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  1. Artikel ; Online: IL-15 Superagonist NAI in BCG-Unresponsive Non-Muscle-Invasive Bladder Cancer.

    Chamie, Karim / Chang, Sam S / Kramolowsky, Eugene / Gonzalgo, Mark L / Agarwal, Piyush Kumar / Bassett, Jeffrey C / Bjurlin, Marc / Cher, Michael L / Clark, William / Cowan, Barrett E / David, Richard / Goldfischer, Evan / Guru, Khurshid / Jalkut, Mark W / Kaffenberger, Samuel D / Kaminetsky, Jed / Katz, Aaron E / Koo, Alec S / Sexton, Wade J /
    Tikhonenkov, Sergei N / Trabulsi, Edouard J / Trainer, Andrew F / Spilman, Patricia / Huang, Megan / Bhar, Paul / Taha, Sharif A / Sender, Lennie / Reddy, Sandeep / Soon-Shiong, Patrick

    NEJM evidence

    2022  Band 2, Heft 1, Seite(n) EVIDoa2200167

    Abstract: BACKGROUND: Patients with Bacillus Calmette–Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC) have limited treatment options. The immune cell–activating interleukin-15 (IL-15) superagonist Nogapendekin alfa inbakicept (NAI), also known ...

    Abstract BACKGROUND: Patients with Bacillus Calmette–Guérin (BCG)–unresponsive non–muscle-invasive bladder cancer (NMIBC) have limited treatment options. The immune cell–activating interleukin-15 (IL-15) superagonist Nogapendekin alfa inbakicept (NAI), also known as N-803, may act synergistically with BCG to elicit durable complete responses (CRs) in this patient population. METHODS: In this open-label, multicenter study, patients with BCG-unresponsive bladder carcinoma in situ (CIS) with or without Ta/T1 papillary disease were treated with intravesical NAI plus BCG (cohort A) or NAI alone (cohort C). Patients with BCG-unresponsive high-grade Ta/T1 papillary NMIBC also received NAI plus BCG (cohort B). The primary end point was the incidence of CR at the 3- or 6-month assessment visit for cohorts A and C, and the disease-free survival (DFS) rate at 12 months for cohort B. Durability, cystectomy avoidance, progression-free survival, disease-specific survival (DSS), and overall survival were secondary end points for cohort A. RESULTS: In cohort A, CR was achieved in 58 (71%) of 82 patients (95% confidence interval [CI]=59.6 to 80.3; median follow-up, 23.9 months), with a median duration of 26.6 months (95% CI=9.9 months to [upper bound not reached]). At 24 months in patients with CR, the Kaplan–Meier estimated probability of avoiding cystectomy and of DSS was 89.2% and 100%, respectively. In cohort B (n=72), the Kaplan–Meier estimated DFS rate was 55.4% (95% CI=42.0% to 66.8%) at 12 months, with median DFS of 19.3 months (95% CI=7.4 months to [upper bound not reached]). Most treatment-emergent adverse events for patients receiving BCG plus NAI were grade 1 to 2 (86%); three grade 3 immune-related treatment-emergent adverse events occurred. CONCLUSIONS: In patients with BCG-unresponsive bladder carcinoma in situ and papillary NMIBC treated with BCG and the novel agent NAI, CRs were achieved with a persistence of effect, cystectomy avoidance, and 100% bladder cancer–specific survival at 24 months. The study is ongoing, with an estimated target enrollment of 200 participants (Funded by ImmunityBio.)
    Mesh-Begriff(e) Humans ; BCG Vaccine ; Non-Muscle Invasive Bladder Neoplasms ; Interleukin-15 ; Urinary Bladder Neoplasms/therapy
    Chemische Substanzen BCG Vaccine ; Interleukin-15
    Sprache Englisch
    Erscheinungsdatum 2022-11-10
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ISSN 2766-5526
    ISSN (online) 2766-5526
    DOI 10.1056/EVIDoa2200167
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  2. Artikel ; Online: Validation of an mRNA-based Urine Test for the Detection of Bladder Cancer in Patients with Haematuria.

