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Rituximab Improves Progression-Free Survival in Relapsed Follicular Lymphoma: Presented at ASCO

By Paula Moyer

ATLANTA, G.A. -- June 7, 2006 -- Maintenance treatment with rituximab (Rituxan) after an initial course of chemotherapy combined with rituximab is an effective way to improve progression-free survival in relapsed follicular lymphoma, according to findings presented here at the American Society of Clinical Oncology 2006 Annual Meeting.

"The maintenance concept, consisting of combined chemotherapy and immunotherapy, has changed the management of follicular lymphoma," said principal investigator Martin H. Dreyling, MD, PhD, head, lymphoma section, department of internal medicine, University of Munich, Munich, Germany. "This strategy was highly effective in improving progression-free survival, with very little toxicity."

Previous research has shown that rituximab prolongs progression-free survival in such patients either simultaneously with chemotherapy or as maintenance after chemotherapy is completed. In the present study, Dr. Dreyling and colleagues wanted to determine whether rituximab would be effective for these patients after they had gone into remission following simultaneous treatment with rituximab and chemotherapy.

Their study involved 195 patients with advanced-stage relapsed or refractory lymphoma of either the follicular or mantle cell type. Patients underwent 4 courses of chemotherapy consisting of fludarabine 25 mg/m²/day on days 1 to 3, cyclophosphamide 200 mg/m²/day on days 1 to 3, and mitoxantrone 8 mg/m² on day 1. The day before the start of chemotherapy patients received rituximab at a dose of 375 mg/m².

Patients who went into either complete or partial remission were then randomized to observation or rituximab maintenance -- 4 weekly doses of 375 mg/m² at months 3 and 9 after induction chemotherapy.

The investigators stratified the randomization for histology, prior therapies (whether up to 2 lines more than 2), induction with or without rituximab, and complete or partial response.

After the investigators observed improved outcome of the rituximab-chemotherapy in the initial 147 randomized patients, all subsequent patients received this regimen.

So far, 138 patients had received a rituximab-containing induction out of 176 whose data were evaluable. In these patients as well as in the total group, the median progression-free survival after the end of induction had not been reached in the rituximab-maintenance arm. In the observation arm, however, the median progression-free survival was found to be 17 months (P =.001). The investigators saw this improvement in the 81 follicular lymphoma patients and in the 47 mantle cell lymphoma patients, Dr. Dreyling said (P =.035 and P =.049, respectively). However, he noted that the study involved a relatively small number of mantle cell lymphoma patients.

The investigators also observed an improvement in the overall survival rate after rituximab maintenance, with a 3-year overall survival rate of 82% in the maintenance arm and 55% in the observation arm. However, the difference did not meet the threshold of statistical significance (P =.056).

No major adverse effects were associated with rituximab maintenance, and that the 2 arms had similar low rates of serious infections, Dr. Dreyling added.


[Presentation title: Rituximab Maintenance Improves Progression-Free and Overall Survival Rates After Combined Immuno-Chemotherapy (R-FCM) in Patients With Relapsed Follicular and Mantle Cell Lymphoma: Final Results of a Prospective Randomized Trial of the German Low Grade Lymphoma Study Group (GLSG). Abstract 7502]

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