Journal
JOURNAL OF CANCER RESEARCH AND CLINICAL ONCOLOGY
Volume 132, Issue 2, Pages 105-112Publisher
SPRINGER
DOI: 10.1007/s00432-005-0023-2
Keywords
bendamustine; cyclophosphamide; indolent; non-Hodgkin's lymphoma; prednisone; vincristine; mantle cell lymphoma
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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/m(2) (days 1-5) + bendamustine 60 mg/m(2) (days 1-5) or + cyclophosphamide 400 mg/m(2) (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.
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