Daniel J Sargent

Daniel J Sargent

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Daniel J Sargent

Publications by authors named "Daniel J Sargent"

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A hierarchical Bayesian design for randomized Phase II clinical trials with multiple groups.

J Biopharm Stat 2018 7;28(3):451-462. Epub 2017 Jun 7.

a Division of Biomedical Statistics and Informatics , Mayo Clinic , Rochester , Minnesota , USA.

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http://dx.doi.org/10.1080/10543406.2017.1321007DOI Listing
July 2019

Combining Survival and Toxicity Effect Sizes from Clinical Trials: NCCTG 89-20-52 (Alliance).

Int J Stat Med Res 2018 16;7(4):137-146. Epub 2018 Nov 16.

Division of Biomedical Statistics and Bioinformatics, Mayo Clinic, Rochester, MN 55905, USA.

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http://dx.doi.org/10.6000/1929-6029.2018.07.04.4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6686677PMC
November 2018

Reporting of patient characteristics and stratification factors in phase 3 trials investigating first-line systemic treatment of metastatic colorectal cancer: A systematic review.

Eur J Cancer 2018 06 2;96:115-124. Epub 2018 May 2.

Department of Medical Oncology, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands. Electronic address:

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http://dx.doi.org/10.1016/j.ejca.2018.03.026DOI Listing
June 2018

International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study.

Authors:
Franck Pagès Bernhard Mlecnik Florence Marliot Gabriela Bindea Fang-Shu Ou Carlo Bifulco Alessandro Lugli Inti Zlobec Tilman T Rau Martin D Berger Iris D Nagtegaal Elisa Vink-Börger Arndt Hartmann Carol Geppert Julie Kolwelter Susanne Merkel Robert Grützmann Marc Van den Eynde Anne Jouret-Mourin Alex Kartheuser Daniel Léonard Christophe Remue Julia Y Wang Prashant Bavi Michael H A Roehrl Pamela S Ohashi Linh T Nguyen SeongJun Han Heather L MacGregor Sara Hafezi-Bakhtiari Bradly G Wouters Giuseppe V Masucci Emilia K Andersson Eva Zavadova Michal Vocka Jan Spacek Lubos Petruzelka Bohuslav Konopasek Pavel Dundr Helena Skalova Kristyna Nemejcova Gerardo Botti Fabiana Tatangelo Paolo Delrio Gennaro Ciliberto Michele Maio Luigi Laghi Fabio Grizzi Tessa Fredriksen Bénédicte Buttard Mihaela Angelova Angela Vasaturo Pauline Maby Sarah E Church Helen K Angell Lucie Lafontaine Daniela Bruni Carine El Sissy Nacilla Haicheur Amos Kirilovsky Anne Berger Christine Lagorce Jeffrey P Meyers Christopher Paustian Zipei Feng Carmen Ballesteros-Merino Jeroen Dijkstra Carlijn van de Water Shannon van Lent-van Vliet Nikki Knijn Ana-Maria Mușină Dragos-Viorel Scripcariu Boryana Popivanova Mingli Xu Tomonobu Fujita Shoichi Hazama Nobuaki Suzuki Hiroaki Nagano Kiyotaka Okuno Toshihiko Torigoe Noriyuki Sato Tomohisa Furuhata Ichiro Takemasa Kyogo Itoh Prabhu S Patel Hemangini H Vora Birva Shah Jayendrakumar B Patel Kruti N Rajvik Shashank J Pandya Shilin N Shukla Yili Wang Guanjun Zhang Yutaka Kawakami Francesco M Marincola Paolo A Ascierto Daniel J Sargent Bernard A Fox Jérôme Galon

Lancet 2018 05 10;391(10135):2128-2139. Epub 2018 May 10.

INSERM, Laboratory of Integrative Cancer Immunology, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France; Centre de Recherche des Cordeliers, Université Pierre et Marie Curie, Sorbonne Universités, Paris, France. Electronic address:

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http://dx.doi.org/10.1016/S0140-6736(18)30789-XDOI Listing
May 2018

Duration of Adjuvant Chemotherapy for Stage III Colon Cancer.

N Engl J Med 2018 Mar;378(13):1177-1188

From the Divisions of Medical Oncology (A.G.) and Biomedical Statistics and Informatics (Q.S., J.P.M., L.A.R., D.J.S.), Mayo Clinic, Rochester, MN; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) San Martino-IST, Genoa (A.F. Sobrero), Ospedale Papa Giovanni XXIII, Bergamo (R.L.), and IRCCS Mario Negri Institute for Pharmacological Research, Milan (V.T.) - all in Italy; Karmanos Cancer Institute, Wayne State University, Detroit (A.F. Shields); National Cancer Center Hospital East, Chiba (T. Yoshino), Yokohama City University School of Medicine, Yokohama (T. Yamanaka), and the University of Tokyo, Tokyo (T.W.) - all in Japan; the Institute of Cancer Sciences, University of Glasgow, Glasgow (J.P.), the University of Oxford, Oxford (R.K.), Christie Hospital, Manchester (M.S.), and University Hospital Southampton, Southampton (T.I.) - all in the United Kingdom; Hôpital Européen Georges-Pompidou, Sorbonne Paris Cite/Paris Descartes University (J.T.), and Saint-Antoine Hospital and Sorbonne Universités, Pierre and Marie Curie University-Paris 6 (T.A.), Paris, and Methodology and Quality of Life Unit, INSERM Unité 1098, Besançon (D.V.) - all in France; the Department of Medical Oncology, University Hospital of Heraklion, Faculty of Medicine, University of Crete, Heraklion (J.S.), and Bioclinic Thessaloniki, Thessaloniki (I.B.) - both in Greece; Dana-Farber Cancer Institute, Boston (J.A.M.); and Duke Cancer Institute, Durham, NC (D.N.).

