsugu Muramaki, Hideaki Miyake, Tomoaki Terakawa, Masafumi Kumano, Iori Sakai, Masato FujisawaAbstract:The objective of this study was to investigate the impact of the expression profile of E-cadherin and N-cadherin in newly diagnosed non-muscle-invasive bladder cancer (NMIBC) on the probability of Intravesical recurrence in patients undergoing transurethral resection (TUR). This study included 115 consecutive patients diagnosed as having NMIBC following TUR. Expression levels of E-cadherin and N-cadherin in TUR specimens from these patients were measured by immunohistochemical staining. In this series, Intravesical recurrence occurred in 35 of 115 patients (30.4%). Immunohistochemical study showed that positive expression of E-cadherin and N-cadherin were noted in 62 (53.9%) and 48 (41.7%) specimens, respectively. Intravesical recurrence was detected in only 7 of 62 patients (11.3%) with positive E-cadherin expression, while 33 of 48 patients (68.8%) with positive N-cadherin expression developed Intravesical recurrence. When patients were divided into 4 groups according to the positivities of E-cadherin and N-cadherin expression, Intravesical recurrence was detected in 27 of 30 patients (90.0%) with negative E-cadherin as well as positive N-cadherin expression, and the Intravesical recurrence-free survival of this group was significantly poorer than those of the remaining 3 groups. Furthermore, negative E-cadherin as well as positive N-cadherin expression was identified as the most powerful independent predictor for Intravesical recurrence following TUR on multivariate analysis. These findings suggest that the loss of E-cadherin and gain of N-cadherin expression in on NMIBC appeared to be significantly associated with postoperative recurrence; therefore, the switch from E-cadherin to N-cadherin expression might be involved in the mechanism underlying Intravesical recurrence of on NMIBC.
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Risk factors for Intravesical recurrence after surgical management of transitional cell carcinoma of the upper urinary tract.
Urology, 2008Co-Authors: Tomoaki Terakawa, Mototsugu Muramaki, A. Takenaka, Hideaki Miyake, Isao Hara, Masato FujisawaAbstract:OBJECTIVES: To identify risk factors for developing subsequent bladder cancer in patients undergoing surgical management of transitional cell carcinoma (TCC) of the upper urinary tract. METHODS: This study included 177 patients who were diagnosed as having clinically localized upper urinary tract TCC and thereafter underwent nephroureterectomy after exclusion of those with a previous and/or concurrent history of bladder cancer. Univariate and multivariate analyses using both the logistic regression model and the Cox proportional hazards model were carried out in these 177 patients to determine the risk factors for Intravesical recurrence after nephroureterectomy. RESULTS: Of the 177 patients, 63 (35.6%) developed recurrent bladder cancer after a median interval of 7.5 months. Intravesical recurrence-free survival rates for these 177 patients at 1, 3, and 5 years were 75.7%, 63.7%, and 54.1%, respectively. Univariate analyses showed that patients with low-stage tumors and those with multifocal tumors were likely to undergo subsequent Intravesical recurrence; however, there was no significant impact of other factors on subsequent Intravesical recurrence, including age, tumor side, tumor location, surgical modality, operation time, management of the distal ureter, tumor grade, lymph node metastasis, microvascular invasion, lymphatic invasion, and margin status. Furthermore, pathologic stage and tumor multifocality were identified as independent predictors for the development of recurrent bladder cancer by multivariate analyses. CONCLUSIONS: The incidence of Intravesical recurrence after nephroureterectomy for upper urinary tract TCC is comparatively high. It could be important to perform careful follow-up targeting Intravesical recurrence for such patients after nephroureterectomy, particularly those with low-stage tumors and/or multifocal tumors.
Lamont J Barlow - One of the best experts on this subject based on the ideXlab platform.
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phase ii trial of Intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus calmette guerin treatment failure
The Journal of Urology, 2014Co-Authors: James M Mckiernan, Lamont J Barlow, Max Kates, Dara Holder, Rashed Ghandour, Jennifer Ahn, Gina M Badalato, Arindam Roychoudhury, Joel G Decastro, Mitchell C BensonAbstract:Purpose: Response rates to current second line Intravesical therapies for recurrent nonmuscle invasive bladder cancer range between 10% and 30%. Nanoparticle albumin bound (nab-)paclitaxel has increased solubility and lower toxicity compared to other taxanes. Results of the phase I Intravesical trial of this compound demonstrated minimal toxicity during dose escalation. We now report the results of a phase II trial to assess efficacy.Materials and Methods: This study was an investigator initiated, single center, single arm, phase II trial investigating the use of nab-paclitaxel in patients with recurrent Tis, T1 and Ta urothelial carcinoma in whom at least 1 prior regimen of Intravesical bacillus Calmette-Guerin failed. Patients received 500 mg/100 ml nab-paclitaxel administered in 6 weekly Intravesical instillations. Efficacy was evaluated with cystoscopy, biopsy, cytology and imaging. If complete response was achieved, patients were treated with full dose monthly maintenance treatments for 6 months.Resu...
