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VP6-2022: Adjuvant pertuzumab and trastuzumab in patients with early HER-2 positive breast cancer in APHINITY: 8.4 years' follow-up

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Annals of Oncology 2022年第9期33卷 986-987页

作者： S. Loibl J. Jassem A. Sonnenblick D. Parlier E. Winer J. Bergh R.D. Gelber E. Restuccia Y-H. Im C. Huang F. Dalenc I. Calvo M. Procter C. Caballero E. Clark H.L. Gomez Moreno J. Bliss G. Viale J. Bines M. Piccart Medicine and Research Dept. German Breast Group (GBG) Forschungs GmbH Neu-Isenburg Germany Oncology & Radiotherapy Medical University of Gdansk Gdansk Poland Oncology Department Tel Aviv Sourasky Medical Center-(Ichilov) Tel Aviv Israel Clinical Trials Support Unit Institut Jules Bordet Brussels Belgium Yale Cancer Center Yale University School of Medicine - Yale Cancer Center New Haven CT USA Department of Oncology-Pathology Karolinska Institutet and Breast Cancer Centre Cancer Theme Karolinska University Hospital Stockholm Sweden Biostatistics Dana Farber Cancer Institute Boston MA USA Product Development Oncology F. Hoffmann-La Roche Ltd Basel Switzerland Medicine Dept. Hematology/Medical Oncology Division Samsung Medical Center (SMC) - Sungkyunkwan University School of Medicine Seoul Republic of Korea Surgery Dept. NTUH - National Taiwan University Hospital Taipei Taiwan Oncologie 1A Institut Universitaire du Cancer Toulouse - Oncopole Toulouse France Breast Cancer Unit MD Anderson Cancer Center Madrid Madrid Spain Statistics and Programming Frontier Science Scotland Kincraig UK Medical Department Breast International Group (BIG) - AISBL Brussels Belgium Data Sciences - Data & Statistical Sciences (DSS) Roche Products Limited Welwyn Garden City UK Medicine Department INEN - Instituto Nacional de Enfermedades Neoplasicas Lima Peru Clinical Trials and Statistics Unit ICR - Institute of Cancer Research London UK Department of Oncology Università degli Studi di Milano Milan Italy Medical Oncology Department Instituto Nacional de Cancer - Research Center Rio de Janeiro Brazil Institut Jules Bordet Brussels Belgium

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The EORTC QLQ-F17 as a shortened version of the EORTC QLQ-C30 to assess self-reported functioning in cancer patients: investigating equivalence and psychometric properties in a randomized cross-over trial

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eClinicalMedicine 2025年 84卷

作者： Florian Zeman Johannes M. Giesinger Tobias Pukrop Morten Aa Petersen Mogens Groenvold Sandra Nolte Dagmara Kuliś Sunil Shrestha Laurence Leysen Kim Cocks Corneel Coens Georgios Ioannidis Cecilia Pompili Michael Koller Center for Clinical Studies University Hospital Regensburg Regensburg Germany Bavarian Cancer Research Center (BZKF) Regensburg Germany Department of Psychiatry Psychotherapy Psychosomatics and Medical Psychology Innsbruck Medical University Innsbruck Austria Department of Internal Medicine III Hematology and Oncology University Hospital Regensburg Regensburg Germany Palliative Care Research Unit Department of Geriatrics and Palliative Medicine GP Bispebjerg and Frederiksberg Hospital University of Copenhagen Copenhagen Denmark Department of Public Health University of Copenhagen Copenhagen Denmark Person-Centred Research Eastern Health Clinical School Monash University Melbourne VIC Australia School of Health Sciences Swinburne University of Technology Melbourne VIC Australia European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Department Brussels Belgium Department of Research and Academics Kathmandu Cancer Center Tathali Bhaktapur Nepal Statistics and Programming Adelphi Values Bollington Cheshire England UK Oncology Department Nicosia General Hospital State of Health Services Organisation Nicosia Cyprus University of Hull Hull and York Medical School Hull UK

