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Thalidomide - dexamethasone combination in multiple myeloma
looks promising
December 4-7, 2004. San Diego, California.
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The American Society of Hematology is the world's largest professional society concerned with the
management of blood disorders.
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ROCHESTER, Minn. -- The combination of two pills --
thalidomide and dexamethasone -- may be an effective alternative
to the intravenous chemotherapy commonly prescribed to patients
with multiple myeloma, according to a large collaborative study
conducted by the Eastern Cooperative Oncology Group and led by a
Mayo Clinic investigator. More than 15,000 Americans are
diagnosed annually with multiple myeloma, an incurable cancer of
the bone marrow.
Mayo Clinic researchers announced their findings today during
a press conference at the annual meeting of the American Society
of Hematology in San Diego. They also announced a second new
finding: results of a smaller study using a less toxic and more
effective "cousin" to thalidomide that they believe will soon
assume a leading role in the treatment of myeloma.
The fact that thalidomide -- an old drug with a tragic past
of causing birth defects -- can slow the progression of
recurrent multiple myeloma is not new. But the studies discussed
today show that thalidomide and its analog can be effectively
combined with dexamethasone as the initial treatment for
patients newly diagnosed with multiple myeloma.
"These oral regimens are as effective as the standard
intravenous chemotherapy treatments commonly used as initial
therapy for myeloma," says Vincent Rajkumar, M.D., the Mayo
Clinic hematologist/oncologist who led the studies. "However,
the treatment of multiple myeloma is like a marathon. In
addition to improving the initial therapy to get the disease
under control, we need to improve other phases of treatment
which include stem cell transplantation, maintenance therapy and
treatment of relapse. At Mayo, we are committed to improving all
phases of treatment, and at the same time, we are striving to
develop a cure."
Major findings of the two studies
In the first study, 207 patients newly diagnosed with myeloma
were treated. Half were randomly assigned to the combination
regimen of thalidomide and dexamethasone. The other half were
assigned to take dexamethasone alone as the first treatment for
their disease. After four months, a significantly greater
proportion of patients -- 63 percent -- responded to the
combination of thalidomide plus dexamethasone compared to the 41
percent whose cancer responded to dexamethasone alone.
While these results are encouraging, the side effects of
thalidomide plus dexamethasone were significantly higher
compared to dexamethasone alone, particularly blood clots. Blood
clots occurred in about 18 percent of patients who took the
combination drug regimen, compared to only 3 percent of patients
who took dexamethasone alone. The researchers stated that the
risks and benefits need to be weighed for each patient in
determining what regimen to use for initial therapy. Researchers
also recommend patients receive blood thinners to minimize the
risk of blood clots when using thalidomide plus dexamethasone.
"Based on this study, thalidomide plus dexamethasone has
probably become an appropriate replacement for intravenous
vincristine, adriamycin, dexamethasone (VAD) chemotherapy,
except for patients with less aggressive disease for whom
dexamethasone alone may be adequate," says Dr. Rajkumar.
In the second study, Mayo Clinic researchers showed that
using a new "cousin" of thalidomide may be more effective and
safer in treating newly diagnosed myeloma. This analog of
thalidomide is called CC-5013 (lenalidomide) and is not
currently commercially available.
Mayo Clinic began a small, tightly-controlled study in 30
patients who were newly diagnosed with multiple myeloma.
Patients were treated with CC-5013 plus dexamethasone. The
results of this study were announced for the first time at the
San Diego meeting. Out of 30 patients treated, 83 percent
responded to this therapy, and -- in dramatic contrast to the
thalidomide experience -- no blood clots have been observed so
far.
"This regimen appears more effective than the thalidomide-dexamethasone
regimen, with fewer side effects, and may in the future replace
other regimens including the thalidomide-dexamethasone
combination as initial treatment for myeloma," Dr. Rajkumar
says.
The Eastern Cooperative Oncology Group has just initiated a
large, multicenter trial to study CC-5013 in more than 400 newly
diagnosed multiple myeloma patients.
Legal Disclaimer
The materials presented here were prepared by independent authors
under the editorial supervision of The Doctors Lounge, and do not
represent a publication of the American Society of Hematology. These
materials and the related activity are not sanctioned by the American
Society of Hematology or the commercial supporter of the conference,
and do not constitute an official part of that conference.
The material presented here does not reflect the views of The
Doctors Lounge or the companies providing unrestricted educational
grants. These materials may discuss uses and dosages for therapeutic
products that have not been approved by the United States Food and
Drug Administration. A qualified health care professional should
be consulted before using any therapeutic product discussed. All
readers or continuing education participants should verify all information
and data before treating patients or employing any therapies described
in this educational activity.
Copyright © 2004 The Doctors Lounge.
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