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Over the past 20 years, more than 15,000 women with
breast cancer have been treated with an arduous yet largely unproven procedure:
high doses of chemotherapy followed by blood cell transplants to replenish the
bone marrow damaged by the chemotherapy.
In the early 1990s, after a few encouraging preliminary reports, breast cancer
patients and advocates began demanding the treatment. Some state legislatures
responded by mandating that insurance companies pay for the intensive
procedure, which can cost up to $100,000 per case, much more than conventional
treatments. By mid-decade, more people were receiving the treatment for breast
cancer than for any other cancer.
However, the vast majority of these women who received the high-dose regimens
did so outside of a clinical trial, which meant that the success or failure of
the treatment could not be reliably established. Results from well-conducted,
carefully monitored, randomized trials were urgently needed to figure out which
breast cancer patients, if any, might benefit from high-dose therapy plus
transplants, said Jeff Abrams, M.D., a breast cancer researcher at NCI.
So in the late 1990s, multiple randomized studies were begun. In early 2000,
reports from three of these clinical trials were published. Two showed that
high doses of chemotherapy were no more effective than standard chemotherapy
for women with advanced or high-risk breast cancer. Results from the third
study contradicted these findings and came out in favor of the high-dose
treatment. However, this study was later discounted after the lead South
African researcher admitted fraud and misconduct.
These developments left the practice of high-dose chemotherapy for breast
cancer in limbo. At that point, the American Society of Clinical Oncology
(ASCO) recommended that women receive the treatment only if they were taking
part in a "high-quality" clinical trial. Editorials in the March 18,
2000, issue of the Lancet and the April 13, 2000, New England Journal of
Medicine made the same argument.
In another sign of support for the clinical trials approach, in early 2000 one
of the nation's largest insurers,
Aetna/U.S. Healthcare, announced
that it will pay for high-dose chemotherapy plus transplants only for patients
enrolled in federally sponsored clinical trials. The company previously
reimbursed expenses for women who were not in clinical trials.
Researchers at the National Cancer Institute (NCI) have long supported this
approach. As of spring 2001,
four large national trials
sponsored by NCI had all completed enrollment, with results beginning to become
available.
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