In a long-term follow-up analysis, patients with newly diagnosed, aggressive B-cell lymphoma who received rituximab with 4 cycles of high-dose chemotherapy and autologous hematopoietic stem cell transplantation (R-MegaCHOEP) did not show improved outcomes over those who received rituximab with 8 cycles of conventional chemotherapy (R-CHOEP-14). Results of the analysis were recently reported in Lancet Haematology.
“To our knowledge, this is the first 10-year follow-up report on younger patients with aggressive B-cell lymphoma treated within a phase 3 trial,” the study investigators wrote in their report.
In this multicenter, phase 3 clinical trial conducted in Germany (ClinicalTrials.gov Identifier: NCT00129090), patients who were 60 years of age or younger were stratified by age-adjusted International Prognostic Index scores, bulky disease, and treatment center, then randomly assigned to receive either R-MegaCHOEP or R-CHOEP-14.
Chemotherapy included cyclophosphamide, doxorubicin, vincristine, etoposide, and prednisolone in both treatment arms, but at escalated doses for R-MegaCHOEP, and patients received hematopoietic stem cell transplantation after completing chemotherapy in this arm. Crossover was allowed to the R-CHOEP-14 arm. Event-free survival in the intention-to-treat population was the primary study endpoint.
The intention-to-treat population included 132 patients in the R-MegaCHOEP arm and 130 patients in the R-CHOEP-14 arm. With a median follow-up of 9.3 years (interquartile range, 5.1-11.1), the 10-year event-free survival rate was 51% (95% CI, 42%-61%) with R-MegaCHOEP, and it was 57% (95% CI, 47%-67%) with R-CHOEP-14 (adjusted hazard ratio [HR], 1.3 [95% CI, 0.9-1.8]; P =.23).
Other long-term efficacy results were also similar between groups. The 10-year progression-free survival rate was 59% with R-MegaCHOEP, and it was 60% with R-CHOEP-14 (adjusted HR, 1.1 [95% CI, 0.7-1.7]; P =.64). Ten-year overall survival rates were 66% with R-MegaCHOEP and 72% with R-CHOEP-14 (adjusted HR, 1.3 [95% CI, 0.8-2.1]; P =.26). Analyses including only patients treated per protocol showed similar results for these comparisons.
R-MegaCHOEP also did not appear to confer an overall survival advantage when patients were evaluated according to molecular subgroup. However, the researchers did identify 1-year progression-free survival to be a predictor of long-term overall survival.
The study investigators concluded that R-MegaCHOEP as first-line therapy did not improve survival in the long term for younger patients with high-risk, aggressive B-cell lymphoma. They also determined that the study results supported continued use of R-CHOEP-14 for this patient population.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Frontzek F, Ziepert M, Nichelsen M, et al. Rituximab plus high-dose chemotherapy (MegaCHOEP) or conventional chemotherapy (CHOEP-14) in young, high-risk patients with aggressive B-cell lymphoma: 10-year follow-up of a randomised, open-label, phase 3 trial. Lancet Haematol. Published online March 2, 2021. doi:10.1016/S2352-3026(21)00022-3