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Annals of Oncology 13:1364-1369, 2002
© 2002 European Society for Medical Oncology

Original Paper

Randomized trial of 8-week versus 12-week VNCOP-B plus G-CSF regimens as front-line treatment in elderly aggressive non-Hodgkin’s lymphoma patients

P. L. Zinzani1,+, F. Gherlinzoni1, S. Storti2, A. Zaccaria3, E. Pavone4, L. Moretti5, P. Gentilini6, L. Guardigni7, A. De Renzo8, P. P. Fattori9, B. Falini10, V. M. Lauta11, D. Mannina12, F. Zaja13, P. Mazza14, E. Volpe15, F. Lauria16, E. Aitini17, F. Ciccone18, M. Tani1, V. Stefoni1, L. Alinari1, M. Baccarani1 and S. Tura1

1 Institute of Hematology ‘Seràgnoli’, University of Bologna, Bologna; 2 Chair of Hematology, ‘Cattolica’ University of Roma, Roma; 3 Hematology Division, Ravenna Hospital, Ravenna; 4 Chair of Hematology, University of Bari, Bari; 5 Hematology Division, Pesaro Hospital, Pesaro; 6 Oncology Division, Forlì Hospital, Forlì; 7 Hematology Unit, Cesena Hospital, Cesena; 8 Division of Hematology, Federico II University, Napoli; 9 Oncology Division, Rimini Hospital, Rimini; 10 Chair of Hematology, University of Perugia, Perugia; 11 Chair of Medicine, University of Bari, Bari; 12 Hematology Division, Messina Hospital, Messina; 13 Chair of Hematology, University of Udine, Udine; 14 Hematology Division, Taranto Hospital, Taranto; 15 Department of Hematology, Avellino Hospital, Avellino; 16 Department of Hematology, University of Siena, Siena; 17 Oncology Division, Mantova Hospital, Mantova; 18 Hematology Division, Latina Hospital, Latina, Italy

Received 22 January 2002; accepted 5 March 2002

Background:

Among the third-generation chemotherapy regimens specifically adapted in the last decade for elderly aggressive non-Hodgkin’s lymphoma (NHL) patients, we designed an 8-week cyclophosphamide, mitoxantrone, vincristine, etoposide, bleomycin and prednisone (VNCOP-B) plus granulocyte colony-stimulating factor (G-CSF) regimen which, in a national multicenter trial, induced good complete response (CR) and relapse-free survival rates with only moderate toxic effects. Here we report a prospective, multicenter, randomized trial comparing the efficacy and toxicity of 8- and 12-week regimens of VNCOP-B plus G-CSF.

Patients and methods:

From February 1996 to June 2001, 306 consecutive previously untreated stage II–IV aggressive NHL patients >=60 years of age were enrolled from 12 Italian cooperative institutions. Of the 297 evaluable patients, 149 and 148 received 8- and 12-week regimens, respectively, of VNCOP-B.

Results:

The CR rates were 63% and 56% in the 8- and 12-week groups; at a median of 32 months (range 3–62 months), relapse-free survival rates were 59% and 55%, respectively. Hematological and non-hematological toxicities were similar in both treatment groups.

Conclusions:

Our data show that extending induction treatment with the VNCOP-B plus G-CSF regimen from 8 to 12 weeks does not raise the CR rate or provide a more durable remission.

Key words: aggressive non-Hodgkin’s lymphoma, elderly patients, granulocyte colony-stimulating factor, VNCOP-B regimen


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