Abstract |
In follicular lymphoma (FL) and mantle cell lymphoma (MCL) the monoclonal antibody rituximab (R) improves the prognosis when combined with chemotherapy. The present study investigated R-maintenance after R- chemotherapy. Patients with recurring or refractory FL and MCL were randomized to 4 courses of fludarabine, cyclophosphamide, and mitoxantrone (FCM) alone or combined with R (R-FCM). Responding patients underwent a second randomization for R-maintenance comprising 2 further courses of 4-times-weekly doses of R after 3 and 9 months. The first randomization was stopped after 147 patients, when R-FCM revealed a significantly better outcome. All subsequent patients received R-FCM. Of the 176 patients who are currently evaluable (as of October 2005), 138 received R-FCM for remission induction. Response duration was significantly prolonged by R-maintenance after R-FCM, with the median not being reached in this evaluation versus an estimated median of 16 months (P = .001). This beneficial effect was also observed when analyzing FL (P = .035) and MCL (P = .049) separately. Hence, R-maintenance is effective after salvage with R- chemotherapy and significantly prolongs response duration in patients with recurring or refractory FL or MCL.
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Authors | Roswitha Forstpointner, Michael Unterhalt, Martin Dreyling, Hans-Peter Böck, Roland Repp, Hannes Wandt, Christiane Pott, John F Seymour, Bernd Metzner, Annette Hänel, Tanja Lehmann, Frank Hartmann, Hermann Einsele, Wolfgang Hiddemann, German Low Grade Lymphoma Study Group (GLSG) |
Journal | Blood
(Blood)
Vol. 108
Issue 13
Pg. 4003-8
(Dec 15 2006)
ISSN: 0006-4971 [Print] United States |
PMID | 16946304
(Publication Type: Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Murine-Derived
- Rituximab
- Cyclophosphamide
- Mitoxantrone
- Vidarabine
- fludarabine
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Antibodies, Monoclonal
(administration & dosage)
- Antibodies, Monoclonal, Murine-Derived
- Antineoplastic Combined Chemotherapy Protocols
- Cyclophosphamide
(administration & dosage)
- Disease-Free Survival
- Female
- Germany
- Humans
- Lymphoma, Follicular
(drug therapy, mortality)
- Lymphoma, Mantle-Cell
(drug therapy, mortality)
- Male
- Middle Aged
- Mitoxantrone
(administration & dosage)
- Prospective Studies
- Recurrence
- Remission Induction
- Rituximab
- Salvage Therapy
(methods)
- Survival Rate
- Vidarabine
(administration & dosage, analogs & derivatives)
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