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http://dx.doi.org/10.1056/NEJMoa1713709DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6426127PMC
March 2018

Repeated measures dose-finding design with time-trend detection in the presence of correlated toxicity data.

Clin Trials 2017 Dec 2;14(6):611-620. Epub 2017 Aug 2.

1 Department of Health Sciences Research, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1177/1740774517723829DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5714674PMC
December 2017

Altered regulation of TERMINAL FLOWER 1 causes the unique vernalisation response in an arctic woodland strawberry accession.

New Phytol 2017 Nov 16;216(3):841-853. Epub 2017 Aug 16.

Department of Agricultural Sciences, Viikki Plant Science Centre, University of Helsinki, 00014, Helsinki, Finland.

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http://dx.doi.org/10.1111/nph.14734DOI Listing
November 2017

Use of Bayesian Decision Analysis to Minimize Harm in Patient-Centered Randomized Clinical Trials in Oncology.

JAMA Oncol 2017 Sep 14;3(9):e170123. Epub 2017 Sep 14.

Laboratory for Financial Engineering, MIT Sloan School of Management, Cambridge, Massachusetts.

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http://dx.doi.org/10.1001/jamaoncol.2017.0123DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5824294PMC
September 2017

Lack of Caudal-Type Homeobox Transcription Factor 2 Expression as a Prognostic Biomarker in Metastatic Colorectal Cancer.

Clin Colorectal Cancer 2017 06 17;16(2):124-128. Epub 2016 Sep 17.

Department of Oncology, Mayo Clinic, Rochester, MN. Electronic address:

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http://dx.doi.org/10.1016/j.clcc.2016.09.003DOI Listing
June 2017

Clinical Calculator for Early Mortality in Metastatic Colorectal Cancer: An Analysis of Patients From 28 Clinical Trials in the Aide et Recherche en Cancérologie Digestive Database.

J Clin Oncol 2017 Jun 17;35(17):1929-1937. Epub 2017 Apr 17.

Lindsay A. Renfro, Axel Grothey, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Richard M. Goldberg, The Ohio State University, Columbus, OH; Alberto Sobrero, Ospedale San Martino, Genoa; Alfredo Falcone, University Hospital of Pisa, Pisa, Italy; Richard Adams, Cardiff University, Cardiff; Matthew T. Seymour, St James's Hospital and University of Leeds, Leeds, United Kingdom; Volker Heinemann, University of Munich, Munich; Hans-Joachim Schmoll, University Clinic Halle (Saale), Halle; Rainer Porschen, Klinikum Bremen-Ost Klinik für Innere Medizin, Bremen; Carsten Bokemeyer, University Hospital, Hamburg-Eppendorf, Germany; Jean-Yves Douillard, Centre René Gauducheau, Nantes; Christophe Tournigand, University of Paris Est Creteil; Christophe Tournigand, Assistance Hopitaux Publique de Paris Henri-Mondor Hospital, Créteil; Benoist Chibaudel and Aimery de Gramont, Franco-British Institute, Levallois-Perret, France; Herbert Hurwitz, Duke University Medical Center, Durham, NC; Charles S. Fuchs; Dana-Farber Cancer Institute, Boston, MA; Eduardo Diaz-Rubio, Hospital Clínico San Carlos, Universidad Complutense, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain; Paulo M. Hoff, Hospital Sírio-Libanês and University of São Paulo, São Paulo, Brazil; Fairooz F. Kabbinavar and J. Randolph Hecht, David Geffen School of Medicine at University of California at Los Angeles, Los Angeles, CA; Niall C. Tebbutt, Austin Health, Heidelberg, Victoria, Australia; Cornelis J.A. Punt, University of Amsterdam, Amsterdam, the Netherlands; John Souglakos, University of Crete, Heraklion, Greece; Eric Van Cutsem, University Hospital Leuven, Leuven, Belgium; and Leonard Saltz, Memorial Sloan Kettering Cancer Center, New York, NY.

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http://dx.doi.org/10.1200/JCO.2016.71.5771DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5466009PMC
June 2017

Prognostic Value of BRAF and KRAS Mutations in MSI and MSS Stage III Colon Cancer.

J Natl Cancer Inst 2017 05 31;109(5). Epub 2016 Dec 31.

Affiliations of authors: Department of Gastroenterology and GI Oncology, Université Paris Descartes, Hopital Européen Georges Pompidou, Paris, France (JTai); Fédération Francophone de Cancérologie Digestive (FFCD), Dijon, France (KLM); Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (QS, DJS); Department of Pathology, Centre Jean Perrin, EA ERTICa, Université d'Auvergne, Clermont-Ferrand, France (FPL); Centre Hospitalier Universitaire Robert Debré, Reims, France (OB); Medical Oncology Department, Vall d'Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain (JTab); Spanish Gastrointestinal Tumors TTD Group, Universitat Autònoma de Barcelona, Barcelona, Spain (JTab); Section of Clinical Pharmacology and Oncology, Department of Health Sciences, University of Florence, Florence, Italy (EM); Division of Medical Oncology, Ohio State University Comprehensive Cancer Center, Columbus, OH (RMG); First Medical Department, University Hospital Carl Gustav Carus, Dresden, Germany (GF); Department of Gastroenterology, Hôpital Universitaire Erasme, Brussels, Belgium (JLVL); Department of Oncology, Mayo Clinic and Mayo Cancer Center, Rochester, MN (SRA, FAS); Pathology Department, Ambroise Paré Hospital, Boulogne, France (JFE); Université Paris Descartes, Sorbonne Paris Cité, France (PLP); Assistance Publique Hôpitaux de Paris, Department of Biology, Hôpital Européen Georges Pompidou, Paris, France (PLP); INSERM UMR-S1147, Paris, France (PLP).

