Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma

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...

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Bibliographic Details
Published in:Blood 1997-06, Vol.89 (11), p.3974-3979
Main Authors: ZINZANI, P. L, PAVONE, E, BENDANDI, M, GHERLINZONI, F, MAGAGNOLI, M, VENTURI, S, AITINI, E, TABANELLI, M, LEONE, G, LISO, V, TURA, S, STORTI, S, MORETTI, L, FATTORI, P. P, GUARDIGNI, L, FALINI, B, GOBBI, M, GENTILINI, P, LAUTA, V. M
Format: Article
Language:English
Subjects:
Age Factors
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Biological and medical sciences
Bleomycin - administration & dosage
Chemotherapy
Cyclophosphamide - administration & dosage
Etoposide - administration & dosage
Granulocyte Colony-Stimulating Factor - administration & dosage
Hematologic and hematopoietic diseases
Humans
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Lymphoma, Non-Hodgkin - drug therapy
Lymphoma, Non-Hodgkin - physiopathology
Medical sciences
Middle Aged
Mitoxantrone - administration & dosage
Pharmacology. Drug treatments
Prednisone - administration & dosage
Treatment Outcome
Vincristine - administration & dosage
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Summary: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.
ISSN:0006-4971
1528-0020