    Valenberg, Franciscus Johannes P van / Hiar, Andrew M / Wallace, Ellen / Bridge, Julia A / Mayne, Donna J / Beqaj, Safedin / Sexton, Wade J / Lotan, Yair / Weizer, Alon Z / Jansz, Godfrey K / Stenzl, Arnulf / Danella, John F / Cline, Kevin J / Williams, Michael B / Montgomery, Scott / David, Richard D / Harris, Richard / Klein, Eric W / Bradford, Timothy J /
    Wolk, Fred N / Westenfelder, Karl R / Trainer, Andrew F / Richardson, Timothy A / Egerdie, Russell B / Goldfarb, Bernard / Zadra, Joseph A / Lu, Xixi / Simon, Iris M / Campbell, Scott A / Bates, Michael P / Higuchi, Russell G / Witjes, J Alfred

    European urology oncology

    2020  Band 4, Heft 1, Seite(n) 93–101

    Abstract: Background: In patients with haematuria, a fast, noninvasive test with high sensitivity (SN) and negative predictive value (NPV), which is able to detect or exclude bladder cancer (BC), is needed. A newly developed urine assay, Xpert Bladder Cancer ... ...

    Abstract Background: In patients with haematuria, a fast, noninvasive test with high sensitivity (SN) and negative predictive value (NPV), which is able to detect or exclude bladder cancer (BC), is needed. A newly developed urine assay, Xpert Bladder Cancer Detection (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC.
    Objective: To validate the performance of Xpert in patients with haematuria.
    Design, setting, and participants: Voided precystoscopy urine specimens were prospectively collected at 22 sites from patients without prior BC undergoing cystoscopy for haematuria. Xpert, cytology, and UroVysion procedures were performed. Technical validation was performed and specificity (SP) was determined in patients without BC.
    Outcome measurements and statistical analysis: Test characteristics were calculated based on cystoscopy and histology results, and compared between Xpert, cytology, and UroVysion.
    Results and limitations: We included 828 patients (mean age 64.5 yr, 467 males, 401 never smoked). Xpert had an SN of 78% (95% confidence interval [CI]: 66-87) overall and 90% (95% CI: 76-96) for high-grade (HG) tumours. The NPV was 98% (95% CI: 97-99) overall. The SP was 84% (95% CI: 81-86). In patients with microhaematuria, only one HG patient was missed (NPV 99%). Xpert had higher SN and NPV than cytology and UroVysion. Cytology had the highest SP (97%). In a separate SP study, Xpert had an SP of 89% in patients with benign prostate hypertrophy and 92% in prostate cancer patients.
    Conclusions: Xpert is an easy-to-use, noninvasive test with improved SN and NPV compared with cytology and UroVysion, representing a promising tool for identifying haematuric patients with a low likelihood of BC who might not need to undergo cystoscopy.
    Patient summary: Xpert is an easy-to-perform urine test with good performance compared with standard urine tests. It should help identify (micro)haematuria patients with a very low likelihood to have bladder cancer.
    Mesh-Begriff(e) Cystoscopy ; Female ; Hematuria/diagnosis ; Humans ; Male ; Middle Aged ; RNA, Messenger/analysis ; Urinalysis ; Urinary Bladder Neoplasms/diagnosis
    Chemische Substanzen RNA, Messenger
    Schlagwörter covid19
    Sprache Englisch
    Erscheinungsdatum 2020-09-28
    Erscheinungsland Netherlands
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2588-9311
    ISSN (online) 2588-9311
    DOI 10.1016/j.euo.2020.09.001
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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  3. Artikel: Validation of an mRNA-based Urine Test for the Detection of Bladder Cancer in Patients with Haematuria

