Literature DB >> 25421275

Pragmatic issues in biomarker evaluation for targeted therapies in cancer.

Armand de Gramont1, Sarah Watson2, Lee M Ellis3, Jordi Rodón4, Josep Tabernero4, Aimery de Gramont5, Stanley R Hamilton6.   

Abstract

Predictive biomarkers are becoming increasingly important tools in drug development and clinical research. The importance of using both guidelines for specimen acquisition and analytical methods for biomarker measurements that are standardized has become recognized widely as an important issue, which must be addressed in order to provide high-quality, validated assays. Herein, we review the major challenges in biomarker validation processes, including pre-analytical (sample-related), analytical, and post-analytical (data-related) aspects of assay development. Recommendations for improving biomarker assay development and method validation are proposed to facilitate the use of predictive biomarkers in clinical trials and the practice of oncology.

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Year:  2014        PMID： 25421275     DOI： 10.1038/nrclinonc.2014.202

Source DB:  PubMed          Journal:  Nat Rev Clin Oncol        ISSN： 1759-4774            Impact factor:   66.675


  172 in total

Review 1.  Biomarkers and surrogate endpoints: preferred definitions and conceptual framework.

Authors: 
Journal:  Clin Pharmacol Ther       Date:  2001-03       Impact factor: 6.875

2.  Evaluation of HER2, p53, bcl-2, topoisomerase II-alpha, heat shock proteins 27 and 70 in primary breast cancer and metastatic ipsilateral axillary lymph nodes.

Authors:  F Cardoso; A Di Leo; D Larsimont; D Gancberg; G Rouas; S Dolci; F Ferreira; M Paesmans; M Piccart
Journal:  Ann Oncol       Date:  2001-05       Impact factor: 32.976

Review 3.  Tissue handling for genome-wide expression analysis: a review of the issues, evidence, and opportunities.

Authors:  Fabiola Medeiros; C Ted Rigl; Glenda G Anderson; Shawn H Becker; Kevin C Halling
Journal:  Arch Pathol Lab Med       Date:  2007-12       Impact factor: 5.534

4.  ER, HER2, and TOP2A expression in primary tumor, synchronous axillary nodes, and asynchronous metastases in breast cancer.

Authors:  Jeanette Dupont Jensen; Ann Knoop; Marianne Ewertz; Anne-Vibeke Laenkholm
Journal:  Breast Cancer Res Treat       Date:  2011-06-11       Impact factor: 4.872

5.  A phase two randomised trial of neratinib monotherapy versus lapatinib plus capecitabine combination therapy in patients with HER2+ advanced breast cancer.

Authors:  Miguel Martin; Jacques Bonneterre; Charles E Geyer; Yoshinori Ito; Jungsil Ro; Istvan Lang; Sung-Bae Kim; Caroline Germa; Jennifer Vermette; Kenneth Wang; Kongming Wang; Ahmad Awada
Journal:  Eur J Cancer       Date:  2013-08-15       Impact factor: 9.162

6.  Stability of K-ras mutations throughout the natural history of human colorectal cancer.

Authors:  L Losi; J Benhattar; J Costa
Journal:  Eur J Cancer       Date:  1992       Impact factor: 9.162

7.  Differential activation of ras genes by point mutation in human colon cancer with metastases to either lung or liver.

Authors:  J J Oudejans; R J Slebos; F A Zoetmulder; W J Mooi; S Rodenhuis
Journal:  Int J Cancer       Date:  1991-12-02       Impact factor: 7.396

8.  Molecular changes in the Ki-ras and APC genes in primary colorectal carcinoma and synchronous metastases compared with the findings in accompanying adenomas.

Authors:  P Zauber; M Sabbath-Solitare; S P Marotta; D T Bishop
Journal:  Mol Pathol       Date:  2003-06

9.  Ki67 measured after neoadjuvant chemotherapy for primary breast cancer.

Authors:  Gunter von Minckwitz; Wolfgang D Schmitt; Sibylle Loibl; Berit M Müller; Jens U Blohmer; Bruno V Sinn; Holger Eidtmann; Wolfgang Eiermann; Bernd Gerber; Hans Tesch; Jörn Hilfrich; Jens Huober; Tanja Fehm; Jana Barinoff; Thomas Rüdiger; Erhard Erbstoesser; Peter A Fasching; Thomas Karn; Volkmar Müller; Christian Jackisch; Carsten Denkert
Journal:  Clin Cancer Res       Date:  2013-06-27       Impact factor: 12.531

10.  Comparison of HER-2 overexpression in primary breast cancer and metastatic sites and its effect on biological targeting therapy of metastatic disease.

