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Report: Herceptin May Delay Metastatic Breast Cancer Progression and Increase Survival Time

PLYMOUTH MEETING, PA -— July 15, 2003 -- ECRI’s evaluation of published studies of Herceptin concludes that when combined with chemotherapy, the treatment may slow tumor progression in some patients with metastatic breast cancer. Herceptin is a monoclonal antibody that inhibits development of cells that express too much of the protein HER2. All humans have this protein, but when it is overexpressed, HER2 stimulates rapid cell growth that may contribute to the formation of 20% to 30% of breast tumors.

Studies suggest that by blocking tumor cell growth and inducing an immune system attack on the tumor, Herceptin may improve tumor response rates, delay tumor progression, and increase median survival time by four to six months, with few adverse effects. The drug is either administered in combination with paclitaxel for women who have not previously undergone chemotherapy, or used alone as a follow-up treatment for patients whose disease was unresponsive to previous chemotherapy treatments.

ECRI’s Windows on Medical Technology™ report, “Trastuzumab (Herceptin®) for the Treatment of Breast Cancer,” addressed four key issues in determining the effectiveness and safety of Herceptin: overall patient survival rates, quality of life, tumor response rate, and time-to-disease progression. Research included comprehensive literature searches for all published studies and use of predetermined criteria to select and analyze studies. One of the trials selected for analysis compared Herceptin plus chemotherapy to chemotherapy alone for metastatic breast cancer, and the other compared two different doses of Herceptin alone for metastatic breast cancer. Evidence suggests that increasing Herceptin dosage beyond the standard dosage had little or no impact on its effectiveness. The available evidence is currently insufficient to determine the safety or efficacy of Herceptin for early-stage (I or II) breast cancer or as an adjuvant therapy, but several clinical trials are in progress to assess Herceptin’s effectiveness for these patients.

Windows on Medical Technology assessment reports offer an accurate overview of a specific medical technology for a specific application; many of these reports are on new and emerging medical treatments and procedures. Members of ECRI’s Health Technology Assessment Information Service (HTAIS) receive Windows on Medical Technology reports as part of their Custom Membership, and nonmembers can purchase individual copies of reports. Members include healthcare providers and health systems, health plans, and state and federal government agencies.

For more information about HTAIS, or to purchase a copy of “Trastuzumab (Herceptin®) for the Treatment of Breast Cancer,” contact ECRI by mail at 5200 Butler Pike, Plymouth Meeting, PA 19462-1298, USA; by telephone at +1 (610) 825-6000, ext. 5170; by e-mail at; or by fax at +1 (610) 834-1275.

Source: ECRI

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