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http://dx.doi.org/10.1093/jnci/djw272DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6075212PMC
May 2017

Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and the American Society of Clinical Oncology.

J Clin Oncol 2017 May 6;35(13):1453-1486. Epub 2017 Feb 6.

Antonia R. Sepulveda, Columbia University, New York, NY; Stanley R. Hamilton, Scott E. Kopetz, and Bruce D. Minsky, University of Texas MD Anderson Cancer Center, Houston, TX; Carmen J. Allegra, University of Florida Medical Center, Gainesville, FL; Wayne Grody, UCLA Medical Center, Los Angeles, CA; Allison M. Cushman-Vokoun, University of Nebraska Medical Center, Omaha, NE; William K. Funkhouser, University of North Carolina School of Medicine, Chapel Hill, NC; Christopher Lieu, University of Colorado Denver School of Medicine, Denver, CO; Noralane M. Lindor, Mayo Clinic, Scottsdale, AZ; Federico A. Monzon, Castle Biosciences, Friendswood, TX; Daniel J. Sargent, Mayo Clinic, Rochester, MN; Veena M. Singh, Biocept, San Diego, CA; Joseph Willis, Case Western Reserve University, Cleveland, OH; Jennifer Clark, American Society for Clinical Pathology, Washington, DC; Carol Colasacco and Christina B. Ventura, College of American Pathologists, Northfield, IL; R. Bryan Rumble, American Society of Clinical Oncology, Alexandria, VA; Robyn Temple-Smolkin, Association for Molecular Pathology, Bethesda, MD; and Jan A. Nowak, Roswell Park Cancer Institute, Buffalo, NY.

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http://dx.doi.org/10.1200/JCO.2016.71.9807DOI Listing
May 2017

Molecular Biomarkers for the Evaluation of Colorectal Cancer: Guideline Summary From the American Society for Clinical Pathology, College of American Pathologists, Association for Molecular Pathology, and American Society of Clinical Oncology.

J Oncol Pract 2017 05 28;13(5):333-337. Epub 2017 Mar 28.

Columbia University, New York; Roswell Park Cancer Institute, Buffalo, NY; University of Texas MD Anderson Cancer Center, Houston; Castle Biosciences, Friendswood, TX; University of Florida Medical Center, Gainesville, FL; University of California Los Angeles Medical Center, Los Angeles; Biocept, San Diego, CA; University of Nebraska Medical Center, Omaha, NE; University of North Carolina School of Medicine, Chapel Hill, NC; University of Colorado Denver School of Medicine, Denver, CO; Mayo Clinic, Scottsdale, AZ; Mayo Clinic, Rochester, MN; Case Western Reserve University, Cleveland, OH; American Society for Clinical Pathology, Washington, DC; College of American Pathologists, Northfield, IL; American Society of Clinical Oncology, Alexandria, VA; and Association for Molecular Pathology, Bethesda, MD.

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http://dx.doi.org/10.1200/JOP.2017.022152DOI Listing
May 2017

Thirty-Month Complete Response as a Surrogate End Point in First-Line Follicular Lymphoma Therapy: An Individual Patient-Level Analysis of Multiple Randomized Trials.

J Clin Oncol 2017 Feb 28;35(5):552-560. Epub 2016 Dec 28.

Qian Shi and Daniel J. Sargent, Mayo Clinic, Rochester; Bruce A. Peterson, University of Minnesota, Minneapolis, MN; Christopher R. Flowers, Winship Cancer Institute of Emory University, Atlanta, GA; Wolfgang Hiddemann and Eva Hoster, Ludwig-Maximilians University Hospital, Munich; Michael Herold, HELIOS Kliniken, Erfurt, Germany; Robert Marcus, Addenbrooke's Hospital, Cambridge, United Kingdom; Anton Hagenbeek, Academic Medical Center, Amsterdam, the Netherlands; Eva Kimby, Karolinska Institutet, Stockholm, Sweden; Howard Hochster, Yale Cancer Center, New Haven, CT; Umberto Vitolo, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin; Marco Ladetto, Azienda Ospedaliera SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy; Emmanuel Gyan, University Hospital, Tours; Franck Morschhauser, Service Université de Lille 2, Lille; Gilles Salles, Université Claude Bernard, Pierre Bénite, France; Michele Ghielmini and Emanuele Zucca, Oncology Institute of Southern Switzerland, Bellinzona; Michele Ghielmini and Emanuele Zucca, Swiss Group for Clinical Cancer Research, Bern; Tina Nielsen, F. Hoffmann-La Roche, Basel; Sabine De Bedout, Celgene, Boudry, Switzerland; Tommy Fu, Celgene, Summit, NJ; Nancy Valente, Genentech, South San Francisco, CA; and Nathan H. Fowler, University of Texas MD Anderson Cancer Center, Houston, TX.

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http://dx.doi.org/10.1200/JCO.2016.70.8651DOI Listing
February 2017

A Bayesian dose-finding design incorporating toxicity data from multiple treatment cycles.

Stat Med 2017 01 15;36(1):67-80. Epub 2016 Sep 15.

Department of Health Sciences Research, Mayo Clinic, 55905, Rochester, MN, U.S.A.

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http://dx.doi.org/10.1002/sim.7134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5138146PMC
January 2017

Estimation of tumour regression and growth rates during treatment in patients with advanced prostate cancer: a retrospective analysis.

