Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study

Abstract

Abstract: In the phase 3 POLARIX study, Pola-R-CHP (polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone) improved progression-free survival (PFS) vs R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) in patients with previously untreated diffuse large B-cell lymphoma (DLBCL). This post hoc subgroup analysis of POLARIX evaluated the efficacy and safety of Pola-R-CHP vs R-CHOP in older patients aged ≥60, ≥65, ≥70, and ≥75 years. As of 15 June 2022 (median follow-up, 40 months), 629 patients aged ≥60 years were included (Pola-R-CHP, n = 311; R-CHOP, n = 318). Clinically meaningful improvements in PFS with Pola-R-CHP vs R-CHOP were observed across all age groups, particularly in patients aged ≥70 years whereby the risk of disease progression, relapse, or death was reduced by 37% (unstratified hazard ratio [HR], 0.63; 95% confidence interval [CI], 0.41-0.96). In patients aged ≥60 years, overall survival was similar with Pola-R-CHP vs R-CHOP (unstratified HR, 0. 99; 95% CI, 0.67-1.47). Safety profiles were similar for Pola-R-CHP vs R-CHOP among patients aged ≥60 years, including rates of grade 3 to 4 adverse events (AEs; 62.7% vs 61.5%), grade 3 to 5 infections (15.0% vs 12.9%), and grade 5 AEs (3.6% vs 3.2%); no novel toxicities were reported. Incidence of grade 3 to 4 febrile neutropenia was higher with Pola-R-CHP than R-CHOP (16.3% vs 7.6%), highlighting the importance of granulocyte colony-stimulating factor prophylaxis in older patients receiving Pola-R-CHP. The benefit-risk profile favored Pola-R-CHP vs R-CHOP in older patients with previously untreated DLBCL. This trial was registered at www.ClinicalTrials.gov as #NCT03274492.