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  1. Article ; Online: Ibrutinib as part of risk-stratified treatment for post-transplant lymphoproliferative disorder: The phase 2 TIDaL trial.

    Chaganti, Sridhar / Maycock, Shanna / McIlroy, Graham / Jackson, Aimee E / Bishop, Rebecca / Johnson, Sarah / Kanfer, Edward / Kassam, Shireen / Cwynarski, Kate / Wrench, David J / Arumainathan, Arvind / Fox, Christopher P / Johnson, Rod J / McKay, Pamela / Paneesha, Shankara / Rowntree, Clare / Balotis, Constantine / Collins, Graham P / Davies, Andrew J /
    Wright, Josh / Burns, Sarah / Laurence, Arian Dominic John / Wheatley, Keith / Menne, Tobias

    Blood

    2024  

    Abstract: Post-transplant lymphoproliferative disorder (PTLD) is a rare complication of solid organ transplantation, and cytotoxic chemotherapy is associated with treatment-related morbidity and mortality. Current treatment takes a sequential, risk-stratified ... ...

    Abstract Post-transplant lymphoproliferative disorder (PTLD) is a rare complication of solid organ transplantation, and cytotoxic chemotherapy is associated with treatment-related morbidity and mortality. Current treatment takes a sequential, risk-stratified approach, patients with low-risk disease following initial immunotherapy can avoid escalation to immunochemotherapy. TIDaL is a prospective, single-arm phase 2 trial investigating the activity and tolerability of ibrutinib combined with risk-stratified therapy for first-line treatment of PTLD. Eligible patients were adults with newly-diagnosed CD20-positive B-cell PTLD after solid organ transplant and performance status 0 to 2. Initial treatment comprised 49 days of ibrutinib 560mg once daily, with 4 doses of weekly rituximab. Treatment response on interim scan and baseline international prognostic index were used to allocate patients to either a low-risk arm (who continued ibrutinib, alongside 4 further doses of 3-weekly rituximab) or high-risk (escalation to R-CHOP immunochemotherapy, ibrutinib continuing in patients aged <65 years). The primary outcome was complete response on interim scan, achieved by 11/38 patients (29%, 95% confidence interval (CI) 15% - 46%). This did not reach the pre-specified threshold for clinically significant activity. Secondary outcomes included allocation to the low-risk arm (41% of patients), 2-year progression-free survival (58%, 95% CI 44% - 76%), and 2-year overall survival (76%, 95% CI 63% - 91%). Adverse events were mostly haematological, gastrointestinal and infective. Whilst TIDaL does not support adding ibrutinib into first-line treatment of PTLD, increasing the proportion of patients who can be treated without cytotoxic chemotherapy remains an important aim of future research. This trial was registered as ISRCTN32667607.
    Language English
    Publishing date 2024-04-21
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80069-7
    ISSN 1528-0020 ; 0006-4971
    ISSN (online) 1528-0020
    ISSN 0006-4971
    DOI 10.1182/blood.2024023847
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Selenium and Vitamin E for Prevention of Non-Muscle-Invasive Bladder Cancer Recurrence and Progression: A Randomized Clinical Trial.

    Bryan, Richard T / Pirrie, Sarah J / Abbotts, Ben / Maycock, Shanna / During, Vinnie / Lewis, Carolyn / Grant, Margaret / Bird, Deborah / Devall, Adam J / Wallace, D Michael A / James, Nicholas D / Billingham, Lucinda J / Zeegers, Maurice P / Cheng, K K

    JAMA network open

    2023  Volume 6, Issue 10, Page(s) e2337494

    Abstract: Importance: Selenium and vitamin E have been identified as promising agents for the chemoprevention of recurrence and progression of non-muscle-invasive bladder cancer.: Objective: To determine whether selenium and/or vitamin E may prevent disease ... ...