Lancet Oncol 2017 01 13;18(1):143-154. Epub 2016 Dec 13.

Division of Medical Oncology, Department of Medicine, Columbia University/New York Presbyterian Hospital, Manhattan, NY, USA; James J Peters VA Medical Center, Bronx, NY, USA. Electronic address:

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http://dx.doi.org/10.1016/S1470-2045(16)30633-7DOI Listing
January 2017

Beyond Composite Endpoints Analysis: Semicompeting Risks as an Underutilized Framework for Cancer Research.

J Natl Cancer Inst 2016 12 5;108(12). Epub 2016 Jul 5.

Department of Biostatistics, Harvard T. H. Chan School of Public Health, Boston, MA (IJ, SH); Division of Population Sciences, Dana Farber Cancer Institute, Boston, MA (DS); Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN (DJS).

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http://dx.doi.org/10.1093/jnci/djw154DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5241896PMC
December 2016

Findings from the Adjuvant Colon Cancer End Points (ACCENT) Collaborative Group: the power of pooled individual patient data from multiple clinical trials.

Chin Clin Oncol 2016 Dec;5(6):80

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA.

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http://dx.doi.org/10.21037/cco.2016.12.02DOI Listing
December 2016

Surrogate End Points in Soft Tissue Sarcoma: Methodologic Challenges.

J Clin Oncol 2016 11;34(32):3949-3950

Lindsay A. Renfro, Qian Shi, and Daniel J. Sargent, Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.1200/JCO.2016.67.8730DOI Listing
November 2016

Enrollment Trends and Disparity Among Patients With Lung Cancer in National Clinical Trials, 1990 to 2012.

J Clin Oncol 2016 11 30;34(33):3992-3999. Epub 2016 Sep 30.

Herbert H. Pang and Perry Cheng, School of Public Health, Li Ka Shing Faculty of Medicine, Hong Kong, Special Administrative Region, People's Republic of China; Herbert H. Pang, Xiaofei Wang, Ying Zhang, Thomas E. Stinchcombe, and Harvey J. Cohen, Duke University School of Medicine, Durham, NC; Melisa L. Wong, Helen Diller Family Comprehensive Cancer Center, University of California, San Francisco, San Francisco; David Gandara, University of California, Davis Comprehensive Cancer Center, Sacramento, CA; Apar Kishor Ganti, Veterans Affairs Nebraska Western Iowa Health Care System and University of Nebraska Medical Center, Omaha, NE; Daniel J. Sargent and Sumithra J. Mandrekar, Mayo Clinic, Rochester, MN; Chen Hu, NRG Oncology Statistics and Data Management Center, Philadelphia, PA; Chen Hu, Johns Hopkins University School of Medicine, Baltimore, MD; Mary W. Redman, Fred Hutchinson Cancer Research Center, Seattle, WA; Judith B. Manola, Dana-Farber Cancer Institute, Boston, MA; Richard L. Schilsky, ASCO, Alexandria, VA; Jeffrey D. Bradley, Washington University School of Medicine, St Louis, MO; Alex A. Adjei, Roswell Park Cancer Institute, Buffalo, NY; Suresh S. Ramalingam, The Winship Cancer Institute of Emory University, Atlanta, GA; and Everett E. Vokes, University of Chicago, Chicago, IL.

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http://dx.doi.org/10.1200/JCO.2016.67.7088DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5477832PMC
November 2016

Further Evaluating the Benefit of Adjuvant Chemotherapy for Colon Cancer.

J Clin Oncol 2016 Oct;34(30):3711-3712

Mayo Clinic, Rochester, MN.

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http://dx.doi.org/10.1200/JCO.2016.68.4886DOI Listing
October 2016

American Joint Committee on Cancer acceptance criteria for inclusion of risk models for individualized prognosis in the practice of precision medicine.

CA Cancer J Clin 2016 09 19;66(5):370-4. Epub 2016 Jan 19.

Professor, Life Science, Arizona State University, Tempe, AZ; Professor, Laboratory Medicine and Pathology, Mayo Clinic School of Medicine, Rochester, MN; Chief Medical Officer, National Biomarker Development Alliance, Scottsdale, AZ.

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http://dx.doi.org/10.3322/caac.21339DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4955656PMC
September 2016

Adjuvant Therapy for Colon Cancer: Small Steps Toward Precision Medicine.

JAMA Oncol 2016 Sep;2(9):1133-4

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota.

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http://dx.doi.org/10.1001/jamaoncol.2016.2304DOI Listing
September 2016

New insights into the evaluation of randomized controlled trials for rare diseases over a long-term research horizon: a simulation study.

Stat Med 2016 08 30;35(19):3245-58. Epub 2016 Mar 30.

Biostatistics and Epidemiology Unit, Gustave Roussy, Villejuif, France.

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http://dx.doi.org/10.1002/sim.6942DOI Listing
August 2016

One good DNA-damage deserves another: Oxaliplatin in MSI-high colon cancer.

J Natl Cancer Inst 2016 Jul 5;108(7). Epub 2016 Feb 5.

Yale Cancer Center and School of Medicine, New Haven CT Mayo Clinic, Rochester MN.

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http://dx.doi.org/10.1093/jnci/djw011DOI Listing
July 2016

Flexible Bayesian survival modeling with semiparametric time-dependent and shape-restricted covariate effects.

Bayesian Anal 2016 Jun 14;11(2):381-402. Epub 2015 May 14.

Division of Biostatistics, The University of Minnesota.

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http://dx.doi.org/10.1214/15-BA954DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4811615PMC
June 2016

Impact of Copula Directional Specification on Multi-Trial Evaluation of Surrogate End Points.

