A study published in the Journal of Clinical Oncology found that early rituximab intensification during treatment with R-CHOP-14 (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone every 14 days) does not improve outcomes in patients with untreated diffuse large B-cell lymphoma (DLBCL).
The randomized study assessed whether rituximab intensification during the first four cycles of R-CHOP-14 would improve outcomes compared with standard R-CHOP administration. The study included 574 patients with DLBCL aged 18 to 80 years who were randomized to receive induction therapy with six or eight cycles of R-CHOP-14 with (n=288) or without (n=286) rituximab intensification in the first four cycles.
Complete remission (primary endpoint) was achieved in 89% (n=254) of patients who received standard R-CHOP and in 86% (n=249) of patients who received rituximab intensification (hazard ratio [HR], 0.82; 95% confidence interval [CI], 0.50-1.36; P=0.44).
After a median follow-up of 92 months (range, 1-131 months), three-year failure-free survival was 74% (95% CI, 68-78) in the standard R-CHOP-14 arm versus 69% (95% CI, 63-74) in the rituximab intensification group (HR, 1.26; 95% CI, 0.98-1.61; P=0.07). Three-year progression-free survival was 74% (95% CI, 69-79) and 71% (95% CI, 66-76), respectively (HR, 1.20; 95% CI, 0.94-1.55; P=0.15), and three-year overall survival was 81% (95% CI, 76-85) and 76% (95% CI, 70-80), respectively (HR, 1.27; 95% CI, 0.97-1.67; P=0.09).
Patients aged 66 to 80 years experienced significantly more toxicities during the first four cycles in the rituximab intensification cohort, especially related to neutropenia and infections.