Originally published as JCO Early Release 10.1200/JCO.2005.12.191 on January 18 2005
Journal of Clinical Oncology, Vol 23, No 6 (February 20), 2005: pp. 1088-1095
© 2005 American Society of Clinical Oncology.
Maximizing Therapeutic Benefit of Rituximab: Maintenance Therapy Versus Re-Treatment at Progression in Patients With Indolent Non-Hodgkin's Lymphoma—A Randomized Phase II Trial of the Minnie Pearl Cancer Research Network
John D. Hainsworth,
Sharlene Litchy,
Don W. Shaffer,
Van L. Lackey,
Manuel Grimaldi,
F. Anthony Greco
From the Sarah Cannon Cancer Center and Tennessee Oncology PLLC, Nashville, TN; Northwest Georgia Oncology Centers, Marietta, GA; Jackson Oncology Associates, Jackson, MS; and Consultants in Blood Disorders and Cancer, Louisville, KY
Address reprint requests to John D. Hainsworth, MD, 250 25th Avenue North, Sarah Cannon Cancer Center, Suite 110, Nashville, TN 37203; e-mail: jhainsworth{at}tnonc.com
PURPOSE: To compare the benefit of maintenance rituximab therapy versus rituximab re-treatment at progression in patients with previously treated indolent non-Hodgkin's lymphoma.
PATIENTS AND METHODS: Between June 1998 and August 2002, 114 patients who had received previous chemotherapy for indolent non-Hodgkin's lymphoma were treated with a standard 4-week course of rituximab. Patients with objective response or stable disease were randomly assigned to receive either maintenance rituximab therapy (standard 4-week courses administered at 6-month intervals) or rituximab re-treatment at the time of lymphoma progression. The duration of rituximab benefit was measured from the date of first rituximab treatment until the date other treatment was required.
RESULTS: Ninety (79%) of 114 patients had objective response or stable disease after initial rituximab treatment, and were randomly assigned to treatment. Progression-free survival was prolonged in the maintenance group (31.3 v 7.4 months; P = .007). Final overall and complete response rates were higher in the maintenance group. Duration of rituximab benefit was similar in the maintenance and re-treatment groups (31.3 v 27.4 months, respectively). More maintenance patients remain in continuous remission, and more are currently in complete remission. Both treatment approaches were well tolerated.
CONCLUSION: In patients who have objective response or stable disease with single-agent rituximab therapy, duration of rituximab benefit is substantially prolonged with either scheduled maintenance treatment or rituximab re-treatment at the time of progression. At present, the magnitude of benefit with either approach appears similar. However, additional follow-up of this trial is required, and completion of phase III randomized trials is necessary to definitively answer this question.
Supported in part by grants from Genentech Inc and the Minnie Pearl Foundation.
Authors' disclosures of potential conflicts of interest are found at the end of this article.
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