Highdose Therapy For Highrisk Breast Cancer Phase II studies

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The use of high-dose therapy with, initially, BM and, later, Peripheral blood progenitor cell(s) (PBPC) rescue was first explored and reported by Peters et al.25 at Duke University and by Gianni et al.26 at Milan. Each reported results that appeared superior to outcomes after conventional-dose chemotherapy using similar patient selection criteria. Specifically, Peters et al. reported a 72% 5-year EFS in a prospective phase II trial of high-dose cyclophosphamide/cisplatin/BCNU in patients with 10 or more positive axillary nodes. These results have stood the scrutiny of time, with 61% EFS rate at 11-year follow-up.27 Gianni et al.26 used a sequential high-dose single-agent regimen in this patient population. At a median follow-up of 4 years, the observed EFS rate was 57%.

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