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Jean · 06-18-2009, 06:52 PM

How Risky Are Small HER-2-Positive Tumors?

The major adjuvant trials of trastuzumab have centered on high-risk, node-negative or node-positive breast cancer. The benefit of trastuzumab in patients with small, node-negative but HER-2-positive cancers is not well established because the natural history of these lesions is not well known. Investigators from the M.D. Anderson Cancer Center reported on outcomes of tumors 1 cm or smaller as a function of HER-2 status.[4] This observational cohort did not receive either chemotherapy or trastuzumab, and thus the study does not permit one to know how each of these interventions might be of benefit. What was observed, however, was that prognosis clearly depended on HER-2 status. For HER-2-negative tumors, the 10-year risk for recurrence-free survival with T1abN0 breast cancer was 88% if the tumor was ER positive and was 80% if "triple negative." However, if the tumor was HER-2 positive, 10-year recurrence-free survival was only 62%.
This observation suggests that even small tumors that are HER-2 positive carry a substantial risk for recurrence and might benefit from adjuvant treatment with chemotherapy and trastuzumab. This is consistent with current guidelines from the National Comprehensive Cancer Network, which suggest consideration of chemotherapy and trastuzumab for HER-2-positive tumors that measure between 6 and 10 mm. A prospective study conducted at the Dana-Farber Cancer Institute and affiliated sites is testing the effectiveness of paclitaxel plus trastuzumab for stage 1, HER-2-positive tumors.
Summary

Anti-HER-2 therapy remains a field of vital clinical investigation. New agents from both the antibody-based and small molecular/tyrosine kinase inhibitor-based domains are in development. Emerging data raise fascinating questions about the interplay of ER and HER-2 signaling pathways that are being explored in ongoing clinical trials. Meanwhile, the risk for HER-2-positive lesions continues to be marked in the absence of trastuzumab, underscoring the value of that agent in treating early-stage breast cancer.
This activity is supported by an independent educational grant from Susan G. Komen for the Cure.
References
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References

Vukelja S, Rugo H, Vogel C, et al. A phase II study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer. Cancer Res. 2009;69(suppl 2):71s. Abstract 33.
Burstein HJ, Sun Y, Tan AR, et al. Neratinib (HKI-272), an irreversible pan erbB receptor tyrosine kinase inhibitor: phase 2 results in patients with advanced HER2+ breast cancer. Cancer Res. 2009;69(suppl 2):73s. Abstract 37.
Johnston S, Pegram M, Press M, et al. Lapatinib combined with letrozole vs letrozole alone for front line postmenopausal hormone receptor positive (HR+) metastatic breast cancer (MBC): first results from the EGF30008 trial. Cancer Res. 2009;69(suppl 2):74s. Abstract 46.
Rakkhit R, Broglio K, Peintinger F, et al. Significant increased recurrence rates among breast cancer patients with HER2-positive, T1a,bN0M0 tumors. Cancer Res. 2009;69(suppl 2):96s. Abstract 701.

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Authors and Disclosures

As an organization accredited by the ACCME, Medscape, LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest.
Medscape, LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content.
Author(s)

Harold J Burstein, MD, PhD

Associate Professor of Medicine, Harvard Medical School, Boston, Massachusetts

Disclosure: Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships.
Editor(s)

Margie Miller

Group Editorial Director, Medscape Hematology-Oncology

Disclosure: Margie Miller has disclosed no relevant financial relationships.
Emma Hitt, PhD

Freelance editor and writer, Marietta, Georgia

Disclosure: Emma Hitt, PhD, has disclosed no relevant financial relationships.
Jill W. Chamberlain

Editorial Director, Medscape Hematology-Oncology

Disclosure: Jill W. Chamberlain has disclosed no relevant financial relationships.

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CME Information

CME Released: 01/20/2009; Valid for credit through 01/20/2010
Target Audience

This activity is intended for oncologists and other healthcare providers who treat patients with breast cancer.
Goal

The goal of this activity is to report and appraise new and emerging treatment regimens and clinical strategies for breast cancer; to enhance the care and outcomes of persons with breast cancer; and to support quality clinical practice of healthcare professionals involved in the management of patients with breast cancer.
Learning Objectives

Upon completion of this activity, participants will be able to:

Appraise the most recent clinical trial data on newer and emerging treatment options for patients with HER-2-positive breast cancer
Evaluate newly reported clinical trial data on the use of endocrine therapy in the adjuvant setting in patients with early-stage breast cancer
List the clinical characteristics of breast cancer stem cells and list potential therapeutic approaches that target such cells

Credits Available

Physicians - maximum of 1.00 AMA PRA Category 1 Credit(s)™
All other healthcare professionals completing continuing education credit for this activity will be issued a certificate of participation.