Background The EORTC QLQ-F17, a shortened version of the EORTC QLQ-C30, solely contains the items related to functioning and omits symptom scales. The QLQ-F17 is conceived an equivalent to the functional part of the QLQ-C30, but to date there is no empirical evidence to support this rationale. Methods This randomized, cross-over, multi-national, questionnaire-based study investigates the equivalence and psychometric properties of the QLQ-F17 compared to the functional scales of the QLQ-C30. Respondents had to fill in both questionnaires, the order of which was presented in a randomized and balanced manner (QLQ-C30—QLQ-F17 vs. QLQ-F17—QLQ-C30). Equivalence testing used Differential Item Functioning (DIF) and linear models. The margin of equivalence was set at ]–5, 5[ points. The study is registered with *** ( NCT05479682 ). Patients were enrolled between February 17 and March 28, 2023. Findings A total of 2672 cancer patients of all major cancer types, aged between 18 and 92 years with an equal gender distribution (50/50) from 11 countries, were recruited between 17 February and 28 March 2023. Adjusted mean differences between QLQ-C30 and QLQ-F17 ranged between −1·55 and 3·25 for all scales, and the limits of the 95%-CIs, ranging from −3·11 to 4·87, were all within the equivalence margin. All effect sizes of the DIF analyses were <0·01. For the scales of the QLQ-F17, Cronbach's Alpha ranged from 0·73 to 0·89, item–own scale correlations from 0·47 to 0·78 and item–other scale correlations from 0·19 to 0·70. Interpretation The QLQ-F17 yielded score values that are equivalent to the functional part of the QLQ-C30. Consequently, future clinical studies can employ the QLQ-F17 as a generic tool without losing comparability to studies using the QLQ-C30. Supplementing the QLQ-F17 with relevant symptom items from the EORTC Item Library allows for a time-efficient and flexible measurement strategy. Funding This research was funded by the European Organisation fo

关键词： Quality of life Patient-reported outcomes EORTC QLQ-C30 EORTC QLQ-F17 Equivalence Psychometric properties

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Estimation of group means in generalized linear mixed models

arXiv

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arXiv 2019年

作者： Duan, Jiexin Levine, Michael Luo, Junxiang Qu, Yongming Department of Statistics Purdue University West LafayetteIN47906 United States Biostatistics and programming 55 Corporate Drive Bridgewater SanofiNJ08807 United States Department of Biometrics Eli Lilly Corporate Center Drop Code 2232 IndianapolisIN United States

In this manuscript, we investigate the concept of the mean response for a treatment group mean as well as its estimation and prediction for generalized linear models with a subject-wise random effect. Generalized linear models are commonly used to analyze categorical data. The model-based mean for a treatment group usually estimates the response at the mean covariate. However, the mean response for the treatment group for studied population is at least equally important in the context of clinical trials. New methods were proposed to estimate such a mean response in generalized linear models;however, this has only been done when there are no random effects in the model. We suggest that, in a generalized linear mixed model (GLMM), there are at least two possible definitions of a treatment group mean response that can serve as estimation/prediction targets. The estimation of these treatment group means is important for healthcare professionals to be able to understand the absolute benefit versus risk. For both of these treatment group means, we propose a new set of methods that suggests how to estimate/predict both of them in a GLMM models with a univariate subject-wise random effect. Our methods also suggest an easy way of constructing corresponding confidence and prediction intervals for both possible treatment group means. Simulations show that proposed confidence and prediction intervals provide correct empirical coverage probability under most circumstances. Proposed methods have also been applied to analyze hypoglycemia data from diabetes clinical trials. Copyright © 2019, The Authors. All rights reserved.

关键词： Random processes

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Enabling Research through the SCIP Optimization Suite 8.0

