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[PMID]:28749042
[Au] Autor:Hooi KS; Lemetayer JD
[Ad] Endereço:Department of Clinical Studies, Ontario Veterinary College, University of Guelph, Guelph, ON, N1G 2W1, Canada.
[Ti] Título:The use of intravesicular alteplase for thrombolysis in a dog with urinary bladder thrombi.
[So] Source:J Vet Emerg Crit Care (San Antonio);27(5):590-595, 2017 Sep.
[Is] ISSN:1476-4431
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To describe the use of alteplase for intravesicular thrombolysis in a dog after development of urinary tract obstruction from a blood clot in the urinary bladder. CASE SUMMARY: A 5.8 kg, 6.5-year-old female neutered Bichon Frise was presented for signs of acute hematuria. A complete blood count (CBC) revealed marked thrombocytopenia and leukopenia, and nonregenerative anemia. Bone marrow aspirate cytology revealed mild hypercellularity, mild megakaryocytic hyperplasia, mildly left-shifted erythroid maturation, and moderately left-shifted myeloid maturation, suggesting ongoing recovery from an acute bone marrow insult. Thrombocytopenia and hematuria resolved concurrently; however, stranguria and oliguria developed acutely. Ultrasonography identified two large presumed thrombi within the urinary bladder. A urinary catheter was placed and 4 doses of 0.5 mg of alteplase diluted in 10 mL of 0.9% sodium chloride were instilled into the bladder with a 4-hour dwell time at 12-hour intervals. Prothombin and activated partial thromboplastin times were monitored during therapy and remained within normal limits. One thrombus was successfully dissolved after 48 hours of therapy and the remaining thrombus was reduced in size and was voided upon removal of the urinary catheter. NEW OR UNIQUE INFORMATION PROVIDED: This report describes the use of alteplase in a dog for thrombolysis of intravesicular thrombi. In patients that develop intravesicular thrombi, intravesical instillation of alteplase can be considered as a method for dissolution of these thrombi.
[Mh] Termos MeSH primário: Fibrinolíticos/uso terapêutico
Trombocitopenia/veterinária
Ativador de Plasminogênio Tecidual/uso terapêutico
Doenças da Bexiga Urinária/veterinária
[Mh] Termos MeSH secundário: Administração Intravesical
Animais
Cães
Feminino
Fibrinolíticos/administração & dosagem
Trombocitopenia/tratamento farmacológico
Trombose/tratamento farmacológico
Ativador de Plasminogênio Tecidual/administração & dosagem
Doenças da Bexiga Urinária/tratamento farmacológico
[Pt] Tipo de publicação:CASE REPORTS
[Nm] Nome de substância:
0 (Fibrinolytic Agents); EC 3.4.21.68 (Tissue Plasminogen Activator)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170728
[St] Status:MEDLINE
[do] DOI:10.1111/vec.12627


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[PMID]:28470465
[Au] Autor:Myers AL; Zhang YP; Kawedia JD; Zhou X; Sobocinski SM; Metcalfe MJ; Kramer MA; Dinney CPN; Kamat AM
[Ad] Endereço:Department of Pharmacy Research, The University of Texas MD Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX, 77030, USA. almyers@mdanderson.org.
[Ti] Título:Solubilization and Stability of Mitomycin C Solutions Prepared for Intravesical Administration.
[So] Source:Drugs R D;17(2):297-304, 2017 Jun.
