Michael E. Williams, MD, ScM reviewing Cortelazzo S et al. J Clin Oncol 2016 Nov.

High-dose sequential therapy plus autologous transplantation did not improve outcomes when compared with standard immunochemotherapy.

Although survival of patients with diffuse large B-cell lymphoma (DLBCL) has improved in the rituximab (R) era, those with high-risk or high-intermediate–risk International Prognostic Index scores (IPI 2–3) have poorer outcomes with standard R-chemotherapy than those with lower-risk IPI scores.

To test the benefit of high-dose therapy followed by autologous stem cell transplant (ASCT) consolidation in this setting, investigators in Italy conducted a multicenter, randomized, phase III trial comparing R plus high-dose sequential chemotherapy (R-HDS) and ASCT versus eight cycles of R-CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone)-14 in 235 high-risk and high-intermediate–risk DLBCL patients (median age, 51 years).

At median follow-up of 5 years, no significant differences were observed between R-CHOP-14 and R-HDS in 3-year event-free survival (the primary outcome; 62% vs. 65%), complete response (78% vs. 76%), primary refractory disease (15% vs. 11%), central nervous system progression (5.7% vs. 4.4%), death within 100 days of treatment initiation (1.6% vs. 2.6%), or overall survival (OS; 74% vs. 77%). Toxicity was significantly higher with R-HDS including grade 3–4 neutropenia and severe infections. No benefit for R-HDS was observed for patients in the highest-risk IPI subset or for those with germinal center versus nongerminal center cell of origin.

CITATION(S):

Cortelazzo S 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 Nov; 34:4015. 

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