arXiv

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arXiv 2023年

作者： Bestuzheva, Ksenia Besançon, Mathieu Chen, Wei-Kun Chmiela, Antonia Donkiewicz, Tim van Doornmalen, Jasper Eifler, Leon Gaul, Oliver Gamrath, Gerald Gleixner, Ambros Gottwald, Leona Graczyk, Christoph Halbig, Katrin Hoen, Alexander Hojny, Christopher van der Hulst, Rolf Koch, Thorsten Lübbecke, Marco Maher, Stephen J. Matter, Frederic Mühmer, Erik Müller, Benjamin Pfetsch, Marc E. Rehfeldt, Daniel Schlein, Steffan Schlösser, Franziska Serrano, Felipe Shinano, Yuji Sofranac, Boro Turner, Mark Vigerske, Stefan Wegscheider, Fabian Wellner, Philipp Weninger, Dieter Witzig, Jakob Zuse Institute Berlin Department AIS2T Takustr. 7 Berlin14195 Germany ZIB-AIS2T Germany School of Mathematics and Statistics Beijing Institute of Technology Beijing100081 China RWTH Aachen University Lehrstuhl für Operations Research Kackertstr. 7 Aachen52072 Germany Eindhoven University of Technology Department of Mathematics and Computer Science Netherlands ZIB-AIS2T I2DAMO GmbH Englerallee 19 Berlin14195 Germany ZIB-AIS2T HTW Berlin Germany Friedrich-Alexander Universität Erlangen-Nürnberg Department of Data Science Cauerstr. 11 Erlangen91058 Germany University of Twente Department of Discrete Mathematics and Mathematical Programming P.O. Box 217 Enschede7500 AE Netherlands Technische Universität Berlin Software and Algorithms for Discrete Optimization Straße des 17. Juni 135 Berlin10623 Germany ZIB Department A2IM Takustr. 7 Berlin14195 Germany RWTH Aachen-Lehrstuhl für OR Germany University of Exeter College of Engineering Mathematics and Physical Sciences Exeter United Kingdom Technische Universität Darmstadt Fachbereich Mathematik Dolivostr. 15 Darmstadt64293 Germany TU Darmstadt Fachbereich Mathematik Germany ZIB-A2IM Germany TU Berlin Germany ZIB-A2IM Software and Algorithms for Discrete Optimization Institute of Mathematics TU Berlin Germany GAMS Software GmbH c/o ZIB-AIS2T Germany

The SCIP Optimization Suite provides a collection of software packages for mathematical optimization centered around the constraint integer programming framework SCIP. The focus of this paper is on the role of the SCIP Optimization Suite in supporting research. SCIP's main design principles are discussed, followed by a presentation of the latest performance improvements and developments in version 8.0, which serve both as examples of SCIP's application as a research tool and as a platform for further developments. Further, the paper gives an overview of interfaces to other programming and modeling languages, new features that expand the possibilities for user interaction with the framework, and the latest developments in several extensions built upon *** Codes 90C05, 90C10, 90C11, 90C30, 90C90, 65Y05 Copyright © 2023, The Authors. All rights reserved.

关键词： Integer programming

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On σ-quasinormal subgroups of finite groups

arXiv

引用

arXiv 2018年

作者： Hu, Bin Huang, Jianhong Skiba, Alexander N. School of Mathematics and Statistics Jiangsu Normal University Xuzhou221116 China Department of Mathematics and Technologies of Programming Francisk Skorina Gomel State University Gomel246019 Belarus

Let G be a finite group and σ = {σi|i ϵ I} some partition of the set of all primes P, that is, σ = {σi|i ϵ I}, where P = Si2I σi and σi ∩ σj = φ for all i ≠ j. We say that G is σ-primary if G is a σi-group for some i. A subgroup A of G is said to be: σ-subnormal in G if there is a subgroup chain A = A0 ≤ A1 ≤ · · · ≤ An = G such that either Ai-1 E Ai or Ai/(Ai-1)Ai is σ-primary for all i = 1, . . . , n;modular in G if the following conditions hold: (i) hX,A ∩ Zi = hX,Ai ∩ Z for all X ≤ G,Z ≤ G such that X ≤ Z, and (ii) hA, Y ∩ Zi = hA, Y i ∩ Z for all Y ≤ G,Z ≤ G such that A ≤ Z. In this paper, a subgroup A of G is called σ-quasinormal in G if L is modular and σ-subnormal in G. We study σ-quasinormal subgroups of G. In particular, we prove that if a subgroup H of G is σ-quasinormal in G, then for every chief factor H/K of G between HG and HG the semidirect product (H/K) (G/CG(H/K)) is σ-*** Codes 20D10, 20D15 Copyright © 2018, The Authors. All rights reserved.

