1. Phase III study of ACVBP versus ACVBP plus rituximab for patients with localized low-risk diffuse large B-cell lymphoma (LNH03-1B).
- Author
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Ketterer, N., Coiffier, B., Thieblemont, C., Fermé, C., Brière, J., Casasnovas, O., Bologna, S., Christian, B., Connerotte, T., Récher, C., Bordessoule, D., Fruchart, C., Delarue, R., Bonnet, C., Morschhauser, F., Anglaret, B., Soussain, C., Fabiani, B., Tilly, H., and Haioun, C.
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DOXORUBICIN , *CYCLOPHOSPHAMIDE , *VINDESINE , *B cell lymphoma , *PREDNISONE , *RITUXIMAB , *CANCER chemotherapy , *TUMOR treatment - Abstract
Background The superiority of a chemotherapy with doxorubicin, cyclophosphamide, vindesine, bleomycin and prednisone (ACVBP) in comparison 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 evaluates 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 estimates 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. [ABSTRACT FROM PUBLISHER]
- Published
- 2013
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