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Friday 01 February 2008

Role of Mitoxantrone in Combination Therapy for Chronic Lymphocytic Leukemia (CLL) Evaluated


Researchers from Spain have reported preliminary results of initial treatment of patients with chronic lymphocytic leukemia (CLL) with a combination of RituxanŽ (rituximab), FludaraŽ (fludarabine), CytoxanŽ (cyclophosphamide) and Novantrone (mitoxantrone) (R-FCM). However, researchers from the MD Anderson Cancer Center question the utility of adding mitoxantrone to the combination Fludara, Cytoxan and Rituxan (FCR) regimen. These two studies were presented at the 2007 annual meeting of the American Society of Hematology.

Multiagent chemotherapy is the initial treatment of choice for high-risk younger patients with CLL. However, there is still considerable debate over the optimal treatment regimen.

The combination of Fludara, Cytoxan and mitoxantrone was a common regimen for CLL prior to the use of Rituxan. Subsequent studies have shown that adding Rituxan to this regimen improves outcomes of patients with CLL.

The study carried out by the Spanish Group for CLL evaluated 6 cycles of R-FCM in 69 patients with untreated CLL.[1] All were under the age of 70 years and 85% were Binet stage B or C. This regimen included Rituxan in induction and in maintenance. Two thirds of the patients had an elevated LDH and beta-2 microglobulin. The overall response rate was 92%. The complete response rate was 74% and 37% of patients became PCR negative. They reported that diffuse marrow involvement ZAP 70 and cytogenetics were not predictive of response. In the maintenance phase of disease, some PCR negative patients became positive and some positive patients became negative. There was one infectious death.

Researchers from the MD Anderson Cancer Center evaluated the importance of mitoxantrone in combination with Fludara, Cytoxan and Rituxan.[2] The reviewed data on FCR indicated a complete remission rate of 72% with complete molecular remissions in 43%. This study included 30 patients with symptomatic CLL who had a median age of 57 years and a maximum age of 69 years. Beta-2 microglobulin levels were less than 4 mg/L and 13% were RAI stage III-IV. All were treated with FCM-R with NeulastaŽ (pegfilgrastim) support. The overall response rate was 97%, the complete response rate was 80% and 65% of these patients had complete molecular remissions. These data were compared to historical controls receiving FCR and there were not differences between the two groups in response of time to treatment failure. These authors concluded that FCM-R may not be better than FCR. However, they reported that the tolerability of the two regimens was equivalent.

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