Researchers from Spain have reported that the combination of Rituxan® (rituximab), Fludara® (fludarabine), Cytoxan® (cyclophosphamide), and Novantrone® (mitoxantrone) is highly active in patients with previously untreated chronic lymphocytic leukemia (CLL). The details of this study appeared in an early online publication on August 24, 2009 in the Journal of Clinical Oncology.[1]
Currently, the most common drug combination for the initial treatment of patients with CLL is Fludara, Cytoxan, and Rituxan. At the 2007 meeting of the American Society of Hematology, researchers from Spain presented the preliminary results of the current study demonstrating high activity with little increased toxicity with the addition of Novantrone to standard Fludara, Cytoxan, and Rituxan followed by Rituxan maintenance. However, at the same meeting, researchers from the M. D. Anderson Cancer Center presented retrospective data suggesting that the addition of Novantrone added little to overall response rates compared with Fludara, Cytoxan, and Rituxan.
The study carried out by the Spanish Group for CLL evaluated six cycles of R-FCM in 72 patients with untreated CLL. All were 70 years of age or younger. Eighty-five percent 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 93%. The complete response (CR) rate with negative PCR for minimal residual disease (MRD) was 46%. The CR rate with positive PCR for MRD was 36%. The partial response (PR) rate was 11%. Neutropenia occurred in 13% with major infections in 8%. Adverse risk factors for achieving a complete response were advanced clinical stage, del (17p), and increased beta 2 microglobulin.
An update of the M. D. Anderson data on Fludara, Cytoxan, and Novantrone for treatment of newly diagnosed patients with CLL was also published online in Leukemia Research on July 29, 2009.[2] This study included 30 patients with newly diagnosed symptomatic CLL who were under the age of 70 years. Their regimen was similar to that of the Spanish study and included support with Neulasta® (pegilgrastim). The CR rate was 83% with a PR rate of 10%. Sixty-seven percent had a CR as defined by less than 1% CD5/CD19 cells in the bone marrow. Sixty-two percent were MRD-negative by PCR for IgV(H). With a median follow-up of 38.5 months, the median time to disease progression had not been reached. When compared with historical patients receiving Fludara, Cytoxan, and Rituxan, they concluded that there were no differences in outcomes.
Comments: These findings, taken together, suggest that only a randomized trial will determine if the addition of Novantrone improves outcomes compared with Fludara, Cytoxan, and Rituxan in newly diagnosed patients with CLL.
You can buy Rituxan® (rituximab), Fludara® (fludarabine), Cytoxan® (cyclophosphamide), and Novantrone® (mitoxantrone) at Pharmacy-Adviser.com
Reference:
[1] Bosch F, Abrisqueta P, Villamor N, et al. Rituximab, fludarabine, cyclophosphamide, and mitoxantrone a new, highly active chemoimmunogherapy regimen for chronic lymphocytic leukemia. Journal of Clinical Oncology [early online publication]. August 24, 2009.
[2] Faderl S, Wierda W, O’Brien, et al. Fludarabine, cylcophosphamide, mitoxantrone plus rituximab (FCM-R) in frontline CLL<70 years. Leukemia Research [early online publication]. July 29, 2009.
Original post: http://professional.cancerconsultants.com/oncology_main_news.aspx?id=44012
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