[Is] ISSN:1179-6901
[Cp] País de publicação:New Zealand
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Mitomycin C (MMC) is an antitumor agent that is often administered intravesically to treat bladder cancer. Pharmacologically optimized studies have suggested varying methods to optimize delivery, with drug concentration and solution volume being the main drivers. However, these MMC concentrations (e.g. 2.0 mg/mL) supersede its solubility threshold, raising major concerns of inferior drug delivery. OBJECTIVE: In this study, we seek to confirm that the pharmacologically optimized MMC concentrations are achievable in clinical practice through careful modifications of the solution preparation methods. METHODS: MMC admixtures (1.0 and 2.0 mg/mL) were prepared in normal saline using conventional and alternative compounding methods. Conventional methodology resulted in poorly soluble solutions, with many visible particulates and crystallates. However, special compounding methods, which included incubation of solutions at 50 °C for 50 min followed by storage at 37 °C, were sufficient to solubilize drug. Chemical degradation of MMC solutions was determined over 6 h using high-performance liquid chromatography (HPLC) analytics, while physical stability was tested in parallel. RESULTS: Immediately following the 50 min incubation, both MMC solutions exhibited approximately 5-7% drug degradation. Based on the measured concentrations and linear regression of degradation plots, additional storage of these solutions at 37 °C for 5 h retained chemical stability criterion (< 10% overall drug loss). No physical changes were observed in any solutions at any test time points. CONCLUSION: We recommend that the described alternative preparation methods may improve intravesicular delivery of MMC in this urological setting, and advise that clinicians employing these changes should closely monitor patients for MMC toxicities and pharmacodynamics (change in clinical outcomes) that result from the potential enhancement of MMC exposure in the bladder.
[Mh] Termos MeSH primário: Antineoplásicos/química
Mitomicina/química
Soluções Farmacêuticas/química
[Mh] Termos MeSH secundário: Administração Intravesical
Estabilidade de Medicamentos
Solubilidade
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antineoplastic Agents); 0 (Pharmaceutical Solutions); 50SG953SK6 (Mitomycin)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1007/s40268-017-0183-y


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[PMID]:29250970
[Au] Autor:Kliton J; Polgár C; Tenke P; Kovács G; Major T; Stelczer G; Ágoston P
[Ad] Endereço:Sugárterápiás Központ, Országos Onkológiai Intézet Budapest, Ráth Gy. u. 7-9., 1122.
[Ti] Título:[Image-guided radiotherapy for muscle invasive bladder cancer with intravesical lipiodol injection. A new option for bladder sparing treatment].
[Ti] Título:Izominvazív hólyagrák képvezérelt sugárkezelése intravesicalisan befecskendezett lipiodolos jelöléssel. A hólyagmegtartó kezelés új lehetosége..
[So] Source:Orv Hetil;158(51):2041-2047, 2017 Dec.
[Is] ISSN:0030-6002
[Cp] País de publicação:Hungary
[La] Idioma:hun
[Ab] Resumo:INTRODUCTION AND AIM: To implement lipiodol as a fiducial marker of the tumor bed for image-guided radiotherapy with simultaneous integrated boost technique as part of radiochemotherapy for muscle invasive bladder tumors. METHOD: Since April 2016, radiochemotherapy was performed in 3 male patients with muscle invasive, transitional cell bladder carcinoma. Prior to radiochemotherapy, tumor bed resection was performed for each patient, at the same time 10 ml of lipiodol solution was injected submucosally into the resection site, thus marking the tumor bed for escalated dose irradiation. During radiochemotherapy 51 Gy (1.7 Gy/die) to the pelvis, 57 Gy (1.9 Gy/die) to the whole bladder, and 63 Gy (2.1 Gy/die) to the lipiodol-labeled tumor bed was delivered with simultaneous integrated boost technique. The accuracy of the irradiation was controlled by daily kilovoltage CT. Early radiogenic urogenital and gastrointestinal side effects were recorded according to Radiation Therapy Oncology Group side-effects grading recommendation. RESULTS: Substantial perioperative side effect or toxicity were not observed during and after the injection of lipiodol. The prescribed dose was successfully delivered in all patients. Radiotherapy duration was 6 weeks. The lipiodol-labeled tumor bed was clearly visible on daily kilovoltage cone beam CT. In one patient grade II cystitis and proctitis was observed, another patient experienced only grade I cystitis. These complaints improved with symptomatic medication. In the third patient no significant side effect occurred. CONCLUSIONS: The injection of lipiodol into the bladder wall is a safe technique, without any perioperative toxicity or complication. The tumor bed demarcated by lipiodol was visible both on treatment planning and kilovoltage CTs. The total treatment time was shortened by 4 days. The treatment was well tolerated, early side effects were moderate, or slight. Orv Hetil. 2017; 158(51): 2041-2047.
