First-line treatment with rituximab plus high-dose sequencing chemotherapy (R-HDS) and autologous hematopoietic cell transplantation (AHCT) did not significantly improve survival outcomes for patients with high-risk diffuse large B-cell lymphoma (DLBCL) compared with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) chemoimmunotherapy.
Sergio Cortelazzo, MD, from the Ospedale Centrale di Bolzano in Italy, and authors reported the results of this phase III study published in the Journal of Clinical Oncology.
The researchers enrolled 246 patients with high-risk DLBCL (according to International Prognostic Index scores) between June 2005 and June 2011: 56 percent of patients were “high-intermediate” risk and 44 percent were “high” risk.
After a median follow-up of five years, the three-year event-free survival (primary endpoint) was not significantly different between those receiving R-CHOP and those receiving R-HDS: 62 percent versus 65 percent (p=0.83). Progression-free survival (65% vs. 75%; p=0.12) and overall survival (74% vs. 77%; p=0.64) were not significantly different either.
Seventy-eight percent of patients in the R-CHOP cohort experienced complete response (CR), including 5 percent with partial response (PR). The rates of CR and PR were similar in the R-HDS cohort: 76 percent and 9 percent, respectively.
After three years, disease-free survival was better for those treated with R-HDS (91%) compared with R-CHOP (79%; p=0.034); however, this “subsequently vanished because of late-occurring treatment-related deaths,” the authors wrote.
R-HDS also was associated with significantly higher hematologic toxicity (p<0.001) and a greater incidence of infectious complications (p<0.001).
Source: 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 October 3. [Epub ahead of print]