Abstract
Background: based on data suggesting synergistic activity of fludarabine (F) and cyclophosphamide (C) combination therapy. This study was conducted to assess the efficacy and tolerability of this combination chemotherapy in Iraqi adult patients with advanced chronic lymphocytic leukemia (CLL), reflected by better response rate, treatment free survival and overall survival benefit. Patient and Methods: A prospective study carried out in Baghdad teaching hospital and national hematology center in Baghdad between February 2005 and fabruary 2009. It included 64 Iraqi patients aged between 39-77 years old with advanced stage CLL. Written informed consent wasobtained from all patients prior to start of therapy. They received FC combination therapy (fludarabine 25 mg/ m2 plus cyclophosphamide 250mg/ m2 for 3 days intravenously, repeated every 28 days). Treatment was administered for 6 courses. Results: Out of 64 CLL patients with Binet stage B&C who were included in this study, 41(64.1%) patients were male and 23 (35.9%) patients were females (M:F ratio1.7:1) with median time of follow-up 26 months. median age was 59.9 years. Forty- eight (75%) patients were previously untreated, of them 22 (45.8%) patients were stage B and 26 (45.1%) patients were stage C while the other 16 (25%) patients with CLL were previously treated with an alkylating agents, of them 7(43.7%) of stage B and 9 (56.2%) with stage C. This combination chemotherapy resulted in 39.1% complete remission and 39.1% partial remission. The two years median treatment-free survival was 90% with the median duration of response was 18 months. there was a significant difference (p<0.005) between the different Binet stage group (C&B) and degree of response, with better response rate in those with stage C than those with stage B. the overall response rate was 88.5%, 65.5% for stage C and B respectively.The major toxicity (grade 3-4) were nausea and vomiting while the myelosupression of grade 1&2 for leucopenia and neutropenia occur in 19%, 14% respectively. Conclusion: Fludarabine and cyclophosphamide combination regimen is an effective therapy for patients with advance CLL with high response and complete remission rate in those untreated and previously treated CLL patients, with good tolerability to this combination.
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