[Mh] Termos MeSH primário: Meios de Contraste/administração & dosagem
Óleo Etiodado/administração & dosagem
Radioterapia Guiada por Imagem/métodos
Radioterapia de Intensidade Modulada/métodos
Neoplasias da Bexiga Urinária/radioterapia
[Mh] Termos MeSH secundário: Administração Intravesical
Quimiorradioterapia
Seres Humanos
Masculino
Procedimentos Cirúrgicos Urológicos/métodos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Contrast Media); 8008-53-5 (Ethiodized Oil)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180215
[Lr] Data última revisão:
180215
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:171219
[St] Status:MEDLINE
[do] DOI:10.1556/650.2017.30904


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[PMID]:28471272
[Au] Autor:Huang Z; Liu H; Wang Y; Zhang C; Xu T
[Ad] Endereço:a Department of Urology , Peking University People's Hospital , Beijing , China.
[Ti] Título:Determining optimal maintenance schedules for adjuvant intravesical bacillus Calmette-Guerin immunotherapy in non-muscle-invasive bladder cancer: a systematic review and network meta-analysis.
[So] Source:Curr Med Res Opin;33(8):1379-1387, 2017 Aug.
[Is] ISSN:1473-4877
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVES: To figure out optimal bacillus Calmette-Guerin (BCG) maintenance schedules for non-muscle-invasive bladder cancer (NMIBC) patients by comparing different schedules in a systematic review using conventional and network meta-analysis. MATERIALS AND METHODS: Literature was searched in the databases of Medline, Embase, Cochrane library, Clinicaltrials.gov, Wanfang, CNKI and SinoMed in April 2016 and 9 randomized clinical trials comparing intravesical BCG maintenance therapy with BCG induction-only therapy or comparing different BCG maintenance schedules (induction-only, 1 year, 1.5 year, 2 year, 3 year maintenance) in NMIBC patients were included. Conventional and network meta-analyses within a Bayesian framework were performed to calculate odds ratios of tumor recurrence, progression and side effects (cystitis, hematuria, general malaise and fever). The surface under the cumulative ranking curve (SUCRA) mean ranking was used to obtain schedule hierarchy. RESULTS: Data from 1951 patients showed that longer-term maintenance BCG therapy does not significantly decrease tumor recurrence and progression rate of NMIBC compared to shorter-term maintenance BCG therapy. However, longer-maintenance therapy does not increase side effect incidence compared to induction-only therapy. According to SUCRA results, induction-only therapy has the highest probability of recurrence and progression but least probability of side effects. CONCLUSIONS: Longer BCG maintenance therapy (such as 3 years) is not superior to shorter maintenance therapy (such as 1 year). But maintenance therapy overall is better than induction-only BCG therapy while not increasing side effects. Though further evidence and clinical practice with balanced confounding factors (risk stratification and BCG strain) are wished for, the current study suggests the common use of 1 year intravesical BCG instillation for NMIBC patients.
[Mh] Termos MeSH primário: Vacina BCG/administração & dosagem
Imunoterapia/métodos
Neoplasias da Bexiga Urinária/tratamento farmacológico
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/administração & dosagem
Administração Intravesical
Antineoplásicos/uso terapêutico
Teorema de Bayes
Progressão da Doença
Seres Humanos
Incidência
Recidiva Local de Neoplasia/tratamento farmacológico
Ensaios Clínicos Controlados Aleatórios como Assunto
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS; REVIEW
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Antineoplastic Agents); 0 (BCG Vaccine)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180213
[Lr] Data última revisão:
180213
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170505
[St] Status:MEDLINE
[do] DOI:10.1080/03007995.2017.1326889


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[PMID]:29371493
[Au] Autor:Luitel BR; Chalise PR; Nathani S; Gupta DK; Subedi P; Chapagain S; Sharma UK; Gyawali PR; Shrestha GK; Joshi BR
[Ad] Endereço:Department of Surgery, Urology Unit, Tribhuvan University Teaching Hospital, Maharajgunj, Kathmandu, Nepal.
