Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2006 Feb;132(2):105-12.
doi: 10.1007/s00432-005-0023-2. Epub 2005 Aug 9.

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)

M Herold  1 , 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)
Affiliations
Randomized Controlled Trial

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)

M Herold et al. J Cancer Res Clin Oncol. 2006 Feb.

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Kaplan-Meier estimate of time to progression for patients who responded to therapy
Fig. 2
Fig. 2
Kaplan-Meier estimate of overall survival for all patients
See this image and copyright information in PMC

References

    1. Bagley CM, Devita VT, Berard CW, Canellos GP (1972) Advanced lymphosarcoma: intensive cyclical combination chemotherapy with cyclophosphamide, vincristine, and prednisone. Ann Intern Med 76(2):227–234 - PubMed
    1. Blumenstengel K, Fricke H-J, Kath R, Höffken K (1999) Bendamustine(B), vincristine(O), prednisolone(P) in relapsed and refractory low-grade non-Hodgkin’s lymphomas (NHL). Ann Hematol 77(Suppl 2):149 (Abstr 591)
    1. Bremer K (2002) High rates of long-lasting remissions after 5-day bendamustine chemotherapy cycles in pre-treated low-grade non-Hodgkin’s lymphomas. J Cancer Res Clin Oncol 128(11):603–609 - PMC - PubMed
    1. Bremer K, Roth W (1996) Bendamustine, a low toxic nitrogen-mustard derivative with high efficacy in malignant lymphomas. Tumordiagn u Ther 17:1–6
    1. Chow KU, Nowak D, Boehrer S, Ruthardt M, Knau A, Hoelzer D, Mitrou PS, Weidmann E (2003) Synergistic effects of chemotherapeutic drugs in lymphoma cells are associated with down-regulation of inhibitor of apoptosis proteins (IAPs), prostate-apoptosis-response-gene 4 (Par-4), death-associated protein (Daxx) and with enforced caspase activation. Biochem Pharmacol 66(5):711–724 - PubMed

Publication types

MeSH terms

Supplementary concepts