J Biopharm Stat 2015 ;25(4):857-77

a Division of Biomedical Statistics and Informatics , Mayo Clinic , Rochester , Minnesota , USA.

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http://dx.doi.org/10.1080/10543406.2014.920870DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4270950PMC
April 2016

Determinants of Early Mortality Among 37,568 Patients With Colon Cancer Who Participated in 25 Clinical Trials From the Adjuvant Colon Cancer Endpoints Database.

J Clin Oncol 2016 Apr 8;34(11):1182-9. Epub 2016 Feb 8.

Winson Y. Cheung, British Columbia Cancer Agency, Vancouver, British Columbia; Chris O'Callaghan, Queen's University, Kingston, Ontario, Canada; Lindsay A. Renfro, Axel Grothey, Steven R. Alberts, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; David Kerr, University of Oxford, Oxford; Chris Twelves, University of Leeds and St James Institute of Oncology, Leeds, United Kingdom; Aimery de Gramont, Franco-British Institute, Levallois-Perret; Thierry Andre, Hospital Saint-Antoine and Pierre and Marie Curie University, Paris; Jean-Francois Seitz, La Timone Hospital, Aix-Marseille University, Marseille, France; Leonard B. Saltz, Memorial Sloan Kettering Cancer Center, New York, NY; Katherine A. Guthrie, Fred Hutchinson Cancer Center, Seattle, WA; Roberto Labianca, Ospedale Giovanni XXIII, Bergamo; Guido Francini, University of Siena, Siena, Italy; Eric Van Cutsem, University Hospital Leuven, Leuven, Belgium; Daniel G. Haller, University of Pennsylvania, Philadelphia; and Greg Yothers, University of Pittsburgh, Pittsburgh, PA.

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http://dx.doi.org/10.1200/JCO.2015.65.1158DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4933130PMC
April 2016

Association between DPYD c.1129-5923 C>G/hapB3 and severe toxicity to 5-fluorouracil-based chemotherapy in stage III colon cancer patients: NCCTG N0147 (Alliance).

Pharmacogenet Genomics 2016 Mar;26(3):133-7

aDepartment of Molecular Pharmacology and Experimental Therapeutics (MPET), Mayo Clinic Cancer Center bAlliance Statistics and Data Center cDivision of Medical Oncology dDivision of Gastroenterology, Mayo Clinic, Rochester, Minnesota eDepartment of Surgery, Cancer Prevention and Control Program, University of Hawaii Cancer Center, Honolulu, Hawaii fDepartment of Medicine, Center for GI Oncology, The University of Chicago Medicine, Chicago, Illinois gDivision of Hematology Oncology, Vanderbilt-Ingram Cancer Center, Nashville, Tennessee hSurgical Oncology Associates of South Texas, San Antonio, Texas iDepartment of Hematology Oncology, Lehigh Valley Health Network, John and Dorthy Morgan Cancer Center, Allentown, Pennsylvania jDepartment of Oncology, Barbara Ann Karmanos Cancer Institute, Wayne State University, Detroit, Michigan kDepartment of Hematology/Oncology, Division of Medical Oncology, The Ohio State University Medical Center, Columbus, Ohio, USA lDepartment of Medicine, Division of Medical Oncology, University of British Columbia, British Columbia Cancer Agency, Vancouver, British Columbia, Canada.

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http://dx.doi.org/10.1097/FPC.0000000000000197DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4738010PMC
March 2016

Impact of Patient Factors on Recurrence Risk and Time Dependency of Oxaliplatin Benefit in Patients With Colon Cancer: Analysis From Modern-Era Adjuvant Studies in the Adjuvant Colon Cancer End Points (ACCENT) Database.

J Clin Oncol 2016 Mar 25;34(8):843-53. Epub 2016 Jan 25.

Manish A. Shah, Weill Cornell Medical College, New York/Presbyterian Hospital, New York, NY; Lindsay A. Renfro, Steven R. Alberts, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Carmen J. Allegra, University of Florida, Gainesville, FL; Thierry André, Hôpital Saint Antoine, Paris; Aimery de Gramont, Franco-British Institute, Levallois-Perret, France; Hans-Joachim Schmoll, University Clinic Halle (Saale), Halle, Germany; Daniel G. Haller, University of Pennsylvania, Philadelphia; and Greg Yothers, National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA.

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http://jco.ascopubs.org/content/early/2016/01/21/JCO.2015.63
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http://jco.ascopubs.org/cgi/doi/10.1200/JCO.2015.63.0558
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http://dx.doi.org/10.1200/JCO.2015.63.0558DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4872008PMC
March 2016

Clinical trial designs incorporating predictive biomarkers.

Cancer Treat Rev 2016 Feb 5;43:74-82. Epub 2016 Jan 5.

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.

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http://dx.doi.org/10.1016/j.ctrv.2015.12.008DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4737867PMC
February 2016

Body Mass Index Is Prognostic in Metastatic Colorectal Cancer: Pooled Analysis of Patients From First-Line Clinical Trials in the ARCAD Database.

J Clin Oncol 2016 Jan 26;34(2):144-50. Epub 2015 Oct 26.

