MabThera first-line in CLL
The CLL8 Trial showed that MabThera plus fludarabine and cyclophosphamide (R-FC) is well tolerated in first-line CLL. This phase III trial involved 817 previously untreated CLL patients who were randomised to treatment with 6 cycles of R-FC or fludarabine and cyclophosphamide (FC) alone. The proportion of patients who discontinued treatment because of adverse events (AEs) was similar between the two treatment arms (18%), suggesting that MabThera does not add significant toxicity to the FC regimen.
There was a higher proportion of grade 3/4 AEs among patients who received R-FC compared with those who received FC alone (77% and 62%, respectively). This included a higher incidence of grade 3/4 haematological toxicities (R-FC: 57%, FC: 41%) particularly grade 3/4 neutropenia (R-FC: 30%, FC: 19%). Importantly, however, this did not translate into a statistically significant difference in grade 3/4 infection rates, which were 18% with R-FC and 17% with FC.
<2 plus chemotherapy and those receiving chemotherapy alone>>
References
1. Hallek M, Fingerle-Rowson G, Fink A-M, et al. Blood 2008;112 (Abstract 325).
