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  1. Article ; Online: The Use of Joint Models in Analysis of Aggregate Endpoints in RERF Cohort Studies.

    Sposto, Richard / Cullings, Harry M

    Radiation research

    2024  Volume 201, Issue 4, Page(s) 304–309

    Abstract: In radiation risk estimation based on the Radiation Effects Research Foundation (RERF) cohort studies, one common analysis is Poisson regression on radiation dose and background and effect modifying variables of an aggregate endpoint such as all solid ... ...

    Abstract In radiation risk estimation based on the Radiation Effects Research Foundation (RERF) cohort studies, one common analysis is Poisson regression on radiation dose and background and effect modifying variables of an aggregate endpoint such as all solid cancer incidence or all non-cancer mortality. As currently performed, these analyses require selection of a surrogate radiation organ dose, (e.g., colon dose), which could conceptually be problematic since the aggregate endpoint comprises events arising from a variety of organs. We use maximum likelihood theory to compare inference from the usual aggregate endpoint analysis to analyses based on joint analysis. These two approaches are also compared in a re-analysis of RERF Life Span Study all cancer mortality. We show that, except for a trivial difference, these two analytic approaches yield identical inference with respect to radiation dose response and background and effect modification when based on a single surrogate organ radiation dose. When repeating the analysis with organ-specific doses, an interesting issue of bias in intercept parameters arises when dose estimates are undefined for one sex when sex-specific outcomes are included in the aggregate endpoint, but a simple correction will avoid this issue. Lastly, while the joint analysis formulation allows use of organ-specific doses, the interpretation of such an analysis for inference regarding an aggregate endpoint can be problematic. To the extent that analysis of radiation risk for an aggregate endpoint is of interest, the joint-analysis formulation with a single surrogate dose is an appropriate analytic approach, whereas joint analysis with organ-specific doses may only be interpretable if endpoints are considered separately for estimating dose response. However, for neither approach is inference about dose response well defined.
    MeSH term(s) Male ; Female ; Humans ; Cohort Studies ; Radiation Injuries ; Incidence ; Nuclear Warfare ; Japan/epidemiology
    Language English
    Publishing date 2024-02-13
    Publishing country United States
    Document type Journal Article
    ZDB-ID 80322-4
    ISSN 1938-5404 ; 0033-7587
    ISSN (online) 1938-5404
    ISSN 0033-7587
    DOI 10.1667/RADE-23-00122.1
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  2. Article ; Online: Effect of radiation exposure on survival after first solid cancer diagnosis in A-bomb survivors.

    Sposto, Richard / Sugiyama, Hiromi / Tsuruyama, Tatsuaki / Brenner, Alina V

    Cancer epidemiology

    2023  Volume 83, Page(s) 102341

    Abstract: Background: Comparison of the estimated effect of atomic bomb radiation exposure on solid cancer incidence and solid cancer mortality in the RERF Life Span Study (LSS) reveals a difference in the magnitude and shape of the excess relative risk dose ... ...

    Abstract Background: Comparison of the estimated effect of atomic bomb radiation exposure on solid cancer incidence and solid cancer mortality in the RERF Life Span Study (LSS) reveals a difference in the magnitude and shape of the excess relative risk dose response. A possible contributing factor to this difference is pre-diagnosis radiation effect on post-diagnosis survival. Pre-diagnosis radiation exposure theoretically could influence post-diagnosis survival by affecting the genetic makeup and possibly aggressiveness of cancer, or by compromising tolerance for aggressive treatment for cancer.
    Methods: We analyze the radiation effect on post-diagnosis survival in 20,463 LSS subjects diagnosed with first-primary solid cancer between 1958 and 2009 with particular attention to whether death was caused by the first-primary cancer, other cancer, or non-cancer diseases.
    Results: From multivariable Cox regression analysis of cause-specific survival, the excess hazard at 1 Gy (EH
    Conclusion: There is no detectable large effect of pre-diagnosis radiation exposure on post-diagnosis death from the first primary cancer in A-bomb survivors.
    Impact: A direct effect of pre-diagnosis radiation exposure on cancer prognosis is ruled out as an explanation for the difference in incidence and mortality dose response in A-bomb survivors.
    MeSH term(s) Humans ; Atomic Bomb Survivors ; Neoplasms, Radiation-Induced/etiology ; Risk ; Radiation Exposure ; Incidence ; Japan/epidemiology
    Language English
    Publishing date 2023-02-20
    Publishing country Netherlands
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 2508729-0
    ISSN 1877-783X ; 1877-7821
    ISSN (online) 1877-783X
    ISSN 1877-7821
    DOI 10.1016/j.canep.2023.102341
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  3. Article ; Online: The Association of Radiation Exposure with Stable Chromosome Aberrations in Atomic Bomb Survivors Based on DS02R1 Dosimetry and FISH Methods.

