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).

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.

• 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, East German Study Group Hematology and Oncology (OSHO)
• Journal: Journal of cancer research and clinical oncology (J Cancer Res Clin Oncol) Vol. 132 Issue 2 Pg. 105-12 (Feb 2006) ISSN: 0171-5216 [Print] Germany
• PMID: 16088404 (Publication Type: Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Nitrogen Mustard Compounds
• Vincristine
• Cyclophosphamide
• Bendamustine Hydrochloride
• Prednisone

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (administration & dosage, adverse effects, therapeutic use)
• Bendamustine Hydrochloride
• Cyclophosphamide (administration & dosage)
• Disease-Free Survival
• Female
• Humans
• Leukemia, Lymphocytic, Chronic, B-Cell (drug therapy, mortality)
• Lymphoma, Follicular (drug therapy, mortality)
• Lymphoma, Mantle-Cell (drug therapy, mortality)
• Lymphoma, Non-Hodgkin (drug therapy)
• Male
• Middle Aged
• Nitrogen Mustard Compounds (administration & dosage)
• Prednisone (administration & dosage)
• Survival Analysis
• Treatment Outcome
• Vincristine (administration & dosage)