ABSTRACT
Background: Diffuse large B-cell Lymphoma [DLBCL] is the most common form of aggressive non-Hodgkinis lymphoma [NHL] accounting for 30% of all NHL cases. CHOP chemotherapy containing cyclphosphamide, doxorubicin, vincristine and prednisolone, is the conventional standard treatment for those patients but still curative in less than 50% of patients. Rituximab is a chimeric targeting antibody that binds specifically to CD20 antigen, expressed on 85% of cells of the B-cell lineage; leading to specific elimination of B-cells through multiple mechanisms
Purpose: The addition of rituximab to CHOP [CHOP-R] in management of patients with DLBCL could improve the response rate, event-free survival and overall survival. We conducted this trial is to compare the efficacy and tolerability of CHOP plus rituximab [CHOP-R] with CHOP alone in patients with CD20+ DLBCL
Patients and Methods: Thirty six patients with untreated CD20 positive DLBCL were randomly assigned to receive either eight courses of CHOP chemotherapy alone [cyclophosphamide: 750 mg/m2 IV DI, Vincristine: 1.4 mg/m2 IV DI [Maximum: 2 mg], Doxorubicin: 50mg/m2 IV DI and prednisolone: 100 mg/day PO Dl-D5] every three weeks [19 patients] or eight cycles of CHOP in addition to rituximab: 375 mg /m2 IV on day 1 of each cycles [17 patients]
Results: Thirty sex patients [median age. 62 year] were included and with a median follow-up of 18 months, CHOP-R was significantly superior to CHOP alone in terms of complete response rate [76.4% versus 57.9%]. Event-free survivial [59% versus 42%] and overall survival [76% versus 63% respectively. Sub- analysis have revealed that: the benefit of CHOP-R was seen in patients with both high-and low-risk International prognostic index [IPI] status. Also of great importance was the excellent tolerability profile with no clinically significant increase in the adverse events was seen with rituximab plus CHOP compared to CHOP alone
Conclusions: Rituximab plus CHOP represents a good acievementthe first advance in therapy of patients with CD20+ DLBCL. The magnitude of the effect on improvement of complete response rate, event-free survival and overall survival, was so great that statistically significant benefits were apparent after 18 months follow-up. Rituximab was well- tolerable md did not add any significant toxicity to CHOP chemotherapy