BACKGROUND: The MInT study was the first to show improved 3-year outcomes with the addition of rituximab to a CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-like regimen in young patients with good-prognosis diffuse large-B-cell lymphoma. Extended follow-up was needed to establish long-term effects. METHODS: In the randomised open-label MInT study, patients from 18 countries (aged 18-60 years with none or one risk factor according to the age-adjusted International Prognostic Index [IPI], stage II-IV disease or stage I disease with bulk) were randomly assigned to receive six cycles of a CHOP-like chemotherapy with or without rituximab. Bulky and extranodal sites received additional radiotherapy. Randomisation was done centrally with a computer-based tool and was stratified by centre, bulky disease, age-adjusted IPI, and chemotherapy regimen by use of a modified minimisation algorithm that incorporated a stochastic component. Patients and investigators were not masked to treatment allocation. The primary endpoint was event-free survival. Analyses were by intention to treat. This observational study is a follow-up of the MInT trial, which was stopped in 2003, and is registered at ClinicalTrials.gov, number NCT00400907. FINDINGS: The intention-to-treat population included 410 patients assigned to chemotherapy alone and 413 assigned to chemotherapy plus rituximab. After a median follow-up of 72 months (range 0.03-119), 6-year event-free survival was 55.8% (95% CI 50.4-60.9; 166 events) for patients assigned to chemotherapy alone and 74.3% (69.3-78.6; 98 events) for those assigned to chemotherapy plus rituximab (difference between groups 18.5%, 11.5-25.4, log-rank p<0.0001).>s exact p=0.730). INTERPRETATION: Rituximab added to six cycles of CHOP-like chemotherapy improved long-term outcomes for young patients with good-prognosis diffuse large-B-cell lymphoma. The definition of two prognostic subgroups allows a more refined therapeutic approach to these patients than does assessment by IPI alone. FUNDING: Hoffmann-La Roche.
PubMed ID: 21940214
Projects: German Lymphoma Alliance (GLA)
Journal: Lancet Oncol
Authors: M. Pfreundschuh, E. Kuhnt, L. Trumper, A. Osterborg, M. Trneny, L. Shepherd, D. S. Gill, J. Walewski, R. Pettengell, U. Jaeger, P. L. Zinzani, O. Shpilberg, S. Kvaloy, P. de Nully Brown, R. Stahel, N. Milpied, A. Lopez-Guillermo, V. Poeschel, S. Grass, Markus Löffler, N. Murawski
Created: 9th May 2019 at 14:48
Last updated: 9th May 2019 at 14:50