[MOL] High dose chemo, plus stem-cell rescue no benefit in metastatic BC [00978] Medicine On Line

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[MOL] High dose chemo, plus stem-cell rescue no benefit in metastatic BC....

High-dose chemotherapy plus stem-cell rescue no benefit in metastatic breast cancer

By Steve Mitchell

WESTPORT, Mar 06 (Reuters Health) - Women with metastatic breast cancer who receive high-dose chemotherapy plus transplantation of autologous hematopoietic stem cells fare no better in terms of survival or time to progression of disease than women who receive conventional doses of chemotherapy.

The findings come from a study submitted to The New England Journal of Medicine and released before publication in line with the journal's policy regarding important findings. The study will appear in the April 13th issue of NEJM.

"The routine practice of administering several cycles of conventional induction chemotherapy followed by a single course of high-dose chemotherapy and stem-cell rescue cannot be recommended for women with metastatic breast cancer," the authors of the study say.

Dr. Edward A. Stadtmauer of the University of Pennsylvania Cancer Center in Philadelphia and colleagues administered four to six cycles of standard combination chemotherapy to 553 women with metastatic breast cancer.

Twenty-nine of the patients with a complete or partial response then received a single course of high doses of carboplatin, thiotepa, and cyclophosphamide plus transplantation of autologous hematopoietic stem cells. An additional 16 women with a complete or partial response to the initial chemotherapy received up to 24 cycles of cyclophosphamide, methotrexate, and fluorouracil in conventional doses.

Dr. Stadtmauer's group found no significant difference between the two groups for overall survival at 3 years or median time to progression of disease. The two groups also had similar rates of treatment-related mortality. The authors say that "our results...cannot and should not be extrapolated to patients with nonmetastatic cancer who have multiple positive axillary nodes."

In an accompanying editorial, Dr. Marc E. Lippman of the Lombardi Cancer Center in Washington, DC, says that high-dose chemotherapy plus autologous bone marrow transplantation "for women with metastatic breast cancer has been proved to be ineffective and should be abandoned in favor of well-justified alternative experimental approaches."

However, he says "the disappointing results" of this trial "in no way indicate that variations on this theme may prove unsuccessful." These variations, which still require investigation in clinical trials, "include tandem (successive) transplantations, new preparative or induction regimens, immune modulation, and in vitro purging of malignant cells from the patient's bone marrow," Dr. Lippman comments.

Dr. Lippman urged in his editorial that the negative findings "should not dampen funding by insurance companies for well-designed clinical trials pursuing new ideas under the aegis of institutional-review board-approval."

Last month Aetna U.S. Healthcare said that it was ending coverage for bone marrow transplants for women with breast cancer because several studies, including Dr. Stadtmauer's, showed that the treatment was ineffective. However, the insurance company said that it will cover bone marrow transplants for breast cancer patients enrolled in a clinical trial conducted by the federal government.

N Engl J Med 2000;342:00-00.

-Westport Newsroom 203 319 2700

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