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J Clin Oncol ; 23(4): 694-704, 2005 Feb 01.
Article in English | MEDLINE | ID: mdl-15681517

ABSTRACT

PURPOSE: To evaluate the safety and efficacy of fludarabine plus rituximab in treatment-naive or relapsed patients with low-grade and/or follicular non-Hodgkin's lymphoma. PATIENTS AND METHODS: This was an open-label, single-arm, single-center phase II study enrolling 40 patients. During the first week of the study, patients received two infusions of rituximab 375 mg/m2 administered 4 days apart. Seventy-two hours after the second infusion of rituximab, patients received the first of six cycles of fludarabine chemotherapy (25 mg/m2/d for 5 days on a 28-day cycle). Single infusions of rituximab were administered 72 hours before the second, fourth, and sixth cycles of fludarabine, and two infusions of rituximab were given 4 weeks after the last cycle of fludarabine. Treatment duration was 26 weeks. RESULTS: An overall response rate of 90% (80% complete response rate) was achieved in the intent-to-treat population. Similar response rates were seen in treatment-naive and previously treated patients. The median duration of response has not been reached at 40+ months. The median follow-up time in this study is 44 months (range, 15 to 66 months). In patients positive for the 14;18 translocation in blood and/or marrow at enrollment, molecular remission was achieved in 88% of cases, with patients remaining negative for up to 4 years to date. Hematologic toxicity was manageable, and except for a 15% incidence of herpes simplex/zoster infections, infectious complications were rare. Nonhematologic toxicities were minimal. CONCLUSION: Rituximab plus fludarabine was well tolerated and associated with an excellent complete response rate, including molecular remissions, in patients with low-grade or follicular lymphoma.


Subject(s)
Antibodies, Monoclonal/administration & dosage , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Lymphoma, Follicular/drug therapy , Lymphoma, Non-Hodgkin/drug therapy , Vidarabine/analogs & derivatives , Vidarabine/administration & dosage , Adult , Aged , Antibodies, Monoclonal/adverse effects , Antibodies, Monoclonal, Murine-Derived , Female , Flow Cytometry , Genes, bcl-2 , Humans , Lymphoma, Follicular/immunology , Lymphoma, Follicular/mortality , Lymphoma, Non-Hodgkin/immunology , Lymphoma, Non-Hodgkin/mortality , Male , Middle Aged , Rituximab , T-Lymphocyte Subsets/immunology , Vidarabine/adverse effects
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