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-Hodgkins lymphoma patients
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-Hodgkins 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 IIIV 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 362 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-Hodgkins lymphoma, elderly patients, granulocyte colony-stimulating factor, VNCOP-B regimen
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