MUNICHAdding rituximab (Rituxan) increases the efficacy of FCM
(fludarabine [Fludara], cyclophosphamide [Cytoxan, Neosar], mitoxantrone
[Novantrone]) in relapsed or refractory follicular (FCL) or mantle cell
lymphomas (MCL), reported Martin Dreyling, MD. "This is the first
randomized study that proves the benefit of rituximab in indolent
lymphomas," said Dr. Dreyling, who reported on behalf of the German Low
Grade Lymphoma Study Group (GLSG), directed by W. Hiddemann, Munich, at the
43rd Annual Meeting of the American Society of Hematology.
Salvage Chemotherapy Plus Rituximab
"Rituximab has shown a high activity in relapsed follicular
lymphomas when given alone, and phase II studies indicate that its addition
to chemotherapy may further improve the response rate substantially. Since
prospective randomized studies have not been available so far, the GLSG
started a multicenter national trial in patients with relapsed or refractory
FCL or MCL. Since patients were treated for first-line therapy with CHOP
(cyclophosphamide [Cytoxan, Neosar], doxorubicin HCl, vincristine [Oncovin],
prednisone), the FCM combination was chosen for salvage chemotherapy,"
Dr. Dreyling said.
The FCM regimen included fludarabine at 25 mg/m² days 1-3,
cyclophosphamide at 200 mg/m² days 1-3, and mitoxantrone at 8 mg/m² day 1.
This treatment was repeated for four cycles every 28 days.
Seventy-three patients were prospectively randomized to FCM alone and 74
to FCM plus rituximab at 375 mg/m² on the day before FCM therapy. Eighty
patients were evaluable for response. This included 43 with follicular
lymphomas, 27 with mantle cell lymphomas, and 10 with other indolent
lymphomas (lymphocytic lymphomas). The median age was 61 years in the FCM
group and 66 in the FCM plus rituximab group. "This was not a
good-risk, young patient group," according to Dr. Dreyling.
Interim analysis showed a significant difference between the treatment
arms. Patients treated with FCM alone had a 53% response rate (15% complete
response [CR], 38% partial response [PR],) compared to an 89% response rate
in those randomized to FCM plus rituximab (36% CR, 53% PR, P = .000715).