Journal of Clinical Oncology, Vol 20, Issue 20
(October), 2002: 4261-4267
© 2002 American Society for Clinical Oncology
Rituximab as First-Line and Maintenance Therapy for Patients With Indolent Non-Hodgkin’s Lymphoma
By John D. Hainsworth,
Sharlene Litchy,
Howard A. Burris, III,
Daniel C. Scullin, Jr,
Steven W. Corso,
Denise A. Yardley,
Lisa Morrissey,
F. Anthony Greco
From the Sarah Cannon Cancer Center and Tennessee Oncology, Professional Limited Liability Corporation, Nashville, TN; Consultants in Blood Disorders and Cancer, Louisville, KY; and Upstate Carolina Community Clinical Oncology Program, Spartanburg, SC.
Address reprint requests to John D. Hainsworth, MD, Sarah Cannon Cancer Center, 250 25th Ave N, Suite 412, Nashville, TN 37203; email: jhainsworth{at}tnonc.com
PURPOSE: To evaluate response to single-agent rituximab in patients with indolent non-Hodgkin’s lymphoma (NHL) and no previous systemic therapy, and the feasibility, toxicity, and efficacy of maintenance rituximab, administered at 6-month intervals, in patients with objective response or stable disease after first-line rituximab therapy.
PATIENTS AND METHODS: Patients with indolent NHL (follicular or small lymphocytic subtypes) previously untreated with systemic therapy received rituximab 375 mg/m2 intravenously weekly for 4 weeks. Patients were restaged at week 6 for response; those with objective response or stable disease received maintenance rituximab courses (identical dose and schedule) at 6-month intervals. Maintenance was continued for a maximum of four rituximab courses or until progression. Between March 1998 and May 1999, 62 patients were entered onto this trial; minimum follow-up was 24 months.
RESULTS: Sixty patients (97%) completed the first 4-week course of rituximab and were assessable for response. All have now completed rituximab therapy; 36 (58%) received four courses at 6-month intervals. The objective response rate at 6 weeks was 47%; 45% of patients had stable disease. With continued maintenance, final response rate increased to 73%, with 37% complete responses. Response was similar in patients with follicular versus small lymphocytic subtypes (76% v 70%, respectively). Median actuarial progression-free survival was 34 months. Two patients experienced grade 3/4 toxicity with the first dose; one patient was removed from treatment. No cumulative or additional toxicities were seen with maintenance courses.
CONCLUSION: Rituximab is highly active and extremely well tolerated as first-line single-agent therapy for indolent NHL. First-line treatment with scheduled maintenance at 6-month intervals produces high overall and complete response rates and a longer progression-free survival (34 months) than has been reported with a standard 4-week treatment.
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