Phase III study of ACVBP versus ACVBP plus rituximab for patients with localized low-risk diffuse large B-cell lymphoma (LNH03-1B).

Background The superiority of a chemotherapy with doxorubicin, cyclophosphamide, vindesine, bleomycin and prednisone (ACVBP) in comparaison with cyclophosphamide, doxorubicin, vincristin and prednisone plus radiotherapy for Young patients with localized diffuse large B-cell lymphoma (DLBCL) was previously demonstrated. We report the results of a trial which évaluâtes the role of rituximab combined with ACVBP (R- ACVBP) in these patients. Patients and methods untreated patients younger than 66 years with stage I or II DLBCL and no adverse prognostic factors of the age-adjusted International Prognostic Index were randomly assigned to receive three cycles of ACVBP plus sequential consolidation with or without the addition of four infusions of rituximab. Results a total of 223 patients were randomly allocated to the study, 110 in the R-ACVBP group and 113 in the ACVBP group. After a median follow-up of 43 months, our 3-year estimate of event-free survival was 93% in the R-ACVBP group and 82% in the ACVBP group (P=0.0487). Three-year estimate of progression-free survival was increased in the R-ACVBP group (95% versus 83%, P=0.0205). Overall survival did not differ between the two groups with a 3-year estimâtes of 98% and 97%, respectively (P=0.686). Conclusion in Young patients with low-risk localized DLBCL, rituximab combined with three cycles of ACVBP plus consolidation is significantly Superior to ACVBP plus consolidation alone.