    Sposto, Richard / Cordova, Kismet A / Hamasaki, Kanya / Nakamura, Nori / Noda, Asao / Kodama, Yoshiaki

    Radiation research

    2023  Volume 199, Issue 2, Page(s) 170–181

    Abstract: The frequency of stable chromosome aberrations (sCA) in lymphocytes is a recognized radiation biological dosimeter. Its analysis can provide insights into factors that affect individual susceptibility as well as into the adequacy of radiation dose ... ...

    Abstract The frequency of stable chromosome aberrations (sCA) in lymphocytes is a recognized radiation biological dosimeter. Its analysis can provide insights into factors that affect individual susceptibility as well as into the adequacy of radiation dose estimates used in studies of atomic bomb survivors. We analyzed the relationship between atomic bomb radiation exposure using the most recent DS02R1 dose estimates and the frequency of sCA as determined by FISH in 1,868 atomic bomb survivors. We investigated factors that may affect the background sCA rate and the shape and magnitude of the dose response. As in previous analyses of sCA in atomic bomb survivors that were based on Giemsa staining methods and used older DS86 dose estimates, the relationship between radiation dose and sCA rate was significant (P < 0.0001) with a linear-quadratic relationship at lower doses that did not persist at higher doses. As before, age at the time of the bombing and type of radiation shielding were significant dose-effect modifiers (P < 0.0001), but in contrast the difference in dose response by city was not so pronounced (P = 0.026) with a city effect not evident at doses below 1.25Gy. Background sCA rate increased with age at the time of examination (P < 0.0001), but neither sex, city, nor smoking was significantly associated with background rate. Based on FISH methods and recent dosimetry, the relationship between radiation dose and sCA frequency is largely consistent with previous findings, although the lesser importance of city as an effect modifier may reflect better dosimetry as well as more reproducible scoring of sCA. The persisting difference in sCA dose response by shielding category points to remaining problems with the accuracy or precision of radiation dose estimates in some A-bomb survivors.
    MeSH term(s) Humans ; Atomic Bomb Survivors ; Radiometry/methods ; Radiation Exposure/adverse effects ; Chromosome Aberrations ; Survivors ; Japan ; Nuclear Warfare ; Dose-Response Relationship, Radiation
    Language English
    Publishing date 2023-01-05
    Publishing country United States
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Research Support, U.S. Gov't, Non-P.H.S.
    ZDB-ID 80322-4
    ISSN 1938-5404 ; 0033-7587
    ISSN (online) 1938-5404
    ISSN 0033-7587
    DOI 10.1667/RADE-22-00154.1
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  4. Article ; Online: Commentary on paper, 'cancer survival analysis'.

    Sposto, Richard

    Surgical oncology

    2010  Volume 19, Issue 2, Page(s) 59–60; discussion 61

    MeSH term(s) Humans ; Kaplan-Meier Estimate ; Models, Statistical ; Neoplasms/mortality ; Proportional Hazards Models ; United States
    Language English
    Publishing date 2010-06
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1107810-8
    ISSN 1879-3320 ; 0960-7404
    ISSN (online) 1879-3320
    ISSN 0960-7404
    DOI 10.1016/j.suronc.2010.04.002
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  5. Article ; Online: Independent Assessment of the Children's Hepatic Tumors International Collaboration Risk Stratification for Hepatoblastoma and the Association of Tumor Histological Characteristics With Prognosis.

