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.

Abstract

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 > or =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.

• Authors: P L Zinzani, F Gherlinzoni, S Storti, A Zaccaria, E Pavone, L Moretti, P Gentilini, L Guardigni, A De Renzo, P P Fattori, B Falini, V M Lauta, D Mannina, F Zaja, P Mazza, E Volpe, F Lauria, E Aitini, F Ciccone, M Tani, V Stefoni, L Alinari, M Baccarani, S Tura
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 13 Issue 9 Pg. 1364-9 (Sep 2002) ISSN: 0923-7534 [Print] England
• PMID: 12196361 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Bleomycin
• Granulocyte Colony-Stimulating Factor
• Vincristine
• Etoposide
• Cyclophosphamide
• Mitoxantrone
• Prednisone

Topics

• Aged
• Aged, 80 and over
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage)
• Bleomycin (administration & dosage)
• Cyclophosphamide (administration & dosage)
• Dose-Response Relationship, Drug
• Drug Administration Schedule
• Etoposide (administration & dosage)
• Female
• Granulocyte Colony-Stimulating Factor (administration & dosage)
• Humans
• Italy
• Logistic Models
• Lymphoma, Non-Hodgkin (drug therapy, mortality, pathology)
• Male
• Middle Aged
• Mitoxantrone (administration & dosage)
• Neoplasm Staging
• Prednisone (administration & dosage)
• Probability
• Prognosis
• Proportional Hazards Models
• Survival Rate
• Treatment Outcome
• Vincristine (administration & dosage)