Efficacy
In the study by McLaughlin et al, 6% patients achieved complete remission (CR) and 42% partial response (PR). Of the remaining patients, 56 of 75 demonstrated at least a decrease in measurable disease. At a median follow-up of 11.8 months, projected time to progression was 13 months with 53 of the 76 patients who responded still in remission.r
Ghielmini et al (n= 185) demonstrated 52% ORR with 8% CR following the standard 4 weekly schedule of rituximab. Chemotherapy naive patients demonstrated a statistically significantly (p=0.0097) greater response rate (RR) of 67% with 9% CR when compared to those who had been previously treated (RR 46%, CR 8%). Event free survival (EFS) in those randomised to receive the standard rituximab schedule was 11.8 months.r
In the phase 3 trial conducted by van Oers et al, rituximab maintenance demonstrated improved progression free survival (PFS) after both CHOP and R-CHOP. After CHOP, the maintenance rituximab arm had a PFS of 42.2 months vs 11.6 months in the observation arm (P < 0.001); and after R-CHOP, maintenance rituximab arm had a PFS of 51.8 months vs 23 months in the observation arm (P< 0.004).r