Background & objective: Fludarabine is one of the most effective agents for indolent lymphoma and chronic lymphocyte leukemia (CLL). Response rate of single agent for chemotherapy-naive patients ranged from 40%to 87% with 14-60% complete remission (CR) rate has been reported abroad while the response rate of 30%-70% and the CR rate of 10%-38% for pre- treated patients. Significantly higher response rate can be yielded by combined regimen such as FN, FMD, and FC, etc. The purpose of this study was to investigate the efficacy and toxicity of fludarabine-based regimen for patients with lymphoma in China.
Methods: Twenty-nine patients with lymphoma were enrolled into this study from April 2001 to December 2003. There were 18 male and 11 female patients with median age of 53 years old (ranged from 27 to 79). Twenty-two patients were low-grade lymphoma and 7 were intermediate-grade lymphoma. Nineteen patients had been treated by FMD(Fludarabine 25 mg/m(2) d1-3,Mitoxantrone 8 mg/m(2) d1 and Dexamethasone 20 mg d1-4) while 3 by R-FMD (Rituximab+FMD) and 7 by other fludarabine- containing regimens. The median therapeutic cycles were 3 (1-6).
Results: Twenty-five patients were available for objective evaluation in 29 enrolled patients. The response rate and the CR rate for indolent group were 86% (18/21) and 38% (8/21). No response was obtained in 4 cases of intermediate grade lymphoma. Myelosuppression and mild GI toxicity were major side effects. The rates of leucopenia, thrombocytopenia, and anemia were 61% (III+IV, 8%), 18% (III+IV, 4%), and 26%, respectively. G-CSF was necessary only in 5% of cycles without red cell or platelet transfusion. Mild nausea and vomiting account for 20%. Five cases of febrile neutropenia during chemotherapy were controlled by intravenous antibiotics and supportive care. Transient liver function abnormality and jaundice encountered in 1 patient and diffusive skin rash in another one.
Conclusion: Fludarabine-based regimen is highly effective for indolent lymphoma with mild toxicity. Further investigation is warranted.