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arXiv 2020年

作者： Jin, Jin Riviere, Marie-Karelle Luo, Xiaodong Dong, Yingwen Department of Biostatistics Johns Hopkins Bloomberg School of Public Health BaltimoreMD United States Department of Biostatistics and Programming Research and Development Sanofi Chilly-Mazarin France Department of Biostatistics and Programming Sanofi BridgewaterNJ United States Department of Biostatistics and Programming Oncology Sanofi CambridgeMA United States

Research in oncology has changed the focus from histological properties of tumors in a specific organ to a specific genomic aberration potentially shared by multiple cancer types. This motivates the basket trial, which assesses the efficacy of treatment simultaneously on multiple cancer types that have a common aberration. Although the assumption of homogeneous treatment effects seems reasonable given the shared aberration, in reality, the treatment effect may vary by cancer type, and potentially only a subgroup of the cancer types respond to the treatment. Various approaches have been proposed to increase the trial power by borrowing information across cancer types, which, however, tend to inflate the type I error rate. In this paper, we review some representative Bayesian information borrowing methods for the analysis of early-phase basket trials. We then propose a novel method called the Bayesian hierarchical model with a correlated prior (CBHM), which conducts more flexible borrowing across cancer types according to sample similarity. We did simulation studies to compare CBHM with independent analysis and three information borrowing approaches: the conventional Bayesian hierarchical model, the EXNEX approach and Liu's two-stage approach. Simulation results show that all information borrowing approaches substantially improve the power of independent analysis if a large proportion of the cancer types truly respond to the treatment. Our proposed CBHM approach shows an advantage over the existing information borrowing approaches, with a power similar to that of EXNEX or Liu's approach, but the potential to provide substantially better control of type I error rate. Copyright © 2020, The Authors. All rights reserved.

关键词： Diseases

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9O Phase I/II, open-label, first-in-human study of the anti-GPC3 T cell engager SAR444200 in patients with advanced solid tumors: Updated safety and pharmacokinetic analysis

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ESMO Open 2025年 10卷 104165-104165页

作者： Almhanna, K. Hong, J.Y. Chenard-Poirier, M. Ryoo, B-Y. Lim, D.W-T. El-Khoueiry, A.B. Goh, B-C. Samol, J. Kefsi, A. Perez, R. Meng, R. Masciari, S. Abbadessa, G. Guillemin-Paveau, H. Lepine, L. Zhang, Y. Dumbrava, E.E. Medical Oncology Warren Alpert Medical School of Brown University Providence United States of America Hematology-Oncology Samsung Medical Center (SMC) Seoul Republic of Korea Gastrointestinal Cancer Unit Centre Intégré de Cancérologie - Chu de Québec Québec Canada Department of Oncology Asan Medical Center - University of Ulsan Seoul Republic of Korea Medical Oncology Department NCCS - National Cancer Centre Singapore Medical Oncology Division USC - Kenneth J. Norris Jr. Comprehensive Cancer Center Los Angeles United States of America Hematology-Oncology NCIS - National University Cancer Institute Singapore Singapore Medical Oncology Department National Healthcare Group - Tan Tock Seng Hospital Singapore Oncology Early Development Sanofi Vitry-sur-Seine France Immuno Modulatory Agents-Early Development Sanofi Bridgewater United States of America Research and Development Department Sanofi Cambridge United States of America Early Development in Oncology Sanofi Cambridge United States of America Oncology Early Development Sanofi Cambridge United States of America Pharmacokinetics/Pharmacodynamics VA Sanofi Vitry-sur-Seine France Pharmacokinetics Dynamics and Metabolism Sanofi Vitry-sur-Seine France Department of Biostatistics and Programming Sanofi Cambridge United States of America Investigational Cancer Therapeutics Department The University of Texas MD Anderson Cancer Center - Main Building Houston United States of America

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Bayesian dose-regimen assessment in early phase oncology incorporating pharmacokinetics and pharmacodynamics

arXiv

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arXiv 2020年

作者： Gerard, Emma Zohar, Sarah Thai, Hoai-Thu Lorenzato, Christelle Riviere, Marie-Karelle Ursino, Moreno Centre de Recherche des Cordeliers Sorbonne Université Inserm Université de Paris ParisF-75006 France Oncology biostatistics Biostatistics and Programming department Sanofi R&D Vitry-sur-Seine France Statistical Methodology Group Biostatistics and Programming department Sanofi R&D Chilly-Mazarin France Translation Disease Modeling Digital and Data Science Sanofi R&D Chilly-Mazarin France F-CRIN PARTNERS platform AP-HP Université de Paris Paris France

