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  1. AU="Karrison, Theodore"
  2. AU="Espigado, I"
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  1. Article ; Online: There is More to Length of Survival than Survival: Endpoints in Oncology Trials.

    Stadler, Walter M / Karrison, Theodore G

    Clinical cancer research : an official journal of the American Association for Cancer Research

    2024  

    Abstract: Progression free survival as a primary endpoint for comparative trials does not fully capture the therapeutic risk/benefit ratio. Additionally, summarization of the treatment effect via a hazard ratio is problematic when the proportional hazards ... ...

    Abstract Progression free survival as a primary endpoint for comparative trials does not fully capture the therapeutic risk/benefit ratio. Additionally, summarization of the treatment effect via a hazard ratio is problematic when the proportional hazards assumption is violated. Restricted mean survival time metrics may address these challenges but have other limitations.
    Language English
    Publishing date 2024-05-20
    Publishing country United States
    Document type Journal Article
    ZDB-ID 1225457-5
    ISSN 1557-3265 ; 1078-0432
    ISSN (online) 1557-3265
    ISSN 1078-0432
    DOI 10.1158/1078-0432.CCR-24-0772
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 4223: Show issues Location:
    Je nach Verfügbarkeit (siehe Angabe bei Bestand)
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    Jg. 1995 - 2021: Lesesall (2.OG)
    ab Jg. 2022: Lesesaal (EG)

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  2. Article ; Online: Nonparametric inference in the accelerated failure time model using restricted means.

    Giurcanu, Mihai C / Karrison, Theodore G

    Lifetime data analysis

    2022  Volume 28, Issue 1, Page(s) 23–39

    Abstract: We propose a nonparametric estimate of the scale-change parameter for characterizing the difference between two survival functions under the accelerated failure time model using an estimating equation based on restricted means. Advantages of our ... ...

    Abstract We propose a nonparametric estimate of the scale-change parameter for characterizing the difference between two survival functions under the accelerated failure time model using an estimating equation based on restricted means. Advantages of our restricted means based approach compared to current nonparametric procedures is the strictly monotone nature of the estimating equation as a function of the scale-change parameter, leading to a unique root, as well as the availability of a direct standard error estimate, avoiding the need for hazard function estimation or re-sampling to conduct inference. We derive the asymptotic properties of the proposed estimator for fixed and for random point of restriction. In a simulation study, we compare the performance of the proposed estimator with parametric and nonparametric competitors in terms of bias, efficiency, and accuracy of coverage probabilities. The restricted means based approach provides unbiased estimates and accurate confidence interval coverage rates with efficiency ranging from 81% to 95% relative to fitting the correct parametric model. An example from a randomized clinical trial in head and neck cancer is provided to illustrate an application of the methodology in practice.
    MeSH term(s) Computer Simulation ; Humans ; Probability ; Survival Analysis
    Language English
    Publishing date 2022-01-12
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial
    ZDB-ID 1479719-7
    ISSN 1572-9249 ; 1380-7870
    ISSN (online) 1572-9249
    ISSN 1380-7870
    DOI 10.1007/s10985-021-09541-5
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  3. Article ; Online: Leveraging external control data in the design and analysis of neuro-oncology trials: Pearls and perils.

    Polley, Mei-Yin C / Schwartz, Daniel / Karrison, Theodore / Dignam, James J

    Neuro-oncology

    2024  Volume 26, Issue 5, Page(s) 796–810

    Abstract: Background: Randomized controlled trials have been the gold standard for evaluating medical treatments for many decades but they are often criticized for requiring large sample sizes. Given the urgent need for better therapies for glioblastoma, it has ... ...

    Abstract Background: Randomized controlled trials have been the gold standard for evaluating medical treatments for many decades but they are often criticized for requiring large sample sizes. Given the urgent need for better therapies for glioblastoma, it has been argued that data collected from patients treated with the standard regimen can provide high-quality external control data to supplement or replace concurrent control arm in future glioblastoma trials.
    Methods: In this article, we provide an in-depth appraisal of the use of external control data in the context of neuro-oncology trials. We describe several clinical trial designs with particular attention to how external information is utilized and address common fallacies that may lead to inappropriate adoptions of external control data.
    Results: Using 2 completed glioblastoma trials, we illustrate the use of an assessment tool that lays out a blueprint for assembling a high-quality external control data set. Using statistical simulations, we draw caution from scenarios where these approaches can fall short on controlling the type I error rate.
    Conclusions: While this approach may hold promise in generating informative data in certain settings, this sense of optimism should be tampered with a healthy dose of skepticism due to a myriad of design and analysis challenges articulated in this review. Importantly, careful planning is key to its successful implementation.
    MeSH term(s) Humans ; Research Design/standards ; Brain Neoplasms/therapy ; Glioblastoma/therapy ; Clinical Trials as Topic/standards ; Randomized Controlled Trials as Topic/methods
    Language English
    Publishing date 2024-05-02
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, N.I.H., Extramural ; Review
    ZDB-ID 2028601-6
    ISSN 1523-5866 ; 1522-8517
    ISSN (online) 1523-5866
    ISSN 1522-8517
    DOI 10.1093/neuonc/noae005
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    Zs.A 5307: Show issues Location:
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  4. Article ; Online: Evaluation of Provider Preferences in First-Line Metastatic Renal Cell Carcinoma: Comparison Between Dual Immunotherapy vs. Immunotherapy/Tyrosine Kinase Inhibitors.

