Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study
Bei Hu, Patrick M. Reagan, Laurie H. Sehn, Jeff P. Sharman, Mark Hertzberg, Huilai Zhang, Austin I. Kim, Charles Herbaux, Lysiane Molina, Dai Maruyama, Frank Stenner, Saibah Chohan, Rucha Kothari, Connie Lee Batlevi, Jamie Hirata, Deniz Şahin, Calvin Lee, Matthew Sugidono, H. Tilly
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.