Joint Israeli-American team
closes in on cause of colon cancer
A closeup of a cancerous colon - it was
found that a huge percentage (86.3) of the cancerous tumors in the large intestine contain
the DNA of the JC virus.
A joint Israeli-American research project could result in a breakthrough in preventing
colorectal cancer. Cancer of the large intestine - also known as colon cancer - affects 5%
of the world's population and claims 56,000 Americans each year. A team led by Dr. C.
Richard Boland, chief of gastroenterology at Baylor University Medical Center at Dallas,
and Prof. Yaron Niv of the Gastroentrology center of Beilinson Hospital in Petah Tikva,
have closed in on a likely agent in colorectal tumor creation - a normally harmless virus
named JC, which is present in 70 percent to 80 percent of all humans. Their findings were
published in the January edition of Current Opinion in Gastroenterology .
http://www.israel21c.org/
Suppression of colon
carcinogenesis by bioactive compounds in grapefruit
Vanamala J, Leonardi T, Patil BS, Taddeo
SS, Murphy ME, Pike LM, Chapkin RS, Lupton JR, Turner ND.
Department of Nutrition and Food Science,
Texas A&M University, College Station, TX-77843; Vegetable and Fruit Improvement
Center, Department of Horticultural Sciences, Texas A&M University, College Station,
TX-77843.
This study evaluated the hypothesis that
untreated and irradiated grapefruit as well as the isolated citrus compounds naringin and
limonin would protect against azoxymethane (AOM) induced aberrant crypt foci (ACF) by
suppressing proliferation and elevating apoptosis through anti-inflammatory activities.
The results suggest that consumption of grapefruit or limonin may help to suppress colon
cancer development.
FDA APPROVES ELOXATIN FOR
COLORECTAL CANCER
The Food and Drug Administration (FDA)
announced the approval of Eloxatin (oxaliplatin) injection for use in combination with
infusional 5-fluorouracil (5-FU) and leucovorin for the treatment of patients with
colorectal cancer whose disease has recurred or become worse following initial therapy
with a combination of irinotecan with bolus 5-FU and leucovorin. The combination including
Eloxatin was shown to shrink tumors in some patients and delay resumed tumor growth. There
are as yet no data on the effects of the combination on survival.
FDA reviewed the marketing application
for Eloxatin in seven weeks, the fastest review to date for a cancer drug. FDA was able to
review and approve this drug so rapidly because the agency utilized the "rolling
review" procedures that are available under new drug applications designated as
"Fast Track." Drugs in development that have the potential to be an advance in
treatment for a serious illness may be identified as "Fast Track" drugs. Under
this designation, rolling applications allow for the submission of some components of the
application before the remaining sections are completed and submitted to the agency.
"Patients diagnosed with colorectal
cancer will now have access to another treatment option for this disease," said
Health and Human Services Secretary Tommy G. Thompson. "I want to commend FDA for
reviewing the drug's safety and effectiveness so quickly."
A multi-center, randomized, controlled
study compared the effectiveness and safety of Eloxatin alone, infusional 5-FU/leucovorin
alone (a standard type of treatment for colorectal cancer), and the combination of these
two treatments in patients who had either relapsed, or progressed while on or shortly
after standard treatment. Although the individual drugs had very little effect, the
combination resulted in a greater number of patients having tumor shrinkage and led to a
delay in resumption of cancer growth.
"Even though long-term benefits such
as increased survival have not yet been demonstrated," said Dr. Lester M. Crawford,
FDA Deputy Commissioner, "early studies have shown that Eloxatin may have significant
benefit for many patients."
Eloxatin is intended for use by
physicians experienced in the use of cancer agents. A black box warning detailing this use
and highlighting anaphylactic-like reactions associated with Eloxatin is included in the
labeling. Eloxatin can have a toxic effect on nerve endings that may result in either an
acute or cumulative pattern of side effects. This may result in the feeling of numbness or
tingling, especially in the hands or feet or around the mouth or throat. For some patients
these symptoms may be worsened by exposure to cold. This side effect usually occurs within
hours or days of dosing. Another side effect is impairment in performing ordinary daily
tasks such as difficulty buttoning clothes. This condition generally improves after the
treatment is complete.
