Elly Lugtenburg, MD, Ph.D. from the Erasmus MC Cancer Institute discusses Rituximab-CHOP With Early Rituximab Intensification for Diffuse Large B-Cell Lymphoma: A Randomized Phase III Trial of the HOVON and the Nordic Lymphoma Group (HOVON-84).
Intent "
For patients with diffuse large B cell lymphoma (DLBCL), immunochemotherapy with rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) has become the standard of treatment. This randomized trial tested whether the intensification of rituximab during the first 4 cycles of R-CHOP relative to regular R-CHOP could improve the outcome of these patients.
METHODS AND PATIENTS
A total of 574 DLBCL patients aged 18 to 80 years were randomly assigned to induction therapy with 6 or 8 R-CHOP-14 cycles, with or without (R-CHOP-14) rituximab intensification in the first 4 cycles. Total remission (CR) on induction was the principal endpoint. Analyses were done with the aim of treatment.
OUTCOMES
In 254 (89%) of 286 patients in the R-CHOP-14 arm and 249 (86%) of 288 patients in the RR-CHOP-14 arm, CR was achieved (hazard ratio [HR], 0.82; 95 % CI, 0.50 to 1.36; P = .44). 3-year failure-free survival was 74 percent (95 percent CI, 68 percent to 78 percent) in the R-CHOP-14 arm following a median follow-up of 92 months (range, 1-131 months), versus 69 percent (95 percent CI, 63 percent to 74 percent) in the RR-CHOP-14 arm (HR, 1.26; 95 percent CI, 0.98 to 1.61; P = .07). At 3 years, progression-free survival was 74% (95 % CI, 69% to 79%) in the R-CHOP-14 arm versus 71% (95 % CI, 66% to 76%) in the RR-CHOP-14 arm (HR, 1.20; 95 % CI, 0.94 to 1.55; P = .15). In the R-CHOP-14 arm, overall survival at 3 years was 81% (95 % CI, 76% to 85%) versus 76% (95 % CI, 70 % to 80%) in the RR-CHOP-14 arm (HR, 1.27; 95 % CI, 0.97 to 1.67; P = .09). In the first 4 cycles of the RR-CHOP-14 arm, patients between the ages of 66 and 80 years experienced significantly more toxicity, particularly neutropenia and infection.
Conclude
In patients with untreated DLBCL, early rituximab intensification during R-CHOP-14 does not improve outcomes.