Tesmilifene in Addition to Doxorubicin Improves Survival in Advanced Breast Cancer
By: 411Cancer.com
02/19/2004
According to a recent article published in the Journal of Clinical Oncology,
a novel agent tesmilifene (DPPE, BMS-217380-01) in addition to doxorubicin
(Adriamycin ®) improves survival compared to doxorubicin alone in
the treatment of advanced breast cancer.
Breast cancer is diagnosed in over 200,000 women annually in the United
States alone. Metastatic breast cancer refers to cancer that has spread
from the breast to distant sites in the body, often invading vital organs.
Recurrent breast cancer refers to cancer that has progressed or returned
following prior therapy. Depending upon the location and extent of cancer
spread, patients with metastatic or recurrent breast cancer are often
treated with the aim of extending the duration of survival and/or improving
quality of life. Chemotherapy is a component of standard treatment for
advanced breast cancer, with the chemotherapy agent doxorubicin being
one of the most active agents in the treatment of breast cancer. Researchers
continue to evaluate novel agents to improve outcomes for patients with
advanced breast cancer.
Tesmilifene is an agent that has just completed the last phase of clinical
trials prior to FDA review. Tesmilifene is used as an agent to enhance
the effects of doxorubicin through a few mechanisms. Researchers speculate
that tesmilifene enhances the anti-cancer effects of doxorubicin by decreasing
a cancer cell's ability to become resistant to chemotherapy, decreasing
the metabolism or "breaking-down" of doxorubicin, and disrupting
a cancer cell's energy source.
A multi-center clinical trial was recently conducted to directly compare
tesmilifene plus doxorubicin to doxorubicin alone in the treatment of
advanced breast cancer. This trial included 305 patients, approximately
half of whom were treated with tesmilifene plus doxorubicin and the other
half of whom were treated with doxorubicin alone. Approximately 20 months
following treatment, there were no significant differences in anti-cancer
response rates, progression-free survival, or the average duration of
response. However, overall survival was significantly improved in the
group of patients treated with tesmilifene/doxorubicin (23.6 months),
compared to those treated with doxorubicin alone (15.6 months). Patients
treated with tesmilifene/doxorubicin experienced more nausea, vomiting,
dizziness, hallucinations, movement disorders and loss of coordination
than those treated with doxorubicin alone.
The researchers concluded that the addition of tesmilifene to doxorubicin
appears to improve survival over doxorubicin alone in the treatment of
metastatic or recurrent breast cancer. Patients with advanced breast
cancer may wish to speak with their physician about the risks and benefits
of participating in a clinical trial further evaluating tesmilifene or
other promising therapeutic approaches.
Reference:
Reyno L, Seymour L, Tu D, et al. Phase III Study of N,N-Diethyl-2-[4-(Phenylmethyl)
Phenoxy]Ethanamine (BMS-217380-01) Combined With Doxorubicin Versus Doxorubicin
Alone in Metastatic/Recurrent Breast Cancer: National Cancer Institute
of Canada Clinical Trials Group Study MA.19. Journal of Clinical Oncology.
2004; 22:269-276.
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