Single-agent paclitaxel in patients with metastatic breast cancer receiving high-dose chemotherapy with peripheral blood stem cell support

The purpose of this trial was to determine the effects of paclitaxel in pat ients with newly diagnosed metastatic breast cancer scheduled to receive hi gh-dose chemotherapy with peripheral blood stem cell support. Eighty-four p atients received anthracycline-based induction and two doses of paclitaxel at 170 mg/m(2) (n = 52) or 250 mg/m(2) (n = 32). Eighty-two (98%) received cyclophosphamide and etoposide (n = 50) or paclitaxel and cyclophosphamide (n = 32) with granulocyte colony-stimulating factor for mobilization of per ipheral blood stem cells, and 79 (94%) received cyclophosphamide, thiotepa, and carboplatin with peripheral blood stem cell support. One patient (1%) died of infection and 56 (67%) died of progressive disease. For patients wi th measurable disease, the complete response rate was 21% after induction a nd 29% after paclitaxel (p = 0.54). Results were compared with those of 125 patients who received the same sequence of therapy without paclitaxel. The complete response rate after high-dose chemotherapy was 54% for patients r eceiving paclitaxel and 62% for those not receiving paclitaxel (p = 0.60). The probabilities of overall survival and event-free survival at 3 years fo r patients receiving paclitaxel were 46% and 24%, respectively, compared wi th 54% and 22%, respectively, for patients not receiving paclitaxel (p = 0. 62). Further trials evaluating this dose and schedule of paclitaxel in pati ents with metastatic breast cancer receiving high-dose chemotherapy are not warranted.