Intensified chemotherapy with ACVBP plus rituximab versus standard CHOP plus rituximab for the treatment of diffuse large B-cell lymphoma (LNH03-2B): An open-label randomized phase 3 trial
The Lancet, 11/28/2011
Clinical Article
Récher C et al. – Compared with standard R-CHOP, intensified immunochemotherapy with R-ACVBP significantly improves survival of patients aged 18—59 years with diffuse large B-cell lymphoma with low-intermediate risk according to the International Prognostic Index. Hematological toxic effects of the intensive regimen were raised but manageable.
Methods- Open-label randomized trial comparing dose-intensive rituximab, doxorubicin, cyclophosphamide, vindesine, bleomycin, and prednisone (R-ACVBP) with subsequent consolidation versus standard rituximab, doxorubicin, cyclophosphamide, vincristine, and prednisone (R-CHOP)
- Random assignment was done with a computer-assisted randomization-allocation sequence with a block size of 4
- Patients were aged 18—59 years with untreated diffuse large B-cell lymphoma and an age-adjusted international prognostic index equal to 1
- Primary endpoint was event-free survival
- Analyses of efficacy and safety were of the intention-to-treat population
- One patient withdrew consent before treatment and 54 did not complete treatment
- After median follow-up of 44 months, 3-year estimate of event-free survival was 81% (95% CI 75—86) in the R-ACVBP group and 67% (59—73) in the R-CHOP group (HR 0·56, 95% CI 0·38—0·83; p=0·0035)
- 3-year estimates of PFS (87% [95% CI, 81—91] vs 73% [66—79]; HR 0·48 [0·30—0·76]; p=0·0015) and overall survival (92% [87—95] vs 84% [77—89]; HR 0·44 [0·28—0·81]; p=0·0071) were also increased in the R-ACVBP group
- 82 (42%) of 196 patients in R-ACVBP group experienced a serious AE compared with 28 (15%) of 183 in R-CHOP group
- Grade 3-4 haematological toxic effects were more common in the R-ACVBP group, with a higher proportion of patients experiencing a febrile neutropenic episode (38% [75 of 196] vs 9% [16 of 183])
