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A newly published study shows that the drug Femara
(generic name, letrozole) may be more effective at treating women with advanced breast cancer than the current standard, tamoxifen. In early 2001, the U.S. Food and Drug
Administration (FDA) approved the drug Femara as an initial treatment option
("first-line therapy") for women with advanced breast cancer. The current study
found that Femara slowed the progression of breast cancer and offered early, improved
chances of survival. This provides further hope that Femara may be a viable option for
women with advanced breast cancer.
Femara belongs to a class of drugs called aromatase inhibitors and works differently
than tamoxifen. To grow and reproduce, breast cancer cells require the female hormone
estrogen. Tamoxifen is an anti-estrogen and works by blocking estrogen from breast cancer
cells, thereby "starving" cancer cells. In contrast, Femara works by reducing
the total amount of estrogen in the body (circulating estrogen levels), thereby limiting
the amount of estrogen that can affect breast cancer cells. Other examples of aromatase
inhibitors include Arimidex (generic name,
anastrozole) and Aromasin (generic name,
exemestane). Both of these drugs are also used to help treat advanced breast cancer in
women whose breast cancer tumors have not responded well to tamoxifen.
In the current study, researcher Henning Mouridsen of the Rigshospitalet in Copenhagen,
Denmark and colleagues compared Femara to the standard breast cancer drug, tamoxifen, in
907 postmenopausal women with advanced breast cancer. Research was supported by a grant
from Novartis Pharma AG, the maker of Femara.
The results showed that after an average of 32 months of follow-up, 48% of the patients
who received Femara were able to prevent a progression of their cancers, compared with 27%
of the women who received tamoxifen. Furthermore, patients treated with Femara were able
to prolong the time before they needed chemotherapy from nine
months (on tamoxifen) to 16 months (with Femara).
The following side effects were noted in the study:
(Femara versus tamoxifen)
- bone pain (22% vs. 21%)
- hot flashes (19% vs. 16%)
- back pain (18% vs. 19%)
- nausea (17% vs. 17%)
- difficulty breathing (18% vs. 17%)
- joint pain16% vs. 15%)
- fatigue (13% vs. 13%)
- coughing (13% vs. 13%)
- constipation (10% vs. 11%)
- chest pain (6% vs. 6%)
- headache (8% vs. 6%).
Previous research has also shown that Femara may be more effective than tamoxifen at
treating advanced breast cancer. In a study presented at the Chemotherapy Foundation
Symposium XVIII in New York in November 2000, 900 women with advanced breast cancer
received either Femara or tamoxifen. After one year of treatment, the number of women
whose cancer had not progressed was nearly 50% greater among those who took Femara,
compared with the women who took tamoxifen.
"FDA approval of this new indication means that thousands of post-menopausal women
with advanced breast cancer will have a more effective hormonal treatment option,"
said David Parkinson, MD, Vice President of Clinical Research at Novartis Oncology in a
Norvartis media release at the time of the drug’s FDA approval. Femara is also
approved to help treat women who do not respond well to tamoxifen or become resistant to
it.
Additional Resources and References
- To learn more about drugs used to treat breast cancer, please visit http://www.imaginis.com/breasthealth/bc_drugs.asp
- The study, "Phase III Study of Letrozole Versus Tamoxifen as First-Line Therapy of
Advanced Breast Cancer in Postmenopausal Women: Analysis of Survival and Update of
Efficacy From the International Letrozole Breast Cancer Group," is published in the
June 2003 issue of the Journal of Clinical Oncology, http://www.jco.org/
- The May 29, 2003 Novartis news release is entitled, "Femara Demonstrated Early
Survival Advantage Over Tamoxifen in Advanced Breast Cancer as Reported in Journal of
Clinical Oncology," http://www.pharma.us.novartis.com/
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