Abstract
631 Background: In single arm studies, HDC (usually single-cycle) with autograft support appeared to produce an unusually high percentage of LTCR in MBC, an observation which was not confirmed in prospective randomised trials (PRT). We have previously reported the results of the protocol-mandated interim three-year analysis of IBDIS I-a, prematurely terminated (post-Bezwoda)PRT of HDC versus CDC in MBC (ASCO 2003). Despite relatively small numbers (110pts), the primary protocol endpoint-event-free survival (EFS i.e. alive without relapse)-was statistically significantly superior for HDC pts. We now present updated results. Methods: PRT in pts without prior CDC for MBC. CDC (mg/m2): doxorubicin 50/ docetaxel 75 (AT) x 4 followed by cyclophosphamide / methotrexate/5FU; versus HD: 3xAT followed by tandem autograft-supported HDC (#1-Ifosphamide12,000/carboplatin AUC18/etoposide 1200; #2:-cyclophosphamide 6000/thiotepa 800). The median five year F/U will coincide with ASCO 2004, however, as median EFS will sti...
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