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Title: Rituximab Provides Additional Benefits to Initial Chemotherapy in Aggressive Non-Hodgkin's Lymphoma: Presented at NHL

"Rituximab Provides Additional Benefits to Initial Chemotherapy in Aggressive Non-Hodgkin's Lymphoma: Presented at NHL"

By Chris Berrie PRAGUE, CZECH REPUBLIC -- September 15, 2004 -- The addition of rituximab to cyclophosphamide/doxorubicin/vincristine/prednisone (CHOP) as initial chemotherapy increases the complete response rate and prolongs the event-free survival and overall survival in patients with aggressive non-Hodgkin's lymphoma (NHL), according to an ongoing study. Lidija Cevreska, MD, PhD, Study Coordinator and Professor of Internal Medicine, Department of Hematology, Clinical Center, Medical Faculty, Skopje, Macedonia, presented the findings here September 11th at a meeting on "The Role of Immunotherapy in NHL: optimising treatment outcomes" sponsored by Roche. "R-CHOP is a new approach relative to CHOP, and because of the good results that were being obtained with rituximab, 5 years ago we started with R-CHOP," said Dr. Cevreska. Over the period of 1989 to 2002, CHOP chemotherapy was the standard treatment for aggressive B-cell NHL in this Department of Hematology. Thus, the Dr. Cevreska and colleagues drew on 95 historical patients over that period to obtain 20 patients recruited from the more recent use of R-CHOP in this setting. The CHOP alone regimen consisted of a combination of cyclophosphamide 700 mg/m[², doxorubicin 50 mg/m² and vincristine 2 mg on day 1, plus prednisone 100 mg on days 1 to 5. The R-CHOP group received the same regimen in addition to rituximab 375 mg/m² on day 1, repeated every 3 weeks. All patients received between 6 and 8 treatment cycles.

There were no significant differences in gender, age or prognostic group according to the International Prognostic Index (IPI), between the two groups of patients, and most had advanced disease at initial presentation (stage III, 24%, stage IV, 43%). B-symptoms were noted in 44% of the patients, and 29% had bone marrow infiltration.

In the CHOP alone arm, complete response was achieved in 60% of patients, and partial response in 4%. There were early deaths in 4% of this group. In comparison, the R-CHOP arm achieved CR in 80% of patients and 5% achieved partial response. There were no early deaths in this group.

Despite the short observation period (6 to 183 months) and ongoing follow-up, significant improvements have been observed in the R-CHOP arm compared with the CHOP arm in term of event-free survival and overall survival, although full quantification will require further data.

Dr. Cevreska said that due to these early improvements in the R-CHOP patients, the results confirm previous studies, which demonstrated that rituximab represents a major advance in the treatment of aggressive lymphoma. Furthermore, she said, R-CHOP should be the standard initial treatment for previously untreated patients with diffuse large B-cell lymphomas.

[Presentation title: "Chemotherapy With Fludarabine, Cyclophosphamide and Rituximab Improves Complete Response, Remission Duration, and Survival as Initial Therapy of Chronic Lymphocytic Leukaemia." Abstract 414]

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