    Valenberg, Franciscus Johannes P van / Hiar, Andrew M / Wallace, Ellen / Bridge, Julia A / Mayne, Donna J / Beqaj, Safedin / Sexton, Wade J / Lotan, Yair / Weizer, Alon Z / Jansz, Godfrey K / Stenzl, Arnulf / Danella, John F / Cline, Kevin J / Williams, Michael B / Montgomery, Scott / David, Richard D / Harris, Richard / Klein, Eric W / Bradford, Timothy J /
    Wolk, Fred N / Westenfelder, Karl R / Trainer, Andrew F / Richardson, Timothy A / Egerdie, Russell B / Goldfarb, Bernard / Zadra, Joseph A / Lu, Xixi / Simon, Iris M / Campbell, Scott A / Bates, Michael P / Higuchi, Russell G / Witjes, J Alfred

    Abstract: BACKGROUND: In patients with haematuria, a fast, noninvasive test with high sensitivity (SN) and negative predictive value (NPV), which is able to detect or exclude bladder cancer (BC), is needed. A newly developed urine assay, Xpert Bladder Cancer ... ...

    Abstract BACKGROUND: In patients with haematuria, a fast, noninvasive test with high sensitivity (SN) and negative predictive value (NPV), which is able to detect or exclude bladder cancer (BC), is needed. A newly developed urine assay, Xpert Bladder Cancer Detection (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC. OBJECTIVE: To validate the performance of Xpert in patients with haematuria. DESIGN, SETTING, AND PARTICIPANTS: Voided precystoscopy urine specimens were prospectively collected at 22 sites from patients without prior BC undergoing cystoscopy for haematuria. Xpert, cytology, and UroVysion procedures were performed. Technical validation was performed and specificity (SP) was determined in patients without BC. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Test characteristics were calculated based on cystoscopy and histology results, and compared between Xpert, cytology, and UroVysion. RESULTS AND LIMITATIONS: We included 828 patients (mean age 64.5 yr, 467 males, 401 never smoked). Xpert had an SN of 78% (95% confidence interval [CI]: 66-87) overall and 90% (95% CI: 76-96) for high-grade (HG) tumours. The NPV was 98% (95% CI: 97-99) overall. The SP was 84% (95% CI: 81-86). In patients with microhaematuria, only one HG patient was missed (NPV 99%). Xpert had higher SN and NPV than cytology and UroVysion. Cytology had the highest SP (97%). In a separate SP study, Xpert had an SP of 89% in patients with benign prostate hypertrophy and 92% in prostate cancer patients. CONCLUSIONS: Xpert is an easy-to-use, noninvasive test with improved SN and NPV compared with cytology and UroVysion, representing a promising tool for identifying haematuric patients with a low likelihood of BC who might not need to undergo cystoscopy. PATIENT SUMMARY: Xpert is an easy-to-perform urine test with good performance compared with standard urine tests. It should help identify (micro)haematuria patients with a very low likelihood to have bladder cancer.
    Schlagwörter covid19
    Verlag WHO
    Dokumenttyp Artikel
    Anmerkung WHO #Covidence: #33004290
    Datenquelle COVID19

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  4. Artikel ; Online: Laparoscopic radical prostatectomy: initial 70 cases at a U.S. university medical center.

    Dahl, Douglas M / L'esperance, James O / Trainer, Andrew F / Jiang, Zhong / Gallagher, Karen / Litwin, Demetrius E M / Blute, Robert D

    Urology

    2002  Band 60, Heft 5, Seite(n) 859–863

    Abstract: Objectives: To report our experience with the first 70 cases of laparoscopic radical prostatectomy. Radical retropubic prostatectomy is an accepted therapy for the management of locally confined prostate cancer. Recently, laparoscopic prostatectomy has ... ...

