Doxil ® Plus Gemzar ® Active in Metastatic Breast Cancer
By: 411Cancer.com
09/23/2003
According to results recently published in the Journal of Clinical Oncology,
the chemotherapy combination of Doxil ® plus Gemzar ® appears active
and well tolerated for the treatment of metastatic breast cancer.
Metastatic breast cancer refers to cancer that has spread outside the
breast to several and/or distant sites in the body. Treatment for metastatic
breast cancer is typically aimed at improving quality of life or duration
of survival for patients, rather than with curative intent. Standard
therapy for metastatic breast cancer consists of chemotherapy, with anthracyclines
(doxorubicin, epirubicin, Doxil) and taxanes (paclitaxel, Taxotere) being
among the most effective chemotherapy agents. However, patients with
metastatic breast cancer have often received one or both of these agents
for treatment of earlier stage breast cancer (adjuvant therapy) or prior
therapy for metastatic breast cancer. Furthermore, some patients are
unable to tolerate the side effects posed by these agents. Therefore,
researchers have been evaluating novel chemotherapy combinations in order
to provide an alternative treatment for these patients as well as improve
survival and quality of life.
Gemzar (gemcitabine) has demonstrated anti-cancer activity in the treatment
of advanced breast cancer, including patients who have been treated with
prior anthracyclines therapy, and is not associated with significant
side effects. Doxil (pegylated liposomal doxorubicin), although categorized
as an anthracycline, is believed to be associated with less risk of cardiotoxicity
(side effects affecting the heart) than the other anthracyclines. Researchers
from the MD Anderson Cancer Center recently conducted a clinical trial
to further evaluate the effectiveness of Gemzar and Doxil in the treatment
of metastatic breast cancer. This trial involved 49 patients, 27 of whom
had received prior adjuvant therapy. Overall, anti-cancer responses were
achieved in 52% of patients. In the group of patients treated with prior
anthracycline therapy, 58% achieved an anti-cancer response. The average
duration of survival for all patients was 16.1 months, with nearly 80%
of patients reportedly deriving some benefit from this treatment regimen.
This treatment combination was well tolerated.
The researchers concluded that Gemzar plus Doxil provides anti-cancer
activity and is well tolerated in patients with metastatic breast cancer,
even in those treated with previous anthracycline therapy. This treatment
combination may provide an effective alternative regimen for patients
who have had progression of cancer following previous therapies or for
those who cannot tolerate anthracycline/taxanes combinations. Future
clinical trials directly comparing Gemzar/Doxil to anthracyclines plus
taxanes are warranted to determine the true clinical benefit of either
approach as initial therapy for metastatic breast cancer. Patients with
metastatic breast cancer may wish to speak with their physician regarding
the risks and benefits of treatment with Gemzar and Doxil or the participation
in a clinical trial evaluating other novel therapeutic approaches.
Reference:
Rivera E, Valero V, Arun B, et al. Phase II study of pegylated liposomal
doxorubicin in combination with gemcitabine in patients with metastatic
breast cancer. Journal of Clinical Oncology. 2003;21:3249-3254.
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