TY - JOUR
T1 - 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
AU - Zinzani, P. L.
AU - Gherlinzoni, F.
AU - Storti, S.
AU - Zaccaria, A.
AU - Pavone, E.
AU - Moretti, L.
AU - Gentilini, P.
AU - Guardigni, L.
AU - De Renzo, A.
AU - Fattori, P. P.
AU - Falini, B.
AU - Lauta, V. M.
AU - Mannina, D.
AU - Zaja, F.
AU - Mazza, P.
AU - Volpe, E.
AU - Lauria, F.
AU - Aitini, E.
AU - Ciccone, F.
AU - Tani, M.
AU - Stefoni, V.
AU - Alinari, L.
AU - Baccarani, M.
AU - Tura, S.
PY - 2002/9
Y1 - 2002/9
N2 - 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.
AB - 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.
KW - Aggressive non-Hogdkin's lymphoma
KW - Elderly patients
KW - Granulocyte colony-stimulating factor
KW - VNCOP-B regimen
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U2 - 10.1093/annonc/mdf208
DO - 10.1093/annonc/mdf208
M3 - Article
C2 - 12196361
AN - SCOPUS:0036739094
VL - 13
SP - 1364
EP - 1369
JO - Annals of Oncology
JF - Annals of Oncology
SN - 0923-7534
IS - 9
ER -