Phase I dose-finding trials in oncology seek to find the maximum tolerated dose (MTD) of a drug under a specific schedule. Evaluating drug-schedules aims at improving treatment safety while maintaining efficacy. However, while we can reasonably assume that toxicity increases with the dose for cytotoxic drugs, the relationship between toxicity and multiple schedules remains elusive. We proposed a Bayesian dose-regimen assessment method (DRtox) using pharmacokinetics/pharmacodynamics (PK/PD) information to estimate the maximum tolerated dose-regimen (MTD-regimen), at the end of the dose-escalation stage of a trial to be recommended for the next phase. We modeled the binary toxicity via a PD endpoint and estimated the dose-regimen toxicity relationship through the integration of a dose-regimen PD model and a PD toxicity model. For the dose-regimen PD model, we considered nonlinear mixed-effects models, and for the PD toxicity model, we proposed the following two Bayesian approaches: a logistic model and a hierarchical model. We evaluated the operating characteristics of the DRtox through simulation studies under various scenarios. The results showed that our method outperforms traditional model-based designs demonstrating a higher percentage of correctly selecting the MTD-regimen. Moreover, the inclusion of PK/PD information in the DRtox helped provide more precise estimates for the entire dose-regimen toxicity curve;therefore the DRtox may recommend alternative untested regimens for expansion cohorts. The DRtox should be applied at the end of the dose-escalation stage of an ongoing trial for patients with relapsed or refractory acute myeloid leukemia (NCT03594955) once all toxicity and PK/PD data are collected. © 2020, CC-BY.

关键词： Toxicity

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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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Baseline Characteristics Of Patients With Chronic Myeloid Leukemia In a Prospective Observational Study (SIMPLICITY)

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BLOOD 2013年第21期122卷 4026-4029页

作者： Cortes, Jorge E. Hehlmann, Rudiger Gambacorti-Passerini, Carlo Goldberg, Stuart Khoury, H. Jean Mauro, Michael Michallet, Mauricette Paquette, Ron Simonsson, Bengt Foreman, Aimee Mohamed, Hesham Zyczynski, Teresa Hirji, Ishan Davis, Catherine Department of Leukemia The University of Texas MD Anderson Cancer Center Houston TX USA Department of Hematology/ Oncology University of Heidelberg Mannheim Germany Department of Internal Medicine and Clinical Research Unit University of Milano-Bicocca Monza Italy Division of Leukemia John Theurer Cancer Center at Hackensack University Medical Center Hackensack NJ USA Department of Hematology and Medical Oncology Winship Cancer Institute of Emory University Emory University Atlanta GA USA Memorial Sloan Kettering Cancer Center New York NY USA Centre Hospitalier Lyon Sud Pierre Benite France Ronald Reagan UCLA Medical Center University of California Los Angeles Los Angeles CA USA Department of Medical Sciences Hematology Uppsala University Hospital Uppsala Sweden ICON Clinical Research Biostatistics & Programming San Francisco CA USA Bristol-Myers Squibb Plainsboro NJ USA Global Health Economics and Outcomes Research Bristol-Myers Squibb Co. Princeton NJ USA Oncology Global Health Outcomes Bristol-Myers Squibb Co. Wallingford CT USA

4026

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187P Impact of KRAS mutational status and primary tumor location on the efficacy of aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer: An exploratory analysis in a phase II study

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Annals of oncology 2017年第SUPPL_10期28卷

作者： K Yamazaki T Satoh Y Komatsu T Taguchi Y Sunaga T Yoshino Gastroenterology Surgery Oncology Shizuoka Cancer Center Sunto Gun Japan Graduate School of Medicine Osaka University Suita Japan Cancer Center Hokkaido University Hospital Sapporo Japan Medical Sanofi Japan Tokyo Japan Biostatistics & Programming Sanofi Japan Tokyo Japan Department of Gastroenterology and Gastrointestinal Oncology National Cancer Center Hospital East Kashiwa Japan