Lindsay A. Renfro and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Fotios Loupakis and Alfredo Falcone, Azienda Ospedaliero-Universitaria Pisana and Università di Pisa, Pisa, Italy; Richard Adams, Cardiff University, Cardiff; Matthew T. Seymour, St James's Hospital and University of Leeds, Leeds, United Kingdom; Volker Heinemann, University of Munich, Munich; Hans-Joachim Schmoll, University Clinic Halle (Saale), Halle; Rainer Porschen, Klinikum Bremen-Ost Klinik für Innere Medizin, Bremen; Carsten Bokemeyer, University Hospital Cancer Center, University Hospital, Hamburg-Eppendorf, Germany; Jean-Yves Douillard, Institut de Cancerologie, Centre René Gauducheau, Nantes; Christophe Tournigand, University of Paris Est Creteil, Henri-Mondor Hospital, Créteil; Benoist Chibaudel and Aimery de Gramont, Franco-British Institute, Levallois-Perret, France; Herbert Hurwitz, Duke University Medical Center, Durham, NC; Charles S. Fuchs, Dana-Farber Cancer Institute Boston, MA; Eduardo Diaz-Rubio, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos, Madrid, Spain; Niall C. Tebbutt, Austin Health, Heidelberg, Victoria, Australia; Cornelis J.A. Punt, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands; J. Randolph Hecht, David Geffen School of Medicine at the University of California at Los Angeles; Heinz-Josef Lenz, University of Southern California/Norris Comprehensive Cancer Center, Keck School of Medicine, Los Angeles, CA; Eric Van Cutsem, University Hospital Leuven, Leuven, Belgium; Richard M. Goldberg, Ohio State University, Columbus, OH; and Leonard B. Saltz, Memorial Sloan-Kettering Cancer Center, New York, NY.

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January 2016

Clinical Utility of Metrics Based on Tumor Measurements in Phase II Trials to Predict Overall Survival Outcomes in Phase III Trials by Using Resampling Methods.

J Clin Oncol 2015 Dec 26;33(34):4048-57. Epub 2015 Oct 26.

Ming-Wen An, Vassar College, Poughkeepsie, NY; Yu Han, Novartis Pharmaceuticals, East Hanover NJ; Jeffrey Meyers, Daniel J. Sargent, and Sumithra J. Mandrekar, Mayo Clinic, Rochester, MN; and Jan Bogaerts, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.

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December 2015

Evaluating Continuous Tumor Measurement-Based Metrics as Phase II Endpoints for Predicting Overall Survival.

J Natl Cancer Inst 2015 Nov 21;107(11). Epub 2015 Aug 21.

Department of Mathematics, Vassar College, Poughkeepsie, NY (MWA); Department of Biostatistics, Analytical Science, Takeda Pharmaceuticals, Deerfield, IL (XD); Department of Health Sciences Research, Mayo Clinic, Rochester, MN (JM, DJS, SJM); Biometrics and Data Management Department, Novartis Pharmaceuticals Corporation, East Hanover, NJ (YH); Department of Oncology, Mayo Clinic, Rochester, MN (AG); European Organisation for Research and Treatment of Cancer (EORTC), Brussels, Belgium (JB).

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http://dx.doi.org/10.1093/jnci/djv239DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4643633PMC
November 2015

Validation of survival prognostic models for non-small-cell lung cancer in stage- and age-specific groups.

Lung Cancer 2015 Nov 18;90(2):281-7. Epub 2015 Aug 18.

Department of Biostatistics & Bioinformatics and Alliance Statistics and Data Center, Duke University, Durham, NC, United States; School of Public Health, Li Ka Shing Faculty of Medicine, The University of Hong Kong, Hong Kong SAR, China.

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November 2015

Molecular genetics and genomics of the Rosoideae: state of the art and future perspectives.

Hortic Res 2014 22;1. Epub 2014 Jan 22.

Research and Innovation Centre , Fondazione Edmund Mach, San Michele all'Adige, Italy.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4591673PMC
October 2015

Racial Differences in BRAF/KRAS Mutation Rates and Survival in Stage III Colon Cancer Patients.

J Natl Cancer Inst 2015 Oct 9;107(10). Epub 2015 Jul 9.

Mayo Clinic, Rochester, MN (HHY, SRA, SNT, FAS); Alliance Statistics and Data Center, Mayo Clinic, Rochester, MN (QS, DJS); Division of Medical Oncology, The Ohio State University, Columbus, OH (RMG).

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5758035PMC
October 2015

Introduction to special issue on biomarker-based clinical trial designs in oncology.

Chin Clin Oncol 2015 Sep;4(3):28

Division of Medical Oncology, Mayo Clinic, Rochester, MN, USA.

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September 2015

Genotype-based clinical trials in cardiovascular disease.

Nat Rev Cardiol 2015 Aug 5;12(8):475-87. Epub 2015 May 5.

Division of Cardiovascular Diseases, Department of Internal Medicine, 200 First Street SW, Rochester, MN 55905, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4687401PMC
August 2015

The Fundamental Difficulty With Evaluating the Accuracy of Biomarkers for Guiding Treatment.

J Natl Cancer Inst 2015 Aug 24;107(8). Epub 2015 Jun 24.

Divisions of Vaccine and Infectious Disease and Public Health Sciences, Fred Hutchinson Cancer Research Center, Seattle, Washington (HJ, MSP); Department of Biostatistics, University of Washington, Seattle, Washington (HJ, MSP, PJH); Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, National Institutes of Health, Rockville, Maryland (LMM); Department of Health Science Research, Mayo Clinic, Rochester, Minnesota (DJS).

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4609557PMC
August 2015

Germline variation in colorectal risk Loci does not influence treatment effect or survival in metastatic colorectal cancer.

PLoS One 2014 11;9(4):e94727. Epub 2014 Apr 11.

DeBartolo Family Personalized Medicine Institute, Division of Population Sciences, Moffitt Cancer Center, Tampa, Florida, United States of America.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3984266PMC
May 2015

Raising the bar for antineoplastic agents: how to choose threshold values for superiority trials in advanced solid tumors.

