Originally published as JCO Early Release 10.1200/JCO.2005.04.164 on December 14 2004

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Effect of Single-Agent Rituximab Given at the Standard Schedule or As Prolonged Treatment in Patients With Mantle Cell Lymphoma: A Study of the Swiss Group for Clinical Cancer Research (SAKK)

From the Oncology Institute of Southern Switzerland, Bellinzona; Swiss Institute of Applied Cancer Research Coordinating Centre, Bern; Institute of Medical Oncology, Inselspital, University of Bern; Swiss Reference Centre for Lymphoma Pathology; Kantonsspital, Aarau; Kantonsspital St Gallen, St Gallen; Kantonsspital Luzern, Luzern; Universitätsspital Zürich, CHUV, Lausanne, Switzerland

Address reprint requests to Michele Ghielmini, MD, Oncology Institute of Southern Switzerland, Ospedale San Giovanni, 6500 Bellinzona, Switzerland; e-mail: mghielmini{at}ticino.com

PURPOSE: To evaluate the effect of single-agent rituximab given at the standard or a prolonged schedule in patients with newly diagnosed, or refractory or relapsed mantle cell lymphoma (MCL).

PATIENTS AND METHODS: After induction treatment with the standard schedule (375 mg/m² weekly x 4), patients who were responding or who had stable disease at week 12 from the start of treatment were randomly assigned to no further treatment (arm A) or prolonged rituximab administration (375 mg/m²) every 8 weeks for four times (arm B).

RESULTS: The trial enrolled 104 patients. After induction, clinical response was 27% with 2% complete responses. Among patients with detectable t(11;14)-positive cells in blood and bone marrow at baseline, four of 20, and one of 14, respectively, became polymerase chain-reaction–negative after induction. Anemia was the only adverse predictor of response in the multivariate analysis. After a median follow-up of 29 months, response rate and duration of response were not significantly different between the two schedules in 61 randomly assigned patients. Median event-free survival (EFS) was 6 months in arm A versus 12 months in arm B; the difference was not significant (P = .1). Prolonged treatment seemed to improve EFS in the subgroup of pretreated patients (5 months in arm A v 11 months in arm B; P = .04). Thirteen percent of patients in arm A and 9% in arm B presented with grade 3 to 4 hematologic toxicity.

CONCLUSION: Single-agent rituximab is active in MCL, but the addition of four single doses at 8-week intervals does not seem to significantly improve response rate, duration of response, or EFS after treatment with the standard schedule.

Supported in part by research funding from Roche Pharma Schweiz AG to the Swiss Group for Clinical Cancer Research (SAKK).

Presented orally (in summary) at the 2003 Annual Meeting of the European Haematology Association (EHA), Lyon, France, June 2003.

Authors' disclosures of potential conflicts of interest are found at the end of this article.

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