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Combination Fludarabine, Cyclophosphamide, and Rituximab for Previously Treated Patients With Chronic Lymphocytic Leukemia

Combination Fludarabine, Cyclophosphamide, and Rituximab for Previously Treated Patients With Chronic Lymphocytic Leukemia

Treatment options for patients with relapsed chronic lymphocytic leukemia (CLL) are limited. In this report, we present our preliminary results of a biochemotherapy combination using 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. Of 84 patients registered, 43 are currently evaluable after more than 3 courses.

Patients had a median age of 57 years (range: 18 to 74 years), 65.1% were male, and 44% were Rai stage IV. The median platelet count was 110 (range: 15 to 367), median hemoglobin was 12.2 (range: 6.8 to 16.0), and median white blood cell count was 45.8 (range: 2.7 to 311). Three or more lymph node sites were involved in 58%, B2 microglobulin was greater than 3 in 79%, and 83% had a performance status of 1 or less. Of the 43 patients, 1 had splenic lymphoma with villous lymphocytes and 1 had marginal zone lymphoma. The median number of prior treatments was 3: 9.3% of patients had received alkylating agents only, 65.1% had been sensitive to fludarabine-containing regimens, and 20.9% had been resistant to fludarabine. The median follow-up time is 5 months.

Using National Cancer Institute criteria, the complete remission (CR) rate is 14% (all in the fludarabine-sensitive group, 21%), nodular partial response (PR) 14%, PR 42%, stabilization of disease 4.7%, and no response 20.9%. Total response rate is 69.9%. One patient died early. Five other patients have died (none during the first course), 3 of them due to progression of disease. Serious toxicities from the treatment include 8 episodes of pneumonia, 4 episodes of neutropenic fever, 2 of sepsis, and 1 prolonged myelosupression. Other frequent toxicities related to rituximab include fever, chills, and nausea; hypotension occurred in 5 (12%) patients.

CONCLUSION: In summary, fludarabine, cyclophosphamide, and rituximab is a very active and well-tolerated program for patients with previously treated CLL, in particular for fludarabine-sensitive disease. Studies evaluating the efficacy and toxicity of this program are ongoing.

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

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