Authors:  J Zidan; I Dashkovsky; C Stayerman; W Basher; C Cozacov; A Hadary
Journal:  Br J Cancer       Date:  2005-09-05       Impact factor: 7.640
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  60 in total

1.  The Challenges of Validating in Precision Medicine: The Case of Excision Repair Cross-Complement Group 1 Diagnostic Testing.

Authors:  Brianna Barsanti-Innes; Spencer Phillips Hey; Jonathan Kimmelman
Journal:  Oncologist       Date:  2016-10-24

2.  National Cancer Institute Biospecimen Evidence-Based Practices: Harmonizing Procedures for Nucleic Acid Extraction from Formalin-Fixed, Paraffin-Embedded Tissue.

Authors:  Sarah R Greytak; Kelly B Engel; Erik Zmuda; Esmeralda Casas-Silva; Ping Guan; Katherine A Hoadley; Andrew J Mungall; David A Wheeler; Harsha V Doddapaneni; Helen M Moore
Journal:  Biopreserv Biobank       Date:  2018-06-19       Impact factor: 2.300

3.  Enrichment of PI3K-AKT-mTOR Pathway Activation in Hepatic Metastases from Breast Cancer.

Authors:  Mariaelena Pierobon; Corinne Ramos; Shukmei Wong; K Alex Hodge; Jessica Aldrich; Sara Byron; Stephen P Anthony; Nicholas J Robert; Donald W Northfelt; Mohammad Jahanzeb; Linda Vocila; Julia Wulfkuhle; Guido Gambara; Rosa I Gallagher; Bryant Dunetz; Nicholas Hoke; Ting Dong; David W Craig; Massimo Cristofanilli; Brian Leyland-Jones; Lance A Liotta; Joyce A O'Shaughnessy; John D Carpten; Emanuel F Petricoin
Journal:  Clin Cancer Res       Date:  2017-04-26       Impact factor: 12.531

4.  Analytic Validation of RNA In Situ Hybridization (RISH) for AR and AR-V7 Expression in Human Prostate Cancer.

Authors:  Liana B Guedes; Carlos L Morais; Fawaz Almutairi; Michael C Haffner; Qizhi Zheng; John T Isaacs; Emmanuel S Antonarakis; Changxue Lu; Harrison Tsai; Jun Luo; Angelo M De Marzo; Tamara L Lotan
Journal:  Clin Cancer Res       Date:  2016-05-10       Impact factor: 12.531

Review 5.  Toward precision immunotherapy using multiplex immunohistochemistry and in silico methods to define the tumor immune microenvironment.

Authors:  Samuel S Widodo; Ryan A Hutchinson; Yitong Fang; Stefano Mangiola; Paul J Neeson; Phillip K Darcy; Alexander D Barrow; Christopher M Hovens; Marija Dinevska; Stanley S Stylli; Theo Mantamadiotis
Journal:  Cancer Immunol Immunother       Date:  2021-01-03       Impact factor: 6.968

Review 6.  Rational selection of biomarker driven therapies for gynecologic cancers: The more we know, the more we know we don't know.

Authors:  Joyce Liu; Shannon N Westin
Journal:  Gynecol Oncol       Date:  2016-04       Impact factor: 5.482

7.  Improving breast cancer sensitivity to paclitaxel by increasing aneuploidy.

Authors:  Sylvie Rodrigues-Ferreira; Anne Nehlig; Hadia Moindjie; Clarisse Monchecourt; Cynthia Seiler; Elisabetta Marangoni; Sophie Chateau-Joubert; Marie-Eglantine Dujaric; Nicolas Servant; Bernard Asselain; Patricia de Cremoux; Magali Lacroix-Triki; Monica Arnedos; Jean-Yves Pierga; Fabrice André; Clara Nahmias
Journal:  Proc Natl Acad Sci U S A       Date:  2019-11-04       Impact factor: 11.205

8.  Pyrenyl carbon nanostructures for ultrasensitive measurements of formaldehyde in urine.

Authors:  Gayan Premaratne; Sabrina Farias; Sadagopan Krishnan
Journal:  Anal Chim Acta       Date:  2017-03-27       Impact factor: 6.558

9.  Germline Findings in Tumor-Only Sequencing: Points to Consider for Clinicians and Laboratories.

Authors:  Victoria M Raymond; Stacy W Gray; Sameek Roychowdhury; Steve Joffe; Arul M Chinnaiyan; D Williams Parsons; Sharon E Plon
Journal:  J Natl Cancer Inst       Date:  2015-11-20       Impact factor: 13.506

10.  Comparison of Quantitative Mass Spectrometry Platforms for Monitoring Kinase ATP Probe Uptake in Lung Cancer.

Authors:  Melissa A Hoffman; Bin Fang; Eric B Haura; Uwe Rix; John M Koomen
Journal:  J Proteome Res       Date:  2017-11-22       Impact factor: 4.466
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