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High-Dose Chemotherapy With Autologous Blood<br />

Stem Cell Transplantation: Increasing Evidence for<br />

Efficacy in Patients With Metastatic Breast Cancer<br />

Stefan Glück, Michael Crump, Gregory R. Bociek, Doug Stewart, a<br />

Members ofNCIC-CTG Group<br />

Departments of Oncology, Medicine <strong>and</strong> Pharmacology, <strong>and</strong> Therapeutics,<br />

Faculty of Medicine, University of Calgary, Alberta, Canada<br />

ABSTRACT<br />

High-dose chemotherapy (HDCT) with <strong>autologous</strong> <strong>blood</strong> stem cell <strong>transplantation</strong><br />

has been increasingly used in patients with breast cancer <strong>and</strong> non-Hodgkin's<br />

lymphoma in Canada. Five ;evels of scientific evidence regarding therapeutic<br />

interventions (Sackett DL: Rules of evidence <strong>and</strong> clinical recommendations on the<br />

use of antithrombotic agents. Chest 95:2S^4S, 1989) have been identified. Level I<br />

evidence is strongest to support efficacy of a novel treatment <strong>and</strong> yet, for patients<br />

with metastatic breast cancer worldwide, no such evidence exists. In close collaboration<br />

with centers across Canada, we created level IV evidence indicating that<br />

patients who respond to initial chemotherapy have a median progression-free<br />

survival (PFS) of 8-12 months <strong>and</strong> median overall survival (OS) of 24-30 months.<br />

Recently, we have provided level III evidence from outcomes of 144 patients<br />

receiving HDCT over the time period of 1991-1995 compared with 135 contemporaneous<br />

controls. Multivariate analysis revealed a statistically significant<br />

difference in favor of HDCT for OS (relative risk [RR] 0.62; 95% CI 0.35-0.97;<br />

P=0.008) <strong>and</strong> PFS (RR 0.46; 95% CI 0.16-0.76; P

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