Clin Cancer Res 2015 Mar 17;21(5):1036-43. Epub 2014 Sep 17.

Medical Oncology and Epidemiology, IRCCS AOU San Martino IST, Genova, Italy.

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March 2015

Key statistical concepts in cancer research.

Clin Adv Hematol Oncol 2015 Mar;13(3):180-5

Department of Health Science Research, Mayo Clinic, Rochester, Minnesota.

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March 2015

Randomized phase II clinical trials.

J Biopharm Stat 2014 ;24(4):802-16

a Department of Biostatistics and Bioinformatics , Duke University , Durham , North Carolina , USA.

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http://dx.doi.org/10.1080/10543406.2014.901343DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4024090PMC
January 2015

Resampling the N9741 trial to compare tumor dynamic versus conventional end points in randomized phase II trials.

J Clin Oncol 2015 Jan 27;33(1):36-41. Epub 2014 Oct 27.

Manish R. Sharma, Elizabeth Gray, and Theodore G. Karrison, University of Chicago, Chicago, IL; Richard M. Goldberg, Ohio State University, Columbus, OH; and Daniel J. Sargent, Mayo Clinic, Rochester, MN.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4268251PMC
January 2015

Individual patient data analysis of progression-free survival versus overall survival as a first-line end point for metastatic colorectal cancer in modern randomized trials: findings from the analysis and research in cancers of the digestive system database.

J Clin Oncol 2015 Jan 10;33(1):22-8. Epub 2014 Nov 10.

Qian Shi, Axel Grothey, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Aimery de Gramont and Benoist Chibaudel, Hospital Saint Antoine; Christophe Tournigand, Université Paris Est Créteil, Paris; Jean-Yves Douillard, Institute of Cancer Research in Western, St Herblain, France; John Zalcberg, Monash University; Niall C. Tebbutt, Austin Health, Melbourne, Victoria, Australia; Hans-Joachim Schmoll, Martin-Luther University, Halle; Rainer Porschen, Klinikum Bremen-Ost, Bremen; Volker Heinemann, University of Munich, München; Carsten Bokemeyer, University Hospital, Hamburg-Eppendorf, Germany; Matthew T. Seymour, Cancer Research UK Clincal Center, Leeds; Richard Adams, Cardiff University, Cardiff, United Kingdom; Leonard Saltz, Memorial Sloan-Kettering Cancer Center, New York, NY; Richard M. Goldberg, Ohio State University, Columbus, OH; Cornelis J.A. Punt, Academic Medical Center, Amsterdam, the Netherlands; Paulo M. Hoff, Hospital Sírio-Libanês, Sao Paulo, Brazil; Joel Randolph Hecht and Fairooz F. Kabbinavar, University of California at Los Angeles, Los Angeles, CA; Herbert Hurwitz, Duke University, Durham, NC; Eduardo Díaz-Rubio, Hospital Clinico San Carlos, Madrid, Spain; Charles Fuchs, Dana-Farber Cancer Institute, Boston, MA; John Souglakos, University of Crete, Heraklion, Greece; Alfredo Falcone, University of Pisa, Pisa, Italy; Eric Van Cutsem, University Hospital Gasthuisberg, Leuven; and Marc Buyse, International Drug Development Institute, Louvain-la-Neuve, Belgium.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482837PMC
January 2015

ACCENT-based web calculators to predict recurrence and overall survival in stage III colon cancer.

J Natl Cancer Inst 2014 Dec 29;106(12). Epub 2014 Oct 29.

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN (LAR, DJS); Department of Oncology, Mayo Clinic, Rochester, MN (AMG, SRA, CLL); Department of Statistics, University of Virginia, Charlottesville, VA (YX); Gastrointestinal Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, NY (LBS); Hôpital Saint Antoine, Paris, France; Pierre and Marie Curie University, Paris, France (TA); Leeds Institute of Cancer and Pathology, University of Leeds and St. James's University Hospital, Leeds Cancer Research UK Centre, UK (CT); Oncology Unit, Ospedale Giovanni XXIII, Bergamo, Italy (RL); Division of Hematology and Oncology, University of Florida, Gainesville, FL (CJA); National Surgical Adjuvant Breast and Bowel Project Biostatistical Center, Pittsburgh, PA (GY).

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December 2014

DPYD variants as predictors of 5-fluorouracil toxicity in adjuvant colon cancer treatment (NCCTG N0147).

J Natl Cancer Inst 2014 Dec 7;106(12). Epub 2014 Nov 7.

Department of Molecular Pharmacology and Experimental Therapeutics (AML, RBD), Alliance Statistics and Data Center (QS, EP, DJS), Division of Medical Oncology (SRA, FAS, RBD), Division of Gastroenterology (FAS), Mayo Clinic Cancer Center, Rochester, MN; Cancer Prevention and Control Program, University of Hawaii Cancer Center, Honolulu, HI (JLB); Division of Medical Oncology, The Ohio State University Medical Center, Columbus, OH (RMG).

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4271081PMC
December 2014

Decade in review--clinical trials: shifting paradigms in cancer clinical trial design.

Nat Rev Clin Oncol 2014 Nov 7;11(11):625-6. Epub 2014 Oct 7.

Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, 9609 Medical Center Drive, Room 5W112, Bethesda, MD 20892-9735, USA.

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http://dx.doi.org/10.1038/nrclinonc.2014.167DOI Listing
November 2014

Center-Within-Trial Versus Trial-Level Evaluation of Surrogate Endpoints.