Other common side effects of Eloxatin are
vomiting, diarrhea, anemia, increased risk of bleeding or infection, or allergic reaction.
Women should be advised to avoid becoming pregnant while receiving this treatment, because
it may cause harm to the fetus.
Cancers of the colon and rectum
(colorectal) are the fourth most commonly diagnosed cancers and rank second among cancer
deaths in the United States. About 150,000 new cases of these cancers occur each year, and
they cause approximately 56,000 deaths.
Exloxatin was developed and will be
distributed by Sanofi-Synthelabo.
FDA Approves First Angiogenesis
Inhibitor to Treat Colorectal Cancer
FDA today approved Avastin (bevacizumab)
as a first-line treatment for patients with metastatic colorectal cancer -- cancer that
has spread to other parts of the body. Avastin, a monoclonal antibody, is the first
product to be approved that works by preventing the formation of new blood vessels, a
process known as angiogenesis. Avastin was shown to extend patients' lives by about five
months when given intravenously as a combination treatment along with standard
chemotherapy drugs for colon cancer (the "Saltz regimen" also known as IFL). IFL
treatment includes ironotecan, 5-fluorouracil (5FU) and leucovorin.
Avastin is a genetically engineered
version of a mouse antibody that contains both human and mouse components. (Antibodies are
substances produced by the body's immune system to fight foreign substances.) Special
technology also allows it to be produced in large quantities in the laboratory.
This new monoclonal antibody is believed
to work by targeting and inhibiting the function of a natural protein called
"vascular endothelial growth factor" (VEGF) that stimulates new blood vessel
formation. When VEGF is targeted and bound to Avastin, it cannot stimulate the growth of
blood vessels, thus denying tumors blood, oxygen and other nutrients needed for growth.
Angiogenesis inhibitors such as Avastin have been studied, first in the laboratory and
then in patients, for three decades with the hope they might prevent the growth of cancer.
This is the first such product that has been proven to delay tumor growth and more
importantly, significantly extend the lives of patients.
"The approval of Avastin is the
result of many years of research and development exploring a promising new approach to
fighting cancer, and it is one of a number of recent new treatments for colorectal cancer
that taken together, have significantly improved the armamentarium for fighting this
disease," said Mark B. McClellan, M.D., Ph.D., FDA Commissioner. "These medical
achievements reflect the innovation of drug developers and the hard work of FDA's cancer
review teams, and they are proof of the promise offered by biomedical innovation. The
dedication of everyone involved in these efforts is making a real difference in the lives
of cancer patients."
Colorectal cancer -- cancer of the colon
or rectum -- is the third most common cancer affecting men and women in the U.S. and,
according to the Centers for Disease Control and Prevention (CDC), is the second leading
cause of cancer-related death. Colorectal cancer is also one of the most commonly
diagnosed cancers in the U.S.; approximately 147,500 new cases were diagnosed in 2003.
The safety and efficacy of Avastin was
primarily shown in a randomized, double-blind clinical trial of more than 800 patients
with metastatic colorectal cancer designed to find out whether Avastin extended the lives
of patients. Roughly half the patients received IFL, the standard chemotherapy
combination, and the other half received Avastin once every two weeks in addition to IFL.
Overall, patients given Avastin in combination with IFL survived about five months longer
and the average time before tumors started regrowing or new tumors appeared was four
months longer than patients receiving IFL alone. The overall response rate to the
treatment was 45% compared to 35% for the control arm of the trial.
Serious, but uncommon, side-effects of
Avastin include formation of holes in the colon (gastrointestinal perforation) generally
requiring surgery and sometimes leading to intra-abdominal infections, impaired wound
healing, and bleeding from the lungs or internally. Other, more common, side-effects are
high blood pressure, tiredness, blood clots, diarrhea, decreased white blood cells
(lowering immunity to diseases) headache, appetite loss and mouth sores.
Avastin is manufactured by Genentech,
Inc., South San Francisco, Calif.
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