Fludarabine in lymphoproliferative malignancies: a single-centre experience.

ABSTRACT

BACKGROUND: Fludarabine has been reported to be an effective drug for the treatment of chronic lymphocytic leukaemia (CLL) and indolent lymphomas. However, its safety and efficacy in Indian patients has not been studied. We retrospectively analysed our experience with fludarabine in low grade lymphomas and CLL. METHODS: The records of all patients with low grade lymphoma or CLL who received fludarabine between April 1999 and November 2006 were analysed. Response evaluation was done as per the National Cancer Institute-Working Group guidelines for CLL and International Workshop criteria for non-Hodgkin lymphomas, respectively, in those patients who received at least 3 cycles of fludarabine. Toxicity was graded as per the common terminology criteria for adverse events, version 3.0. Median event-free survival was obtained using Kaplan-Meier survival analysis. RESULTS: Forty-seven patients were included in the study and 189 cycles were administered (median 4 cycles per patient). Sixteen patients had a treatment delay, 14 due to myelosuppression. Twenty-five patients had low grade lymphoma and 22 had CLL. The response was evaluable in 22 patients with low grade lymphoma and 20 with CLL. The overall response rate for CLL was 100% in those treated upfront (n=9) and 55% in those with relapsed disease (n=11). The overall response rate for low grade lymphoma was 88% (63% complete remission) in untreated patients and 79% (43% complete remission) in those with relapsed disease. Common adverse events were myelosuppression and infection. Two patients died of sepsis and 4 due to disease progression on treatment. Median event-free survival for patients treated upfront with fludarabine was 31.4 months. CONCLUSION: In our patient population, response to fludarabine is similar to that in the published literature. Our patients had a higher frequency of haematological toxicity.