Advertisement

help button home button The Oncologist
HOME HELP CONTACT US SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS

  


The Oncologist, Vol. 13, No. 5, 477-493, May 2008; doi:10.1634/theoncologist.2007-0248
© 2008 AlphaMed Press

This Article
Right arrow Full Text
Right arrow Full Text (PDF)
Right arrow An erratum has been published
Right arrow eLetters: Submit a response to this article
Right arrow Purchase Article
Right arrow View Shopping Cart
Right arrow Alert me when this article is cited
Right arrow Alert me when eLetters are posted
Right arrow Alert me if a correction is posted
Right arrow Citation Map
Services
Right arrow E-mail this article link to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Download to citation manager
Right arrow Reprints/Permissions
Citing Articles
Right arrow Citing Articles via HighWire
Right arrow Citing Articles via Google Scholar
Google Scholar
Right arrow Articles by Ross, J. S.
Right arrow Articles by Hortobágyi, G. N.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Ross, J. S.
Right arrow Articles by Hortobágyi, G. N.

Breast Cancer

Commercialized Multigene Predictors of Clinical Outcome for Breast Cancer

Jeffrey S. Rossa, Christos Hatzisb, W. Fraser Symmansc, Lajos Pusztaid, Gabriel N. Hortobágyid

aDepartment of Pathology and Laboratory Medicine, Albany Medical College, Albany, New York, USA; bNuvera Biosciences, Woburn, Massachusetts, USA; cDepartment of Pathology and dDepartment of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, Houston, Texas, USA

Key Words. Breast cancer • oncotype DX • MammaPrint • Rotterdam signature • Invasiveness signature • Two-gene expression ratio

Correspondence: Jeffrey S. Ross, M.D., Department of Pathology and Laboratory Medicine, Albany Medical College, 47 New Scotland Avenue, Albany, New York 12208, USA. Telephone: 518-262-5461; Fax: 518-262-3663; e-mail: rossj{at}mail.amc.edu

Received December 19, 2007; accepted for publication March 10, 2008.

Disclosure: C.H. is employed by, owns stock in, and discloses receipt of intellectual property rights/patent holder in Nuvera Biosciences (Nuvoselect). G.N.H. discloses that except for oncotype DXTM and MammaPrint®, all predictors described in the article are investigational and the indications are evolving. L.P. is a founder and stockholder of Nuvera Biosciences (Nuvoselect test), has acted as a consultant for Roche, Dako, Bristol-Myers Squibb, and Pfizer, and discloses that the article discusses the Affymetrix U133 GeneChip® System (Affymetrix Corporation) for potential use as a diagnostic test. W.F.S. has ownership and intellectual property in Nuvera BioSciences (Nuvoselect test) and he discloses that the article discusses prognostic/predictive genomic signatures by Genomic Health, Inc, Agendia, and Nuvera Biosciences for breast cancer diagnostics.

In the past 5 years, a number of commercialized multigene prognostic and predictive tests have entered the complex and expanding landscape of breast cancer companion diagnostics. These tests have used a variety of formats ranging from the familiar slide-based assays of immunohistochemistry and fluorescence in situ hybridization to the nonmorphology-driven molecular platforms of quantitative multiplex real-time polymerase chain reaction and genomic microarray profiling. In this review, 14 multigene assays are evaluated as to their scientific validation, current clinical utility, regulatory approval status, and estimated cost–benefit ratio. Emphasis is placed on two tests: oncotype DXTM and MammaPrint®. Current evidence indicates that the oncotype DXTM test has the advantages of earlier commercial launch, wide acceptance for payment by third-party payors in the U.S., ease of use of formalin-fixed paraffin-embedded tissues, recent listing by the American Society of Clinical Oncology Breast Cancer Tumor Markers Update Committee as recommended for use, continuous scoring system algorithm, ability to serve as both a prognostic test and predictive test for certain hormonal and chemotherapeutic agents, demonstrated cost-effectiveness in one published study, and a high accrual rate for the prospective validation clinical trial (Trial Assigning Individualized Options for Treatment). The MammaPrint® assay has the advantages of a 510(k) clearance by the U.S. Food and Drug Administration, a larger gene number, which may enhance further utility, and a potentially wider patient eligibility, including lymph node–positive, estrogen receptor (ER)-negative, and younger patients being accrued into the prospective trial (Microarray in Node-Negative Disease May Avoid Chemotherapy). A number of other assays have specific predictive goals that are most often focused on the efficacy of tamoxifen in ER-positive patients, such as the two-gene ratio test and the cytochrome P450 CYP2D6 genotyping assay.