    Abstract Importance: Selenium and vitamin E have been identified as promising agents for the chemoprevention of recurrence and progression of non-muscle-invasive bladder cancer.
    Objective: To determine whether selenium and/or vitamin E may prevent disease recurrence in patients with newly diagnosed NMIBC.
    Design, setting, and participants: This multicenter, prospective, double-blinded, placebo-controlled, 2 × 2 factorial randomized clinical trial included patients with newly diagnosed NMIBC recruited from 10 secondary or tertiary care hospitals in the UK. A total of 755 patients were screened for inclusion; 484 did not meet the inclusion criteria, and 1 declined to participate. A total of 270 patients were randomly assigned to 4 groups (selenium plus placebo, vitamin E plus placebo, selenium plus vitamin E, and placebo plus placebo) in a double-blind fashion between July 17, 2007, and October 10, 2011. Eligibility included initial diagnosis of NMIBC (stages Ta, T1, or Tis); randomization within 12 months of first transurethral resection was required.
    Interventions: Oral selenium (200 μg/d of high-selenium yeast) and matched vitamin E placebo, vitamin E (200 IU/d of d-alfa-tocopherol) and matched selenium placebo, selenium and vitamin E, or placebo and placebo.
    Main outcome and measures: Recurrence-free interval (RFI) on an intention-to-treat basis (analyses completed on November 28, 2022).
    Results: The study randomized 270 patients (mean [SD] age, 68.9 [10.4] years; median [IQR] age, 69 [63-77] years; 202 male [75%]), with 65 receiving selenium and vitamin E placebo, 71 receiving vitamin E and selenium placebo, 69 receiving selenium and vitamin E, and 65 receiving both placebos. Median overall follow-up was 5.5 years (IQR, 5.1-6.1 years); 228 patients (84%) were followed up for more than 5 years. Median treatment duration was 1.5 years (IQR, 0.9-2.5 years). The study was halted because of slow accrual. For selenium (n = 134) vs no selenium (n = 136), there was no difference in RFI (hazard ratio, 0.92; 95% CI, 0.65-1.31; P = .65). For vitamin E (n = 140) vs no vitamin E (n = 130), there was a statistically significant detriment to RFI (hazard ratio, 1.46; 95% CI, 1.02-2.09; P = .04). No significant differences were observed for progression-free interval or overall survival time with either supplement. Results were unchanged after Cox proportional hazards regression modeling to adjust for known prognostic factors. In total, 1957 adverse events were reported; 85 were serious adverse events, and all were considered unrelated to trial treatment.
    Conclusions and relevance: In this randomized clinical trial of selenium and vitamin E, selenium supplementation did not reduce the risk of recurrence in patients with NMIBC, but vitamin E supplementation was associated with an increased risk of recurrence. Neither selenium nor vitamin E influenced progression or overall survival. Vitamin E supplementation may be harmful to patients with NMIBC, and elucidation of the underlying biology is required.
    Trial registration: isrctn.org Identifier: ISRCTN13889738.
    MeSH term(s) Humans ; Male ; Aged ; Vitamin E/therapeutic use ; Selenium/therapeutic use ; Non-Muscle Invasive Bladder Neoplasms ; Prospective Studies ; Neoplasm Recurrence, Local/prevention & control ; Neoplasm Recurrence, Local/drug therapy ; Urinary Bladder Neoplasms/prevention & control ; Urinary Bladder Neoplasms/drug therapy
    Chemical Substances Vitamin E (1406-18-4) ; Selenium (H6241UJ22B)
    Language English
    Publishing date 2023-10-02
    Publishing country United States
    Document type Randomized Controlled Trial ; Multicenter Study ; Journal Article ; Research Support, Non-U.S. Gov't
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2023.37494
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  3. Article ; Online: Phase II study of intravenous etoposide in patients with relapsed ependymoma (CNS 2001 04).

    Apps, John R / Maycock, Shanna / Ellison, David W / Jaspan, Timothy / Ritzmann, Timothy A / Macarthur, Donald / Mallucci, Conor / Wheatley, Keith / Veal, Gareth J / Grundy, Richard G / Picton, Susan

    Neuro-oncology advances

    2022  Volume 4, Issue 1, Page(s) vdac053

    Abstract: Background: Relapsed ependymoma has a dismal prognosis, and the role of chemotherapy at relapse remains unclear. This study prospectively evaluated the efficacy of intensive intravenous (IV) etoposide in patients less than 21 years of age with relapsed ... ...

