Gemzar ®
plus Paclitaxel Improves Survival in Advanced Breast Cancer
According to results presented at the 40th annual meeting of the American
Society of Clinical Oncology (ASCO), the chemotherapy combination
consisting of Gemzar ® (gemcitabine) and paclitaxel (Taxol ®)
improves anti-cancer responses, time to cancer progression
and survival at one year compared to paclitaxel alone in the
treatment of metastatic breast cancer. Gemzar ® in combination
with paclitaxel was recently approved by the FDA for the initial
treatment of metastatic breast cancer.
Breast cancer is the most common cancer diagnosed in women
in the United States, claiming the lives of approximately
40,000 women annually. Although treatment for patients with
early-stage breast cancer (or cancer that has not spread from
its site of origin) results in high cure rates, some patients
ultimately experience a recurrence and spread of their cancer.
Metastatic breast cancer refers to cancer that has spread
from the breast to distant sites in the body, often invading
vital organs. Survival for patients with metastatic breast
cancer is poor, with the average survival time from diagnosis
of this advanced stage of cancer being 18 to 30 months. Patients
whose cancer has recurred following previous therapy and has
developed into metastatic breast cancer are often treated
with the chemotherapy agent paclitaxel.
The recent trial involved 529 patients with metastatic breast
cancer who were treated with either Gemzar ®/paclitaxel
or paclitaxel alone and were directly compared. Patients had
received prior treatment with anthracyclines (doxorubicin
or epirubicin) for earlier-stage disease and had experienced
disease progression. Anti-cancer response rates were 40.8%
for patients treated with Gemzar ®/paclitaxel, compared
to only 22.1% for those treated with paclitaxel alone. The
average overall survival was 18.5 months for patients treated
with Gemzar ®/paclitaxel, compared with 15.8 months for
those treated with paclitaxel alone. At one year, patients
treated with Gemzar ®/paclitaxel had a significantly improved
survival rate (70.7%) compared to those treated with paclitaxel
alone (60.9%).
The researchers concluded that the chemotherapy combination
consisting of Gemzar ® plus paclitaxel is superior to paclitaxel
alone in the treatment of metastatic breast cancer. Furthermore,
the presenters at ASCO stated that the Gemzar ®/paclitaxel
regimen was very well tolerated and is associated with fewer
side effects than some single-agent therapies for breast cancer.
They also stated that clinical trials evaluating Gemzar ®/paclitaxel
are warranted for earlier stage breast cancer. Patients diagnosed
with breast cancer who will undergo chemotherapy may wish
to speak with their physician about the risks and benefits
of Gemzar ®/paclitaxel or the participation in a clinical
trial further evaluating Gemzar ® regimens or novel therapeutic
approaches. Two sources of information regarding ongoing clinical
trials include the National Cancer Institute (cancer.gov)
and www.cancerconsultants.com. Personalized clinical trial
searches are also performed by cancerconsultants.com.
Reference: Albain K, Nag S, Calderillo-Ruiz G, et al. Global
phase III study of gemcitabine plus paclitaxel (GT) vs. paclitaxel
(T) as frontline therapy for metastatic breast cancer (MBC):
First report of overall survival. Proceedings from the 40th
annual meeting of the American Society of Clinical Oncology.
New Orleans, LA. 2004. Abstract #510.
These results indicate that the addition of Femara ® following
5 years of tamoxifen significantly reduces the risk of death
and cancer recurrence in women with breast cancer, with node-positive
patients gaining the greatest survival benefit. Clinical trials
are ongoing to determine the optimal timing and sequencing
of aromatase inhibitors and tamoxifen in the treatment of
hormone-positive breast cancer. Postmenopausal patients with
hormone-positive breast cancer may wish to speak with their
physician about the risks and benefits of continued Femara ®
following tamoxifen in their treatment regimen, or the participation
in a clinical trial further evaluating the role of aromatase
inhibitors. Two sources of information regarding ongoing clinical
trials include the National Cancer Institute (cancer.gov)
and www.cancerconsultants.com. Personalized clinical trial
searches are also performed at cancerconsultants.com.
References:
1. Goss P, Ingle J, Martino S, et al. Updated analysis of
the NCIC CTC MA.17 randomized placebo (P) controlled trial
of letrozole (L) after five years of tamoxifen in postmenopausal
women with early stage breast cancer. Proceedings from the
40th annual meeting of the American Society of Clinical Oncology.
New Orleans, LA. 2004. Abstract #847. “Best of oncology
symposium” presented June 8, 2004.
2. Goss P, Ingle J, Martino S, et al. A randomized trial
of letrozole in postmenopausal women after five years of tamoxifen
therapy for early-stage breast cancer. The New England Journal
of Medicine. Early publication available at: www.nejm.org.
October 9, 2003.
3. Goss, et al. A randomized trial of letrozole in postmenopausal
women after five years of tamoxifen therapy for early-stage
breast cancer. Proceedings from the 2003 San Antonio Breast
Cancer Symposium. December 2003.
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