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Journal of Clinical Oncology, Vol 19, Issue 8 (April), 2001: 2153-2164
© 2001 American Society for Clinical Oncology

Rituximab Using A Thrice Weekly Dosing Schedule in B-Cell Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma Demonstrates Clinical Activity and Acceptable Toxicity

By John C. Byrd, Timothy Murphy, Robin S. Howard, Margaret S. Lucas, Amy Goodrich, Kathy Park, Michael Pearson, Jamie K. Waselenko, Geoffrey Ling, Michael R. Grever, Antonio J. Grillo-Lopez, Jay Rosenberg, Lori Kunkel, Ian W. Flinn

From the Division of Hematology-Oncology, Department of Medicine and the Department of Clinical Investigation, Walter Reed Army Medical Center, Washington, DC; Division of Hematologic Malignancies, Johns Hopkins Oncology Center, Baltimore; Department of Critical Care Medicine, Uniformed Services University of Health Sciences, Bethesda, MD; Department of Medicine, The Ohio State University, Columbus, OH; IDEC Pharmaceuticals Inc, San Diego; and Genentech Pharmaceuticals, Inc, San Francisco, CA.

Address reprint requests to John C. Byrd, MD, The Ohio State University, 320 West 10th Ave, Room 302 SL, Columbus OH 43210; email: byrd-2{at}medctr.osu.edu

PURPOSE: Rituximab has been reported to have little activity in small lymphocytic lymphoma (SLL)/chronic lymphocytic leukemia (CLL) and to be associated with significant infusion-related toxicity. This study sought to decrease the initial toxicity and optimize the pharmacokinetics with an alternative treatment schedule.

PATIENTS AND METHODS: Thirty three patients with SLL/CLL received dose 1 of rituximab (100 mg) over 4 hours. In cohort I (n = 3; 250 mg/m2) and cohort II (n = 7; 375 mg/m2) rituximab was administered on day 3 and thereafter three times weekly for 4 weeks using a standard administration schedule. Cohort III (n = 23; 375 mg/m2) administered rituximab similar to cohort II for the first two treatments and then over 1 hour thereafter.

RESULTS: A total of 33 CLL/SLL patients were enrolled; only one patient discontinued therapy because of infusion-related toxicity. Thirteen patients developed transient hypoxemia, hypotension, or dyspnea that were associated with significant changes in baseline interleukin-6, interleukin-8, tumor necrosis factor alpha, and interferon gamma compared with those not experiencing such reactions. Infusion-related toxicity occurred more commonly in older (median age 73 v 62 years; P = .02) patients with no other pretreatment clinical or laboratory features predicting occurrence of these events. The overall response rate was 45% (3% CR, 42% PR; 95% CI 28% to 64%). Median response duration for these 15 patients was 10 months (95% CI, 6.8-13.2; range, 3 to 17+).

CONCLUSION: Rituximab administered thrice weekly for 4 weeks demonstrates clinical efficacy and acceptable toxicity. Initial infusion-related events seem to be cytokine mediated and resolve by the third infusion making rapid administration possible. Future combination studies of rituximab with other therapies in CLL seem warranted.

J.C.B. and I.W.F. contributed equally to the design, implementation, and analysis of this study.




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