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Blood, 1 October 2001, Vol. 98, No. 7, pp. 2059-2064
CLINICAL OBSERVATIONS, INTERVENTIONS, AND THERAPEUTIC TRIALS
Randomized trial of filgrastim versus chemotherapy and filgrastim
mobilization of hematopoietic progenitor cells for rescue in
autologous transplantation
Uma Narayanasami,
Rajani Kanteti,
Julie Morelli,
Alanna Klekar,
Asma Al-Olama,
Claire Keating,
Colleen O'Connor,
Eugene Berkman,
John K. Erban,
Kellie A. Sprague,
Kenneth B. Miller, and
David P. Schenkein
From the Division of Hematology-Oncology, Cancer Center
and Tupper Research Institute, New England Medical Center, Tufts
University School of Medicine, Boston, MA.
Peripheral blood cell (PBC) rescue has become the mainstay for
autologous transplantation in patients with lymphoma, multiple myeloma,
and solid tumors. Different methods of hematopoietic progenitor cell
(HPC) mobilization are in use without an established standard.
Forty-seven patients with relapsed or refractory lymphoma received
salvage chemotherapy and were randomized to have HPC mobilization using
filgrastim [granulocyte-colony-stimulating factor (G-CSF)] alone for
4 days at 10 µg/kg per day (arm A) or cyclophosphamide (5 g/m2) and G-CSF at 10 µg/kg per day until hematologic
recovery (arm B). Engraftment and ease of PBC collection were primary
outcomes. All patients underwent the same high-dose chemotherapy
followed by reinfusion of PBCs. There were no differences in median
time to neutrophil engraftment (11 days in both arms;
P = .5) or platelet engraftment (14 days in arm A, 13 days in arm B; P = .35). Combined chemotherapy and G-CSF
resulted in higher CD34+ cell collection than G-CSF alone
(median, 7.2 vs 2.5 × 106 cells/kg;
P = .004), but this did not impact engraftment. No differences were found in other PBC harvest outcomes or resource utilization measures. A high degree of tumor contamination, as studied
by consensus CDR3 polymerase chain reaction of the mobilized PBCs, was
present in both arms (92% in arm A vs 90% in arm B; P = 1). No differences were found in overall survival or
progression-free survival at a median follow-up of 21 months. This
randomized trial provides clinical evidence that the use of G-CSF alone
is adequate for HPC mobilization, even in heavily pretreated patients
with relapsed lymphoma.
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