Gemzar® Plus Herceptin® Produces High Responses in HER-2 Positive Breast Cancer

Gemzar® Plus Herceptin® Produces High Responses in HER-2 Positive Breast Cancer

According to results recently presented at the 2004 San Antonio Breast Cancer Symposium (SABCS), the treatment combination consisting of the chemotherapy agent Gemzar® (gemcitabine) plus the biologic agent Herceptin® (trastuzumab) appears to provide encouraging anti-cancer activity in patients with HER2-positive metastatic breast cancer.

Breast cancer claims the lives of approximately 40,000 women annually in the United States alone. If breast cancer is caught and treated early, cure rates remain high. However, once breast cancer has spread to several and/or distant sites in the body, cure rates greatly diminish. Metastatic breast cancer refers to cancer that has spread from the breast to distant sites in the body, often invading vital organs. Treatment for metastatic breast cancer is typically aimed at improving a patient’s quality of life and/or increasing the duration of survival. Research is ongoing in an attempt to improve long-term survival for patients with this disease.

A significant portion of patients with breast cancer over-express the human epidermal growth factor-2 (HER2), which is a protein that is displayed on the outside of a cell. HER2 is involved in cellular growth and replication. Over-expression of HER2 is implicated in the uncontrolled growth of cancer. The level of HER2 expression may be determined through laboratory processes. Herceptin® (trastuzumab) is a monoclonal antibody that has been made through laboratory processes to bind to HER2, and ultimately inactivate or slow the growth and replication pathway that HER2 is involved in. Herceptin® is currently FDA-approved in combination with paclitaxel (Taxol®) for the treatment of metastatic breast cancer that over-expresses HER2 or alone for the treatment of metastatic breast cancer that over-expresses HER-2 and has recurred following previous therapy. Clinical trials are underway to evaluate Herceptin® earlier in the course of the disease of HER2 over-expressing breast cancer, as well as in combination with various chemotherapy agents. It has been demonstrated that the combination of Herceptin® plus Adriamycin® (doxorubicin) may result in heart failure. Although uncommon, researchers are evaluating different agents with Herceptin® and closely monitoring side effects.

A recent multi-institutional clinical trial was recently conducted to evaluate the chemotherapy agent Gemzar® in addition to Herceptin® in patients with HER2-positive metastatic breast cancer. The first stage of the trial included 25 patients who had not received prior therapy for metastatic disease, who were treated with the Gemzar®/Herceptin® combination. Overall, anti-cancer response rates were achieved in 64% of patients. Only 4% of patients experienced severely low levels of immune cells (neutropenia). Due to these results, the researchers will continue to accrue 41 additional patients for further evaluation of Gemzar®/Herceptin®.

The researchers concluded that the treatment combination of Gemzar® and Herceptin® appears to produce high anti-cancer response rates and is well tolerated in patients with HER2-positive, metastatic breast cancer. Patients with advanced breast cancer that is HER2-positive may wish to speak with their physician about their individual risks and benefits of participating in a clinical trial further evaluating chemotherapy agents with Herceptin®, or other novel therapeutic approaches. Two sources of information regarding ongoing clinical trials include the National Cancer Institute ( and Personalized clinical trials are also performed on behalf of patients at

Reference: Brufsky A, Orlando M, Fox K, Jame A, Katherine T, Franco S, Vincent H, Terry E, LaTrice H, Steven S, Allen M: Phase II study of gemcitabine (Gem) and trastuzumab (T) combination therapy in patients (pts) with HER2-overexpressing metastatic breast cancer (MBC). First stage results [abstract 3047] San Antonio Breast Cancer Symposium, San Antonio, TX, Dec 9, 2004.

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