Physicians should only claim credit commensurate with the extent of their participation in the activity.
Accreditation Statements

For Physicians

Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.
Medscape, LLC designates this educational activity for a maximum of 1.0 AMA PRA Category 1 Credit(s)™ . Physicians should only claim credit commensurate with the extent of their participation in the activity.
Contact This Provider
For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact CME@medscape.net
Instructions for Participation and Credit

There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board.

This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page.

Follow these steps to earn CME/CE credit*:

Read the target audience, learning objectives, and author disclosures.
Study the educational content online or printed out.
Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape encourages you to complete the Activity Evaluation to provide feedback for future programming.

You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage.

*The credit that you receive is based on your user profile.
Hardware/Software Requirements

Medscape requires version 4.x browsers or higher from Microsoft or Netscape. Certain educational activities may require additional software to view multimedia, presentation or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Macromedia Flash, Apple Quicktime, Adobe Acrobat, Microsoft Powerpoint, Windows Media Player, and Real Networks Real One Player.

Contents of Highlights of SABCS 2008 All sections of this activity are required for credit.

Highlights in HER-2-Positive Breast Cancer
Highlights in Adjuvant Endocrine Therapy for Breast Cancer
Breast Cancer Stem Cells as Novel Therapeutic Targets: An Expert Interview With Dr. Max S. Wicha

