NHL 2004: Addition of Rituximab to Standard Chemotherapy Regimen Improves Survival in Aggressive Non-Hodgkin’s Lymphoma
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NHL 2004: Addition of Rituximab to Standard Chemotherapy Regimen Improves Survival in Aggressive Non-Hodgkin’s Lymphoma

By Chris Berrie

PRAGUE, CZECH REPUBLIC -- September 13, 2004 -- The addition of rituximab to the previously standard chemotherapy regimen that includes cyclophosphamide, adriamycin, vincristine, and prednisone (CHOP) for aggressive non-Hodgkin’s lymphoma can result in a dramatic improvement in outcome for patients with advanced stage diffuse large B-cell lymphoma (DLBCL).

The findings, from a study conducted in British Columbia, Canada, were presented here September 11th at The Role of Immunotherapy in NHL: Optimising Treatment Outcomes, sponsored by Roche.

"The British Columbia Cancer Agency implemented a new policy in 2001, recommending the combination of rituximab with CHOP (R-CHOP) for all patients with advanced stage DLBCL in British Columbia, regardless of age," said Laurie Sehn, MD, medical oncologist and clinical investigator, the British Columbia Cancer Agency and the University of British Columbia, Vancouver, British Columbia, Canada. Dr. Sehn and colleagues thus designed a population-based retrospective analysis to compare the outcomes of patients with DLBCL treated from 18 months before this policy change (prerituximab) with those treated up to 18 months after (postrituximab).

They searched through case records from the British Columbia Provincial Cancer Registry and Cancer Agency, and the Lymphoma Clinical Database. The main inclusion criteria were biopsy-proven, newly diagnosed DLBCL at clinically advanced disease stages, with the exclusion of HIV-positivity, central nervous system involvement, and evidence of transformation.

After verification by close examination of all the records available on each case, 292 were identified (median age, 64 years), of which 140 were prerituximab and 152 were postrituximab. These 2 groups showed no significant differences in age, sex, serum lactate dehydrogenase levels, tumour stage, International Prognostic Index (IPI) distribution, or the presence of bulky disease. However, more patients in the prerituximab group had received radiation therapy than in the postrituximab group (24% vs 14%; P =.04).

All patients had received a CHOP-like chemotherapy regimen, and in the R-CHOP patients, rituximab had been given at a dose of 375 mg/m2 with each cycle (of 6-8 cycles) of CHOP, 24 to 72 hours after CHOP.

In this follow-up of March 2004, Dr. Sehn said that the median follow-ups were at 42 months (range, 5-52) and 24 months (range, 9-35) for the prerituximab and postrituximab groups, respectively. When compared with the 2-year progression-free survival (PFS) and overall survival (OS) of the prerituximab patients (51% and 52%, respectively), those of the postrituximab patients were significantly greater (69%, P =.002; 78%, P <.0001; respectively).

An analysis by age found increases in these differences in the patients 60 or older (n = 170), with 2-year progression-free survival (PFS) and overall survival (OS) in the prerituximab patients of 44% and 42%, respectively, as compared with those of the postrituximab patients of 68% and 73% (P =.007, P =.0003, respectively).

In a multivariate analysis with a Cox regression model, Dr. Sehn found that "after controlling for age and IPI score, the era of treatment -- as prerituximab versus postrituximab -- remained a very strong independent predictor of both progression-free survival [P =.004] and overall survival [P =.006]."

This analysis thus shows that addition of rituximab to CHOP chemotherapy has led to a dramatic improvement in outcome for advanced stage DLBCL in British Columbia, with a 50% reduction in the risk of dying at 2 years, further demonstrating the impact that this can have when applied to the overall patient population outside of the clinical trial setting.

[Presentation title: The Impact of R-CHOP on Survival in Aggressive NHL. Abstract 535]

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