    Chablani, Priyanka V / Karrison, Theodore / Stadler, Walter M

    Clinical genitourinary cancer

    2022  Volume 20, Issue 6, Page(s) 510–514

    Abstract: Introduction: Dual immunotherapy (ipilimumab/nivolumab, IO/IO) and immunotherapy/tyrosine kinase inhibitor (IO/TKI) combinations (e.g. pembrolizumab/axitinib) are approved for the first-line treatment of intermediate/poor risk metastatic renal cell ... ...

    Abstract Introduction: Dual immunotherapy (ipilimumab/nivolumab, IO/IO) and immunotherapy/tyrosine kinase inhibitor (IO/TKI) combinations (e.g. pembrolizumab/axitinib) are approved for the first-line treatment of intermediate/poor risk metastatic renal cell carcinoma (RCC), but there is limited comparative data between these two options. We sought to understand how oncologists decide between IO/IO vs. IO/TKI.
    Methods: We sent a 10-question electronic survey centered on a patient scenario of intermediate/poor risk metastatic RCC to 294 academic/disease-focused and general oncologists in the US.
    Results: We received 105 responses (36% response rate): 61% (64) of providers chose IO/IO, 39% (41) chose IO/TKI. 78% (82) of oncologists were academic or disease-focused, 22% (23) were general. Academic/disease-focused oncologists were significantly more likely to choose IO/IO (56/82, 68%) than general oncologists (8/23, 35%), P = .004. Among those who chose IO/IO, the perceived main issue with IO/TKI was: long-term toxicities - 31% (20), short-term toxicities - 28% (18), less effective - 28% (18), less convenient - 8% (5). Among those who chose IO/TKI, the perceived main issue with IO/IO was: short-term toxicities - 43% (17), less effective - 28% (11), long-term toxicities - 15% (6), and risk of death - 10% (4). 88% (92) of providers would be comfortable enrolling patients into a phase III trial comparing IO/IO vs. IO/TKI. We found no associations between therapy chosen by a provider and participation as PI in a trial of IO/IO or IO/TKI, or receipt of outside funding from an IO/IO or IO/TKI company.
    Conclusion: In response to a patient scenario of intermediate/poor risk metastatic RCC, 61% of providers chose IO/IO, 39% chose IO/TKI. There was a significant association between type of practice and choice of therapy, with academic/disease-focused oncologists more likely to choose IO/IO. The majority of oncologists would be comfortable enrolling patients into a phase III trial comparing IO/IO vs. IO/TKI.
    MeSH term(s) Humans ; Carcinoma, Renal Cell/drug therapy ; Carcinoma, Renal Cell/pathology ; Immunotherapy ; Kidney Neoplasms/drug therapy ; Kidney Neoplasms/pathology ; Protein Kinase Inhibitors ; Clinical Trials, Phase III as Topic
    Chemical Substances Protein Kinase Inhibitors
    Language English
    Publishing date 2022-06-11
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2225121-2
    ISSN 1938-0682 ; 1558-7673
    ISSN (online) 1938-0682
    ISSN 1558-7673
    DOI 10.1016/j.clgc.2022.06.008
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    Zs.A 6168: Show issues Location:
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  5. Article ; Online: D-dimer and risk for thrombosis in adults with newly diagnosed acute lymphoblastic leukemia.

    Anderson, Daniela R / Stock, Wendy / Karrison, Theodore G / Leader, Avi

    Blood advances

    2022  Volume 6, Issue 17, Page(s) 5146–5151

    Abstract: Patients with acute lymphoblastic leukemia (ALL) are at increased risk of thrombotic and/or bleeding events during early chemotherapy, especially when receiving asparaginase. D-dimer is a marker of fibrinolysis that has been associated with thrombotic ... ...

