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HDC+BMT treatment option for breast cancer patients should continue to be evaluated, NCI researchers say.

High-dose chemotherapy plus bone marrow transplantation (HDC+BMT) may still prove to be a viable option for some breast cancer patients and should continue to be evaluated in clinical trials, according to leading researchers at the National Cancer Institute (NCI) and elsewhere.

In an open letter to members of the American Society of Clinical Oncology (ASCO), NCI Director Richard Klausner, MD urged them not to dismiss HDC+BMT clinical trials as a treatment option for their breast cancer patients. Acknowledging that preliminary results from some transplant trials have been disappointing, Klausner said these findings cannot be generalized and applied to all patients. And he said that contrary to the impression created by some reports, many questions remain unresolved.

"The largest NCI-sponsored trial is still open but is in dire need of your support," Klausner wrote in the letter released at the ASCO's annual meeting May 19-23 in New Orleans. This trial, designated S9623, is assessing HDC+BMT in patients with less advanced disease than those in earlier studies. "Importantly, this trial tests the question in a different subset of patients than did prior NCI-sponsored trials, and, accordingly, the preliminary results of these earlier trials may not be applicable to this subset."

Controversy regarding the role of transplantation for breast cancer intensified over the past year following preliminary reports from several large trials that the rigorous and costly regimen did not prove effective. Enrollment in clinically trials has dropped dramatically.

"Emotions regarding transplants continue to run high," Klausner wrote. "The question has been hotly debated in courtrooms, in legislatures, and especially in the media." Most experts believe that the question can be resolved only through data obtained from ongoing clinical trials.

Despite the controversy, most women would be willing to consider the therapy and to enroll in clinical trials, according to a survey of 925 women ages 35-74 conducted by the NCI and the National Alliance of Breast Cancer Organizations (NABCO). More than 75% of the women who had heard of HDC+BMT said they would be either very likely (50%) or somewhat likely (28%) to consider this form of treatment if they developed the disease. The majority of those favorably disposed toward transplantation said they would consider enrolling in a clinical trial of HDC+BMT.

The survey results show that women have not written off transplants as an option," said Amy Langer, NABCO's executive director and a 14-year breast cancer survivor. "However, in the past, most women with aggressive or advanced breast cancer who turned to bone marrow transplants as their best hope chose the treatment with little information about its efficacy. Only by completing the remaining transplant trials will we be able to offer sound guidance about which treatments work best and permit tomorrow's patients to make choices based on fact, rather than emotion."

Other leading oncologists also have urged continued study of HDC+BMT. In an editorial published in the May issue of Cancer Investigation, Scott Bearman, MD of the University of Colorado Health Sciences Center and principal investigator of S9623 warned against sweeping conclusions that HDC+BMT does not work. "Many more trials will be required before a consensus about the value of dose intensity for breast cancer emerges."

Several patient advocacy organizations have adopted similar positions. "It would be shortsighted to close the door on all transplant trials for breast cancer based on the information we have right now," said Susan Braun, president and chief executive officer of the Susan G. Komen Breast Cancer Foundation.

S9623 is open to breast cancer patients with four or more cancer-positive lymph nodes who are at high-risk of recurrence. Women are randomized to one of two high-dose regimens-HDC+BMT or HDC plus granulocyte colony stimulating factor to stimulate white blood cell production.

"This is the largest US trial looking at transplants in women with less advanced disease," said Jeff Abrams, MD, who coordinates breast cancer trials for the NCI's Cancer Therapy Evaluation Program. "The hypothesis is that a transplant may benefit certain groups of patients is still very much an open question. One of our best shots at improved treatment for certain stages of breast cancer is to complete this trial."
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Comment:HDC+BMT treatment option for breast cancer patients should continue to be evaluated, NCI researchers say.
Publication:Transplant News
Geographic Code:1USA
Date:Jun 12, 2000
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