Abstract
In this phase II study s new high-does regimen was investigated as consolidation after standard-dose adjuvant chemotherapy of primary breast cancer involving 10 or more axillary lymph nodes. Ten patients with a mean age of 45 year and a mean of 14 positive axillary lymph nodes after mastectomy (n = 8) or segmentetomy (n = 2) received two cycles of cyclophosphamide (CY), doxorubicin, and fluorouracil (CAF) within 56 days of surgery. Then, autologous periphera1 blood stem cells (APBSC) were mobilized with CY and granulocyte colony-stimulalting factor (G-CSF) and enriched for CD34+ cells with immunoadsorption. Thereby, 53% of initial CD34+ cells were recovered and a mean purity of 77% was acheived. High-dose chemotherapy consisted of paclitaxel, Carboplatin, and CY followed by infusion of a mean of 5.1 x 106 CD34+/kg h.w.G-CSF was given is continuous infusion starting one day after APBSC transfusion until neutrophil recovery. Main toxicity of the new high-dose regimen consisted of diarrhea WHO grade 1 to 3 (n = 5), peripheral neuropathy WHO grade 1 (n = 4) and transient elevation of liver enzymes (n = 3). All patients experienced rapid and sustained hematologic recovery and are in excellent performance status 1 to 22 (mean 9) months after APBSC transfusion. In conculsion, paciltaxel combination with carboplatin and cyclophosphamiden is a well tolerated high-dose chemotherpy with acceptable toxicity. Evaluation of relapse rates in patients with high-risk primary breast cancer compared with reported high-dose regimens has to await longer observation times and randomized studies. In this phase II study s new high-does regimen was investigated as consolidation after standard-dose adjuvant chemotherapy of primary breast cancer involving 10 or more axillary lymph nodes. Ten patients with a mean age of 45 year and a mean of 14 positive axillary lymph nodes after mastectomy (n = 8) or segmentetomy (n = 2) received two cycles of cyclophosphamide (CY), doxorubicin, and fluorouracil (CAF) within 56 days of surgery. Then, autologous periphera1 blood stem cells (APBSC) were mobilized with CY and granulocyte colony-stimulalting factor (G-CSF) and enriched for CD34+ cells with immunoadsorption. Thereby, 53% of initial CD34+ cells were recovered and a mean purity of 77% was acheived. High-dose chemotherapy consisted of paclitaxel, Carboplatin, and CY followed by infusion of a mean of 5.1 x 106 CD34+/kg h.w.G-CSF was given is continuous infusion starting one day after APBSC transfusion until neutrophil recovery. Main toxicity of the new high-dose regimen consisted of diarrhea WHO grade 1 to 3 (n = 5), peripheral neuropathy WHO grade 1 (n = 4) and transient elevation of liver enzymes (n = 3). All patients experienced rapid and sustained hematologic recovery and are in excellent performance status 1 to 22 (mean 9) months after APBSC transfusion. In conculsion, paciltaxel combination with carboplatin and cyclophosphamiden is a well tolerated high-dose chemotherpy with acceptable toxicity. Evaluation of relapse rates in patients with high-risk primary breast cancer compared with reported high-dose regimens has to await longer observation times and randomized studies.
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