    Abstract Patients with acute lymphoblastic leukemia (ALL) are at increased risk of thrombotic and/or bleeding events during early chemotherapy, especially when receiving asparaginase. D-dimer is a marker of fibrinolysis that has been associated with thrombotic risk in solid cancers and acute myeloid leukemia; however, to date, no ALL-based study has assessed D-dimer level and risk for thrombosis. We sought to examine D-dimer as a biomarker for risk of thrombosis or bleeding during ALL treatment in a retrospective cohort study at The University of Chicago. We identified 61 consecutive adult patients with ALL, gathering demographic characteristics, treatment regimens, initial biomarkers including D-dimer, and assessing occurrence of venous or arterial thrombosis and bleeding in the first 100 days after diagnosis (index). The 100-day cumulative incidence (95% confidence interval [CI]) of venous or arterial thrombosis in patients with high D-dimer (≥4 µg/mL) was 52.9% (95% CI, 26.4-73.8) compared with 13.8% (95% CI, 5.5-25.7) in patients with low to moderate D-dimer (<4 µg/mL), corresponding with a hazard ratio of 5.04 (95% CI, 1.79-14.22). When testing for potential confounders in a series of bivariate logistic regression models, the association between D-dimer and thrombosis remained after adjusting for body mass index, age, sex, asparaginase treatment, disseminated intravascular coagulation score, initial platelet level, and ALL phenotype. In conclusion, D-dimer levels at ALL diagnosis are associated with venous or arterial thrombosis at 100 days. Future studies should include D-dimer collated with other known risk factors to build a risk assessment model for thrombosis in patients with newly diagnosed ALL.
    MeSH term(s) Acute Disease ; Asparaginase/adverse effects ; Biomarkers ; Fibrin Fibrinogen Degradation Products ; Hemorrhage/chemically induced ; Humans ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/complications ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/diagnosis ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy ; Retrospective Studies ; Thrombosis/diagnosis
    Chemical Substances Biomarkers ; Fibrin Fibrinogen Degradation Products ; fibrin fragment D ; Asparaginase (EC 3.5.1.1)
    Language English
    Publishing date 2022-06-14
    Publishing country United States
    Document type Journal Article
    ZDB-ID 2915908-8
    ISSN 2473-9537 ; 2473-9529
    ISSN (online) 2473-9537
    ISSN 2473-9529
    DOI 10.1182/bloodadvances.2022007699
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    Zs.A 7153: Show issues Location:
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  6. Article ; Online: Restricted mean survival time: Does covariate adjustment improve precision in randomized clinical trials?

    Karrison, Theodore / Kocherginsky, Masha

    Clinical trials (London, England)

    2018  Volume 15, Issue 2, Page(s) 178–188

    Abstract: Background: Restricted mean survival time is a measure of average survival time up to a specified time point. There has been an increased interest in using restricted mean survival time to compare treatment arms in randomized clinical trials because ... ...

    Abstract Background: Restricted mean survival time is a measure of average survival time up to a specified time point. There has been an increased interest in using restricted mean survival time to compare treatment arms in randomized clinical trials because such comparisons do not rely on proportional hazards or other assumptions about the nature of the relationship between survival curves.
    Methods: This article addresses the question of whether covariate adjustment in randomized clinical trials that compare restricted mean survival times improves precision of the estimated treatment effect (difference in restricted mean survival times between treatment arms). Although precision generally increases in linear models when prognostic covariates are added, this is not necessarily the case in non-linear models. For example, in logistic and Cox regression, the standard error of the estimated treatment effect does not decrease when prognostic covariates are added, although the situation is complicated in those settings because the estimand changes as well. Because estimation of restricted mean survival time in the manner described in this article is also based on a model that is non-linear in the covariates, we investigate whether the comparison of restricted mean survival times with adjustment for covariates leads to a reduction in the standard error of the estimated treatment effect relative to the unadjusted estimator or whether covariate adjustment provides no improvement in precision. Chen and Tsiatis suggest that precision will increase if covariates are chosen judiciously. We present results of simulation studies that compare unadjusted versus adjusted comparisons of restricted mean survival time between treatment arms in randomized clinical trials.
    Results: We find that for comparison of restricted means in a randomized clinical trial, adjusting for covariates that are associated with survival increases precision and therefore statistical power, relative to the unadjusted estimator. Omitting important covariates results in less precision but estimates remain unbiased.
    Conclusion: When comparing restricted means in a randomized clinical trial, adjusting for prognostic covariates can improve precision and increase power.
    MeSH term(s) Computer Simulation ; Data Interpretation, Statistical ; Humans ; Proportional Hazards Models ; Randomized Controlled Trials as Topic ; Research Design ; Statistics, Nonparametric ; Survival Analysis ; Time Factors
    Language English
    Publishing date 2018-03-04
    Publishing country England
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774518759281
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    Zs.A 5831: Show issues Location:
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  7. Article ; Online: Estimation of progression-free survival in the randomized discontinuation trial design.