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The SCIP optimization suite 8.0

arXiv

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arXiv 2021年

作者： Bestuzheva, Ksenia Besançon, Mathieu Chen, Wei-Kun Chmiela, Antonia Donkiewicz, Tim Van Doornmalen, Jasper Eifler, Leon Gaul, Oliver Gamrath, Gerald Gleixner, Ambros Gottwald, Leona Graczyk, Christoph Halbig, Katrin Hoen, Alexander Hojny, Christopher Van Der Hulst, Rolf Koch, Thorsten Lübbecke, Marco Maher, Stephen J. Matter, Frederic Mühmer, Erik Müller, Benjamin Pfetsch, Marc E. Rehfeldt, Daniel Schlein, Steffan Schlösser, Franziska Serrano, Felipe Shinano, Yuji Sofranac, Boro Turner, Mark Vigerske, Stefan Wegscheider, Fabian Wellner, Philipp Weninger, Dieter Witzig, Jakob Zuse Institute Berlin Department AIS2T Takustr. 7 Berlin14195 Germany School of Mathematics and Statistics Beijing Institute of Technology Beijing100081 China RWTH Aachen University Lehrstuhl für Operations Research Kackertstr. 7 Aachen52072 Germany Technische Universiteit Eindhoven Department of Mathematics and Computer Science P.O. Box 513 Eindhoven5600 MB Netherlands I2DAMO GmbH Englerallee 19 Berlin14195 Germany Friedrich-Alexander Universität Erlangen-Nürnberg Department of Data Science Cauerstr. 11 Erlangen91058 Germany University of Twente Department of Discrete Mathematics and Mathematical Programming P.O. Box 217 Enschede7500 AE Netherlands Technische Universität Berlin Software and Algorithms for Discrete Optimization Straße des 17. Juni 135 Berlin10623 Germany Zuse Institute Berlin Department A2IM Takustr. 7 Berlin14195 Germany University of Exeter College of Engineering Mathematics and Physical Sciences Exeter United Kingdom Technische Universität Darmstadt Fachbereich Mathematik Dolivostr. 15 Darmstadt64293 Germany Technische Universität Berlin Straße des 17. Juni 135 Berlin10623 Germany Software and Algorithms for Discrete Optimization Institute of Mathematics Technische Universität Berlin Straße des 17. Juni 135 Berlin10623 Germany GAMS Software GmbH C/o Zuse Institute Berlin Department AIS2T Takustr. 7 Berlin14195 Germany

The SCIP Optimization Suite provides a collection of software packages for mathematical optimization centered around the constraint integer programming framework SCIP. This paper discusses enhancements and extensions contained in version 8.0 of the SCIP Optimization Suite. Major updates in SCIP include improvements in symmetry handling and decomposition algorithms, new cutting planes, a new plugin type for cut selection, and a complete rework of the way nonlinear constraints are handled. Additionally, SCIP 8.0 now supports interfaces for Julia as well as Matlab. Further, UG now includes a unified framework to parallelize all solvers, a utility to analyze computational experiments has been added to GCG, dual solutions can be postsolved by PaPILO, new heuristics and presolving methods were added to SCIP-SDP, and additional problem classes and major performance improvements are available in *** Codes 90C05, 90C10, 90C11, 90C30, 90C90, 65Y05 Copyright © 2021, The Authors. All rights reserved.

关键词： Integer programming

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ON -QUASINORMAL SUBGROUPS OF FINITE GROUPS

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Bulletin of the Australian Mathematical Society 2018年第3期99卷 413-420页

作者： BIN HU JIANHONG HUANG ALEXANDER N. SKIBA School of Mathematics and Statistics Jiangsu Normal University Xuzhou 221116 PR China email hubin118@*** School of Mathematics and Statistics Jiangsu Normal University Xuzhou 221116 PR China email jhh320@*** Department of Mathematics and Technologies of Programming Francisk Skorina Gomel State University Gomel 246019 Belarus email alexander.skiba49@***

