...the addition of rituximab resulted in clinical benefit in terms of overall survival...

For the past 40 years, treatment of chronic lymphocytic leukemia (CLL) has consisted of various chemotherapies. Improvements in treatment regimens over the past decade, particularly the introduction of fludarabine and cyclophosphamide, have improved clinical responses but have not impacted on overall survival.

Promising results from phase II clinical trials assessing the addition of the anti-CD20 antibody rituximab to fludarabine and cyclophosphamide (chemoimmunotherapy) led to the design of a phase III trial. The German CLL Study Group have conducted a prospective, randomized study in 817 patients with CLL to compare chemoimmunotherapy with chemotherapy (fludarabine and cyclophosphamide)—overall survival was one of the secondary end points.

At 3 years after randomization, significantly more patients in the chemoimmunotherapy group were in complete remission than in the chemotherapy group. Most importantly, the addition of rituximab resulted in clinical benefit in terms of overall survival—significantly more patients in the chemoimmunotherapy group were alive at 3 years after randomization than in the chemotherapy group.

Furthermore, subgroup analysis revealed that chromosomal aberrations frequently observed in CLL affect the efficacy of the immunotherapy, indicating that it may be possible to guide treatment based on molecular genetics—welcome to the age of personalized CLL therapy?