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New Study Results Demonstrate Clinical Effectiveness of
Gemzar(R)-Based Combination Therapy for Advanced Breast Cancer
INDIANAPOLIS, May 16 /PRNewswire-FirstCall/ -- New data from a Phase III
clinical trial(1) show that Eli Lilly and Company's (LLY) Gemzar(R)
(gemcitabine, HCl) in combination with Taxotere(R) (docetaxel) demonstrated
similar efficacy, but with an improved safety profile, when compared to a
regimen of Xeloda(R) (capecitabine) and docetaxel in the treatment of
metastatic breast cancer.
The study, presented today at the 41st annual meeting of the American Society
of Clinical Oncology (ASCO), compared the two combinations as first- or
second-line treatment in patients with metastatic breast cancer. The study
further demonstrates Gemzar's ability to be combined with other agents in
providing patients with the benefit of survival, while maintaining a manageable
level of side effects. Gemzar in combination with Taxol(R) (paclitaxel) is
approved for use in the U.S., Europe and more than 60 countries for the
treatment of metastatic breast cancer.
Patients receiving the Gemzar-based combination had the same progression- free
survival time (the length of time during and after treatment that the cancer
does not grow) and tumor response rate (tumor shrinkage) as patients receiving
the capecitabine-based combination. Patients administered the Gemzar
combination also experienced significantly fewer toxic side effects, such as
mucositis (an inflammation of the gastrointestinal lining resulting in painful
sores in the mouth and throat), diarrhea and hand-foot syndrome (a drug-related
skin condition that results in redness, tenderness, peeling and numbness of the
palms and soles).
"Treatment-related side effects can be severely debilitating for women with
metastatic breast cancer and have a tremendous impact on their quality of
life," said Stephen Chan, M.D., Consultant Oncologist, Nottingham City
Hospital, United Kingdom, and primary investigator of the study. "The
combination of efficacy and improved tolerability seen in this study with
Gemzar/docetaxel suggests that we've taken an important step forward where we
can treat the cancer while helping women live their everyday lives more
comfortably and with less risk of side effects."
Study Highlights
This 16-month study evaluated 302 patients with pre-treated metastatic breast
cancer who were randomized and treated with either Gemzar/docetaxel (n=152) or
capecitabine/docetaxel (n=150) combination therapy. The primary endpoint of
this study was progression-free survival. Secondary endpoints were overall
response rate, time to treatment failure, overall survival, toxicity and
quality of life.
Patients in the Gemzar/docetaxel arm were treated with 1000 mg/m2 of Gemzar
combined with 75 mg/m2 of docetaxel, and patients in the capecitabine/docetaxel
arm were treated with 1250 mg/m2 of capecitabine combined with 75 mg/m2 of
docetaxel. Patients in the Gemzar/docetaxel group and capecitabine/docetaxel
group received 875 and 758 cycles of therapy, respectively.
* Patients receiving Gemzar/docetaxel had the same median progression-
free survival time and overall tumor response rate as patients who
received capecitabine/docetaxel
* The Gemzar/docetaxel combination resulted in fewer non-hematologic
toxic side effects compared to capecitabine/docetaxel
-- Grade 3/4 mucositis - 4 percent vs. 17 percent
-- Grade 3/4 diarrhea - 8 percent vs. 18 percent
-- Grade 3/4 hand-foot syndrome - 0 percent vs. 26 percent
* Gemzar/docetaxel resulted in a slightly higher percentage of
hematologic side effects compared to capecitabine/docetaxel with the
exception of febrile neutropenia (a fever accompanied by a significant
reduction in white blood cell count, leading to greater likelihood of
developing an infection and increased need for hospitalization)
-- Grade 3/4 neutropenia (a lowering of the white blood cell count
that can cause infections and fever, thus requiring
hospitalization) - 85 percent vs. 82 percent
-- Grade 3/4 leukopenia (an abnormal decrease in the number of white
blood cells) - 80 percent vs. 66 percent
-- Grade 3/4 thrombocytopenia (a decrease in the number of platelets
in the blood, resulting in the potential for increased bleeding and
decreased ability for clotting) - 10 percent vs. 3 percent
-- Grade 3/4 febrile neutropenia - 8 percent vs. 13 percent
-- Grade 3/4 anemia (a decrease in red blood cell count resulting in
insufficient oxygen to tissues and organs) - 7 percent vs. 3
percent
* There was a lower discontinuation rate due to adverse events in the
Gemzar/docetaxel group compared to the capecitabine/docetaxel group (13
percent vs. 28 percent, respectively) - more patients stopped their
therapy on the capecitabine/docetaxel arm due to a higher occurrence of
adverse events.