    Zhou, Shengmei / Malvar, Jemily / Chi, Yueh-Yun / Stein, James / Wang, Larry / Genyk, Yuri / Sposto, Richard / Mascarenhas, Leo

    JAMA network open

    2022  Volume 5, Issue 2, Page(s) e2148013

    Abstract: Importance: Hepatoblastoma is the most common pediatric liver malignant neoplasm, and accurate risk stratification is essential for guiding treatment.: Objective: To validate the Children's Hepatic Tumors International Collaboration-Hepatoblastoma ... ...

    Abstract Importance: Hepatoblastoma is the most common pediatric liver malignant neoplasm, and accurate risk stratification is essential for guiding treatment.
    Objective: To validate the Children's Hepatic Tumors International Collaboration-Hepatoblastoma Stratification (CHIC-HS) in an independent cohort of patients with hepatoblastoma and evaluate the association of pretreatment hepatoblastoma histological subtype with prognosis.
    Design, setting, and participants: This is a single-institution retrospective cohort study of 96 pediatric patients with hepatoblastoma diagnosed and treated between June 1, 2000, and December 31, 2016, with recent therapy and independent of the CHIC-HS discovery cohort. Each patient was assigned a risk group according to CHIC-HS. The histological characteristics of each tumor were assessed based on the International Pediatric Liver Tumor Consensus Classification. Data were analyzed from May 2018 to May 2019.
    Main outcomes and measures: The main outcomes were event-free survival (EFS) and overall survival (OS). Cox regression analysis was used to examine the associations of patient characteristics and tumor histological characteristics with survival.
    Results: A total of 96 patients (median [range] age, 1.9 [0.4-18] years; 36 [38%] girls and 60 [63%] boys) were assessed, including 15 with very low risk, 28 with low risk, 23 with intermediate risk, and 30 with high risk, according to CHIC-HS criteria. There were a total of 13 cancer-related deaths; median (range) follow-up was 3.5 (0.1-17.8) years for those alive at the last follow-up. The estimated 5-year OS rates were 100% in the very low-risk group, 94.7% (95% CI, 68.1%-99.2%) in the low-risk group, 89.2% (95% CI, 63.1%-97.2%) in the intermediate-risk group, and 57.9% (95% CI, 34.6%-75.5%) in the high-risk group. In a multivariable analysis, we confirmed that CHIC-HS significantly estimated EFS (high-risk group vs very low- and low-risk groups: hazard ratio [HR], 45.59; 95% CI, 9.39-209.5; P < .001) and OS (high-risk group vs very low- and low-risk groups: HR, 21.95; 95% CI, 2.76-174.29; P < .001). In the subcohort of 84 patients for whom pretreatment tumor histological data were available, tumor epithelial histological subtypes were found to be significantly associated with both EFS and OS. Patients in the CHIC-HS high-risk group and with embryonal-only histological subtype had the highest risk of relapse or disease progression (high-risk: HR, 42.62; 95% CI, 9.91-203.9; embryonal: HR, 3.28; 95% CI, 1.21-8.9) and death (high-risk: HR, 18.78; 95% CI, 2.31-152.84; embryonal: HR, 7.12; 95% CI, 1.51-33.52).
    Conclusions and relevance: This cohort study found that CHIC-HS performed as expected in an independent cohort that was more recently treated. Incorporation of pretreatment tumor histological data into CHIC-HS may provide additional prognostic value.
    MeSH term(s) Adolescent ; Child ; Child, Preschool ; Cohort Studies ; Female ; Hepatoblastoma/epidemiology ; Hepatoblastoma/physiopathology ; Hepatoblastoma/therapy ; Humans ; Infant ; Infant, Newborn ; International Cooperation ; Liver Neoplasms/epidemiology ; Liver Neoplasms/physiopathology ; Liver Neoplasms/therapy ; Male ; Neoplasm Grading/standards ; Neoplasm Recurrence, Local/epidemiology ; Neoplasm Recurrence, Local/physiopathology ; Neoplasm Recurrence, Local/therapy ; Practice Guidelines as Topic ; Prognosis ; Retrospective Studies ; Risk Assessment/statistics & numerical data ; Risk Factors
    Language English
    Publishing date 2022-02-01
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
    ISSN 2574-3805
    ISSN (online) 2574-3805
    DOI 10.1001/jamanetworkopen.2021.48013
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  6. Article ; Online: Bias in retrospective analyses of biomarker effect using data from an outcome-adaptive randomized trial.

