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Update of Results of the Combination of Fludarabine, Cyclophosphamide, and Rituximab for Previously Treated Patients With Chronic Lymphocytic Leukemia

Update of Results of the Combination of Fludarabine, Cyclophosphamide, and Rituximab for Previously Treated Patients With Chronic Lymphocytic Leukemia

In this report, we present our results of the biochemotherapy combination of rituximab (Rituxan), a monoclonal antibody against CD20, with fludarabine (Fludara) and cyclophosphamide (Cytoxan, Neosar). During course 1, rituximab is given at a slow rate at 375 mg/m² on day 1 followed by fludarabine at 25 mg/m² and cyclophosphamide at 250 mg/m² on days 2-4. During subsequent courses (2-6), rituximab is given at 500 mg/m² on day 1 and fludarabine and cyclophosphamide are given at the same doses but on days 1-3. From November 1999 to July 2001, 167 patients were registered, and 102 patients are currently evaluable after more than 6 months of follow-up.

Patient characteristics are as follows: median age, 59 years (range: 36-81 years); males, 72.5%; Rai stage IV, 42%; median platelet count, 117 × 109 cells/L (range: 15-367 × 109 cells/L); median hemoglobin, 12.1 g/dL (range: 6.8-16.5 g/dL); median white blood cell count, 52 × 109 cells/L (range: 1.3-584 × 109 cells/L); three or more lymph node sites involved, 59%; beta-2-microglobulin greater than 3 mg/dL, 83%; performance status of ≤ 1, 79%. The median number of prior treatments was 2: 14.7% of the patients had received alkylating agents only, 58.8% had been sensitive to fludarabine-containing regimens, and 26.4% had been resistant to fludarabine.

The median follow-up time is 13+ months. Using National Cancer Institute criteria, the complete response (CR) rate is 23%; nodular partial response, 14%; partial response, 36%; and no response, 20.9%. The total response rate was 72.2%. Of 13 patients (38%) in CR, five had immunoglobulin rearrangements undetectable by polymerase chain reaction. Responses based on prior therapy are summarized as follows:

Frequent toxicities related to rituximab included chills and fever. Other toxicities included nausea/vomiting, hypotension, and dyspnea. Serious toxicities from the treatment included eight episodes of pneumonia, seven episodes of neutropenic fever, five of sepsis, and one prolonged myelosuppression. A total of 26 patients have died.

CONCLUSION: The combination of fludarabine, cyclophosphamide, and rituximab is a very active program for patients with previously treated CLL.

Click here to read Dr. Bruce Cheson's commentary on this abstract.

 
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