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Tuesday December 5 6:35 AM ET
Leukemia Drug Generates Excitement
By COLLEEN VALLES, Associated Press Writer
SAN FRANCISCO (AP) - A leukemia drug that brought
cancer into remission in most patients in clinical trials is
generating excitement among cancer specialists and patients
as a gentler, more effective treatment that may mean cancer
researchers are on the right track.
``This drug is a major breakthrough,'' said Dr. Hagop
Kantarjian, who oversees trials of the drug at the MD
Anderson Cancer Center in Houston.
In manufacturer-financed clinical trials, more than 90 percent of patients in the
first phase of chronic myeloid leukemia saw their cancer go into remission
within the first six months of taking the pill, according to trial findings
presented Monday at a meeting of the American Society of Hematology.
A study of patients in the second phase of the disease showed more than 90
percent of those patients responded positively to the treatment, and in 63
percent, the cancer went into remission. The trials involved 530 first-phase
and 230 second-phase patients.
The early success has propelled researchers to test the Novartis AG-made
drug STI-571, or Glivec, on almost 3,000 patients around the world; CML
affects about 10,000 adults each year.
Anyone diagnosed with leukemia should make every effort to get the new pill,
said Edward Benz, president of the Dana-Farber Cancer Institute at Harvard
Medical School (news - web sites), who was not involved in the research.
``This is not a miracle drug,'' he said, but it is a model for future cancer study
because it targets the cause of the disease without damaging other cells.
CML, caused by an abnormal protein that is the product of an abnormal
chromosome, leads to a huge increase in the number of white blood cells in
the body, which can interfere with the functioning of other organs.
Glivec blocks a signal that protein sends out and effectively prevents the
abnormal growth and production of other cancerous cells.
``The whole of cancer research has been to identify the differences between
cancer cells and normal cells. That's been the goal of cancer research and
here it is,'' said Brian Druker, an Oregon Health Sciences University
researcher who was the drug's principal developer. ``I view it as a new era of
cancer therapeutics. It's the most effective treatment we know of for CML.''
Researchers chose CML because they knew about the abnormal
chromosome and its abnormal protein. They are hoping to transfer the model
- targeting a specific abnormality with minimal effect on healthy tissue - to
other cancers, but first they must isolate those cancers' causes.
Currently, bone marrow transplants are the only proven way of curing
leukemia, but the transplants carry a mortality rate of up to 40 percent and
are only successful in 55 to 65 percent of cases. Other drugs are used to
maintain the health of leukemia patients, but don't decrease the number of
white blood cells or help make the blood normal again.
The common treatment for CML is interferon, which can extend a leukemia
patient's life by up to two years but can have side effects that cause about 20
percent of patients to stop using it.
Glivec has been studied on humans for only about two years, so how long it
will prolong a patient's life is not yet known. But it has had few side effects,
and only about 2 percent of patients stopped using it because of those side
effects.
The drug is expected to hit the market in June, and clinical trials will continue,
studying such things as the drug's long-term effects.
In the meantime, patients who hope to receive the treatment have to join a
clinical trial. Those in the first phase of the disease are put on a waiting list,
while patients in more advanced stages are added to clinical trials, Druker
said.
Carol Stuckey, a 50-year-old mother of two from West Linn, Ore., involved
in the clinical trials, was diagnosed with CML seven years ago and was close
to being in the final phase of the disease, when a patient only has months to
live.
She has been on STI-571 since December 1999, and said the treatment has
helped her lead a normal life. She said that she has sometimes had leg cramps
or puffy eyes since starting to take Glivec, but that those are minimal side
effects compared to the lack of energy she was experiencing.
``The main thing is that I got my life back,'' Stuckey said. ``I have energy
again. Just prior to taking the medication, I was totally drained. Within two
weeks of taking STI, I had wonderful energy. I went Christmas shopping.''
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On the Net:
American Society of Hematology: hematology.org
Novartis: novartis.com
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