[Ti] Título:Risk-based Management of Non-muscle Invasive Bladder Cancer: Experience from Tribhuvan University Teaching Hospital.
[So] Source:Kathmandu Univ Med J (KUMJ);14(56):352-356, 2016 Oct.-Dec..
[Is] ISSN:1812-2078
[Cp] País de publicação:Nepal
[La] Idioma:eng
[Ab] Resumo:Background Most of the recent evidences suggest for risk-based management of non muscle invasive bladder cancer (NMIBC) to reduce the risk of recurrence and progression. Objective This study was conducted to assess the recurrence and progression of non muscle invasive bladder cancer in Nepalese patients using European Organization for Research and Treatment of Cancer (EORTC) risk tables and to assess the effectiveness of intravesical therapy to reduce the risk of recurrence. Method A prospective observational single centre study was conducted at Tribhuvan University Teaching Hospital from January 2010- December 2012. Forty six patients with non muscle invasive bladder cancer who underwent transurethral resection of bladder tumor and completed two years follow up were included. According to the European Organization for Research and Treatment of Cancer (EORTC) risk table, the patients were divided into low, intermediate and high risk groups. The patients received postoperative adjuvant therapy and surveillance as per the European Association of Urology guidelines. Result Among the 46 patients, the overall two year recurrence and progression rate was 8 (17%) and 1 (2%) respectively. Out of seven patients in low risk category, none of them developed recurrence or progression of disease. Out of 15 patients in intermediate risk category the one year and two year recurrence rate was 13% and 20% respectively. Out of 24 patients in high risk category the one and two year recurrence rate was 17% and 21% respectively. The risk reduction by use of intravesical Bacillus Calmette Guerin (BCG) for recurrence in high risk category was 58% and 60% in first and second year respectively. In our study, the overall and individual risk group, the one and two year recurrence rate was lower than that predicted by European Organization for Research and Treatment of Cancer risk table. Conclusion Risk-based management of non muscle invasive bladder cancer by using the European Organization for Research and Treatment of Cancer risk table is a useful method of management, though its prediction rates are lower in Nepalese population.
[Mh] Termos MeSH primário: Neoplasias da Bexiga Urinária/patologia
Neoplasias da Bexiga Urinária/cirurgia
[Mh] Termos MeSH secundário: Administração Intravesical
Idoso
Progressão da Doença
Feminino
Hospitais de Ensino
Seres Humanos
Masculino
Meia-Idade
Recidiva Local de Neoplasia
Nepal/epidemiologia
Estudos Prospectivos
Medição de Risco
Fatores de Risco
[Pt] Tipo de publicação:JOURNAL ARTICLE; OBSERVATIONAL STUDY
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180212
[Lr] Data última revisão:
180212
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:180127
[St] Status:MEDLINE


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[PMID]:29240363
[Au] Autor:Gezginci E; Yyigun E; Yalcin S; Ozgok IY
[Ti] Título:Symptoms Control for Patients with Superficial Bladder Cancers Before and After TURBT and Intravesical Epirubicin Instillation.
[So] Source:Urol Nurs;37(1):31-5, 2017 Jan-Feb.
[Is] ISSN:1053-816X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Bladder cancer is one of the most common cancers among urologic cancers. Intravesical instillation following transurethral resection of bladder tumor (TURBT) is used as a treatment of bladder cancer. According to results of this study, before and after intravesical instillations following TURBT have no effect on symptom outcomes of patients with superficial bladder cancer.
[Mh] Termos MeSH primário: Antibióticos Antineoplásicos/administração & dosagem
Carcinoma de Células de Transição/terapia
Cistoscopia/métodos
Epirubicina/administração & dosagem
Neoplasias da Bexiga Urinária/terapia
[Mh] Termos MeSH secundário: Administração Intravesical
Adolescente
Adulto
Idoso
Ansiedade/epidemiologia
Carcinoma de Células de Transição/epidemiologia
Carcinoma de Células de Transição/patologia
Depressão/epidemiologia
Fadiga/epidemiologia
Feminino
Seres Humanos
Masculino
Meia-Idade
Náusea/epidemiologia
Invasividade Neoplásica
Dor Pós-Operatória/epidemiologia
Período Pós-Operatório
Avaliação de Sintomas
Turquia/epidemiologia
Neoplasias da Bexiga Urinária/epidemiologia
Neoplasias da Bexiga Urinária/patologia
Adulto Jovem
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antibiotics, Antineoplastic); 3Z8479ZZ5X (Epirubicin)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180123
[Lr] Data última revisão:
180123
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:171215
[St] Status:MEDLINE


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[PMID]:29240329
[Au] Autor:Hensley D
[Ti] Título:Hazardous Drugs in the Urology Workplace: Focus on Intravesical Medications.