Comput Stat Data Anal 2014 Oct;78:1-20

Division of Biomedical Statistics and Informatics, Mayo Clinic.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4104720PMC
October 2014

Expression of Fragaria vesca PIP aquaporins in response to drought stress: PIP down-regulation correlates with the decline in substrate moisture content.

PLoS One 2013 23;8(9):e74945. Epub 2013 Sep 23.

Research and Innovation Centre, Fondazione Edmund Mach, San Michele all'Adige, Trentino, Italy ; East Malling Research, East Malling, Kent, United Kingdom.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3781111PMC
August 2014

Patient and tumor characteristics and BRAF and KRAS mutations in colon cancer, NCCTG/Alliance N0147.

J Natl Cancer Inst 2014 Jul 12;106(7). Epub 2014 Jun 12.

Affiliations of authors: Division of Hematology/Division of Medical Oncology (WIG), Division of Biomedical Statistics & Informatics (MRM, GDN), Cancer Center Statistics (DJS), Division of Medical Oncology (SRA, AG, JMH, RRM), Division of Gastroenterology & Hepatology/Division of Medical Oncology (FAS), Division of Gastroenterology & Hepatology (PJL), Molecular Genetics (SNT), Mayo Clinic, Rochester, MN; Department of Internal Medicine, Division of Medical Oncology, Ohio State University, Columbus, OH (RMG); Division of Hematology/Oncology, Vanderbilt University, Nashville, TN (EC); Section of Hematology/Medical Oncology, Lehigh Valley Health Network, Allentown, PA (SN); Cancer Prevention & Control Program, University of Hawaii Cancer Center, Honolulu, HI (JLB).

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4110470PMC
July 2014

Calibration of quality-adjusted life years for oncology clinical trials.

J Pain Symptom Manage 2014 Jun 15;47(6):1091-1099.e3. Epub 2013 Nov 15.

Department of Colon and Rectal Surgery and Gastrointestinal Endoscopy, Mayo Clinic, Rochester, Minnesota, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4193473PMC
June 2014

KRAS codon 12 and 13 mutations in relation to disease-free survival in BRAF-wild-type stage III colon cancers from an adjuvant chemotherapy trial (N0147 alliance).

Clin Cancer Res 2014 Jun 31;20(11):3033-43. Epub 2014 Mar 31.

Authors' Affiliations: Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota; Lehigh Valley Hospital, Allentown, Pennsylvania; and Ohio State University, Columbus, Ohio

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http://clincancerres.aacrjournals.org/cgi/doi/10.1158/1078-0
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http://dx.doi.org/10.1158/1078-0432.CCR-13-3140DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4040326PMC
June 2014

Association study of the let-7 miRNA-complementary site variant in the 3' untranslated region of the KRAS gene in stage III colon cancer (NCCTG N0147 Clinical Trial).

Clin Cancer Res 2014 Jun 11;20(12):3319-27. Epub 2014 Apr 11.

Authors' Affiliations: Department of Molecular Pharmacology and Experimental Therapeutics (MPET); Alliance Statistics and Data Center; Division of Medical Oncology; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; and Department of Medical Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Ji'nan, Shandong Province, ChinaAuthors' Affiliations: Department of Molecular Pharmacology and Experimental Therapeutics (MPET); Alliance Statistics and Data Center; Division of Medical Oncology; Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota; and Department of Medical Oncology, Shandong Provincial Hospital Affiliated to Shandong University, Ji'nan, Shandong Province, China

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4084689PMC
June 2014

Drug designs fulfilling the requirements of clinical trials aiming at personalizing medicine.

Chin Clin Oncol 2014 Jun;3(2):14

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4236025PMC
June 2014

Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse.

J Clin Oncol 2014 Mar 10;32(8):841-50. Epub 2014 Feb 10.

Sumithra J. Mandrekar, Jeffrey Meyers, Axel Grothey, and Daniel J. Sargent, Mayo Clinic, Rochester, MN; Ming-Wen An, Vassar College, Poughkeepsie, NY; and Jan Bogaerts, European Organisation for Research and Treatment of Cancer, Brussels, Belgium.

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http://ascopubs.org/doi/10.1200/JCO.2013.52.3019
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3940541PMC
March 2014

Overview: biostatistician's role in oncology clinical trials-strive for sound, efficient and practical studies.

Chin Clin Oncol 2014 Mar;3(1)

Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA.

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March 2014

Adaptive randomized phase II design for biomarker threshold selection and independent evaluation.

Chin Clin Oncol 2014 Mar;3(1)

Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA.

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http://www.thecco.net/article/view/3489/4336
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March 2014

Application of tumor measurement-based metrics in the real world.

J Clin Oncol 2013 Dec 28;31(34):4374. Epub 2013 Oct 28.

Vassar College, Poughkeepsie, NY.

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December 2013

Prognostic impact of deficient DNA mismatch repair in patients with stage III colon cancer from a randomized trial of FOLFOX-based adjuvant chemotherapy.

J Clin Oncol 2013 Oct 9;31(29):3664-72. Epub 2013 Sep 9.

Frank A. Sinicrope, Michelle R. Mahoney, Thomas C. Smyrk, Stephen N. Thibodeau, Garth D. Nelson, Daniel J. Sargent, and Steven R. Alberts, Mayo Clinic, Mayo Cancer Center and the North Central Cancer Treatment Group, Rochester, MN; Robert S. Warren, University of California San Francisco, San Francisco, CA; Monica M. Bertagnolli, Brigham and Women's Hospital, Boston, MA; and Richard M. Goldberg, The Ohio State University Comprehensive Cancer Center, Columbus, OH.

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http://dx.doi.org/10.1200/JCO.2013.48.9591DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3789216PMC
October 2013