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Randomized trial with or without granulocyte colony-stimulating factor as
adjunct to induction VNCOP-B treatment of elderly high-grade non- Hodgkin's
lymphoma
PL Zinzani, E Pavone, S Storti, L Moretti, PP Fattori, L Guardigni, B Falini, M Gobbi, P Gentilini, VM Lauta, M Bendandi, F Gherlinzoni, M Magagnoli, S Venturi, E Aitini, M Tabanelli, G Leone, V Liso and S Tura
Institute of Hematology Seragnoli, University of Bologna, Italy.
Age is an important prognostic parameter, especially in patients with
advanced high-grade non-Hodgkin's lymphoma (HG-NHL) who require more
intensive and extensive therapy for any possible chance of cure. We
investigated the potential of granulocyte colony-stimulating factor (G-
CSF) for reducing myelotoxicity, which is the most important dose- limiting
factor for chemotherapy. Between March 1993 and June 1995, 158 previously
untreated patients 60 years and older with HG-NHL were included in a
cooperative randomized comparative trial and treated with a combination
therapy including VNCOP-B (cyclophosphamide, mitoxantrone, vincristine,
etoposide, bleomycin, and prednisone) with or without G-CSF. G-CSF was
administered at 5 microg/kg/d throughout the treatment starting on day 3 of
every week for 5 consecutive days. Of the 158 patients registered for the
trial, 149 patients were evaluable: 77 received VNCOP-B plus G-CSF and 72
received VNCOP-B alone. The overall response rate was 81.5%, with complete
response in 59%: 60% in the VNCOP-B plus G-CSF group, and 58% in the
VNCOP-B group. At 30 months (median 24 months), 68% of all complete
responders were alive without disease in the G-CSF group and 65% in the
control group. Neutropenia occurred in 18 out of 77 (23%) of the G-CSF
treated patients and in 40 out of 72 (55.5%) of the controls (P = .00005).
Clinically relevant infections occurred in 4 out of 77 (5%) of the G- CSF
group and in 15 out of 72 (21%) of the controls (P = .004). The delivered
dose intensity was higher in patients receiving G-CSF (95% v 85%), but the
difference was not statistically significant. Our data show that VNCOP-B is
a feasible and effective regimen in elderly HG-NHL patients, and that the
use of G-CSF reduces infection and neutropenia rates without producing any
significant modifications to the dose intensity, CR rate, and relapse-free
survival curve.
Volume 89,
Issue 11,
pp. 3974-3979,
06/01/1997
Copyright © 1997 by The American Society of Hematology
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