    Ji, Lingyun / McShane, Lisa M / Krailo, Mark / Sposto, Richard

    Clinical trials (London, England)

    2019  Volume 16, Issue 6, Page(s) 599–609

    Abstract: Background/aims: Biomarker-stratified outcome-adaptive randomization trials, in which randomization probabilities depend on both biomarker value and outcomes of previously treated patients, are receiving increased attention in oncology research. Data ... ...

    Abstract Background/aims: Biomarker-stratified outcome-adaptive randomization trials, in which randomization probabilities depend on both biomarker value and outcomes of previously treated patients, are receiving increased attention in oncology research. Data from these trials can also form the basis of investigation of additional biomarkers that may not have been incorporated into the original trial design. In this article, we investigate the validity of a standard analytical method that utilizes data from a biomarker-stratified outcome-adaptive randomization trial to assess the effect of a newly identified biomarker on patient outcomes.
    Methods: In the context of an ancillary biomarker study for a two-arm phase II trial with a response endpoint, we conduct analytic and simulation studies to investigate bias in estimated biomarker effects under outcome-adaptive randomization. Conditions under which bias arises and magnitude of the bias are examined in several settings. We then propose unbiased estimators of biomarker effects with appropriate variance estimators.
    Results: We demonstrate that use of biomarker-stratified outcome-adaptive randomization perturbs the patient population and treatment assignments. Consequently, application of standard analysis methods to data from an outcome-adaptive randomization trial either to estimate prognostic effect of a new biomarker in uniformly treated patients or to estimate effect of treatment in relation to the new biomarker can lead to substantially biased estimates. The proposed adjusted estimators are asymptotically unbiased, and the proposed variance estimators correctly reflect the sample variability in the estimators.
    Conclusion: This article demonstrates existence of bias when standard, naïve statistical methods are utilized to assess biomarker effects using data from a biomarker-stratified outcome-adaptive randomization trial, and hence that results from naïve analyses must be interpreted with great caution. These findings highlight that, in an era where data and specimens are increasingly being shared for biomarker studies, care must be taken to document and understand implications of the study design under which specimens or data have been obtained.
    MeSH term(s) Bias ; Biomarkers ; Clinical Trials, Phase II as Topic ; Humans ; Models, Statistical ; Odds Ratio ; Probability ; Randomized Controlled Trials as Topic/methods ; Randomized Controlled Trials as Topic/statistics & numerical data ; Research Design ; Retrospective Studies ; Sample Size
    Chemical Substances Biomarkers
    Language English
    Publishing date 2019-10-03
    Publishing country England
    Document type Journal Article
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774519875969
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  7. Article ; Online: Rejoinder.

    Ji, Lingyun / McShane, Lisa M / Krailo, Mark / Sposto, Richard

    Clinical trials (London, England)

    2019  Volume 16, Issue 6, Page(s) 613–615

    MeSH term(s) Clinical Trials as Topic ; Random Allocation
    Language English
    Publishing date 2019-10-03
    Publishing country England
    Document type Journal Article ; Comment
    ZDB-ID 2138796-5
    ISSN 1740-7753 ; 1740-7745
    ISSN (online) 1740-7753
    ISSN 1740-7745
    DOI 10.1177/1740774519875971
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  8. Article ; Online: Cure trends in acute lymphoblastic leukemia: is it time for a revised concept of cure?

    Zwaan, Christian Michel / Sposto, Richard

    Haematologica

    2013  Volume 98, Issue 5, Page(s) 655–656

    MeSH term(s) Female ; Humans ; Male ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/mortality
    Language English
    Publishing date 2013-04-30
    Publishing country Italy
    Document type Letter ; Comment
    ZDB-ID 2333-4
    ISSN 1592-8721 ; 0017-6567 ; 0390-6078
    ISSN (online) 1592-8721
    ISSN 0017-6567 ; 0390-6078
    DOI 10.3324/haematol.2013.084269
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  9. Article: Cure model analysis in cancer: an application to data from the Children's Cancer Group.

