Published in:
01-02-2006 | Original Paper
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)
Authors:
M. Herold, A. Schulze, D. Niederwieser, A. Franke, H. J. Fricke, P. Richter, M. Freund, B. Ismer, K. Dachselt, C. Boewer, V. Schirmer, J. Weniger, R. Pasold, C. Winkelmann, C. Klinkenstein, M. Schulze, H. Arzberger, K. Bremer, S. Hahnfeld, A. Schwarzer, C. Müller, Chr. Müller, for the East German Study Group Hematology and Oncology (OSHO)
Published in:
Journal of Cancer Research and Clinical Oncology
|
Issue 2/2006
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Abstract
Purpose: 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. Methods: 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. Results: 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. Conclusions: 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