Gemzar® Plus Herceptin®
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 (cancer.gov) and
www.cancerconsultants.com. Personalized clinical trials are also performed on
behalf of patients at cancerconsultants.com.
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.
Source :
http://patient.cancerconsultants.com/breast_cancer_news.aspx?id=33206