[So] Source:Urol Nurs;36(4):183-9, 2016 Jul-Aug.
[Is] ISSN:1053-816X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:The Society of Urologic Nurses and Associates (SUNA) and the American Urological Association (AUA) collaborated to develop a standard operating procedure in 2015 for instillation of intravesical cytotoxic, immunotherapeutic, and/or therapeutic drugs for patients with urothelial carcinoma of the bladder and interstitial cystitis. This is a synthesis of the standard operating procedure in the context of hazardous drug administration, including indications for administration, guidelines, and principles of hazardous drugs in the clinical setting, peri-treatment concerns, and patient and staff education.
[Mh] Termos MeSH primário: Adjuvantes Imunológicos/efeitos adversos
Antineoplásicos/efeitos adversos
Vacina BCG/efeitos adversos
Carcinoma de Células de Transição/tratamento farmacológico
Enfermagem em Nefrologia
Saúde do Trabalhador
Neoplasias da Bexiga Urinária/tratamento farmacológico
[Mh] Termos MeSH secundário: Adjuvantes Imunológicos/uso terapêutico
Administração Intravesical
Antineoplásicos/uso terapêutico
Vacina BCG/uso terapêutico
Seres Humanos
Exposição Ocupacional
Educação de Pacientes como Assunto
Equipamento de Proteção Individual
Local de Trabalho
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 0 (Antineoplastic Agents); 0 (BCG Vaccine)
[Em] Mês de entrada:1801
[Cu] Atualização por classe:180123
[Lr] Data última revisão:
180123
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:171215
[St] Status:MEDLINE


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[PMID]:29049231
[Au] Autor:Quan Y; Jeong CW; Kwak C; Kim HH; Kim HS; Ku JH
[Ad] Endereço:aDepartment of Urology, Seoul National University Hospital, Seoul bDepartment of Urology, Dongguk University Ilsan Medical Center, Goyang, Korea.
[Ti] Título:Dose, duration and strain of bacillus Calmette-Guerin in the treatment of nonmuscle invasive bladder cancer: Meta-analysis of randomized clinical trials.
[So] Source:Medicine (Baltimore);96(42):e8300, 2017 Oct.
[Is] ISSN:1536-5964
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Intravesical bacillus Calmette-Guerin (BCG) instillation is widely used as an adjuvant therapy after transurethral resection of bladder tumor (TURBT) in patients with intermediate- and high-risk nonmuscle invasive bladder cancer (NMIBC). However, the effective dose, duration, and strain of BCG have not yet been clearly determined. We aimed to elucidate the relationship between dose, duration, and strain of BCG and clinical outcomes in NMIBC patients treated with TURBT. METHODS: We conducted a literature search in Embase, Scopus, and PubMed databases for all relevant articles published up to October 2016 in accordance with the Preferred Reporting Items for Systematic Review and Meta-analysis guidelines. The relative risks of clinical outcomes, including recurrence, progression, cancer-specific mortality, and all-cause mortality according to dose (standard vs low), duration (induction vs maintenance), and strain of BCG were presented as the pooled risk ratio (RR) and 95% confidence interval (CI). RESULTS: Nineteen studies meeting the inclusion criteria were finally selected in this meta-analysis. The risk of recurrence was significantly highly observed in case of low-dose BCG (RR, 1.17; 95% CI 1.06-1.30) and induction BCG (RR, 1.33; 95% CI 1.17-1.50) only group without heterogeneity among the included studies. Although there were no significant differences between dose or duration and other clinical outcomes. On direct comparison in each study comparing BCG strains, the Tice stain showed a relatively high probability of recurrence compared with the Connaught (RR, 1.29; 95% CI 1.01-1.64) and RIVM (RR, 2.04, 95% CI 1.28-3.25) strains. Funnel plot testing revealed no significant publication bias. CONCLUSION: The use of standard dose and maintenance BCG instillation may be effective to reduce recurrence rate after TURBT for NMIBC. Further large scale, well-designed, and prospective studies, with stratification of the patients into risk group at randomization, will be required to determine the optimal guideline of BCG use to improve clinical outcomes in NMIBC.
