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

Pier Luigi Zinzani, Enzo Pavone, Sergio Storti, Luciano Moretti, Pier Paolo Fattori, Luciano Guardigni, Brunangelo Falini, Marco Gobbi, Patrizia Gentilini, Vito Michele Lauta, Maurizio Bendandi, Filippo Gherlinzoni, Massimo Magagnoli, Stefamia Venturi, Enrico Aitini, Maurizio Tabanelli, Giuseppe Leone, Vincenzo Liso, Sante Tura

Research output: Contribution to journalArticle

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Abstract

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 μg/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.

Original languageEnglish
Pages (from-to)3974-3979
Number of pages6
JournalBlood
Volume89
Issue number11
Publication statusPublished - Jun 1 1997

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Granulocyte Colony-Stimulating Factor
Non-Hodgkin's Lymphoma
Therapeutics
Neutropenia
Mitoxantrone
Chemotherapy
Bleomycin
Vincristine
Etoposide
Prednisone
Infection
Cyclophosphamide
Recurrence
Drug Therapy
Control Groups
Survival

ASJC Scopus subject areas

  • Hematology

Cite this

Zinzani, P. L., Pavone, E., Storti, S., Moretti, L., Fattori, P. P., Guardigni, L., ... Tura, S. (1997). Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma. Blood, 89(11), 3974-3979.

Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma. / Zinzani, Pier Luigi; Pavone, Enzo; Storti, Sergio; Moretti, Luciano; Fattori, Pier Paolo; Guardigni, Luciano; Falini, Brunangelo; Gobbi, Marco; Gentilini, Patrizia; Lauta, Vito Michele; Bendandi, Maurizio; Gherlinzoni, Filippo; Magagnoli, Massimo; Venturi, Stefamia; Aitini, Enrico; Tabanelli, Maurizio; Leone, Giuseppe; Liso, Vincenzo; Tura, Sante.

In: Blood, Vol. 89, No. 11, 01.06.1997, p. 3974-3979.

Research output: Contribution to journalArticle

Zinzani, PL, Pavone, E, Storti, S, Moretti, L, Fattori, PP, Guardigni, L, Falini, B, Gobbi, M, Gentilini, P, Lauta, VM, Bendandi, M, Gherlinzoni, F, Magagnoli, M, Venturi, S, Aitini, E, Tabanelli, M, Leone, G, Liso, V & Tura, S 1997, 'Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma', Blood, vol. 89, no. 11, pp. 3974-3979.
Zinzani, Pier Luigi ; Pavone, Enzo ; Storti, Sergio ; Moretti, Luciano ; Fattori, Pier Paolo ; Guardigni, Luciano ; Falini, Brunangelo ; Gobbi, Marco ; Gentilini, Patrizia ; Lauta, Vito Michele ; Bendandi, Maurizio ; Gherlinzoni, Filippo ; Magagnoli, Massimo ; Venturi, Stefamia ; Aitini, Enrico ; Tabanelli, Maurizio ; Leone, Giuseppe ; Liso, Vincenzo ; Tura, Sante. / Randomized trial with or without granulocyte colony-stimulating factor as adjunct to induction VNCOP-B treatment of elderly high-grade non-Hodgkin's lymphoma. In: Blood. 1997 ; Vol. 89, No. 11. pp. 3974-3979.
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AU - Storti, Sergio

AU - Moretti, Luciano

AU - Fattori, Pier Paolo

AU - Guardigni, Luciano

AU - Falini, Brunangelo

AU - Gobbi, Marco

AU - Gentilini, Patrizia

AU - Lauta, Vito Michele

AU - Bendandi, Maurizio

AU - Gherlinzoni, Filippo

AU - Magagnoli, Massimo

AU - Venturi, Stefamia

AU - Aitini, Enrico

AU - Tabanelli, Maurizio

AU - Leone, Giuseppe

AU - Liso, Vincenzo

AU - Tura, Sante

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N2 - 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 μg/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.

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