    Sposto, Richard

    Statistics in medicine

    2002  Volume 21, Issue 2, Page(s) 293–312

    Abstract: The most commonly used statistical methods for evaluating treatment or prognostic effects on cancer outcome--the logrank test and Cox regression analysis--rely on the proportional hazards (PH) assumption in that they have maximal power in this ... ...

    Abstract The most commonly used statistical methods for evaluating treatment or prognostic effects on cancer outcome--the logrank test and Cox regression analysis--rely on the proportional hazards (PH) assumption in that they have maximal power in this circumstance. Implicitly, these methods emphasize covariate effects on failure times rather than their effects on the proportion of long-term survivors ('cures'), which may be of equal or primary interest. In paediatric cancer, treatment has progressed dramatically in recent decades, and in many diagnoses cures are obtained in a large fraction of patients. A primary focus of clinical research is therefore the achievement of cure. Parametric cure model (PCM) analysis, introduced 50 years ago, is arguably better suited to the analytic requirements of clinical research in paediatric and other cancers where cure is achieved. In this paper two classes of PCMs are described and used to analyse examples from the Children's Cancer Group. These are compared to analyses using Cox regression analysis. Results from PCM analyses are similar or identical to Cox regression analysis when the PH assumption is appropriate. When it is not, PCMs can provide a coherent way to investigate and report covariate effects on the proportion cured separately from their effect on time to failure. Despite their reliance on explicit parametric forms, PCMs often provide a good description of cancer outcome, and are insensitive to lack of fit provided that follow-up is sufficient.
    MeSH term(s) Child ; Data Interpretation, Statistical ; Disease-Free Survival ; Hodgkin Disease/drug therapy ; Hodgkin Disease/mortality ; Humans ; Lymphoma, Non-Hodgkin/drug therapy ; Lymphoma, Non-Hodgkin/mortality ; Models, Statistical ; Neoplasms/mortality ; Neoplasms/therapy ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/drug therapy ; Precursor Cell Lymphoblastic Leukemia-Lymphoma/mortality ; Proportional Hazards Models ; Survival Analysis ; Treatment Outcome
    Language English
    Publishing date 2002-01-01
    Publishing country England
    Document type Comparative Study ; Journal Article ; Research Support, U.S. Gov't, P.H.S.
    ZDB-ID 843037-8
    ISSN 1097-0258 ; 0277-6715
    ISSN (online) 1097-0258
    ISSN 0277-6715
    DOI 10.1002/sim.987
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  10. Article ; Online: Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL): Overview and introduction to the proceedings of the 2016 TACL investigator meeting.

    Wayne, Alan S / Shin-Kashiyama, Erika / Sposto, Richard / Gaynon, Paul

    Pediatric hematology and oncology

    2017  Volume 34, Issue 6-7, Page(s) 349–354

    Abstract: Despite great success in the development of curative therapies for pediatric hematologic malignancies, new approaches are needed to overcome resistance to treatment and to reduce associated side effects. The Therapeutic Advances in Childhood Leukemia and ...

    Abstract Despite great success in the development of curative therapies for pediatric hematologic malignancies, new approaches are needed to overcome resistance to treatment and to reduce associated side effects. The Therapeutic Advances in Childhood Leukemia and Lymphoma (TACL) Consortium is an early phase clinical trial group dedicated to developing innovative therapies for currently incurable pediatric leukemias and lymphomas ( https://tacl.chla.usc.edu/tacl/ ). In November of 2016, a TACL Investigator Meeting was held, the proceedings of which appear in this edition of Pediatric Hematology Oncology. This introductory article provides an overview of TACL and introduces the five-part proceedings.
    MeSH term(s) Adolescent ; Child ; Child, Preschool ; Clinical Trials as Topic ; Congresses as Topic ; Female ; Humans ; Infant ; Infant, Newborn ; Leukemia/therapy ; Lymphoma/therapy ; Male
    Language English
    Publishing date 2017-11-09
    Publishing country England
    Document type Journal Article
    ZDB-ID 632914-7
    ISSN 1521-0669 ; 0888-0018
    ISSN (online) 1521-0669
    ISSN 0888-0018
    DOI 10.1080/08880018.2017.1377329
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