Adjuvant Herceptin: Am Soc of Breast Disease Statement

Press release

November 10, 2006

American Society of Breast Disease Issues Statement on the Use of Adjuvant Trastuzumab in Women with HER2-Positive, Operable Breast Cancer

Interest among patients and clinicians on use of adjuvant trastuzumab for breast cancer treatment requires clear statement of what we know and do not know. While acknowledging that this is a rapidly changing field, the Consensus Committee of the American Society of Breast Disease presents the following conclusions on the present status of trastuzumab use for HER2-positive, operable breast cancer.

Invasive breast cancers should be tested for over-expression or amplification of the HER2 proto-oncogene. Women with HER2-positive, operable, lymph node positive breast cancer should be offered trastuzumab. While data are less robust for women with HER2-positive, operable, lymph node negative breast cancer, those with high risk disease should be offered adjuvant trastuzumab.

The optimal schedule of trastuzumab administration remains to be determined, although weekly administrations and three-weekly administrations are both associated with similar levels of benefit.

Adjuvant trastuzumab with dose-dense chemotherapy is presently being investigated and recommendations cannot yet be made. The optimal timing and duration of adjuvant treatment with trastuzumab remains to be established. The bulk of evidence was based on regimens utilizing one year of trastuzumab.

Women should be without clinically significant cardiac disease at outset and monitored for cardiac toxicity during treatment. The Committee supports the published guidelines for monitoring cardiac toxicity and for dose modifications. Women older than age 60 have higher risk of cardiac toxicity, as do those with preexisting risk factors.

Cardiac toxicity appears lower for sequential chemotherapy-trastuzumab regimens compared to the simultaneous regimens. Trastuzumab was beneficial across all adjuvant and neo-adjuvant chemotherapy regimens in clinical trials. Data suggest that co-amplification of TOPO2A with HER2 is associated with greater benefit from anthracycline-containing regimens than non-anthracycline regimens whereas co-amplification of cMYC with HER2 is associated with greater benefit from trastuzumab.

There are no data on the use of trastuzumab without chemotherapy in the adjuvant setting. For an individual woman who has completed adjuvant chemotherapy beyond the time specified by the clinical trials, we believe it is reasonable to evaluate risk of recurrence at her given point in time when deciding to recommend adjuvant trastuzumab.

The American Society of Breast Disease encourages participation in clinical trials.

Complete statement and background paper found here:

http://www.asbd.org/images/ASBD_Adjuvant_Trastuzumab_11-8-06.pdf

American Society of Breast Disease

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