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Stem-Cell Transplantation Does Not Improve Survival in Metastatic Breast Cancer

In the 1980s, uncontrolled clinical trials of high-dose chemotherapy followed by autologous hematopoietic stem-cell transplantation suggested improved outcomes in patients with chemotherapy-responsive metastatic breast cancer. Despite the absence of studies comparing transplantation with conventional chemotherapy, breast cancer became the most common indication for such transplantations by the late 1980s. In this multicenter, clinical trial, 199 women (aged 18 to 60) with locally recurrent or distant metastatic breast cancer who had a complete or partial response to 4 to 6 cycles of standard combination chemotherapy were randomized to either 2 years of conventional-dose chemotherapy (89) or high-dose chemotherapy followed by stem-cell transplantation (110).

Over a median follow-up of 37 months, the median survival rate was 26 months in the conventional-chemotherapy group and 24 months in the transplantation group. Three-year survival rates were 38% and 32%, respectively. Median time to disease progression was similar in the 2 treatment groups. The incidence of severe adverse events was higher in the transplantation group. One fatal adverse event occurred in the transplantation group, while none occurred in the conventional-chemotherapy group. No benefit of stem-cell transplantation over conventional chemotherapy was noted in any particular subgroup.

Comment: These important findings suggest that the routine practice of treating patients with metastatic breast cancer with conventional chemotherapy followed by high-dose chemotherapy with stem-cell transplantation is not appropriate. In addition, the discrepancies between these findings and those of the earlier uncontrolled studies remind us of the important role of well-designed clinical trials in guiding treatment decisions.

— AM Kaunitz

Published in Journal Watch Women's Health June 1, 2000

Citation(s):

EA Stadtmauer et al. Conventional-dose chemotherapy compared with high-dose chemotherapy plus autologous hematopoietic stem-cell transplantation for metastatic breast cancer. N Engl J Med 2000 Apr 13 342 1069-1076.

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