Let $G$ be a finite group and $\unicode[STIX]{x1D70E}=\{\unicode[STIX]{x1D70E}_{i}\mid i\in I\}$ some partition of the set of all primes $\mathbb{P}$, that is, $\mathbb{P}=\bigcup _{i\in I}\unicode[STIX]{x1D70E}_{i}$ and $\unicode[STIX]{x1D70E}_{i}\cap \unicode[STIX]{x1D70E}_{j}=\emptyset$ for all $i\neq j$. We say that $G$ is $\unicode[STIX]{x1D70E}$-primary if $G$ is a $\unicode[STIX]{x1D70E}_{i}$-group for some $i$. A subgroup $A$ of $G$ is said to be: $\unicode[STIX]{x1D70E}$-subnormal in$G$ if there is a subgroup chain $A=A_{0}\leq A_{1}\leq \cdots \leq A_{n}=G$ such that either $A_{i-1}\unlhd A_{i}$ or $A_{i}/(A_{i-1})_{A_{i}}$ is $\unicode[STIX]{x1D70E}$-primary for all $i=1,\ldots ,n$; modular in$G$ if the following conditions hold: (i) $\langle X,A\cap Z\rangle =\langle X,A\rangle \cap Z$ for all $X\leq G,Z\leq G$ such that $X\leq Z$ and (ii) $\langle A,Y\cap Z\rangle =\langle A,Y\rangle \cap Z$ for all $Y\leq G,Z\leq G$ such that $A\leq Z$; and $\unicode[STIX]{x1D70E}$-quasinormal in$G$ if $A$ is modular and $\unicode[STIX]{x1D70E}$-subnormal in $G$. We study $\unicode[STIX]{x1D70E}$-quasinormal subgroups of $G$. In particular, we prove that if a subgroup $H$ of $G$ is $\unicode[STIX]{x1D70E}$-quasinormal in $G$, then every chief factor $H/K$ of $G$ between $H^{G}$ and $H_{G}$ is $\unicode[STIX]{x1D70E}$-central in$G$, that is, the semidirect product $(H/K)\rtimes (G/C_{G}(H/K))$ is $\unicode[STIX]{x1D70E}$-primary.

关键词： finite group 𝜎-nilpotent group 𝜎-subnormal subgroup modular subgroup 𝜎-quasinormal subgroup

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Imbalanced randomization in clinical trials

arXiv

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arXiv 2018年

作者： Chandereng, Thevaa Wei, Xiaodan Chappell, Rick Department of Statistics University of Wisconsin-Madison WI United States Department of Biostatistics & Medical Informatics University of Wisconsin-Madison WI United States Morgridge Institute of Research WI United States Biostatistics and Programming Sanofi BridgewaterNJ United States

Randomization is a common technique used in clinical trials to eliminate potential bias and confounders in a patient population. Equal allocation to treatment groups is the standard due to its optimal efficiency in many cases. However, in certain scenarios, unequal allocation can improve efficiency. In superiority trials with more than two groups, the optimal randomization is not always a balanced randomization. In non-inferiority trials, additive margin with equal variance is the only instance with balanced randomization. Optimal randomization for non-inferiority trials can be far from 1:1 and can greatly improve efficiency, a fact which is commonly overlooked. A tool for sample size calculation for non-inferiority trials with additive or multiplicative margin with normal, binomial or Poisson distribution is available at http://***/shiny/SSNI/. Copyright © 2018, The Authors. All rights reserved.

关键词： Efficiency

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Cardiac Troponin I and Cardiovascular Risk in Patients With Chronic Obstructive Pulmonary Disease (vol 72, pg 1126, 2018)

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JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY 2018年第18期72卷 2282-2282页

作者： Adamson, P. D. Anderson, J. A. Brook, R. D. Calverley, P. M. A. Celli, B. R. Cowans, N. J. Crim, C. Dixon, I. J. Martinez, F. J. Newby, D. E. Vestbo, J. Yates, J. C. Mills, N. L. [a]British Heart Foundation Centre for Cardiovascular Science University of Edinburgh Edinburgh United Kingdom [b]Research & Development GSK Stockley Park Middlesex United Kingdom [c]Division of Cardiovascular Medicine University of Michigan Ann Arbor Michigan [d]Department of Medicine Clinical Sciences Centre University of Liverpool University Hospital Aintree Liverpool United Kingdom [e]Pulmonary and Critical Care Division Brigham and Women’s Hospital Harvard Medical School Boston Massachusetts [f]Statistics and Programming Veramed Twickenham United Kingdom [g]Research & Development GSK Research Triangle Park North Carolina [h]Joan and Sanford I. Weill Department of Medicine Weill Cornell Medicine New York New York [i]Division of Infection Immunity and Centre for Respiratory Medicine and Allergy Manchester Academic Health Science Centre The University of Manchester and Manchester University NHS Foundation Trust Manchester United Kingdom

