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)

  • 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)
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

Authors and Affiliations

  • M. Herold
    • 1
  • A. Schulze
    • 1
  • D. Niederwieser
    • 2
  • A. Franke
    • 3
  • H. J. Fricke
    • 4
  • P. Richter
    • 5
  • M. Freund
    • 6
  • B. Ismer
    • 7
  • K. Dachselt
    • 8
  • C. Boewer
    • 9
  • V. Schirmer
    • 10
  • J. Weniger
    • 11
  • R. Pasold
    • 12
  • C. Winkelmann
    • 13
  • C. Klinkenstein
    • 14
  • M. Schulze
    • 15
  • H. Arzberger
    • 16
  • K. Bremer
    • 17
  • S. Hahnfeld
    • 18
  • A. Schwarzer
    • 19
  • C. Müller
    • 20
  • Chr. Müller
    • 21
  • for the East German Study Group Hematology and Oncology (OSHO)
    • 21
  1. 1.HELIOS Klinikum Erfurt GmbH, 2. Medizinische KlinikBereich Hämatologie/OnkologieErfurtGermany
  2. 2.Universitätsklinikum Leipzig Germany
  3. 3.Universitätsklinikum Magdeburg Germany
  4. 4.Universitätsklinikum Jena Germany
  5. 5.Bezirkskrankenhaus Zella-Mehlis Germany
  6. 6.Universitätsklinikum Rostock Germany
  7. 7.Bezirkskrankenhaus Eisenach Germany
  8. 8.Südharz Krankenhaus Nordhausen Germany
  9. 9.St. Hedwig Krankenhaus Berlin Germany
  10. 10.Vogtlandklinik Plauen Germany
  11. 11.Gemeinschaftspraxis Hämatologie/Onkologie Erfurt Germany
  12. 12.Klinikum Ernst von Bergmann Potsdam Germany
  13. 13.Bezirkskrankenhaus Wittenberg Germany
  14. 14.Medizinisches Zentrum Frankfurt/Oder Germany
  15. 15.Bezirkskrankenhaus Zittau Germany
  16. 16.Gemeinschaftspraxis Hämatologie/Onkologie Meißen Germany
  17. 17.Augusta Krankenanstalt Bochum Germany
  18. 18.Gemeinschaftspraxis Hämatologie/Onkologie Jena Germany
  19. 19.Gemeinschaftspraxis Hämatologie/Onkologie Leipzig Germany
  20. 20.Gemeinschaftspraxis Hämatologie/Onkologie Arnstadt Germany
  21. 21.Katholisches Krankenhaus Erfurt Germany