Abstract

In 1998, the GELA (Groupe d’Etude des Lymphomes de l’Adulte) ran a randomized study to evaluate the benefit of the addition of rituximab to CHOP chemotherapy in elderly patients (60 to 80 years old) with diffuse large B-cell lymphoma. Early results were presented at ASH 2000 and published in

NEJM
(
2002
;
346
:
235
)
with a median follow-up of 1 and 2 years, respectively. An update of these results is presented with a median follow-up of 5 years. 399 patients were included, 197 in the CHOP group and 202 in the R-CHOP group, 60% had a high risk disease according to the IPI score. Characteristics of the patients did not differ between both groups. Rituximab was given at 375 mg/m² the same day of CHOP for 8 cycles. Primary endpoint was event-free survival with events defined as progressive disease (PD) during or after treatment, relapse, institution of a new treatment, and death whatever the cause. Secondary endpoints were overall survival (OS) and progression-free survival (PFS) with progression defined as PD, relapse, or death from lymphoma or lymphoma treatment. Response rates for R-CHOP and CHOP were: CR/CRu 75% and 63%, PD 9% and 22%, and death during treatment 6% and 6%, respectively (P=.005), as previously published. With a median follow-up of 5 years, 106 events (52.5% of the patients) were observed in R-CHOP arm and 142 (72%) in CHOP arm: 19% and 31% PD or death during treatment, 5.5% and 4.5% institution of a new treatment, 20% and 34% relapses, 8% and 2.5% death in CR for R-CHOP and CHOP, respectively. Survival outcomes are presented in the table.

Table 1. 5-year survivals

R-CHOPCHOPP value
Median event-free survival 3.8 y 1.1 y =0.00002 
5-year event-free survival 47% 29%  
Median progression-free survival Not reached 1 y <0.00001 
5-year progression-free survival 54% 30%  
Median overall survival Not reached 3.1 y =0.0073 
5-year overall survival 58% 45%  
R-CHOPCHOPP value
Median event-free survival 3.8 y 1.1 y =0.00002 
5-year event-free survival 47% 29%  
Median progression-free survival Not reached 1 y <0.00001 
5-year progression-free survival 54% 30%  
Median overall survival Not reached 3.1 y =0.0073 
5-year overall survival 58% 45%  

Progression-free survival is shown in the figure; PFS does not included 19 patients who died in CR from causes not related to lymphoma or its treatment, 5 in CHOP arm and 14 in R-CHOP arm. It better reflects the long term effect of treatment on the disease. No severe late toxicity was observed in R-CHOP treated patients and deaths not related to lymphoma did not show any pattern.

In conclusion, long term results continue to show a major benefit for the addition of rituximab to CHOP in the treatment of patients with DLBCL. This improvement increases with time.

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