The role of trastuzumab in adjuvant and neoadjuvant therapy in women with HER2/<em>neu</em>-overexpressing breast cancer

Brief Summary

GUIDELINE TITLE

The role of trastuzumab in adjuvant and neoadjuvant therapy in women with HER2/neu-overexpressing breast cancer: a clinical practice guideline.

BIBLIOGRAPHIC SOURCE(S)

Trudeau M, Madarnas Y, McCready D, Pritchard KI, Messersmith H, Breast Cancer Disease Site Group. The role of trastuzumab in adjuvant and neoadjuvant therapy in women with HER2/neu-overexpressing breast cancer: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2006 May 12. 28 p. (Evidence-based series; no. 1-24). [58 references]

GUIDELINE STATUS

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline, over time will expand to contain new information emerging from their reviewing and updating activities.

Please visit the Cancer Care Ontario Web site for details on any new evidence that has emerged and implications to the guidelines.

REGULATORY ALERT

FDA WARNING/REGULATORY ALERT

Note from the National Guideline Clearinghouse: This guideline references a drug(s) for which important revised regulatory and/or warning information has been released.

On August 31, 2005, Genentech and the U.S. Food and Drug Administration (FDA) notified healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab), obtained from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a randomized, Phase III trial that was conducted in 2043 women with operable, HER2 overexpressing breast cancer (IHC 3+ or FISH+). This study demonstrated a significant increase in cardiotoxicity in patients who were randomized to the Herceptin-containing arm as compared to patients who received chemotherapy alone. See the FDA Web site for more information.

BRIEF SUMMARY CONTENT

** REGULATORY ALERT **
RECOMMENDATIONS
EVIDENCE SUPPORTING THE RECOMMENDATIONS
IDENTIFYING INFORMATION AND AVAILABILITY
DISCLAIMER

Go to the Complete Summary

Trastuzumab should be offered for one year to all patients with HER2-positive node-positive or node-negative, tumour greater than 1 cm in size, and primary breast cancer and who are receiving or have received (neo)adjuvant chemotherapy. Trastuzumab should be offered after chemotherapy.

CLINICAL ALGORITHM(S)

None provided

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EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by randomized controlled trials.

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IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

Trudeau M, Madarnas Y, McCready D, Pritchard KI, Messersmith H, Breast Cancer Disease Site Group. The role of trastuzumab in adjuvant and neoadjuvant therapy in women with HER2/neu-overexpressing breast cancer: a clinical practice guideline. Toronto (ON): Cancer Care Ontario (CCO); 2006 May 12. 28 p. (Evidence-based series; no. 1-24). [58 references]

ADAPTATION

Not applicable: The guideline was not adapted from another source.

DATE RELEASED

2006 May 12

GUIDELINE DEVELOPER(S)

Program in Evidence-based Care - State/Local Government Agency [Non-U.S.]

GUIDELINE DEVELOPER COMMENT

The Program in Evidence-based Care (PEBC) is a Province of Ontario initiative sponsored by Cancer Care Ontario and the Ontario Ministry of Health and Long-Term Care.

SOURCE(S) OF FUNDING

Cancer Care Ontario
Ontario Ministry of Health and Long-Term Care

GUIDELINE COMMITTEE

Provincial Breast Cancer Disease Site Group

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

For a current list of past and present members, please see the Cancer Care Ontario Web site.

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Three lead authors of this document (YM, DM, HM) reported no potential conflict of interest. KP reported receiving consultant or advisory fees from several pharmaceutical companies that produce agents evaluated by this document. MT reported receiving support through the National Cancer Institute of Canada for a clinical trial of trastuzumab from an involved pharmaceutical company.

GUIDELINE STATUS

This is the current release of the guideline.

The EVIDENCE-BASED SERIES report, initially the full original Guideline, over time will expand to contain new information emerging from their reviewing and updating activities.

Please visit the Cancer Care Ontario Web site for details on any new evidence that has emerged and implications to the guidelines.

GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site.

AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

The role of Trastuzumab in adjuvant and neoadjuvant therapy in women with HER2/neu-overexpressing breast cancer: a clinical practice guideline. Summary. Toronto (ON): Cancer Care Ontario (CCO), 2006 May 12. Various p. (Practice guideline; no. 1-24). Electronic copies: Available in Portable Document Format (PDF) from the Cancer Care Ontario Web site.
Browman GP, Levine MN, Mohide EA, Hayward RSA, Pritchard KI, Gafni A, et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol 1995;13(2):502-12.

PATIENT RESOURCES

None available

NGC STATUS

This NGC summary was completed by ECRI on June 21, 2006. The information was verified by the guideline developer on July 6, 2006.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to the guideline developer's copyright restrictions. Please refer to the Copyright and Disclaimer Statements posted at the Program in Evidence-Based Care section of the Cancer Care Ontario Web site.

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DISCLAIMER

NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce, approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies, relevant professional associations, public or private organizations, other government agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers, and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC, AHRQ, and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover, the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.

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Brief Summary

GUIDELINE TITLE

BIBLIOGRAPHIC SOURCE(S)

GUIDELINE STATUS

REGULATORY ALERT

FDA WARNING/REGULATORY ALERT

BRIEF SUMMARY CONTENT

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

CLINICAL ALGORITHM(S)

EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

ADAPTATION

DATE RELEASED

GUIDELINE DEVELOPER(S)

GUIDELINE DEVELOPER COMMENT

SOURCE(S) OF FUNDING

GUIDELINE COMMITTEE

COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

GUIDELINE STATUS

GUIDELINE AVAILABILITY

AVAILABILITY OF COMPANION DOCUMENTS

PATIENT RESOURCES

NGC STATUS

COPYRIGHT STATEMENT

DISCLAIMER

NGC DISCLAIMER

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