Disappointing News About Stem-Cell-Supported High-Dose Chemotherapy for Breast Cancer

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Disappointing News About Stem-Cell-Supported High-Dose Chemotherapy for Breast Cancer

At last year's American Society of Clinical Oncology meetings, several research groups reported preliminary findings that showed no benefit from high-dose chemotherapy plus autologous stem-cell transplantation for patients with metastatic or high-risk primary breast cancer. There was widespread publicity in the United States about these findings, particularly because many patients already had undergone this procedure outside of research protocols and some third-party payers were reluctantly footing the bill.

The full results from 1 of the trials now have been published in the New England Journal of Medicine. A multicenter, U.S. research group randomized 199 women with metastatic breast cancer -- all with complete or partial responses to induction chemotherapy -- to receive either monthly cycles of conventional-dose chemotherapy or high-dose chemotherapy followed by autologous stem-cell transplantation. During a median follow-up of 37 months, median survival was 26 months in the conventional group and 24 months in the transplantation group, and 3-year survival rates were 38 percent and 32 percent, respectively; these differences were not significant. Adverse effects (notably, myelosuppression, infection, and diarrhea) were more common in the transplantation group.

At the same ASCO meeting last year, only 1 research group reported positive findings: Bezwoda and colleagues from South Africa allegedly randomized 154 women with high-risk primary breast cancer (i.e., with many positive lymph nodes or other unfavorable prognostic signs) to receive either standard chemotherapy or high-dose chemotherapy with peripheral blood stem-cell rescue. The researchers reported dramatically improved survival in the latter group. However, a visiting team recently conducted an onsite review of the data and found serious irregularities; as a result, the study was discredited, and the lead researcher has been fired. The results of the review were reported in the Lancet.

These events -- both the full report of a negative study and the discrediting of a positive one -- have dampened enthusiasm for high-dose chemotherapy plus stem-cell rescue for patients with metastatic or high-risk primary breast cancer. Although it is possible that certain subgroups would benefit or that ongoing trials will yield positive results, editorialists in both Lancet and the New England Journal of Medicine suggest that we turn our attention to new innovations and test such concepts in randomized trials.

— AS Brett

Published in Journal Watch General Medicine April 28, 2000

Citation(s):

Stadtmauer EA 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.

Original article (Subscription may be required)
Medline abstract (Free)

Lippman ME. High-dose chemotherapy plus autologous bone marrow transplantation for metastatic breast cancer. N Engl J Med 2000 Apr 13 342 1119-1120.

Original article (Subscription may be required)
Medline abstract (Free)

Weiss RB et al. High-dose chemotherapy for high-risk primary breast cancer: An on-site review of the Bezwoda study. Lancet 2000 Mar 18 355 999-1003.