Originally published as JCO Early Release 10.1200/JCO.2006.06.4618 on April 9 2007
Journal of Clinical Oncology, Vol 25, No 15 (May 20), 2007: pp. 1986-1992
© 2007 American Society of Clinical Oncology.
Rituximab Added to First-Line Mitoxantrone, Chlorambucil, and Prednisolone Chemotherapy Followed by Interferon Maintenance Prolongs Survival in Patients With Advanced Follicular Lymphoma: An East German Study Group Hematology and Oncology Study
Michael Herold,
Antje Haas,
Stefanie Srock,
Sabine Neser,
Kathrin Haifa Al-Ali,
Andreas Neubauer,
Gottfried Dölken,
Ralph Naumann,
Wolfgang Knauf,
Mathias Freund,
Robert Rohrberg,
Klaus Höffken,
Astrid Franke,
Thomas Ittel,
Erika Kettner,
Ursula Haak,
Ulrich Mey,
Christian Klinkenstein,
Michael Aßmann,
Ullrich von Grünhagen
From the HELIOS Klinikum Erfurt GmbH, Erfurt; Klinikum Ernst von Bergmann, Potsdam; Charité, Rudolph-Virchow-Klinikum; Charité, Campus Klinikum Benjamin Franklin, Berlin; Klinikum Chemnitz, Chemnitz; Klinikum der Universität Leipzig, Leipzig; Klinikum der Philips Universität Marburg, Marburg; Klinikum der Ernst-Moritz-Arndt Universität, Greifswald; Klinikum der Technischen Universität Dresden, Dresden; Onkologische Schwerpunktpraxis Frankfurt/Main, Frankfurt/Main; Klinikum der Universität Rostock, Rostock; Onkologische Schwerpunktpraxis; Städitisches Krankenhaus Martha-Maria Halle-Dölau, Halle; Klinikum der Friedrich-Schiller-Universität, Jena; Klinikum der Otto-von-Guericke-Universität; Städtisches Klinikum Magdeburg, Magdeburg; Klinikum der Hansestadt Stralsund GmbH, Stralsund; Klinikum der Rheinischen Friedrich-Wilhelms Universität Bonn, Bonn; Klinikum Frankfurt/Oder, Frankfurt; Krankenhaus Riesa, Riesa; and Onkologische Schwerpunktpraxis, Cottbus, Germany
Address reprint requests to Michael Herold, MD, HELIOS Klinikum Erfurt GmbH, 2 Medizinische Klinik, Bereich Hamatologie/Onkologie, Nordhauserstr 74, 99089, Erfurt, Germany; e-mail: miherold{at}erfurt.helios-kliniken.de
Purpose: Rituximab has been shown to be active in follicular lymphoma (FL), both as monotherapy and in combination with chemotherapy. We conducted a randomized trial comparing mitoxantrone, chlorambucil, and prednisolone (MCP) chemotherapy plus rituximab with MCP alone.
Patients and Methods: Previously untreated patients with stage III or IV CD20+ indolent or mantle cell lymphoma were randomly assigned to either eight 28-day cycles of MCP plus rituximab (R-MCP; n = 181) or eight cycles of MCP alone (n = 177). All patients who achieved a complete or partial remission were treated with interferon maintenance until relapse. Herein, we report the results from the primary analysis population of patients with FL, who constituted the majority of patients (56%) recruited to the trial (n = 201; R-MCP, n = 105; MCP, n = 96).
Results: Rates of overall and complete response were significantly higher in the R-MCP arm than the MCP arm (overall response, 92% v 75%, respectively; P = .0009; complete response, 50% v 25%, respectively; P = .004). With a median follow-up time of 47 months, median event-free survival (EFS) and progression-free survival (PFS) times were significantly prolonged with R-MCP compared with MCP (EFS, not reached v 26 months, respectively; P < .0001; PFS, not reached v 28.8 months, respectively; P < .0001), and overall survival (OS) was significantly improved with R-MCP compared with MCP (4-year OS rate, 87% v 74%, respectively; P = .0096).
Conclusion: The R-MCP regimen significantly improves complete and overall response rates, EFS, PFS, and OS in patients with previously untreated advanced FL, without a clinically significant increase in toxicity.
published online ahead of print at www.jco.org on April 9, 2007.
Supported by grants from F. HoffmannLa Roche Ltd, Germany.
Presented in part at the 46th Annual Meeting of the American Society of Hematology, December 4-7, 2004, San Diego, CA; the 9th International Conference on Malignant Lymphoma, June 8-11, 2005, Lugano, Switzerland; and the 48th Annual Meeting of the American Society of Hematology, December 9-12, 2006, Orlando, FL.
Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
This article has been cited by other articles:

|
 |

|
 |
 
R. Marcus, K. Imrie, P. Solal-Celigny, J. V. Catalano, A. Dmoszynska, J. C. Raposo, F. C. Offner, J. Gomez-Codina, A. Belch, D. Cunningham, et al.
Phase III Study of R-CVP Compared With Cyclophosphamide, Vincristine, and Prednisone Alone in Patients With Previously Untreated Advanced Follicular Lymphoma
J. Clin. Oncol.,
October 1, 2008;
26(28):
4579 - 4586.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
S. J. Horning
Follicular Lymphoma, Survival, and Rituximab: Is It Time to Declare Victory?
J. Clin. Oncol.,
October 1, 2008;
26(28):
4537 - 4538.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Bendandi
Aiming at a Curative Strategy for Follicular Lymphoma
CA Cancer J Clin,
September 1, 2008;
58(5):
305 - 317.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
B. D. Cheson and J. P. Leonard
Monoclonal Antibody Therapy for B-Cell Non-Hodgkin's Lymphoma
N. Engl. J. Med.,
August 7, 2008;
359(6):
613 - 626.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. Herbst, I. Monsef, N. Skoetz, and A. Engert
Eighth Biannual Report of the Cochrane Haematological Malignancies Group--Focus on Chronic Lymphatic Leukemia
J Natl Cancer Inst,
August 6, 2008;
100(15):
E1 - E1.
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
C. Sebban, P. Brice, R. Delarue, C. Haioun, B. Souleau, N. Mounier, N. Brousse, P. Feugier, H. Tilly, P. Solal-Celigny, et al.
Impact of Rituximab and/or High-Dose Therapy With Autotransplant at Time of Relapse in Patients With Follicular Lymphoma: A GELA Study
J. Clin. Oncol.,
July 20, 2008;
26(21):
3614 - 3620.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
A. Hagenbeek, O. Gadeberg, P. Johnson, L. Moller Pedersen, J. Walewski, A. Hellmann, B. K. Link, T. Robak, M. Wojtukiewicz, M. Pfreundschuh, et al.
First clinical use of ofatumumab, a novel fully human anti-CD20 monoclonal antibody in relapsed or refractory follicular lymphoma: results of a phase 1/2 trial
Blood,
June 15, 2008;
111(12):
5486 - 5495.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
F. Buchegger, O. W. Press, A. B. Delaloye, and N. Ketterer
Radiolabeled and Native Antibodies and the Prospect of Cure of Follicular Lymphoma
Oncologist,
June 1, 2008;
13(6):
657 - 667.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
M. Taskinen, M.-L. Karjalainen-Lindsberg, and S. Leppa
Prognostic influence of tumor-infiltrating mast cells in patients with follicular lymphoma treated with rituximab and CHOP
Blood,
May 1, 2008;
111(9):
4664 - 4667.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
N. Schmitz, P. Dreger, B. Glass, and A. Sureda
Allogeneic transplantation in lymphoma: current status
Haematologica,
November 1, 2007;
92(11):
1533 - 1548.
[Abstract]
[Full Text]
[PDF]
|
 |
|

|
 |

|
 |
 
G. A. Salles
Clinical Features, Prognosis and Treatment of Follicular Lymphoma
Hematology,
January 1, 2007;
2007(1):
216 - 225.
[Abstract]
[Full Text]
[PDF]
|
 |
|
|