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a phase i trial of Intravesical nanoparticle albumin bound paclitaxel in the treatment of bacillus calmette guerin refractory nonmuscle invasive bladder cancer
The Journal of Urology, 2011Co-Authors: James M Mckiernan, Lamont J Barlow, Melissa Laudano, Mark Mann, Daniel P Petrylak, Mitchell C BensonAbstract:Purpose: Up to 50% of patients treated with Intravesical agents for high grade nonmuscle invasive bladder cancer will have disease recurrence. Response rates to current second line Intravesical therapies are low and for these high risk patients novel agents are necessary. Our previously completed phase I trial showed docetaxel was a safe agent for Intravesical use. Nanoparticle albumin-bound paclitaxel (Abraxane®, ABI-007) has been shown to have increased solubility and lower toxicity compared to docetaxel in systemic therapy. Thus, we assessed the dose limiting toxicity and maximum deliverable dose of Intravesical nanoparticle albumin-bound paclitaxel.Materials and Methods: Inclusion criteria for this institutional review board approved phase I trial were recurrent high grade Ta, T1 and Tis transitional cell carcinoma of the bladder for which at least 1 prior standard Intravesical regimen failed. Six weekly instillations of nanoparticle albumin-bound paclitaxel were administered with a modified Fibonacci...
Max Kates - One of the best experts on this subject based on the ideXlab platform.
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impact of Intravesical therapy for non muscle invasive bladder cancer on the accuracy of urine cytology
World Journal of Urology, 2019Co-Authors: Mohit Gupta, Christopher J Vandenbussche, Niv Milbar, Giorgia Tema, Filippo Pederzoli, Meera Chappidi, Max Kates, Trinity J BivalacquaAbstract:Urine cytology remains an essential diagnostic tool in the surveillance of patients with non-muscle invasive bladder cancer (NMIBC). The correlation of urine cytology with biopsy specimens to determine its accuracy following induction Intravesical therapy has not been investigated. A retrospective review was performed of patients who underwent Intravesical therapy for biopsy-proven non-muscle invasive disease between 2013 and 2016 at our institution. All patients uniformly underwent cytology and systematic bladder biopsies in the operating room within 12 weeks following Intravesical therapy. The accuracy of urinary cytology in predicting high-grade disease recurrence following Intravesical therapy was confirmed by correlating cytology results to post-treatment systematic biopsies, regardless of endoscopic findings. Only patients with complete information regarding urine cytology and pathologic biopsy results, both pre- and post-Intravesical therapy, were included. 90 cytology samples following Intravesical therapy were analyzed from 76 patients who met inclusion criteria. 72 (80.0%) and 18 (20.0%) of the samples were collected from patients initially treated for high- and low-grade disease, respectively. Fifty-six (62.2%) specimens were obtained from patients following induction of bacillus Calmette–Guerin (BCG) therapy; the remainder were from patients treated with Intravesical gemcitabine/docetaxel, mitomycin, or BCG/interferon. For patients treated with BCG, cytology was positive for high-grade disease in 8/15 patients with high-grade pathology on follow-up biopsy, thus demonstrating a sensitivity of 53% (95% CI 27–79%), specificity of 95% (95% CI 84–99%), positive predictive value of 80% (95% CI 44–98%), and negative predictive value of 85% (95% CI 71–94%). If cytologic interpretation was broadened to include high-grade and “suspicious for high-grade” findings, sensitivity increased to 67% (95% CI 38–88%) and specificity decreased to 88% (95% CI 74–96%). While urinary cytology maintains a high specificity following Intravesical therapy, it demonstrates a low sensitivity for potentially aggressive high-grade urothelial carcinoma. Further evaluation of more effective, clinic-based enhanced cystoscopy techniques and biomarkers is warranted to better identify patients at risk for disease recurrence following BCG therapy.
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phase ii trial of Intravesical nanoparticle albumin bound paclitaxel for the treatment of nonmuscle invasive urothelial carcinoma of the bladder after bacillus calmette guerin treatment failure
The Journal of Urology, 2014Co-Authors: James M Mckiernan, Lamont J Barlow, Max Kates, Dara Holder, Rashed Ghandour, Jennifer Ahn, Gina M Badalato, Arindam Roychoudhury, Joel G Decastro, Mitchell C BensonAbstract:Purpose: Response rates to current second line Intravesical therapies for recurrent nonmuscle invasive bladder cancer range between 10% and 30%. Nanoparticle albumin bound (nab-)paclitaxel has increased solubility and lower toxicity compared to other taxanes. Results of the phase I Intravesical trial of this compound demonstrated minimal toxicity during dose escalation. We now report the results of a phase II trial to assess efficacy.Materials and Methods: This study was an investigator initiated, single center, single arm, phase II trial investigating the use of nab-paclitaxel in patients with recurrent Tis, T1 and Ta urothelial carcinoma in whom at least 1 prior regimen of Intravesical bacillus Calmette-Guerin failed. Patients received 500 mg/100 ml nab-paclitaxel administered in 6 weekly Intravesical instillations. Efficacy was evaluated with cystoscopy, biopsy, cytology and imaging. If complete response was achieved, patients were treated with full dose monthly maintenance treatments for 6 months.Resu...
