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Letrozole Reduces the Risk of Post-Surgery Recurrence of Early Breast Cancer When Compared With Tamoxifen, Study Shows

St. Gallen, Switzerland (ots/PRNewswire)

In postmenopausal women
with early breast cancer, letrozole offers better post-surgery
protection against breast cancer recurrence than does tamoxifen, the
current standard of care, according to data presented today at the
Primary Therapy of Early Breast Cancer 9th International Conference
in St. Gallen, Switzerland. The data from the Breast International
Group (BIG) 1-98 Trial showed a significant difference in
disease-free survival (DFS) in favor of letrozole.
"The results of BIG 1-98 are of great importance for the majority
patients with breast cancer. Letrozole reduced the risk of cancer
recurrence by 19% beyond the risk reduction achieved by tamoxifen. We
now have an additional tool to improve the outcome for postmenopausal
women with hormone sensitive breast cancer. Together with optimal
surgery, followed by chemotherapy and radiotherapy if needed,
incorporation of letrozole in the treatment plan is a step forward in
the patients' way of remaining disease from cancer. Further
investigations and longer follow-up are necessary to optimize the use
of letrozole in order establish longterm safety and tolerability of
the drug and to further improve its treatment benefits," says PD Dr.
Thurlimann, BIG 1-98 Trial study chair.
BIG 1-98 is the first clinical trial ever designed to incorporate
both a head-to-head comparison of letrozole with tamoxifen and a
sequencing of both agents, during the first five years following
breast cancer surgery, to determine the most effective approach to
minimizing the risk of breast cancer recurrence.
The study compares:
- five years of tamoxifen versus five years of letrozole;
    - tamoxifen for two years followed by letrozole for three years
    - letrozole for two years followed by tamoxifen for three years
Data from the study are expected to answer important questions
regarding the optimal sequencing of aromatase inhibitor therapy in
postmenopausal women with endocrineresponsive early breast cancer.
Methods and Results
BIG 1-98 is a multinational Phase III double-blind, randomized
multicenter trial that is being conducted in 27 countries and
involves more than 8000 postmenopausal women with early breast cancer
who have hormone receptor-positive tumors. A primary goal of the
study was to determine if letrozole could reduce the risk of a
disease-free survival event (breast cancer relapse, occurrence of a
second (non-breast) malignancy or death without recurrence) compared
with tamoxifen. At a median follow-up of 26 months the study shows
that, compared with tamoxifen, letrozole reduced the risk of such
events by 19%. Among the 4003 patients in the letrozole group, 84.0%
remained alive and disease-free at five years compared with 81.4% of
the 4007 patients in the tamoxifen group.
    There was also a difference in side effects between letrozole and
    tamoxifen.
    - More on tamoxifen
    -- venous thrombosis and embolism (clots)
    -- vaginal bleeding more often and led to more endometrial
       abnormalities (changes in the lining of the womb) and endometrial
       biopsies.
    - More on letrozole
    -- bone fractures
    -- elevation of cholesterol, though this was usually mild.
       Heart attacks and strokes slightly more often, though these events
       were very rare with both treatments
Early breast cancer is defined as cancer that is localized to
breast tissue and/or nearby lymph nodes. Worldwide, about 800,000
women are diagnosed with early breast cancer every year. Primary
therapy for early breast cancer usually involves surgery to remove
the tumor and surrounding tissue. Standard post-surgery therapy
(early adjuvant) typically includes radiation and/or chemotherapy,
followed by treatment with five years of tamoxifen, previously the
"gold standard of care" for postmenopausal women.
BIG 1-98 is being conducted under the umbrella of the Breast
International Group, coordinated and managed by the International
Breast Cancer Study Group (IBCSG). Novartis, the producer and
distributer of letrozole (Femara(R)) gave financial support. The
IBCSG is an active member of the BIG organization.
About The International Breast Cancer Study Group
The International Breast Cancer Study Group (IBCSG) is a
non-profit organization founded as the 'Ludwig Breast Cancer Study
Group' in 1977, which has always been dedicated to innovative
clinical research designed to improve the outcome of women with
breast cancer. The IBCSG is headquartered in Bern as a foundation
under Swiss law. The Statistical and Data Management Centers are in
the United States (Boston, MA and Amherst, NY), and the central
pathology review offices are in Milan, Italy and Glasgow, Scotland.
About the Breast International Group
The Breast International Group is an international non-profit
organization dedicated to serve as a network for large breast cancer
trials among its members. The participants are well established
clinical research and cooperative groups based in Europe, Australia,
New Zealand, South Africa, and Canada, with affiliated centers around
the world.
Additional information regarding BIG 1-98 and IBCSG can be found
on the website http://www.ibcsg.org.
    Contact persons:
    PD Dr. Beat Thurlimann, BIG 1-98 Study Chair, Senologie-Zentrum
    Ostschweiz, Rorschacherstrasse 95, 9007 St. Gallen. Phone:
    +41-71-494-11-78, email:  beat.thuerlimann@kssg.ch
    Dr. Nadia Munarini, IBCSG Head of Communication, Effingerstrasse 40, 3008
    Bern. Phone: +41-31-389-92-27, email:  nadia.munarini@ibcsg.org.
Web Site: http://www.ibcsg.org

Contact:

Nadia Munarini, PhD, IBCSG, +41-31-389-92-27, or
nadia.munarini@ibcsg.org; PD Dr. Beat Thurlimann, BIG 1-98 Study
Chair, +41-71-494-11-78, or beat.thuerlimann@kssg.ch

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