187P Impact of KRAS mutational status and primary tumor location on the efficacy of aflibercept plus FOLFIRI in Japanese patients with metastatic colorectal cancer: An exploratory analysis in a phase II study K Yamazaki Gastroenterology, Surgery, oncology, Shizuoka Cancer Center, Sunto Gun, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar K Yamazaki T Satoh Graduate School of Medicine, Osaka University, Suita, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Satoh Y Komatsu Cancer Center, Hokkaido University Hospital, Sapporo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar Y Komatsu T Taguchi Medical, Sanofi Japan, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Taguchi Y Sunaga biostatistics & programming, Sanofi Japan, Tokyo, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar Y Sunaga T Yoshino department of Gastroenterology and Gastrointestinal oncology, National Cancer Center Hospital East, Kashiwa, Japan Search for other works by this author on: Oxford Academic PubMed Google Scholar T Yoshino Annals of oncology, Volume 28, Issue suppl_10, 1 November 2017, mdx659.044, https://***/10.1093/annonc/mdx659.044 Published: 22 November 2017

关键词： k-ras oncogene kras2 gene

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277MO SAR439859, an oral selective estrogen receptor (ER) degrader (SERD), in ER+/ HER2- metastatic breast cancer (mBC): Biomarker analyses from a phase I/II study

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Annals of oncology 2020年 31卷 S351-S351页

作者： S. Chandarlapaty A. Bardia S. Lord H. Linden V. Pelekanou N. Ternes J. Ming V. Boutet E. Boitier A. Gosselin J. Sang Lee W. Dos-Santos Bele A. Protopopov M. Celanovic A-L. Bauchet M. Campone Medicine Memorial Sloan Kettering Cancer Center New York NY USA Medical Oncology Massachusetts General Hospital Harvard Medical School Boston MA USA Department of Oncology University of Oxford Churchill Hospital Oxford UK Department of Medicine University of Washington Medical Center Seattle WA USA Clinical Precision Oncology-Tranlsational Medicine Early Development Sanofi Cambridge MA USA Biostatistics and Programming Sanofi Paris France Oncology Sanofi Bridgewater NJ USA TMED & Biomarkers & Clinical Bioanalyses Sanofi Paris France Precision Oncology Sanofi Cambridge MA USA Molecular Profiling Precision Oncology Sanofi Paris France Oncology-OMD Sanofi Cambridge MA USA Medical Oncology Institut de Cancérologie de l'Ouest Saint-Herblain France

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1411P Tusamitamab ravtansine plus ramucirumab as 2L therapy or beyond in patients with metastatic NSq NSCLC and high CEACAM5 expression (CARMEN-LC04)

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Annals of oncology 2023年 34卷 S807-S807页

作者： G.K. Dy B.C. Cho J. Oliveira M.D. Isla Casado A. Blasco Cordellat M. Zemanova J. Roubec L. Vila Martinez L. Charbonnier C. Soufflet J. de Castro Carpeño Department of Medicine Roswell Park Comprehensive Cancer Center Buffalo NY USA Division of Medical Oncology Yonsei Cancer Center Yonsei University College of Medicine Seoul Republic of Korea Medical Oncology Service Early Phase Clinical Trial Unit-IPO Porto/RISE@CI-IPOP (Health Research Network Experimental Pathology and Therapeutics Group Research Center (CI-IPOP)/RISE@CI-IPOP (Health Research Network) Portuguese Oncology Institute of Porto (IPO Porto)/Porto Comprehensive Cancer Center Porto Portugal Medical Oncology Department Hospital Clínico Universitario Lozano Blesa Zaragoza Spain Medical Oncology Department Hospital General de Valencia Valencia Spain Department of Oncology First Faculty of Medicine Charles University and General University Hospital in Prague Prague Czech Republic Pneumooncology Nemocnice AGEL Ostrava-Vítkovice Ostrava-Vítkovice Czech Republic Oncology Department Consorci Corporació Sanitària Parc Taulí de Sabadell Sabadell Spain Biostatistics & Programming Sanofi Chilly-Mazarin France Clinical Development Sanofi Vitry-sur-Seine France Medical Oncology Service Hospital Universitario La Paz Madrid Spain

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