[Mh] Termos MeSH primário: Vacina BCG/uso terapêutico
Neoplasias da Bexiga Urinária/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração Intravesical
Vacina BCG/administração & dosagem
Quimioterapia Adjuvante
Relação Dose-Resposta a Droga
Esquema de Medicação
Seres Humanos
Recidiva Local de Neoplasia
Estudos Prospectivos
Ensaios Clínicos Controlados Aleatórios como Assunto
Neoplasias da Bexiga Urinária/mortalidade
Neoplasias da Bexiga Urinária/cirurgia
[Pt] Tipo de publicação:JOURNAL ARTICLE; META-ANALYSIS
[Nm] Nome de substância:
0 (BCG Vaccine)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171122
[Lr] Data última revisão:
171122
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171020
[St] Status:MEDLINE
[do] DOI:10.1097/MD.0000000000008300


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[PMID]:28834453
[Au] Autor:Shore ND; Boorjian SA; Canter DJ; Ogan K; Karsh LI; Downs TM; Gomella LG; Kamat AM; Lotan Y; Svatek RS; Bivalacqua TJ; Grubb RL; Krupski TL; Lerner SP; Woods ME; Inman BA; Milowsky MI; Boyd A; Treasure FP; Gregory G; Sawutz DG; Yla-Herttuala S; Parker NR; Dinney CPN
[Ad] Endereço:Neal D. Shore, Carolina Urologic Research Center, Myrtle Beach, SC; Stephen A. Boorjian, Mayo Clinic, Rochester, MN; Daniel J. Canter, Ochsner Health System, New Orleans, LA; Kenneth Ogan, Emory University, Atlanta, GA; Lawrence I. Karsh, The Urology Center of Colorado, Denver, CO; Tracy M. Downs, U
[Ti] Título:Intravesical rAd-IFNα/Syn3 for Patients With High-Grade, Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study.
[So] Source:J Clin Oncol;35(30):3410-3416, 2017 Oct 20.
[Is] ISSN:1527-7755
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Purpose Many patients with high-risk non-muscle-invasive bladder cancer (NMIBC) are either refractory to bacillus Calmette-Guerin (BCG) treatment or may experience disease relapse. We assessed the efficacy and safety of recombinant adenovirus interferon alfa with Syn3 (rAd-IFNα/Syn3), a replication-deficient recombinant adenovirus gene transfer vector, for patients with high-grade (HG) BCG-refractory or relapsed NMIBC. Methods In this open-label, multicenter (n = 13), parallel-arm, phase II study ( ClinicalTrials.gov identifier: NCT01687244), 43 patients with HG BCG-refractory or relapsed NMIBC received intravesical rAd-IFNα/Syn3 (randomly assigned 1:1 to 1 × 10 viral particles (vp)/mL or 3 × 10 vp/mL). Patients who responded at months 3, 6, and 9 were retreated at months 4, 7, and 10. The primary end point was 12-month HG recurrence-free survival (RFS). All patients who received at least one dose were included in efficacy and safety analyses. Results Forty patients received rAd-IFNα/Syn3 (1 × 10 vp/mL, n = 21; 3 × 10 vp/mL, n = 19) between November 5, 2012, and April 8, 2015. Fourteen patients (35.0%; 90% CI, 22.6% to 49.2%) remained free of HG recurrence 12 months after initial treatment. Comparable 12-month HG RFS was noted for both doses. Of these 14 patients, two experienced recurrence at 21 and 28 months, respectively, after treatment initiation, and one died as a result of an upper tract tumor at 17 months without a recurrence. rAd-IFNα/Syn3 was well tolerated; no grade four or five adverse events (AEs) occurred, and no patient discontinued treatment because of an adverse event. The most frequently reported drug-related AEs were micturition urgency (n = 16; 40%), dysuria (n = 16; 40%), fatigue (n = 13; 32.5%), pollakiuria (n = 11; 28%), and hematuria and nocturia (n = 10 each; 25%). Conclusion rAd-IFNα/Syn3 was well tolerated. It demonstrated promising efficacy for patients with HG NMIBC after BCG therapy who were unable or unwilling to undergo radical cystectomy.
