2.50
Hdl Handle:
http://hdl.handle.net/10755/165744
Category:
Abstract
Type:
Presentation
Title:
Fish Testing Ensures Accurate Identification of HER2-Positive Patients
Author(s):
Chorn, Nathalie
Author Details:
Nathalie Chorn, University of California-Los Angeles, School of Nursing, Los Angeles, California, USA, email: nchorn@mednet.ucla.edu
Abstract:
Objectives: Herceptin (trastuzumab) is a humanized monoclonal antibody that has antitumor activity in HER2-positive breast cancer. Over expression of HER2 is frequently assessed using a standardized, semiquantitative immunohistochemistry (IHC) assay. An IHC score of 2+ or 3+ (on a scale of 0-3+) was used as the entry requirement for Herceptin clinical studies. Additional analyses have shown that HER2 gene amplification, identified by fluorescence in situ hybridization (FISH), occurs in 89% of 3+ tumors and in 24% of 2+ tumors, and that measurement of patient HER2 status by FISH may be a more accurate method of identifying patients for Herceptin treatment. Our primary objectives were to evaluate testing results of IHC assays and to reiterate the importance of accurate patient identification through the use of FISH testing for IHC-negative (0, 1+, and 2+) patients. Methods: Our experience has shown the need to retest patients who initially test IHC 1+ and 2+ for HER2 over expression (1+ is considered mildly negative, and 2+ is considered mildly positive). Some of these patients continue to show clinical signs of aggressive disease and may benefit from further testing with FISH for HER2 gene amplification. Results: Four hundred fifty one subjects who enrolled in the combination therapy pivotal trial were retrospectively tested using FISH. All were positive by IHC (i.e., 2+ and 3+). In the FISH-negative group, 38% (n = 56) were in the chemotherapy-alone arm and 38% (n = 50) were in the chemotherapy + trastuzumab arm. There appeared to be no benefit in adding trastuzumab to the FISH-negative group. In the FISH-positive group, only 31% (n = 169) of the subjects enrolled in the chemotherapy-alone arm responded compared with 54% (n = 176) of subjects who responded to the chemotherapy + Herceptin arm, therefore confirming the benefit of adding Herceptin to first-line metastatic breast cancer treatment. Conclusion: Proper identification of patients who may benefit from the use of Herceptin is important in providing quality patient care. Although IHC testing is commonly used to determine the level of HER2 protein over expression, FISH testing for HER2 gene amplification appears to be the most accurate measure for selecting patients who will benefit from Herceptin therapy.
Repository Posting Date:
27-Oct-2011
Date of Publication:
27-Oct-2011
Conference Date:
2002
Conference Name:
27th Annual Oncology Nursing Society Congress
Conference Host:
Oncology Nursing Society
Conference Location:
Washington, D.C., USA
Note:
This is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.

Full metadata record

DC FieldValue Language
dc.type.categoryAbstracten_US
dc.typePresentationen_GB
dc.titleFish Testing Ensures Accurate Identification of HER2-Positive Patientsen_GB
dc.contributor.authorChorn, Nathalieen_US
dc.author.detailsNathalie Chorn, University of California-Los Angeles, School of Nursing, Los Angeles, California, USA, email: nchorn@mednet.ucla.eduen_US
dc.identifier.urihttp://hdl.handle.net/10755/165744-
dc.description.abstractObjectives: Herceptin (trastuzumab) is a humanized monoclonal antibody that has antitumor activity in HER2-positive breast cancer. Over expression of HER2 is frequently assessed using a standardized, semiquantitative immunohistochemistry (IHC) assay. An IHC score of 2+ or 3+ (on a scale of 0-3+) was used as the entry requirement for Herceptin clinical studies. Additional analyses have shown that HER2 gene amplification, identified by fluorescence in situ hybridization (FISH), occurs in 89% of 3+ tumors and in 24% of 2+ tumors, and that measurement of patient HER2 status by FISH may be a more accurate method of identifying patients for Herceptin treatment. Our primary objectives were to evaluate testing results of IHC assays and to reiterate the importance of accurate patient identification through the use of FISH testing for IHC-negative (0, 1+, and 2+) patients. Methods: Our experience has shown the need to retest patients who initially test IHC 1+ and 2+ for HER2 over expression (1+ is considered mildly negative, and 2+ is considered mildly positive). Some of these patients continue to show clinical signs of aggressive disease and may benefit from further testing with FISH for HER2 gene amplification. Results: Four hundred fifty one subjects who enrolled in the combination therapy pivotal trial were retrospectively tested using FISH. All were positive by IHC (i.e., 2+ and 3+). In the FISH-negative group, 38% (n = 56) were in the chemotherapy-alone arm and 38% (n = 50) were in the chemotherapy + trastuzumab arm. There appeared to be no benefit in adding trastuzumab to the FISH-negative group. In the FISH-positive group, only 31% (n = 169) of the subjects enrolled in the chemotherapy-alone arm responded compared with 54% (n = 176) of subjects who responded to the chemotherapy + Herceptin arm, therefore confirming the benefit of adding Herceptin to first-line metastatic breast cancer treatment. Conclusion: Proper identification of patients who may benefit from the use of Herceptin is important in providing quality patient care. Although IHC testing is commonly used to determine the level of HER2 protein over expression, FISH testing for HER2 gene amplification appears to be the most accurate measure for selecting patients who will benefit from Herceptin therapy.en_GB
dc.date.available2011-10-27T12:24:07Z-
dc.date.issued2011-10-27en_GB
dc.date.accessioned2011-10-27T12:24:07Z-
dc.conference.date2002en_US
dc.conference.name27th Annual Oncology Nursing Society Congressen_US
dc.conference.hostOncology Nursing Societyen_US
dc.conference.locationWashington, D.C., USAen_US
dc.description.noteThis is an abstract-only submission. If the author has submitted a full-text item based on this abstract, you may find it by browsing the Virginia Henderson Global Nursing e-Repository by author. If author contact information is available in this abstract, please feel free to contact him or her with your queries regarding this submission. Alternatively, please contact the conference host, journal, or publisher (according to the circumstance) for further details regarding this item. If a citation is listed in this record, the item has been published and is available via open-access avenues or a journal/database subscription. Contact your library for assistance in obtaining the as-published article.-
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