- Drug shown to prolong survival of patients with stage III colon
LAVAL, QC, Jan. 15 /CNW/ - Health Canada has approved Eloxatin(R)
(oxaliplatin for injection), in combination with infusional 5-fluorouracil
(5-FU) and leucovorin (LV) (FOLFOX4), for the adjuvant (post-surgical)
treatment of patients with stage III colon cancer, after complete resection of
the primary tumour. This indication is based on a demonstrated improvement in
disease-free survival. Data also show a numerical improvement in overall
survival after six years.
"Colorectal cancer has had a profound impact on my life and the lives of
thousands of Canadians who, up until this point, have had few treatment
options," says Neil Crone, Canadian actor and colorectal cancer survivor.
"Canadians with colorectal cancer are fortunate to have this new treatment
which provides hope for a successful recovery."
Colon cancer grows very slowly and oncologists have found that this
growth is often predictable, making it simpler to treat when detected early.
"The approval of Eloxatin for use after surgery provides my patients with the
hope that they can better their chances of being cancer-free," says Dr.
Yoo-Joung Ko, a Toronto-based oncologist. "The safety and efficacy profile of
Eloxatin is clinically superior to the previous standard treatment, making
this an important advancement in the treatment of the disease."
Barry D. Stein, president of the Colorectal Cancer Association of Canada,
acknowledges the need for new treatment options. "My personal battle with
colorectal cancer has been extremely challenging and I'm thankful that I am in
a position where there is no evidence of the disease," he says. "With so many
Canadians being diagnosed with colorectal cancer, the approval of Eloxatin for
use in the earlier stages of the disease provides an additional opportunity
for patients to prolong their lives. It brings hope to patients, their
families and friends."
Health Canada's approval of Eloxatin was based on clinical data collected
over several years. The Multicenter International Study of
Oxaliplatin/5-Fluorouracil/Leucovorin in the Adjuvant Treatment of Colon
Cancer (MOSAIC) trial compared the efficacy and evaluated the safety of
Eloxatin in combination with an infusional schedule of 5-FU/LV (FOLFOX4) to
infusional 5-FU/LV alone, in patients with stage II or III colon cancer who
had undergone complete resection of the primary tumour. In the overall study
population, disease-free survival was statistically and significantly improved
in the Eloxatin combination arm compared to infusional 5-FU/LV alone.(1)
Survival data at six years show a numerical improvement in overall survival in
patients with stage III colon cancer.
About Eloxatin(R) (oxaliplatin for injection):
Eloxatin is a platinum agent which binds to the DNA in cancer cells and
inhibits the replication process, causing the eventual death of the cancer
Eloxatin, manufactured by sanofi-aventis, is currently available in more
than 60 countries. In Canada, Eloxatin, in combination with infusional 5-FU
and LV (FOLFOX4), was first approved in June 2007 for the treatment of
metastatic colorectal cancer.
Side effects observed in the clinical trial setting included fatigue,
neuropathy, nausea, vomiting, diarrhea, stomatitis, neutropenia,
thrombocytopenia, anemia, hepatotoxicity and respiratory problems.
Anaphylactic reactions have been reported and may occur within minutes of
Eloxatin administration. Eloxatin should be administered under the supervision
of a qualified physician experienced in the use of cancer chemotherapeutic
About Colorectal Cancer in Canada
In Canada, colorectal cancer is the second-leading cause of death from
cancer. In 2007, an estimated 20,800 Canadians were expected to be diagnosed
with colorectal cancer, resulting in an estimated 8,700 deaths.(2)
According to the Colorectal Cancer Association of Canada, risk factors
include being 50 years of age and older, having a history of polyps in the
colon or rectum, poor diet (high in red meat, and low in fibre and fruits and
vegetables) and having a family history of colorectal cancer.
Colorectal cancer often begins in the cells within the lining of the
colon or rectum. Screening techniques such as the fecal occult blood test
(FOBT) can help identify polyps early on and before they become cancerous. The
Canadian Cancer Society recommends that men and women over 50 years of age
have an FOBT at least every two years.(3)
Sanofi-aventis, a leading global pharmaceutical company, discovers,
develops and distributes therapeutic solutions to improve the lives of
everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York
(NYSE: SNY). In Canada, sanofi-aventis employs more than 1,000 people and is
headquartered in Laval, Quebec.
For more information on colorectal cancer, visit the Colorectal Cancer
Association of Canada at www.colorectal-cancer.ca.
Date: Tuesday January 15, 2008
Time: 10:30 a.m. to 11:00 a.m.
2:30 p.m. to 3:00 p.m.
Coordinates: Anik F2 C
Audio subcarrier 6.2 and 6.8
Downlink frequency 4020 vertical
1. Andre T, Boni C, Mounedji-Boudiaf L, et al: Oxaliplatin, fluorouracil,
and leucovorin as adjuvant treatment for colon cancer. N Engl J Med
2. Canadian Cancer Society.
For further information:
For further information: or to book an interview with a physician or
patient, please contact: Sarah Habib, Manning Selvage & Lee (MS&L), (416)