    Abstract Background: Relapsed ependymoma has a dismal prognosis, and the role of chemotherapy at relapse remains unclear. This study prospectively evaluated the efficacy of intensive intravenous (IV) etoposide in patients less than 21 years of age with relapsed intracranial ependymoma (NCT00278252).
    Methods: This was a single-arm, open-label, phase II trial using Gehan's two-stage design. Patients received IV etoposide 100 mg/m
    Results: Twenty-five patients were enrolled and included in the intention-to-treat (ITT) analysis. Three patients were excluded in per-protocol (PP) analysis. After 3 cycles of etoposide, 5 patients (ITT 20%/PP 23%) had a complete response (CR), partial response (PR), or objective response (OR). Nine patients (ITT 36%/PP 41%,) had a best overall response of CR, PR, or OR. 1-year PFS was 24% in ITT and 23% in PP populations. 1-year OS was 56% and 59%, 5-year OS was 20% and 18%, respectively, in ITT and PP populations. Toxicity was predominantly hematological, with 20/25 patients experiencing a grade 3 or higher hematological adverse event.
    Conclusions: This study confirms the activity of IV etoposide against relapsed ependymoma, however, this is modest, not sustained, and similar to that with oral etoposide, albeit with increased toxicity. These results confirm the dismal prognosis of this disease, provide a rationale to include etoposide within drug combinations, and highlight the need to develop novel treatments for recurrent ependymoma.
    Language English
    Publishing date 2022-04-13
    Publishing country England
    Document type Journal Article
    ZDB-ID 3009682-0
    ISSN 2632-2498 ; 2632-2498
    ISSN (online) 2632-2498
    ISSN 2632-2498
    DOI 10.1093/noajnl/vdac053
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  4. Article ; Online: Venetoclax combined with low dose cytarabine compared to standard of care intensive chemotherapy for the treatment of favourable risk adult acute myeloid leukaemia (VICTOR): Study protocol for an international, open-label, multicentre, molecularly-guided randomised, phase II trial.

    Dillon, Richard / Maycock, Shanna / Jackson, Aimee / Fox, Sonia / Freeman, Sylvie / Craddock, Charles / Thomas, Catherine / Homer, Emma / Leahy, Jane / Mamwell, Anna / Potter, Nicola / Russell, Nigel / Wei, Andrew / Ommen, Hans Beier / Hemmaway, Claire / Knapper, Steve / Billingham, Lucinda

    BMC cancer

    2022  Volume 22, Issue 1, Page(s) 1174

    Abstract: Background: For patients with acute myeloid leukaemia (AML), the only potentially curative treatment is intensive chemotherapy (IC). This is highly toxic, particularly for patients > 60 years, potentially leading to prolonged hospitalisations requiring ... ...

    Abstract Background: For patients with acute myeloid leukaemia (AML), the only potentially curative treatment is intensive chemotherapy (IC). This is highly toxic, particularly for patients > 60 years, potentially leading to prolonged hospitalisations requiring intensive supportive care, and sometimes treatment-related death. This also results in extensive healthcare costs and negatively impacts quality of life (QoL). Venetoclax with low-dose cytarabine (VEN + LDAC) is a novel, low-intensity treatment for AML patients who cannot receive IC. VEN + LDAC is given as an outpatient and toxicity appears significantly lower than with IC. Analysis of clinical trials performed to date are promising for patients with the genotype NPM1
    Methods: VICTOR is an international, two-arm, open-label, multi-centre, non-inferiority, randomised-controlled phase II trial to assess VEN + LDAC compared to standard of care (IC) as first-line treatment in older patients (initially aged ≥ 60 years) with newly diagnosed AML. The trial will recruit patients with a NPM1
    Discussion: The principle underpinning the VICTOR trial is that the chance of cure for patients in the experimental arm should not be compromised, therefore, an adaptive design with regular checks on accumulating data has been employed, which will allow for a staged expansion of the trial population to include younger patients if, and when, there is sufficient evidence of non-inferiority in older patients.
    Trial registration: EudraCT: 2020-000,273-24; 21-Aug-2020.
    Isrctn: 15,567,173; 08-Dec-2020.
    MeSH term(s) Humans ; Adult ; Aged ; Cytarabine ; Quality of Life ; Bayes Theorem ; Standard of Care ; Antineoplastic Combined Chemotherapy Protocols/adverse effects ; Neoplasm Recurrence, Local/drug therapy ; Leukemia, Myeloid, Acute/drug therapy ; Leukemia, Myeloid, Acute/genetics ; Antineoplastic Agents/therapeutic use ; Nuclear Proteins ; Clinical Trials, Phase II as Topic ; Multicenter Studies as Topic
    Chemical Substances Cytarabine (04079A1RDZ) ; venetoclax (N54AIC43PW) ; Antineoplastic Agents ; Nuclear Proteins
    Language English
    Publishing date 2022-11-14
    Publishing country England
    Document type Clinical Trial Protocol ; Journal Article
    ZDB-ID 2041352-X
    ISSN 1471-2407 ; 1471-2407
    ISSN (online) 1471-2407
    ISSN 1471-2407
    DOI 10.1186/s12885-022-10221-2
    Database MEDical Literature Analysis and Retrieval System OnLINE

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