Background Patients with chronic obstructive pulmonary disease (COPD) have increased risk of cardiovascular *** This study evaluated the association between high-sensitivity cardiac troponin I concentration and cardiovascular events in patients with COPD and heightened cardiovascular *** In a double-blind randomized controlled trial, 16,485 patients with COPD and cardiovascular disease or risk factors were randomized to once daily inhaled placebo, fluticasone furoate (100 μg), vilanterol (25 μg), or their combination. Plasma high-sensitivity cardiac troponin I concentrations were measured in a subgroup of 1,599 patients. Outcomes were on-treatment cardiovascular events and COPD exacerbations over a median of 18 months, and cardiovascular death over a median of 27 *** Baseline plasma cardiac troponin I concentrations were above the limit of detection (1.2 ng/l) in 1,542 (96%) patients. Concentrations were unaffected by inhaled therapies at 3 months (p > 0.05). Compared with the lowest quintile (cardiac troponin <2.3 ng/l), patients in the highest quintile (≥7.7 ng/l) were at greater risk of cardiovascular events (hazard ratio [HR] 3.7; 95% confidence interval [CI]: 1.3 to 10.1; p = 0.012) and cardiovascular death (HR: 20.1; 95% CI: 2.4 to 165.2; p = 0.005) after adjustment for risk factors. By contrast, there were no differences in exacerbations between quintiles (HR: 1.1; 95% CI: 0.8 to 1.5; p = 0.548).Conclusions In patients with COPD and heightened cardiovascular risk, plasma cardiac troponin I concentrations are a specific and major indicator of future cardiovascular events and cardiovascular death. Inhaled therapies did not affect cardiac troponin I concentrations consistent with their neutral effect on mortality and cardiovascular outcomes. (Study to Evaluate the Effect of Fluticasone Furoate/Vilanterol on Survival in Subjects With Chronic Obstructive Pulmonary Disease [SUMMIT]; NCT01313676)

关键词： cardiac troponin cardiovascular risk chronic obstructive pulmonary disease

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On generalized σ-soluble groups

arXiv

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arXiv 2017年

作者： Huang, Jianhong Hu, Bin Skiba, Alexander N. School of Mathematics and Statistics Jiangsu Normal University Xuzhou221116 China Department of Mathematics and Technologies of Programming Francisk Skorina Gomel State University Gomel246019 Belarus

Let σ = {σi|i ∈ I} be a partition of the set of all primes P and G a finite group. Let σ(G) = {σi: σi∩ π(G) 6= Ø. A set H of subgroups of G is said to be a complete Hall σ-set of G if every member ≠ 1 of H is a Hall σi-subgroup of G for some i ∈ I and H contains exactly one Hall σi-subgroup of G for every i such that σi∈ σ (G). We say that G is σ-full if G possesses a complete Hall σ-set. A complete Hall σ-set H of G is said to be a σ-basis of G if every two subgroups A,B ∈ H are permutable, that is, AB = BA. In this paper, we study properties of finite groups having a σ-basis. In particular, we prove that if G has a a σ-basis, then G is generalized σ-soluble, that is, G has a complete Hall σ-set and for every chief factor H/K of G we have |σ (H/K)| ≤ 2. Moreover, answering to Problem 8.28 in [3], we prove the following Theorem A. Suppose that G is σ-full. Then every complete Hall σ-set of G forms a σ-basis of G if and only if G is generalized σ-soluble and for the automorphism group G/CG(H/K), induced by G on any its chief factor H/K, we have either σ (H/K) = σ (G/CG(H/K)) or σ (H/K) = {σi} and G/CG(H/K) is a σi∪ σj-group for some i ≠ j. Copyright © 2017, The Authors. All rights reserved.

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