This article has been cited by other articles:


Home page
Therapeutic Advances in Medical OncologyHome page
S. Mehta, A. Shelling, A. Muthukaruppan, A. Lasham, C. Blenkiron, G. Laking, and C. Print
Predictive and prognostic molecular markers for cancer medicine
Therapeutic Advances in Medical Oncology, March 1, 2010; 2(2): 125 - 148.
[Abstract] [PDF]


Home page
Clin. Chem.Home page
S. Schwers, E. Reifenberger, M. Gehrmann, A. Izmailov, and K. Bohmann
A High-Sensitivity, Medium-Density, and Target Amplification-Free Planar Waveguide Microarray System for Gene Expression Analysis of Formalin-Fixed and Paraffin-Embedded Tissue
Clin. Chem., November 1, 2009; 55(11): 1995 - 2003.
[Abstract] [Full Text] [PDF]


Home page
Clin. Cancer Res.Home page
J. Aster and J. Kutok
Complexity Made Simple in Diffuse Large B-Cell Lymphoma
Clin. Cancer Res., September 1, 2009; 15(17): 5291 - 5293.
[Abstract] [Full Text] [PDF]


Home page
Am J Clin PatholHome page
J. S. Ross and E. A. Slodkowska
Circulating and Disseminated Tumor Cells in the Management of Breast Cancer
Am J Clin Pathol, August 1, 2009; 132(2): 237 - 245.
[Abstract] [Full Text] [PDF]


Home page
INT J SURG PATHOLHome page
F. Correa Geyer and J. S. Reis-Filho
Microarray-based Gene Expression Profiling as a Clinical Tool for Breast Cancer Management: Are We There Yet?
International Journal of Surgical Pathology, August 1, 2009; 17(4): 285 - 302.
[Abstract] [PDF]


Home page
Hum Reprod UpdateHome page
M. Hickey, M. Peate, C.M. Saunders, and M. Friedlander
Breast cancer in young women and its impact on reproductive function
Hum. Reprod. Update, May 1, 2009; 15(3): 323 - 339.
[Abstract] [Full Text] [PDF]


Home page
JNMHome page
J. H. Lee, E. L. Rosen, and D. A. Mankoff
The Role of Radiotracer Imaging in the Diagnosis and Management of Patients with Breast Cancer: Part 1--Overview, Detection, and Staging
J. Nucl. Med., April 1, 2009; 50(4): 569 - 581.
[Abstract] [Full Text] [PDF]


Home page
Clin. Chem.Home page
J. B. Overdevest, D. Theodorescu, and J. K. Lee
Utilizing the Molecular Gateway: The Path to Personalized Cancer Management
Clin. Chem., April 1, 2009; 55(4): 684 - 697.
[Abstract] [Full Text] [PDF]


Home page
The OncologistHome page
J. S. Ross, E. A. Slodkowska, W. F. Symmans, L. Pusztai, P. M. Ravdin, and G. N. Hortobagyi
The HER-2 Receptor and Breast Cancer: Ten Years of Targeted Anti-HER-2 Therapy and Personalized Medicine
Oncologist, April 1, 2009; 14(4): 320 - 368.
[Abstract] [Full Text] [PDF]


Home page
NEJMHome page
C. Sotiriou and L. Pusztai
Gene-Expression Signatures in Breast Cancer
N. Engl. J. Med., February 19, 2009; 360(8): 790 - 800.
[Full Text] [PDF]


Home page
Annals of Clinical & Laboratory ScienceHome page
E. Stevens, B. F. Kimler, M. K. Davis, F. Fan, P. Thomas, X.-Y. Wang, I. Damjanov, and O. W. Tawfik
A Newly Proposed Semi-Automated Method of Grading Invasive Lobular Carcinoma: A Unifying Concept and Correlation with Prognostic Markers and Patient Survival
Ann. Clin. Lab. Sci., January 1, 2009; 39(1): 25 - 31.
[Abstract] [Full Text] [PDF]


Home page
Molecular Cancer TherapeuticsHome page
Z. S. Boyd, Q. J. Wu, C. O'Brien, J. Spoerke, H. Savage, P. J. Fielder, L. Amler, Y. Yan, and M. R. Lackner
Proteomic analysis of breast cancer molecular subtypes and biomarkers of response to targeted kinase inhibitors using reverse-phase protein microarrays
Mol. Cancer Ther., December 1, 2008; 7(12): 3695 - 3706.
[Abstract] [Full Text] [PDF]




HOME HELP CONTACT US SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS
THE ONCOLOGIST STEM CELLS CME ALPHAMED PRESS JOURNALS


Copyright © 2008 by AlphaMed Press.
Advertisement