Bendamustine, vincristine and prednisone (BOP) versus cyclophosphamide, vincristine and prednisone (COP) in advanced indolent non-hodgkin's lymphoma and mantle cell lymphoma : results of a randomised phase III trial (OSHO# 19)

The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine + prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine + prednisone (COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lym...

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Bibliographic Details
Published in:Journal of cancer research and clinical oncology 2006-02, Vol.132 (2), p.105-112
Main Authors: HEROLD, M, SCHUIZE, A, SCHIRMER, V, WENIGER, J, PASOLD, R, WINKELMANN, C, KLINKENSTEIN, C, SCHUIZE, M, ARZBERGER, H, BREMER, K, HAHNFELD, S, SCHWARZER, A, NIEDERWIESER, D, MÜLLER, C, MÜLLER, Chr, FRANKE, A, FRICKE, H. J, RICHTER, P, FREUND, M, ISMER, B, DACHSELT, K, BOEWER, C
Format: Article
Language:English
Subjects:
Adult
Aged
Antineoplastic agents
Antineoplastic Combined Chemotherapy Protocols - administration & dosage
Antineoplastic Combined Chemotherapy Protocols - adverse effects
Antineoplastic Combined Chemotherapy Protocols - therapeutic use
Bendamustine Hydrochloride
Biological and medical sciences
Chemotherapy
Comparative analysis
Cyclophosphamide - administration & dosage
Disease-Free Survival
Female
Hematologic and hematopoietic diseases
Humans
Leukemia, Lymphocytic, Chronic, B-Cell - drug therapy
Leukemia, Lymphocytic, Chronic, B-Cell - mortality
Leukemias. Malignant lymphomas. Malignant reticulosis. Myelofibrosis
Lymphoma
Lymphoma, Follicular - drug therapy
Lymphoma, Follicular - mortality
Lymphoma, Mantle-Cell - drug therapy
Lymphoma, Mantle-Cell - mortality
Lymphoma, Non-Hodgkin - drug therapy
Male
Medical sciences
Middle Aged
Nitrogen Mustard Compounds - administration & dosage
Pharmacology
Pharmacology. Drug treatments
Prednisone - administration & dosage
Survival Analysis
Treatment Outcome
Vincristine - administration & dosage
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Summary:The purpose of this study was to compare the efficacy and toxicity of bendamustine, vincristine + prednisone (BOP) with a standard regimen of cyclophosphamide, vincristine + prednisone (COP) in patients with previously untreated advanced indolent non-Hodgkin's lymphoma (NHL) and mantle cell lymphoma. A total of 164 patients with follicular lymphoma (grade 1/2), mantle cell lymphoma or lymphoplasmacytic lymphoma (immunocytoma) was randomised to treatment with vincristine 2 mg (day 1) and prednisone 100 mg/m2 (days 1-5) + bendamustine 60 mg/m2 (days 1-5) or + cyclophosphamide 400 mg/m2 (days 1-5) for a total of eight 21-day cycles. The rate of complete remission was 22% with BOP and 20% with COP. The projected 5-year survival rate was 61% with BOP and 46% with COP. The BOP-associated 5-year survival advantage almost reached significance in the subgroup of patients who responded to therapy (74% vs. 56%; P = 0.05), and did reach significance in responders who did not receive interferon maintenance therapy (70% vs. 47%; P = 0.03). Toxicity was acceptable in both treatment groups, although alopecia and leucopenia were more severe with COP. Bendamustine can efficaciously and safely replace cyclophosphamide, as used in standard COP therapy, for the treatment of patients with indolent NHL and mantle cell lymphoma. Long-term survival data suggest a clinically significant benefit for patients treated with BOP.
ISSN:0171-5216
1432-1335
DOI:10.1007/s00432-005-0023-2