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Blood, 15 June 2004, Vol. 103, No. 12, pp. 4416-4423.
Prepublished online as a Blood First Edition Paper on February 19, 2004; DOI 10.1182/blood-2003-10-3411.
Submitted October 14, 2003
Accepted February 8, 2004
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
Michele Ghielmini*, Shu-Fang Hsu Schmitz, Sergio B Cogliatti, Gabriella Pichert, Joerg Hummerjohann, Ursula Waltzer, Martin F Fey, Daniel C Betticher, Giovanni Martinelli, Fedro Peccatori, Urs Hess, Emanuele Zucca, Roger Stupp, Tibor Kovacsovics, Claudine Helg, Andreas Lohri, Mario Bargetzi, Daniel Vorobiof, and Thomas Cerny
Oncology Institute of Southern Switzerland, Bellinzona, Switzerland
SIAK Coordinating Centre, Bern, Switzerland
Swiss Reference Centre for Malignant Lymphoma, St Gallen, Switzerland
Universitaetsspital, Zuerich, Switzerland
Universitaetsspital, Bern, Switzerland
Istituto Europeo di Oncologia, Milano, Italy
Kantonsspital, St Gallen, Switzerland
CHUV, Lausanne, Switzerland
University Hospital, Geneva, Switzerland
Universitaetsspital, Basel, Switzerland
Kantonsspital, Aarau, Switzerland
Sandton Oncology Centre, Johannesburg, South Africa
* Corresponding author; email: mghielmini{at}ticino.com.
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/m2 weekly x 4). In 185 evaluable patients, the overall response rate was 67% in chemotherapy-naive patients and 46% in pre-treated cases (p<0.01). Patients responding or with stable disease at Week 12 (n=151) were randomized to no further treatment or prolonged rituximab administration (375 mg/m2 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 arm vs. 23 months in the prolonged treatment arm (p=0.02), the difference being particularly notable in chemotherapy-naive patients (19 vs. 36 months, p=0.009) and in patients responding to induction treatment (16 vs. 36 months, p=0.004). The number of t(14;18)-positive cells in peripheral blood (p=0.0035) and in bone marrow (p=0.0052) at baseline was predictive for clinical response. Circulating normal B-lymphocytes and 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.
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