Prolonged treatment with rituximab in patients with follicular lymphoma significantly increases event-free survival and response duration compared with the standard weekly x 4 schedule

Publication

Prolonged treatment with rituximab in patients with follicular lymphoma significantly increases event-free survival and response duration compared with the standard weekly x 4 schedule

Journal Paper/Review - Jun 15, 2004

Ghielmini Michele, Vorobiof Daniel, Bargetzi Mario, Lohri Andreas, Helg Claudine, Kovacsovics Tibor, Stupp Roger, Zucca Emanuele, Hess Urs, Peccatori Fedro, Martinelli Giovanni, Betticher Daniel C, Fey Martin F, Waltzer Ursula, Hummerjohann Jörg, Pichert Gabriella, Cogliatti Sergio B, Schmitz Shu-Fang Hsu, Cerny Thomas

Citation

Ghielmini M, Vorobiof D, Bargetzi M, Lohri A, Helg C, Kovacsovics T, Stupp R, Zucca E, Hess U, Peccatori F, Martinelli G, Betticher D, Fey M, Waltzer U, Hummerjohann J, Pichert G, Cogliatti S, Schmitz S, Cerny T. Prolonged treatment with rituximab in patients with follicular lymphoma significantly increases event-free survival and response duration compared with the standard weekly x 4 schedule. Blood 2004; 103:4416-23.

Type

Journal Paper/Review (English)

Journal

Blood 2004; 103

Publication Date

Jun 15, 2004

Issn Print

0006-4971

Pages

4416-23

Brief description/objective

The potential benefits of extended rituximab treatment have been investigated in a randomized trial comparing the standard schedule with prolonged treatment in 202 patients with newly diagnosed or refractory/relapsed follicular lymphoma (FL). All patients received standard treatment (rituximab 375 mg/m(2) weekly x 4). In 185 evaluable patients, the overall response rate was 67% in chemotherapy-naive patients and 46% in pretreated cases (P <.01). Patients responding or with stable disease at week 12 (n = 151) were randomized to no further treatment or prolonged rituximab administration (375 mg/m(2) every 2 months for 4 times). At a median follow-up of 35 months, the median event-free survival (EFS) was 12 months in the no further treatment versus 23 months in the prolonged treatment arm (P =.02), the difference being particularly notable in chemotherapy-naive patients (19 vs 36 months; P =.009) and in patients responding to induction treatment (16 vs 36 months; P =.004). The number of t(14;18)-positive cells in peripheral blood (P =.0035) and in bone marrow (P =.0052) at baseline was predictive for clinical response. Circulating normal B lymphocytes and immunoglobulin M (IgM) plasma levels decreased for a significantly longer time after prolonged treatment, but the incidence of adverse events was not increased. In patients with FL, the administration of 4 additional doses of rituximab at 8-week intervals significantly improves the EFS.