Rituximab/CHOP combination effective and safe for early Non-Hodgkin’s Lymphoma
Results of Multi-center Phase IV Study: Rituximab (MabThera) in Combination with CHOP Chemotherapy in Patients with Previously Untreated Non-Hodgkin’s Lymphoma.
MabThera is a chimerical anti-CD20 monoclonal antibody, and is the first MAb approved by FDA for the treatment of non-Hodgkin’s Lymphoma (NHL). It has shown significant efficacy and well tolerance in both relapsed and untreated NHL. Researchers prompted this multi-center phase IV trial in newly diagnosed NHL patients to evaluate the efficacy and safety of MabThera combined with standard CHOP chemotherapy.All patients either received A regimen that 4-6 infusions of MabThera (375 mg/m2 per dose), each MabThera given on day 1 of each CHOP chemotherapy cycle, or received B regimen that 4-6 infusions of MabThera (375 mg/m2 per dose) given once a week.Betweem Feb. 2002 and Dec. 2003, 347 pts with newly diagnosed pathologically proven CD20+ NHL were enrolled. Among them 235 were male, 112 were female. There were 94 over 60 years and 191 under 60 years old.The main subtypes are DLBCL 196(56.5%), FL 41(11.8%), SLL/CLL 13(3.7%), MALT 11(3.2%). Ann Arbor degree: I grade 52(15%); II grade 80(23%); III grade 90(26%); IV grade 105(30.2%); Of 314 were evaluable, the overall response (OR) of was 93.6% and complete response (CR) was 56%, part response (PR) was 37.5%, stead disease (SD) was 3.8%, progress disease (PD) was 2.5% respectively. The CR of 6 cycles and 4 cycles was 63.5% and 43.6% respectively. The OR of A regimen and B regimen was 93.9% and 93.4% respectively.In all eligible patients, leucopenia 122 case; digestive System 66; Rhinitis (inflammation of the mucous membrane of the nose) 3; Bronchospasm 4; Nervous System 6; Rash 15.Researchers concluded all results suggest that the regimen of MabThera combined with CHOP chemotherapy in newly diagnosed pathologically proven CD20+ NHL patients is effective and safety. Meanwhile this safety profile and efficacy achieved in this study indicated that more doses of MabThera are superior to standard four weekly doses in untreated NHL.If you would like more information on the HOTT congress please contact our office on (08) 9388 0344 or email us at adean@virtualcancercentre.com
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