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autologous blood and marrow transplantation - Blog Science ...

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Final Report of the First Prospective, Stratified,<br />

R<strong>and</strong>omized Trial Comparing G-CSF-Primed<br />

Bone Marrow Cells With G-CSF-Mobilized<br />

Peripheral Blood Cells for Pace of Hematopoietic<br />

Engraftment <strong>and</strong> Disease-Free Survival<br />

After High-Dose Therapy <strong>and</strong> Autotransplant<br />

William E. Janssen, Gerald J. Elfenbein, Janelle B. Perkins,<br />

James 5. Partyka, Renee C. Smilee, Oscar E Ballester,<br />

Steven C. Goldstein, Karen K. Fields, John W. Hiemenz,<br />

Robert Sackstein, Paul E. Zorsky<br />

Departments of Internal Medicine (W.E.J., G.J.E., J.B.P., J.S.P., R.C.S.,<br />

O.F.B., S.C.G., K.K.F., J.W.H., R.S., P.E.Z.) <strong>and</strong> Pathology/Lab Medicine<br />

(W.E.J., R.S.) at the H. Lee Moffitt Cancer Center,<br />

University of South Florida, Tampa, FL<br />

ABSTRACT<br />

It has been widely reported that peripheral <strong>blood</strong> stem cell (PBSC) auto<strong>transplantation</strong><br />

produces not only more rapid neutrophil recovery but also more rapid<br />

platelet recovery than bone <strong>marrow</strong> (BM) auto<strong>transplantation</strong>. These<br />

observations are based on uncontrolled trials in which recovery data from PBSC<br />

mobilized by chemotherapy <strong>and</strong>/or hematopoietic growth factors were compared<br />

with historical data from autotransplants with BM harvested under resting<br />

(unstimulated) conditions. To confirm (or deny) these observations, we<br />

conducted a prospective, stratified, r<strong>and</strong>omized trial wherein all participating<br />

patients had both BM <strong>and</strong> PBSC harvested after 5 days of granulocyte colonystimulating<br />

factor (G-CSF, 16 pg/kg/d) administration. Seventy patients<br />

consented to participate in this trial after conditioning with ifosfamide (20.1<br />

g/m 2<br />

), carboplatin (1.8 g/m 2<br />

), <strong>and</strong> etoposide (3.0 g/m 2<br />

) or with mitoxantrone<br />

(75-90 mg/m 2<br />

) <strong>and</strong> thiotepa (0.9-1.2 g/m 2<br />

) with or without paclitaxel (360<br />

mg/m 2<br />

). Patients were r<strong>and</strong>omized to receive either BM (n=25) or PBSC («=22).<br />

Patients (n=23) whose PBSC collection was inadequate according to preestablished<br />

criteria were removed from r<strong>and</strong>omization <strong>and</strong> infused with both BM <strong>and</strong><br />

580

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