CONTACT: JENNIFER CRONIN
2130 Medical Laboratories
Iowa City IA 52242
(319) 335-5661; fax (319) 335-9917
Release: May 28, 1999
UI study yields encouraging results for new breast
IOWA CITY, Iowa -- A University of Iowa Health Care
treatment using high-dose chemotherapy followed by a bone marrow transplant
may be more effective in fighting advanced breast cancer than standard treatment
approaches -- despite recent reports of conflicting results from similar strategies
In the just-released issue of the journal Biology
of Blood and Marrow Transplantation, UI researchers suggest that a four-drug,
high-dose chemotherapy treatment along with a bone marrow transplant may improve
survival for some women with stage IV breast cancer -- cancer that has spread
beyond the breast.
"We have women who we treated with a bone marrow transplant
up to 10 years ago who are still alive and free of cancer," said Roger Gingrich,
M.D., Ph.D., UI professor of internal medicine and director of the Adult Bone
Marrow Transplant Program at the UI Hospitals and Clinics. "We think it is
very important for women with breast cancer to continue to carefully consider
this treatment approach."
From May 1988 through May 1997, UI physicians treated
158 women with stage IV breast cancer using the four-drug, high-dose chemotherapy
and bone marrow transplant strategy. Preliminary results indicate an overall
survival rate of 38 percent.
At an American Society of Clinical Oncology (ASCO)
meeting last week in Atlanta, researchers presented four studies that showed
women with very risky or advanced breast cancer statistically did no better
with the high-dose chemotherapy and bone marrow transplant treatment than
those who received only low-dose chemotherapy. A fifth, relatively small study
indicated that the high-dose chemotherapy/bone marrow transplant approach
might work better. Each of the studies involved different drugs and doses.
In the two studies presented at the meeting that involved
patients with chemotherapy-responsive stage IV breast cancer, the projected
survival rates using the high-dose chemotherapy/transplant treatment were
32 percent and 30 percent after three years. In the UI study, the projected
survival rates for patients with chemotherapy-responsive stage IV breast cancer
using the high-dose chemotherapy/transplant treatment was 53 percent from
five to more than nine years.
"The reason our study shows
different results may be related to our different approach," Gingrich said.
"The key difference between our technique and those tested elsewhere is that
we have chosen to use a more intensive pre-transplant regimen of chemotherapy
and radiation. Our treatment involves a four-drug regimen and is 35
to 40 percent more intensive than the regimens used in the recently reported
studies. We administer our regimen in a highly specialized transplant unit,
not in the outpatient setting. It is associated with an 11 percent mortality
rate, but the payoff may be a higher proportion of women surviving without
The UI strategy involved treating the women with a
combination of the drugs cisplatin, etoposide, thiotepa and cyclophosphamide
followed by blood or marrow stem cell transplantation. The studies presented
at the ASCO meeting involved combinations of two or three drugs at a time.
"We're not saying that the less intensive approach
is wrong or that the more intensive regimen is the right way, or the only
way," Gingrich said. "What we are saying is that we need more research. This
field is so new that the definitive study on the best approach has not been
An estimated 12,000 women with breast cancer in the
United States have undergone high-dose chemotherapy/bone marrow transplant
procedures since the mid-1980s. The transplants are necessary following the
high-dose chemotherapy to replace the blood cell-producing marrow that the
drugs destroy. High-dose chemotherapy and/or radiation with bone marrow transplants
is standard treatment in some circumstances for some malignancies, including
acute leukemia, chronic myelogenous leukemia, neuroblastoma, lymphoma and
The five studies presented at the ASCO meeting were
all randomized, controlled, phase III clinical trials, which directly compared
one cancer treatment to another -- in this case, high-dose chemotherapy and
bone marrow transplants to standard doses of chemotherapy. The UI study was
a phase II clinical trial designed to test the feasibility of a novel therapy.
In a phase II trial, researchers do not compare treatments directly but rather
compare the new strategy to historical data from accepted treatment.
"While the papers presented at the ASCO meeting may
have cast some doubt about the usefulness of high-dose chemotherapy for patients
with breast cancer, it is too early to discard this approach," Gingrich said.
"All we can be sure of is that some of the first organized comparative trials
to test this approach failed, and this is certainly not the first time this
has happened in the field of oncology.
"Within the high-dose chemotherapy range, therapies
of lower intensity do not appear effective," Gingrich said. "We now need to
examine whether an approach such as ours, when tested in a randomized, comparative
fashion, will be beneficial. We certainly think it will."