Originally published as JCO Early Release 10.1200/JCO.2005.12.052 on January 18 2005

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Rituximab Therapy for Patients With Newly Diagnosed, Advanced-Stage, Follicular Grade I Non-Hodgkin's Lymphoma: A Phase II Trial in the North Central Cancer Treatment Group

From the Department of Internal Medicine, Division of Hematology, and the Division of Hematopathology, Mayo Clinic, Rochester, MN; OHACI, Peoria, IL; Medical Oncology/Hematology, Guthrie Clinic, Milan, PA; Medical Oncology, Allan Blair Cancer Center, Regina, Saskatchewan, Canada; Oncologic Consultants PA, Minneapolis, MN; Hematology/Oncology, Mayo Clinic, Scottsdale, AZ; Medical Oncology and Medical Association, Iowa Oncology Research Association CCOP, Des Moines, IA

Address reprint requests to Thomas E. Witzig, MD, Mayo Clinic 200 First St SW, Rochester, MN 55905; e-mail: witzig{at}mayo.edu

PURPOSE: Patients with newly diagnosed, advanced-stage, follicular grade 1 non-Hodgkin's lymphoma (NHL) are often asymptomatic and can be observed without immediate chemotherapy. The goals of this study were to assess the overall response rate (ORR) to rituximab in this patient population and to determine the time-to-progression (TTP) and time-to-subsequent-chemotherapy (TTSC).

PATIENTS AND METHODS: Eligible patients had untreated follicular grade 1 NHL, and measurable stage III/IV disease. Patients received rituximab 375 mg/m² intravenous weekly x 4 doses and were then followed for response and progression; no maintenance therapy was provided.

RESULTS: Thirty-seven patients were accrued; one patient was ineligible. The median age was 59 years (range, 29 to 83 years). Six patients (18%) had elevated lactate dehydrogenase levels. The ORR was 72%, with 36% complete remissions. Fourteen (39%) of 36 patients remain in unmaintained remission, two died without disease progression, and three died with disease progression. Twenty (56%) of 36 patients have disease progression. The median TTP was 2.2 years (95% CI, 1.3 to not yet reached). Eighteen patients have subsequently been treated with chemotherapy, with a median TTSC of 2.3 years (95% CI, 1.6 to not yet reached). Patients with a high lactate dehydrogenase level had a lower ORR of 33% and a short TTP of only 6 months.

CONCLUSION: Rituximab can be safely administered to patients with advanced-stage follicular grade 1 NHL with efficacy and minimal toxicity. This therapy is highly active and offers an acceptable alternative to observation in this patient population. Patients with high LDH should not be considered for rituximab monotherapy.

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

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