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819P Efficacy of dabrafenib (D) trametinib (T) plus spartalizumab (S) by baseline site of metastases in patients (pts) with previously untreated BRAF V600-mutant unresectable or metastatic melanoma: Post hoc analysis of phase III COMBI-i trial

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Annals of Oncology 2022年 33卷 S921-S922页

作者： P. Nathan J.J. Grob R. Dummer P.A. Ascierto A. Ribas C. Robert D. Schadendorf K.T. Flaherty H.A. Tawbi A. Hauschild M. Mandala R. Shah H. Banerjee R.P. Sarkar M.R. Lau G.V. Long Department of Medical Oncology Mount Vernon Cancer Centre East and North Herts NHS Trust Northwood UK Department of Dermatology and Skin Cancers Timone Hospital AP-HM Aix-Marseille University Marseille France Department of Dermatology University Hospital Zürich Skin Cancer Center Zurich Switzerland Department of Melanoma Cancer Immunotherapy & Developmental Therapeutics Istituto Nazionale Tumori - IRCCS - Fondazione Pascale Naples Italy Department of Medicine Jonsson Comprehensive Cancer Center UCLA Los Angeles CA USA Department of Dermatology Gustave Roussy Cancer Campus Grand Paris & University Paris-Saclay Villejiuf France Department of Dermatology University Hospital Essen and German Cancer Consortium Essen Germany Dana-Farber Cancer Centre Harvard Medical School and Massachusetts General Hospital Boston MA USA Melanoma Medical Oncology Department The University of Texas MD Anderson Cancer Center Houston TX USA Department of Dermatology University Hospital Schleswig-Holstein Kiel Germany Department of Medical Oncology University of Perugia and Papa Giovanni XXIII Cancer Center Hospital Perugia Italy US Medical Affairs - Melanoma Novartis Pharmaceuticals Corporation East Hanover NJ USA Analytics - Global Health Novartis Pharmaceuticals Corporation East Hanover NJ USA Biostatistics and Statistical Programming Novartis Healthcare Pvt Ltd. Hyderabad India Medical Affairs Novartis Pharma AG Basel Switzerland Department of Medical Oncology Melanoma Institute Australia The University of Sydney and Royal North Shore and Mater Hospitals North Sydney NSW Australia

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806P Updated toxicity profile and relapse-free survival outcomes using an adapted pyrexia management algorithm in patients with resected stage III BRAF V600E/K-mutant melanoma treated with adjuvant dabrafenib plus trametinib in COMBI-APlus

引用

Annals of Oncology 2022年 33卷 S914-S914页

作者： M. Del Vecchio V.G. Atkinson B. Ryll A.M. Menzies F. Aubin V. Chiarion Sileni V. Ferraresi T. Lesimple G. Rinaldi P. Saiag C. Robert C. Dutriaux H.J. Gogas L. Demidov A. Gupta H. Banerjee S. Sudhir F. Miranda M.R. Lau J.J. Grob Department of Medical Oncology and Hematology Unit of Melanoma Medical Oncology Fondazione IRCCS - Istituto Nazionale dei Tumori Milan Italy Division of Cancer Services Princess Alexandra Hospital - University of Queensland Qld Australia Melanoma Department Melanoma Patient Network Europe MPNE Uppsala Sweden Department of Medical Oncology Melanoma Institute Australia The University of Sydney Royal North Shore and Mater Hospitals Sydney NSW Australia Department of Dermatology University Hospital and Inserm Besançon France Azienda Ospedaliera Di Padova Padua Italy Sarcomas and Rare Tumors Unit IRCCS Regina Elena National Cancer Institute (IRE) Rome Italy Département d'Oncologie Médicale CLCC Eugène Marquis Rennes France Department of Surgical Oncological and Oral Sciences Section of Oncology University of Palermo Palermo Italy Service de Dermatologie Générale et Oncologique Hôpital A Paré Assistance Publique-Hôpitaux de Paris Boulogne-Billancourt France Department of Medicine Gustave Roussy and Paris-Saclay University Villejiuf France Department of Dermatology University Hospital of Bordeaux / CHU De Bordeaux Hospital Saint-André Bordeaux France First Department of Internal Medicine Laiko General Hospital National and Kapodistrian University of Athens School of Medicine Athens Greece Tumor Biotherapy N.N. Blokhin Russian Cancer Research Center Moscow Russian Federation Medical Oncology The Christie NHS Foundation Trust Manchester UK Analytics Novartis Pharmaceuticals Corporation East Hanover NJ USA Biostatistics & Statistical Programming Novartis Healthcare Private Limited Hyderabad India Clinical Operations Novartis Pharmaceuticals Corporation East Hanover NJ USA Medical Affairs Department Novartis Pharma AG Basel Switzerland Dermatology and Skin Cancer Department Aix-Marseille University Marseille France

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On some "disadvantages" of the population approach

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AAPS Journal 2005年第2期7卷 E374-E382页

作者： Nedelman, Jerry R. Biostatistics and Statistical Programming Novartis Pharmaceuticals East Hanover NJ 07936 One Health Plaza United States

In a seminal article on population pharmacokinetic modeling, researchers demonstrated how means and variances of pharmacokinetic parameters for a patient population could be inferred from sparse data collected under conditions of routine patient care. But they also identified 4 potential concerns about their methodology: unobserved confounding variables may bias the inferences;conditions under which data are collected may lead to inaccuracies of reporting or recording;correlations among important predictor variables may reduce statistical efficiency;and costs cannot be controlled by principles of study design. Experiences are reviewed that relate to these potential disadvantages. A method is presented for diagnosing the possible presence of confounding. A model is constructed and applied that captures the influences of data inaccuracies. An example of selecting from among correlated covariates is summarized. Finally, a methodology for optimal study design is reviewed and applied to an example. Copyright ©2003. All Rights Reserved.

关键词： Confounding Errors in variables Noncompliance Optimal design Variable selection

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