High-dose chemotherapy not superior to conventional chemotherapy in high-risk breast cancer patients

A randomized trial has found that breast cancer patients with four or more positive lymph nodes who receive high-dose chemotherapy with a stem cell transplant have similar survival rates to those who receive conventional chemotherapy. Previous nonrandomized studies had indicated that there was substantial benefit for patients who received high-dose therapy, according to the study, which appears in the July 21 issue of the Journal of the National Cancer Institute.

Approximately two-thirds of breast cancer patients with four or more positive lymph nodes will develop fatal metastases. Adjuvant chemotherapy, the standard treatment for these patients, has been shown to result in prevention or delay of relapse and increase survival. However, nonrandomized trials of high-dose chemotherapy had indicated better results than conventional chemotherapy in patients with metastatic breast cancer and those who had multiple positive lymph nodes.

To test the effects of high-dose chemotherapy, Robert C. F. Leonard, M.D., of the South West Wales Cancer Institute in Swansea, Wales, and colleagues conducted a prospective, unblinded, randomized trial of 605 patients with breast cancer who had four or more positive lymph nodes. About half received conventional chemotherapy while the other half received high-dose chemotherapy and an autologous stem cell transplant. The patients were followed for a median of 6 years after their treatment.

There were no differences between the two groups in either 5-year relapse-free survival or 5-year overall survival.

"These results both in isolation and in the context of the individual analyses of similarly powered, single, high-dose, randomized, controlled trials, indicate that the single, high-dose, late-intensification chemotherapy strategy confers extra cost and toxicity without added anticancer benefit," the authors write.

Contact: Sabiha Hussain, Swansea Clinical School, 44-179-260-2281, sabiha.hussain@swansea.ac.uk

Citation: Leonard RCF, Lind M, Twelves C, Coleman R, van Belle S, Wilson C, et al. Conventional Adjuvant Chemotherapy Versus Single-Cycle, Autograft-Supported, High-Dose, Late-Intensification Chemotherapy in High-Risk Breast Cancer Patients: A Randomized Trial. J Natl Cancer Inst 2004;96:1076-83.

Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at http://jncicancerspectrum.oupjournals.org/.

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