High-dose chemotherapy in high-risk primary breast cancer

The role of high-dose chemotherapy (HDCT) in high-risk primary breast cancer remains controversial. Although results of 8 randomized trials on HDCT in high-risk early-stage breast cancer have become available, the data are still inconclusive. Only one trial revealed a significant benefit in recurrence-free survival for patients treated with HDCT and neither of the 8 trials showed a significant improvement in overall survival. However, interpretation of the data is limited due to a lack of statistical power in some of the trials, a relatively short follow-up, a relatively intensive chemotherapy regimen in the control arm and an inappropriate selection of cytotoxic agents with only moderate activity and/or unacceptable toxicity. The results of ongoing studies are therefore urgently needed to determine the role of HDCT in the management of primary breast cancer. With respect to the substantial morbidity and treatment-related mortality, HDCT should not be considered standard for the treatment of breast cancer outside clinical trials, unless a clear advantage in overall can be demonstrated compared to conventional chemotherapy.