    Abstract Objectives: To report our experience with the first 70 cases of laparoscopic radical prostatectomy. Radical retropubic prostatectomy is an accepted therapy for the management of locally confined prostate cancer. Recently, laparoscopic prostatectomy has been introduced as a minimally invasive alternative to open radical prostatectomy. Several published series from Europe have demonstrated that laparoscopic radical prostatectomy is a safe and feasible approach to the management of localized prostate cancer.
    Methods: From May 2000 to May 2001, transperitoneal laparoscopic radical prostatectomy was performed on 70 men, aged 40 to 76 years, who were appropriate candidates for radical retropubic prostatectomy. Patient characteristics, surgical statistics, and pathologic results were prospectively collected.
    Results: The mean preoperative prostate-specific antigen level was 6.6 ng/mL (range 1.5 to 20.7). The preoperative Gleason sum was 6 in 53 patients (75.7%), 7 in 16 (22.9%), and 8 in 1 patient (1.4%). The mean operating time was 274 minutes (range 165 to 495). The estimated blood loss averaged 449 mL (range 50 to 2750), and 4 patients (5.7%) required blood transfusions. In 1 case, we converted to a standard retropubic approach. Two intraoperative (2.9%) and 14 (20%) overall postoperative complications occurred. Positive surgical margins were reported in 8 specimens (11.4%). At a minimum of 3 months' follow-up, 85% reported use of 0 or 1 pad per day. The operative times, amount of blood loss, and complication rate decreased dramatically with experience.
    Conclusions: Laparoscopic radical prostatectomy is a technically demanding procedure that is a feasible option for the surgical treatment of localized prostate cancer. The morbidity of this operation is significantly less than that of radical retropubic prostatectomy. The laparoscopic approach shows significant promise for reducing surgical morbidity and improving the anatomic radical prostatectomy.
    Mesh-Begriff(e) Adult ; Aged ; Humans ; Laparoscopy/methods ; Male ; Middle Aged ; Prostate-Specific Antigen/blood ; Prostatectomy/adverse effects ; Prostatectomy/methods ; Prostatic Neoplasms/blood ; Prostatic Neoplasms/pathology ; Prostatic Neoplasms/surgery ; Time Factors
    Chemische Substanzen Prostate-Specific Antigen (EC 3.4.21.77)
    Sprache Englisch
    Erscheinungsdatum 2002-11
    Erscheinungsland United States
    Dokumenttyp Journal Article
    ZDB-ID 192062-5
    ISSN 1527-9995 ; 0090-4295
    ISSN (online) 1527-9995
    ISSN 0090-4295
    DOI 10.1016/s0090-4295(02)01953-2
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1142: Hefte anzeigen Standort:
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  5. Artikel ; Online: Prospective Validation of an mRNA-based Urine Test for Surveillance of Patients with Bladder Cancer.

    Valenberg, F Johannes P van / Hiar, Andrew M / Wallace, Ellen / Bridge, Julia A / Mayne, Donna J / Beqaj, Safedin / Sexton, Wade J / Lotan, Yair / Weizer, Alon Z / Jansz, Godfrey K / Stenzl, Arnulf / Danella, John F / Shepard, Barry / Cline, Kevin J / Williams, Michael B / Montgomery, Scott / David, Richard D / Harris, Richard / Klein, Eric W /
    Bradford, Timothy J / Wolk, Fred N / Westenfelder, Karl R / Trainer, Andrew F / Richardson, Timothy A / Egerdie, Russell B / Goldfarb, Bernard / Zadra, Joseph A / Ge, Sijian / Zhao, Suling / Simon, Iris M / Campbell, Scott A / Rhees, Brian / Bates, Michael P / Higuchi, Russell G / Witjes, J Alfred

    European urology

    2018  Band 75, Heft 5, Seite(n) 853–860

    Abstract: Background: A fast, noninvasive test with high sensitivity (SN) and a negative predictive value (NPV), which is able to detect recurrences in bladder cancer (BC) patients, is needed. A newly developed urine assay, Xpert Bladder Cancer Monitor (Xpert), ... ...

