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Brief Summary

GUIDELINE TITLE

Use of bisphosphonates in women with breast cancer.

BIBLIOGRAPHIC SOURCE(S)

  • Breast Cancer Disease Site Group. Warr D, Johnston M. Use of bisphosphonates in women with breast cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2004 Apr [online update]. 34 p. (Practice guideline report; no. 1-11). [68 references]

GUIDELINE STATUS

This is the current release of the guideline.

The FULL REPORT, initially the full original Guideline or Evidence Summary, 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 information has been released.

On March 25, 2005, Novartis and U.S. Food and Drug Administration (FDA) notified healthcare professionals of revisions to the DOSAGE AND ADMINISTRATION and WARNINGS sections of the prescribing information for the drug Zometa (zoledronic acid), to reflect new safety information on management of patients with advanced cancer and renal impairment, whose baseline creatinine clearance is 60 ml/min or lower. The recommended Zometa doses for patients with reduced renal function (mild and moderate renal impairment) are provided in a table. It is recommended that, during treatment, serum creatinine be measured before each dose and treatment should be withheld for renal deterioration. See the FDA Web site for more information.

Subsequently, on May 18, 2005, Novartis and the FDA notified dental healthcare professionals of revisions to the prescribing information to describe the occurrence of osteonecrosis of the jaw (ONJ) observed in cancer patients receiving treatment with intravenous bisphosphonates, Aredia (pamidronate disodium) and Zometa (zoledronic acid). The prescribing information recommends that cancer patients receive a dental examination prior to initiating therapy with intravenous bisphosphonates (Aredia and Zometa), and avoid invasive dental procedures while receiving bisphosphonate treatment. For patients who develop ONJ while on bisphosphonate therapy, dental surgery may exacerbate the condition. 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

RECOMMENDATIONS

MAJOR RECOMMENDATIONS

  • Women with breast cancer who have bone metastases should be offered treatment with oral clodronate, intravenous pamidronate, or intravenous zoledronate.
    • An exception may be patients with a short expected survival (i.e., less than six months), who have well-controlled bone pain.
    • Patients who have difficulty tolerating oral medications (e.g., those with nausea/vomiting or esophagitis) should be offered intravenous pamidronate or zoledronate.
    • Intravenous zoledronate may be preferable to pamidronate when a shorter infusion time (15 minutes versus two hours, respectively) is important.
    • Intravenous clodronate has not been examined for its ability to reduce morbidity from bone metastases with long-term use. When clodronate is used for this purpose, the oral route is recommended.
  • In patients with bone metastases and pain, treatment with pamidronate, zoledronate, or clodronate may be a useful adjunct to conventional measures for pain control.
  • Bisphosphonates are not recommended to prevent bone metastases or improve survival in women with locally advanced breast cancer or non-skeletal metastases.
  • Current evidence is insufficient to support the use of bisphosphonates as adjuvant therapy to either prevent skeletal events or improve survival in women with early-stage breast cancer.

CLINICAL ALGORITHM(S)

None provided

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EVIDENCE SUPPORTING THE RECOMMENDATIONS

TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported by evidence-based practice guidelines, meta-analyses, and randomized controlled trials.

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IDENTIFYING INFORMATION AND AVAILABILITY

BIBLIOGRAPHIC SOURCE(S)

  • Breast Cancer Disease Site Group. Warr D, Johnston M. Use of bisphosphonates in women with breast cancer [full report]. Toronto (ON): Cancer Care Ontario (CCO); 2004 Apr [online update]. 34 p. (Practice guideline report; no. 1-11). [68 references]

ADAPTATION

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

DATE RELEASED

1998 Nov 9 (revised 2004 Apr)

GUIDELINE DEVELOPER(S)

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

GUIDELINE DEVELOPER COMMENT

The Practice Guidelines Initiative (PGI) is the main project of the Program in Evidence-based Care (PEBC), 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

Members of the Breast Cancer Disease Site Group disclosed potential conflict of interest information.

GUIDELINE STATUS

This is the current release of the guideline.

The FULL REPORT, initially the full original Guideline or Evidence Summary, 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 is available:

PATIENT RESOURCES

None available

NGC STATUS

This summary was completed by ECRI on August 19, 1999. The information was verified by the guideline developer as of September 17, 1999. This summary was updated by ECRI on April 12, 2002, July 21, 2003, and September 24, 2004. The updated information was verified by the guideline developer on October 20, 2004. This summary was updated by ECRI on May 20, 2005, following the U.S. Food and Drug Administration advisory on Aredia (pamidronate disodium) and Zometa (zoledronic acid).

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 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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