Journal of Cancer Research and Clinical Oncology

, Volume 132, Issue 2, pp 105–112

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

    • HELIOS Klinikum Erfurt GmbH, 2. Medizinische KlinikBereich Hämatologie/Onkologie
  • A. Schulze
    • HELIOS Klinikum Erfurt GmbH, 2. Medizinische KlinikBereich Hämatologie/Onkologie
  • D. Niederwieser
    • Universitätsklinikum Leipzig
  • A. Franke
    • Universitätsklinikum Magdeburg
  • H. J. Fricke
    • Universitätsklinikum Jena
  • P. Richter
    • Bezirkskrankenhaus Zella-Mehlis
  • M. Freund
    • Universitätsklinikum Rostock
  • B. Ismer
    • Bezirkskrankenhaus Eisenach
  • K. Dachselt
    • Südharz Krankenhaus Nordhausen
  • C. Boewer
    • St. Hedwig Krankenhaus Berlin
  • V. Schirmer
    • Vogtlandklinik Plauen
  • J. Weniger
    • Gemeinschaftspraxis Hämatologie/Onkologie Erfurt
  • R. Pasold
    • Klinikum Ernst von Bergmann Potsdam
  • C. Winkelmann
    • Bezirkskrankenhaus Wittenberg
  • C. Klinkenstein
    • Medizinisches Zentrum Frankfurt/Oder
  • M. Schulze
    • Bezirkskrankenhaus Zittau
  • H. Arzberger
    • Gemeinschaftspraxis Hämatologie/Onkologie Meißen
  • K. Bremer
    • Augusta Krankenanstalt Bochum
  • S. Hahnfeld
    • Gemeinschaftspraxis Hämatologie/Onkologie Jena
  • A. Schwarzer
    • Gemeinschaftspraxis Hämatologie/Onkologie Leipzig
  • C. Müller
    • Gemeinschaftspraxis Hämatologie/Onkologie Arnstadt
  • Chr. Müller
    • Katholisches Krankenhaus Erfurt
  • for the East German Study Group Hematology and Oncology (OSHO)
    • Katholisches Krankenhaus Erfurt
Original Paper

DOI: 10.1007/s00432-005-0023-2

Cite this article as:
Herold, M., Schulze, A., Niederwieser, D. et al. J Cancer Res Clin Oncol (2006) 132: 105. doi:10.1007/s00432-005-0023-2

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

Keywords

BendamustineCyclophosphamideIndolent non-Hodgkin’s lymphomaPrednisoneVincristineMantle cell lymphoma

Copyright information

© Springer-Verlag 2005