Despite standard-dose adjuvant chemotherapy, the prognosis for patients wit
h breast cancer and extensive axillary lymph node involvement at diagnosis
is poor. The efficacy of a paclitaxel-containing, high-dose chemotherapy pr
otocol in 21 high-risk breast cancer patients is assessed. After standard-d
ose chemotherapy followed by peripheral blood stem cell (PBSC) mobilization
, high-dose therapy with paclitaxel, carboplatin, and cyclophosphamide and
CD34-selected PBSC rescue was given. Hematologic reconstitution after high-
dose therapy was rapid. Main toxicity included diarrhea grade I or II in ab
out half of the patients and infections were observed in 19%. Five-year pro
babilities for relapse and failure-free survival were 32% and 62%. respecti
vely. High-dose consolidation with paclitaxel, carboplatin, and cyclophosph
amide achieves a high failure-free survival in patients with high-risk brea
st cancer with acceptable toxicities and stable, long-term hematopoietic re
constitution. Evaluation of the benefit of high-dose therapy in these patie
nts in larger prospective, randomized trials is warranted and currently und
er way.