    Karrison, Theodore G

    Journal of clinical oncology : official journal of the American Society of Clinical Oncology

    2013  Volume 31, Issue 6, Page(s) 814

    MeSH term(s) Carcinoma, Renal Cell/drug therapy ; Carcinoma, Renal Cell/mortality ; Female ; Humans ; Kidney Neoplasms/drug therapy ; Kidney Neoplasms/mortality ; Male ; Neoplasm Recurrence, Local/mortality ; Phenylurea Compounds/administration & dosage ; Quinolines/administration & dosage
    Chemical Substances Phenylurea Compounds ; Quinolines
    Language English
    Publishing date 2013-02-20
    Publishing country United States
    Document type Comment ; Letter
    ZDB-ID 604914-x
    ISSN 1527-7755 ; 0732-183X
    ISSN (online) 1527-7755
    ISSN 0732-183X
    DOI 10.1200/JCO.2012.46.1087
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    Zs.A 1847: Show issues Location:
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    Zs.MO 650: Show issues

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  8. Article ; Online: The addition of pelvic lymph node treatment to prostate bed salvage radiotherapy - Authors' reply.

    Pollack, Alan / Karrison, Theodore G / Feng, Felix / Sartor, Oliver / Sandler, Howard M

    Lancet (London, England)

    2022  Volume 400, Issue 10356, Page(s) 885–886

    MeSH term(s) Humans ; Lymph Nodes ; Male ; Pelvis ; Prostate ; Radiation Oncology ; Salvage Therapy
    Language English
    Publishing date 2022-09-15
    Publishing country England
    Document type Letter ; Comment
    ZDB-ID 3306-6
    ISSN 1474-547X ; 0023-7507 ; 0140-6736
    ISSN (online) 1474-547X
    ISSN 0023-7507 ; 0140-6736
    DOI 10.1016/S0140-6736(22)01434-9
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  9. Article ; Online: A phase I study of selinexor combined with weekly carfilzomib and dexamethasone in relapsed/refractory multiple myeloma.

    Derman, Benjamin A / Chari, Ajai / Zonder, Jeffrey / Major, Ajay / Stefka, Andrew T / Jiang, Ken / Karrison, Theodore / Jasielec, Jagoda / Jakubowiak, Andrzej

    European journal of haematology

    2023  Volume 110, Issue 5, Page(s) 564–570

    Abstract: We performed a phase I study of weekly selinexor, carfilzomib, and dexamethasone (wSKd) in patients with relapsed/refractory multiple myeloma (MM). The primary objective was to identify the maximum tolerated dose (MTD) of wSKd. Secondary endpoints ... ...

    Abstract We performed a phase I study of weekly selinexor, carfilzomib, and dexamethasone (wSKd) in patients with relapsed/refractory multiple myeloma (MM). The primary objective was to identify the maximum tolerated dose (MTD) of wSKd. Secondary endpoints included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). Prior exposure/refractoriness to carfilzomib was permitted. Thirty patients were enrolled; 26 (87%) had triple-class exposed disease and 6 (20%) received chimeric antigen receptor (CAR) T-cell therapy. Dose level 2 (carfilzomib 70 mg/m
    MeSH term(s) Humans ; Multiple Myeloma/diagnosis ; Multiple Myeloma/drug therapy ; Dexamethasone ; Antineoplastic Combined Chemotherapy Protocols/adverse effects
    Chemical Substances carfilzomib (72X6E3J5AR) ; selinexor (31TZ62FO8F) ; Dexamethasone (7S5I7G3JQL)
    Language English
    Publishing date 2023-02-15
    Publishing country England
    Document type Clinical Trial, Phase I ; Journal Article
    ZDB-ID 392482-8
    ISSN 1600-0609 ; 0902-4441
    ISSN (online) 1600-0609
    ISSN 0902-4441
    DOI 10.1111/ejh.13937
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    Zs.A 323: Show issues Location:
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  10. Article ; Online: Building firm foundations for therapy development.

    Dignam, James J / Karrison, Theodore G

    Journal of the National Cancer Institute

    2015  Volume 107, Issue 3

    MeSH term(s) Antineoplastic Agents/administration & dosage ; Antineoplastic Agents/adverse effects ; Clinical Trials, Phase I as Topic/methods ; Dose-Response Relationship, Drug ; Humans ; Maximum Tolerated Dose ; Research Design
    Chemical Substances Antineoplastic Agents
    Language English
    Publishing date 2015-02-20
    Publishing country United States
    Document type Editorial ; Research Support, N.I.H., Extramural ; Comment
    ZDB-ID 2992-0
    ISSN 1460-2105 ; 0027-8874 ; 0198-0157
    ISSN (online) 1460-2105
    ISSN 0027-8874 ; 0198-0157
    DOI 10.1093/jnci/djv016
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