06-18-2009, 06:52 PM	#1
Jean Senior Member Join Date: Oct 2005 Location: New Jersey Posts: 3,154	Often this question arises especially with new members How Risky Are Small HER-2-Positive Tumors? The major adjuvant trials of trastuzumab have centered on high-risk, node-negative or node-positive breast cancer. The benefit of trastuzumab in patients with small, node-negative but HER-2-positive cancers is not well established because the natural history of these lesions is not well known. Investigators from the M.D. Anderson Cancer Center reported on outcomes of tumors 1 cm or smaller as a function of HER-2 status.[4] This observational cohort did not receive either chemotherapy or trastuzumab, and thus the study does not permit one to know how each of these interventions might be of benefit. What was observed, however, was that prognosis clearly depended on HER-2 status. For HER-2-negative tumors, the 10-year risk for recurrence-free survival with T1abN0 breast cancer was 88% if the tumor was ER positive and was 80% if "triple negative." However, if the tumor was HER-2 positive, 10-year recurrence-free survival was only 62%. This observation suggests that even small tumors that are HER-2 positive carry a substantial risk for recurrence and might benefit from adjuvant treatment with chemotherapy and trastuzumab. This is consistent with current guidelines from the National Comprehensive Cancer Network, which suggest consideration of chemotherapy and trastuzumab for HER-2-positive tumors that measure between 6 and 10 mm. A prospective study conducted at the Dana-Farber Cancer Institute and affiliated sites is testing the effectiveness of paclitaxel plus trastuzumab for stage 1, HER-2-positive tumors. Summary Anti-HER-2 therapy remains a field of vital clinical investigation. New agents from both the antibody-based and small molecular/tyrosine kinase inhibitor-based domains are in development. Emerging data raise fascinating questions about the interplay of ER and HER-2 signaling pathways that are being explored in ongoing clinical trials. Meanwhile, the risk for HER-2-positive lesions continues to be marked in the absence of trastuzumab, underscoring the value of that agent in treating early-stage breast cancer. This activity is supported by an independent educational grant from Susan G. Komen for the Cure. References [ CLOSE WINDOW ] References Vukelja S, Rugo H, Vogel C, et al. A phase II study of trastuzumab-DM1, a first-in-class HER2 antibody-drug conjugate, in patients with HER2+ metastatic breast cancer. Cancer Res. 2009;69(suppl 2):71s. Abstract 33. Burstein HJ, Sun Y, Tan AR, et al. Neratinib (HKI-272), an irreversible pan erbB receptor tyrosine kinase inhibitor: phase 2 results in patients with advanced HER2+ breast cancer. Cancer Res. 2009;69(suppl 2):73s. Abstract 37. Johnston S, Pegram M, Press M, et al. Lapatinib combined with letrozole vs letrozole alone for front line postmenopausal hormone receptor positive (HR+) metastatic breast cancer (MBC): first results from the EGF30008 trial. Cancer Res. 2009;69(suppl 2):74s. Abstract 46. Rakkhit R, Broglio K, Peintinger F, et al. Significant increased recurrence rates among breast cancer patients with HER2-positive, T1a,bN0M0 tumors. Cancer Res. 2009;69(suppl 2):96s. Abstract 701. [ CLOSE WINDOW ] [CLOSE WINDOW] Authors and Disclosures As an organization accredited by the ACCME, Medscape, LLC requires everyone who is in a position to control the content of an education activity to disclose all relevant financial relationships with any commercial interest. The ACCME defines "relevant financial relationships" as financial relationships in any amount, occurring within the past 12 months, including financial relationships of a spouse or life partner, that could create a conflict of interest. Medscape, LLC encourages Authors to identify investigational products or off-label uses of products regulated by the US Food and Drug Administration, at first mention and where appropriate in the content. Author(s) Harold J Burstein, MD, PhD Associate Professor of Medicine, Harvard Medical School, Boston, Massachusetts Disclosure: Harold J. Burstein, MD, PhD, has disclosed no relevant financial relationships. Editor(s) Margie Miller Group Editorial Director, Medscape Hematology-Oncology Disclosure: Margie Miller has disclosed no relevant financial relationships. Emma Hitt, PhD Freelance editor and writer, Marietta, Georgia Disclosure: Emma Hitt, PhD, has disclosed no relevant financial relationships. Jill W. Chamberlain Editorial Director, Medscape Hematology-Oncology Disclosure: Jill W. Chamberlain has disclosed no relevant financial relationships. [ CLOSE WINDOW ] CME Information CME Released: 01/20/2009; Valid for credit through 01/20/2010 Target Audience This activity is intended for oncologists and other healthcare providers who treat patients with breast cancer. Goal The goal of this activity is to report and appraise new and emerging treatment regimens and clinical strategies for breast cancer; to enhance the care and outcomes of persons with breast cancer; and to support quality clinical practice of healthcare professionals involved in the management of patients with breast cancer. Learning Objectives Upon completion of this activity, participants will be able to: Appraise the most recent clinical trial data on newer and emerging treatment options for patients with HER-2-positive breast cancer Evaluate newly reported clinical trial data on the use of endocrine therapy in the adjuvant setting in patients with early-stage breast cancer List the clinical characteristics of breast cancer stem cells and list potential therapeutic approaches that target such cells Credits Available Physicians - maximum of 1.00 AMA PRA Category 1 Credit(s)™ All other healthcare professionals completing continuing education credit for this activity will be issued a certificate of participation. Physicians should only claim credit commensurate with the extent of their participation in the activity. Accreditation Statements For Physicians Medscape, LLC is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Medscape, LLC designates this educational activity for a maximum of 1.0 *AMA PRA Category 1 Credit(s)™* . Physicians should only claim credit commensurate with the extent of their participation in the activity. Contact This Provider For questions regarding the content of this activity, contact the accredited provider for this CME/CE activity noted above. For technical assistance, contact CME@medscape.net Instructions for Participation and Credit There are no fees for participating in or receiving credit for this online educational activity. For information on applicability and acceptance of continuing education credit for this activity, please consult your professional licensing board. This activity is designed to be completed within the time designated on the title page; physicians should claim only those credits that reflect the time actually spent in the activity. To successfully earn credit, participants must complete the activity online during the valid credit period that is noted on the title page. Follow these steps to earn CME/CE credit: Read the target audience, learning objectives, and author disclosures. Study the educational content online or printed out. Online, choose the best answer to each test question. To receive a certificate, you must receive a passing score as designated at the top of the test. Medscape encourages you to complete the Activity Evaluation to provide feedback for future programming. You may now view or print the certificate from your CME/CE Tracker. You may print the certificate but you cannot alter it. Credits will be tallied in your CME/CE Tracker and archived for 6 years; at any point within this time period you can print out the tally as well as the certificates by accessing "Edit Your Profile" at the top of your Medscape homepage. The credit that you receive is based on your user profile. Hardware/Software Requirements Medscape requires version 4.x browsers or higher from Microsoft or Netscape. Certain educational activities may require additional software to view multimedia, presentation or printable versions of their content. These activities will be marked as such and will provide links to the required software. That software may be: Macromedia Flash, Apple Quicktime, Adobe Acrobat, Microsoft Powerpoint, Windows Media Player, and Real Networks Real One Player. Contents of Highlights of SABCS 2008 All sections of this activity are required for credit. Highlights in HER-2-Positive Breast Cancer Highlights in Adjuvant Endocrine Therapy for Breast Cancer Breast Cancer Stem Cells as Novel Therapeutic Targets: An Expert Interview With Dr. Max S. Wicha __________________ Stage 1, Grade 1, 3/30/05 Lumpectomy 4/15/05 - 6MM IDC Node Neg. (Sentinel node) ER+ 90% / PR-, Her2+++ by FISH Ki-67 40% Arimidex 5/05 Radiation 32 trt, 5/30/05 Oncotype DX test 4/17/06, 31% high risk TOPO 11 neg. 4/06 Stopped Arimidex 5/06 TCH 5/06, 6 treatments Herceptin 5/06 - for 1 yr. 9/06 Completed chemo Started Femara Sept. 2006 Last edited by Jean; 06-18-2009 at 08:51 PM..