Outpatient sequential high dose alkylation with stem cell support for patients with advanced breast cancer: A phase I-II study

We evaluated the feasibility of administering in an out-patient setting, a sequential high dose alkylating regimen with hematopoietic growth factor (H GF) and stem cell support to patients with advanced breast cancer. peripher al blood stem cells (PBSC) were previously collected after chemotherapy and HGF. Two consecutive cycles of alkylating agents were planned: Thiotepa (T ) then, 15 days later, BCNU (B). Three dose levels of each agent were admin istered in cohorts of consecutive patients: HGF and reinfusion of 400, 500 and 600 mg/m(2) respectively. PBSC followed both cycles. Toxicity and respo nse were evaluated according to the WHO recommendations From April 1996 to August 1988 30 women were enrolled: 8 in the first, 12 in the second and 10 in the third dose level. In all cases, B was administered after T with a m edian delay of 25 days because of grade 3/4 hematological toxicity 4 patien ts did not receive B because of previous lung radiotherapy, persistent tric ytopenia or insufficient PBSC collection. 19 patients with measurable lesio ns were considered for response. The objective response rate was 48% (11% C P, 37% PR). We recommended T and B at a dose of 500 mg/m(2) to conduct a ph ase II study in metastatic breast cancer and even to administer B before T.