    Abstract Background: A fast, noninvasive test with high sensitivity (SN) and a negative predictive value (NPV), which is able to detect recurrences in bladder cancer (BC) patients, is needed. A newly developed urine assay, Xpert Bladder Cancer Monitor (Xpert), measures five mRNA targets (ABL1, CRH, IGF2, UPK1B, and ANXA10) that are frequently overexpressed in BC.
    Objective: To validate Xpert characteristics in patients previously diagnosed with non-muscle-invasive BC.
    Design, setting, and participants: Voided precystoscopy urine samples were prospectively collected at 22 sites. Xpert, cytology, and UroVysion were performed. If cystoscopy was suspicious for BC, a histologic examination was performed. Additionally, technical validation was performed and specificity was determined in patients without a history or clinical evidence of BC.
    Outcome measurements and statistical analysis: Test characteristics were calculated based on cystoscopy and histology results, and compared between Xpert, cytology, and UroVysion.
    Results and limitations: Of the eligible patients, 239 with a history of BC had results for all assays. The mean age was 71 yr; 190 patients were male, 53 never smoked, and 64% had previous intravesical immunotherapy (35%) or chemotherapy (29%). Forty-three cases of recurrences occurred. Xpert had overall SN of 74% (95% confidence interval [CI]: 60-85) and 83% (95% CI: 64-93) for high-grade (HG) tumors. The NPV was 93% (95% CI: 89-96) overall and 98% (95% CI: 94-99) for HG tumors. Specificity was 80% (95% CI: 73-85). Xpert SN and NPV were superior to those of cytology and UroVysion. Specificity in non-BC individuals (n=508) was 95% (95% CI: 93-97).
    Conclusions: Xpert has an improved NPV compared with UroVysion and cytology in patients under follow-up for BC. It represents a promising tool for excluding BC in these patients, reducing the need for cystoscopy.
    Patient summary: Xpert is an easy-to-perform urine test with good performance compared with standard urine tests. It should help optimize the follow-up of recurrent bladder cancer patients.
    Mesh-Begriff(e) Adult ; Aged ; Aged, 80 and over ; Annexins/genetics ; Biopsy ; Corticotropin-Releasing Hormone/genetics ; Cystoscopy ; Female ; Humans ; Insulin-Like Growth Factor II/genetics ; Male ; Middle Aged ; Neoplasm Recurrence, Local/diagnosis ; Neoplasm Recurrence, Local/genetics ; Neoplasm Recurrence, Local/urine ; Population Surveillance/methods ; Predictive Value of Tests ; Prospective Studies ; Proto-Oncogene Proteins c-abl/genetics ; RNA, Messenger/urine ; Urinalysis ; Urinary Bladder/pathology ; Urinary Bladder Neoplasms/genetics ; Urinary Bladder Neoplasms/urine ; Uroplakin Ib/genetics ; Young Adult
    Chemische Substanzen ANXA10 protein, human ; Annexins ; IGF2 protein, human ; RNA, Messenger ; UPK1B protein, human ; Uroplakin Ib ; Insulin-Like Growth Factor II (67763-97-7) ; Corticotropin-Releasing Hormone (9015-71-8) ; ABL1 protein, human (EC 2.7.10.2) ; Proto-Oncogene Proteins c-abl (EC 2.7.10.2)
    Sprache Englisch
    Erscheinungsdatum 2018-12-12
    Erscheinungsland Switzerland
    Dokumenttyp Journal Article ; Research Support, Non-U.S. Gov't ; Validation Study
    ZDB-ID 193790-x
    ISSN 1873-7560 ; 1421-993X ; 0302-2838
    ISSN (online) 1873-7560 ; 1421-993X
    ISSN 0302-2838
    DOI 10.1016/j.eururo.2018.11.055
    Datenquelle MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 1247: Hefte anzeigen Standort:
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    bis Jg. 1994: Bestellungen von Artikeln über das Online-Bestellformular
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    Zs.MO 294: Hefte anzeigen

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