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Blood, 1 October 2000, Vol. 96, No. 7, pp. 2385-2390
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Ex vivo expanded unselected peripheral blood: progenitor cells
reduce posttransplantation neutropenia, thrombocytopenia, and anemia
in patients with breast cancer
Ronald L. Paquette,
Sanaa T. Dergham,
Ellen Karpf,
He-Jing Wang,
Dennis J. Slamon,
Larry Souza, and
John A. Glaspy
From the Departments of Medicine and Biostatistics,
University of California at Los Angeles, Los Angeles, CA.
The safety and efficacy of administering ex vivo expanded
peripheral blood progenitor cells (PBPC) to patients with breast cancer
who undergo high-dose chemotherapy and PBPC transplantation was
investigated. Unselected PBPC were cultured in gas-permeable bags
containing 1-L serum-free media, granulocyte colony-stimulating factor,
stem cell factor, and pegylated megakaryocyte growth and development
factor for 9 days. Cell dose cohorts were assigned to have between 2 and 24 × 109 PBPC cultured at 1, 2, or
3 × 106 cells/mL. Twenty-four patients received
high-dose chemotherapy followed by infusion of the cultured PBPC and at
least 5 × 106 CD34+ uncultured cryopreserved
PBPC per kilogram. No toxicities resulted from infusions of the ex vivo
expanded PBPC. The study patients had shorter times to neutrophil
(P = .0001) and platelet (P = .01) recovery
and fewer red cell transfusions (P = .02) than 48 historical controls who received the same conditioning regimen and
posttransplantation care and at least 5 × 106
CD34+ PBPC per kilogram. Improvements in all these
endpoints were significantly correlated with the expanded cell dose.
Nine of 24 (38%) patients recovered neutrophil counts above 500/µL
by day 5 or 6 after transplantation, whereas none of the controls had
neutrophil recovery before the eighth day. Seven (29%) patients had
neutropenia for 3 or fewer days, and 9 (38%) patients did not
experience neutropenic fevers or require broad-spectrum antibiotics.
Therefore, ex vivo expanded PBPC are capable of ameliorating
posttransplantation neutropenia, thrombocytopenia, and anemia in
patients receiving high-dose chemotherapy.
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