Frontline treatment with rituximab plus high-dose sequential chemotherapy with autologous hematopoietic stem cell transplantation (HSCT) failed to improve progression-free or overall survival compared with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemoimmunotherapy in patients with diffuse large B-cell lymphoma (DLBCL), a study published in the Journal of Clinical Oncology has shown.1
Because the benefit of high-dose chemotherapy with autologous HSCT as first-line therapy in patients with DLBCL remains controversial, researchers sought to compare the efficacy and safety of R-CHOP with rituximab plus high-dose sequential chemotherapy and autologous HSCT.
For the phase 3 study (ClinicalTrials.gov Identifier: NCT00355199), investigators enrolled 246 high-risk patients with a high-intermediate or high International Prognostic Index score. Participants were randomly assigned to receive R-CHOP or rituximab with high-dose sequential chemotherapy.
Results showed that clinical response rates were similar between treatment arms, with 78% of patients treated with R-CHOP achieving a complete response vs 76% of those given high-dose sequential chemotherapy and rituximab.
At a median follow-up of 5 years, investigators found that 3-year event-free survival was 62% and 65% with R-CHOP and sequential chemotherapy with rituximab, respectively (P =.83).
There were also no significant differences in progression-free survival (P =.12) or overall survival (P =.64) between the 2 treatment arms.
However, rituximab plus high-dose sequential chemotherapy was associated with significantly higher hematologic toxicity (P <.001) and a greater incidence of infectious complications (P <.001) than the R-CHOP arm.
1. Cortelazzo S, Tarella C, Gianni AM, et al. Randomized trial comparing R-CHOP versus high-dose sequential chemotherapy in high-risk patients with diffuse large b-cell lymphomas. J Clin Oncol. 2016 Oct 3. doi: 10.1200/JCO.2016.67.2980. [Epub ahead of print]