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Date: Tuesday, May 28, 1996 FOR IMMEDIATE RELEASE Contact: NCI Press Office(301)496-6641
Thousands of breast cancer patients are undergoing high-dose chemotherapy and bone marrow transplantation without definitive evidence that it works better than standard therapies, according to a new report from the U.S. General Accounting Office (GAO). Scientists at the National Cancer Institute (NCI) said the report underscores the urgent need to complete studies of the controversial and difficult treatment.
"The GAO report has made it very clear how much we need real answers about bone marrow transplants for breast cancer," said the NCI's Jeffrey Abrams, M.D. "We must be able to tell women whether they need this treatment or whether they have just as good, or even a better, chance of survival with another form of chemotherapy."
Definitive answers about the treatment -- known as high-dose chemotherapy with autologous bone marrow transplants, or HDC-ABMT -- should come from three studies now under way and a fourth that has just been launched. All four are sponsored by the NCI, which is concerned because patient enrollment in the trials has been slower than expected.
"We worry that women are not enrolling in these clinical trials because they mistakenly assume that HDC-ABMT is already a proven treatment and because they can receive it outside of studies," said Abrams. The fewer women who enroll in the trials, the longer it will take NCI to get the answers.
In HDC-ABMT, patients receive such high doses of chemotherapy that it destroys bone marrow, the source of the body's blood cells. Bone marrow cells are therefore removed before chemotherapy and returned to the patient afterwards. Use of the treatment has grown rapidly, from an estimated 522 cases in 1989 to about 4,000 cases in 1994, according to figures the GAO obtained from the Autologous Blood and Marrow Transplant Registry-North America.
Despite this growing popularity, "most experts say they do not yet know whether [HDC-ABMT] is effective, and for which patients, as compared to conventional therapy," the GAO reported. Medical experts, patient advocates, and insurers told the GAO that "the proliferation of HDC-ABMT outside of randomized trials -- or outside of any research setting at all -- is making it difficult to gather the data necessary to assess whether and for whom HDC-ABMT may be a beneficial treatment."
The three NCI-sponsored studies now under way are comparing HDC-ABMT to standard-dose chemotherapy in patients with advanced breast cancer or at high risk of recurrence. Women who enroll in the trials are assigned randomly to one treatment or the other. At the current rate of enrollment, the findings from these trials will not be available for at least another two years, and they could be delayed longer. The NCI's fourth trial, beginning this summer, will test HDC-ABMT in patients with less advanced breast cancer, comparing it to another form of high-dose chemotherapy without bone marrow cell transplants.
The GAO report focuses primarily on health insurance issues related to HDC-ABMT. It concludes that many insurance companies are now paying for the procedure and that they are doing so partly for non-medical reasons. "The twelve insurers we spoke with said they based their decision to cover the treatment on the preliminary clinical evidence, but also on factors like fear of litigation and adverse public relations," the GAO reported.
Lawsuits over insurance coverage for HDC-ABMT in recent years have received significant media coverage. At least seven states now mandate insurance coverage of the unproven treatment and other states are considering similar legislation.
"To us, the message is very clear," said Abrams. "We must enroll more women in the HDC-ABMT trials, we must complete the trials as soon as possible, and we must be able to give women some definite answers about HDC-ABMT."
The report, Health Insurance: Coverage of Autologous Bone Marrow Transplantation for Breast Cancer (GAO/HEHS-96-83), may be ordered from the United States General Accounting Office by calling (202) 512-6000. It is also available on GAO's Internet home page, at www.gao.gov. Media representatives may obtain copies from the NCI Press Office at (301) 496-6641.
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