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High-Dose Chemotherapy Plus Stem-Cell Rescue in High-Risk Breast Cancer

Two groups of researchers draw conflicting conclusions.

In a study reported in 2000, high-dose chemotherapy plus autologous stem-cell transplantation was not superior to conventional chemotherapy for patients with metastatic breast cancer (Journal Watch Apr 28 2000), which created controversy about the role of stem-cell transplantation for this disease. However, several related studies were in progress at that time. Results from 2 of them now are reported; both included breast cancer patients with positive axillary nodes but not distant metastases.

In the first study, Dutch researchers randomized 885 patients with 4 or more tumor-positive axillary nodes to receive conventional-dose adjuvant chemotherapy or high-dose chemotherapy plus stem-cell rescue. After a median follow-up of 4.8 years, conventional-dose recipients and high-dose recipients showed a marginal difference in 5-year relapse-free survival (59% and 65%; P=0.09) and no difference in overall survival. However, among patients with 10 or more positive nodes, the difference in relapse-free survival just reached significance (51% vs. 61%, respectively; P=0.05).

In a similar U.S. randomized study, researchers enrolled 540 patients with 10 or more tumor-positive axillary nodes. After a median follow-up of 6.1 years, the conventional-dose and high-dose groups did not differ significantly in disease-free survival (47% vs. 49%) or overall survival (62% vs. 58%).

Comment: The Dutch authors are cautiously optimistic about the role of stem-cell transplantation for high-risk breast cancer, whereas the U.S. authors are somewhat pessimistic. An editorialist points out that subtle differences in the design of these trials could explain their divergent outcomes. Moreover, death rates from toxicity of high-dose chemotherapy were higher in the U.S. study than in the Dutch study (about 4% vs. 1%). For now, the role of high-dose chemotherapy with stem-cell rescue remains open for debate.

— Allan S. Brett, MD

Published in Journal Watch General Medicine July 22, 2003

Citation(s):

Rodenhuis S et al. High-dose chemotherapy with hematopoietic stem-cell rescue for high-risk breast cancer. N Engl J Med 2003 Jul 3; 349:7-16.

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Tallman MS et al. Conventional adjuvant chemotherapy with or without high-dose chemotherapy and autologous stem-cell transplantation in high-risk breast cancer. N Engl J Med 2003 Jul 3; 349:17-26.

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• Medline abstract (Free)

Elfenbein GJ. Stem-cell transplantation for high-risk breast cancer. N Engl J Med 2003 Jul 3; 349:80-2.

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• Medline abstract (Free)