Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002-1)

摘要: Summary Background High-dose therapy (HDT) followed by transplantation of autologous haemopoietic stem cells is frequently done as part first-line in young patients with high-risk aggressive B-cell lymphoma. We investigated whether HDT cytotoxic agents identical to those used for conventional stem-cell (ASCT) improved survival outcome compared chemotherapy when rituximab was added both modalities. Methods did an open-label, randomised trial comparing (cyclophosphamide, doxorubicin, vincristine, etoposide, prednisone) and (R-CHOEP-14) dose-escalated sequential (R-MegaCHOEP) repetitive ASCT (age-adjusted International Prognostic Index [IPI] 2 or 3) aged 18–60 years Eligible received radiotherapy bulky, extranodal disease, both. Randomisation (1:1) the Pocock minimisation algorithm; were stratified age-adjusted IPI factors, bulky centre. The primary endpoint event-free survival. All analyses on intention-to-treat population. This registered ClinicalTrials.gov, number NCT00129090. Findings 136 randomly assigned R-CHOEP-14 139 R-MegaCHOEP. 130 group 132 R-MegaCHOEP included After a median 42 months (IQR 29–59), 3-year 69·5% (95% CI 61·3–77·7) 61·4% (52·8–70·0) (p=0·14; hazard ratio 1·3, 95% 0·9–2·0). 128 evaluable treated had grade 4 leucopenia, 48 (58·5%) 82 documented blood counts group. 3–4 thrombocytopenia, 26 (33·8%) 77 counts. most important non-haematological 3 adverse event infection, which occurred 96 (75·0%) 40 (31·3%) R-CHOEP-14. Interpretation In lymphoma, not superior R-CHOEP associated significantly more toxic effects. without remains treatment option these patients, encouraging efficacy. Funding Deutsche Krebshilfe.