* There were two toxic deaths in the trial, both occurring in the
capecitabine/docetaxel group of patients.
According to the World Health Organization, more than one million people
worldwide will be diagnosed with breast cancer this year, making it the most
common cancer among women(2).
"Gemzar has been shown to have significant therapeutic value on its own as a
cancer-fighter and as a highly combinable agent. We are extremely pleased that
Gemzar-based combination therapy continues to deliver in the fight against
breast cancer," said Allen Melemed, M.D., medical advisor, Eli Lilly and
Company. "Women and their physicians deserve our total and ceaseless
commitment to finding new options in breast cancer, and we will continue to
look for ways to improve the treatment picture."
Gemzar
Gemzar is one of the most widely studied treatments in the history of
chemotherapy agents, and has been approved for use in more than 90 countries
worldwide. It is the worldwide standard for care of pancreatic cancer and in
many parts of the world for non-small cell lung, bladder and breast cancers.
Gemzar is approved in more than 75 countries as a single agent for the
treatment of locally advanced or metastatic pancreatic cancer. It is also
approved, in combination with Taxol(R) (paclitaxel), in more than 60 countries
for the treatment of metastatic breast cancer. In most European countries,
Gemzar is approved as a single agent or in combination with cisplatin for the
treatment of advanced non-small cell lung cancer. Gemzar, in combination with
carboplatin, is approved in several European markets for the treatment of
recurrent epithelial ovarian cancer. Most recently, Gemzar was approved in
Mexico for cervical cancer, making it the first approval for this disease.
Gemzar is a nucleoside analogue that interferes with the process of DNA
production; thereby preventing cancer cells from replicating and thus slows or
stops tumor growth.
Eli Lilly and Company
Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Indiana, Lilly provides answers -- through medicines and
information -- for some of the world's most urgent medical needs. Additional
information about Lilly is available at http://www.lilly.com/. P-LLY
This press release contains forward-looking statements about Gemzar in
combination with Taxotere and reflects Lilly's current beliefs. However, as
with any pharmaceutical product under development, there are substantial risks
and uncertainties in the process of development and commercialization. There
is no guarantee that the product will receive additional regulatory approvals
and there is also no guarantee that the product will continue to be
commercially successful. For further discussion of these and other risks and
uncertainties, see Lilly's filing with the United States Securities and
Exchange Commission. Lilly undertakes no duty to update forward-looking
statements.
Gemzar(R) (gemcitabine HCl, Lilly)
Taxol(R) (paclitaxel, Bristol-Myers Squibb)
Xeloda(R) (capecitabine, Roche)
Taxotere(R) (docetaxel, Sanofi-Aventis)
(1) Gemcitabine plus docetaxel versus capecitabine plus docetaxel for
anthracycline-pretreated metastatic breast cancer patients: Results of a
European phase III study; Chan S, Romieu G, Huober J, Delozier T, Tubiana-
Hulin M, Lluch A, Schneeweiss A, Llombart A, Carrasco E, Fumoleau P
(2) "Global cancer rates could increase by 50% to 15 million by 2020." World
Health Organization 3 April 2003; Accessed 26 April 2005
http://www.who.int/mediacentre/news/releases/2003/pr27/en/
Gemzar/docetaxel Xeloda/docetaxel
(n=152) (n=150)
Median Progression-Free Survival Time 35 weeks 35 weeks
Overall Tumor Response Rate 32 percent 32 percent
Grade 3/4 Mucositis 4 percent 17 percent
Grade 3/4 Diarrhea 8 percent 18 percent
Grade 3/4 Hand-Foot Syndrome 0 percent 26 percent
Grade 3/4 Neutropenia 85 percent 82 percent
Grade 3/4 Leukopenia 80 percent 66 percent
Grade 3/4 Thrombocytopenia 10 percent 3 percent
Grade 3/4 Febrile Neutropenia 8 percent 13 percent
Grade 3/4 Anemia 7 percent 3 percent
Serious adverse events 30 percent 38 percent
Discontinuation rate due to adverse events 13 percent 28 percent
(Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO )
http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO
DATASOURCE: Eli Lilly and Company
CONTACT: Gregory L. Clarke (U.S. Media), +1-317-276-5222 (phone),
+1-877-892-7864 (pager), or Carla L. Cox (Non-U.S. Media), +1-317-651-1473
(phone), +1-888-446-5740 (pager), both of Eli Lilly and Company