[Mh] Termos MeSH primário: Terapia Genética/métodos
Interferon-alfa/metabolismo
Neoplasias da Bexiga Urinária/terapia
[Mh] Termos MeSH secundário: Adenoviridae/genética
Administração Intravesical
Idoso
Idoso de 80 Anos ou mais
Vacina BCG/administração & dosagem
Ácidos Cólicos/química
Dissacarídeos/química
Resistência a Medicamentos Antineoplásicos
Fadiga/etiologia
Feminino
Terapia Genética/efeitos adversos
Vetores Genéticos/administração & dosagem
Vetores Genéticos/genética
Seres Humanos
Interferon-alfa/química
Interferon-alfa/genética
Masculino
Meia-Idade
Gradação de Tumores
Invasividade Neoplásica
Recidiva Local de Neoplasia
Proteínas Recombinantes de Fusão/química
Proteínas Recombinantes de Fusão/genética
Proteínas Recombinantes de Fusão/metabolismo
Proteínas Recombinantes/química
Proteínas Recombinantes/genética
Proteínas Recombinantes/metabolismo
Resultado do Tratamento
Neoplasias da Bexiga Urinária/genética
Neoplasias da Bexiga Urinária/patologia
Transtornos Urinários/etiologia
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (BCG Vaccine); 0 (Cholic Acids); 0 (Disaccharides); 0 (Interferon-alpha); 0 (Recombinant Fusion Proteins); 0 (Recombinant Proteins); 0 (Syn3 compound); 43K1W2T1M6 (interferon alfa-2b)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171103
[Lr] Data última revisão:
171103
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170824
[St] Status:MEDLINE
[do] DOI:10.1200/JCO.2017.72.3064


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[PMID]:28716326
[Au] Autor:Kaviani A; Khavari R
[Ad] Endereço:Department of Urology, Houston Methodist Hospital, 6560 Fannin Street, Suite 2100, Houston, TX 77030, USA.
[Ti] Título:Disease-Specific Outcomes of Botulinum Toxin Injections for Neurogenic Detrusor Overactivity.
[So] Source:Urol Clin North Am;44(3):463-474, 2017 Aug.
[Is] ISSN:1558-318X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Intradetrusor injection of botulinum toxin A (BTX-A) is an effective option for managing patients with neurogenic detrusor overactivity (NDO) who do not respond to or tolerate oral pharmacologic agents. There is level I evidence that intradetrusor injection of onabotulinumtoxinA for refractory NDO in patients with multiple sclerosis and spinal cord injury is associated with a significantly greater achievement of goals and improved performance in urodynamic studies than placebo. Pilot studies or small case series support BTX-A for NDO in patients with Parkinson's disease and cerebrovascular accident. BTX-A seems to be effective in children with myelomeningocele. However, no adult data exists.
[Mh] Termos MeSH primário: Toxinas Botulínicas Tipo A/administração & dosagem
Fármacos Neuromusculares/administração & dosagem
Bexiga Urinária Hiperativa/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração Intravesical
Ensaios Clínicos como Assunto
Seres Humanos
Resultado do Tratamento
Bexiga Urinária Hiperativa/etiologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; REVIEW
[Nm] Nome de substância:
0 (Neuromuscular Agents); EC 3.4.24.69 (Botulinum Toxins, Type A)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170922
[Lr] Data última revisão:
170922
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170719
[St] Status:MEDLINE



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