TOPLINE:
Polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) reduces the risk for disease progression, relapse, or death by 37% vs standard therapy in patients ≥ 70 years with diffuse large B-cell lymphoma (DLBCL). Safety profiles were comparable between treatments with similar rates of grade 3-4 adverse events.
METHODOLOGY:
- Researchers conducted a randomized, double-blind phase 3 POLARIX study evaluating Pola-R-CHP vs rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with previously untreated CD20-positive DLBCL.
- A total of 629 patients aged ≥ 60 years (Pola-R-CHP, n = 311; R-CHOP, n = 318) were included in the analysis, with a median follow-up of 40 months as of June 15, 2022.
- Treatment consisted of six 21-day cycles of rituximab 375 mg/m², cyclophosphamide 750 mg/m², and doxorubicin 50 mg/m² on Day 1, and oral prednisone 100 mg daily on Days 1-5, plus either polatuzumab vedotin 1.8 mg/kg or vincristine 1.4 mg/m² (maximum 2 mg).
- Primary prophylaxis with granulocyte colony–stimulating factor was required for all patients during the six treatment cycles.
TAKEAWAY:
- Progression-free survival showed meaningful improvements with Pola-R-CHP vs R-CHOP across all age groups, with patients ≥ 70 years demonstrating a 37% reduction in risk for disease progression, relapse, or death (hazard ratio, 0.63; 95% CI, 0.41-0.96).
- Overall survival at 2 years was comparable between treatment arms, with rates of 88.6% (95% CI, 85.0-91.1) for Pola-R-CHP vs 87.4% (95% CI, 83.7-91.1) for R-CHOP in patients ≥ 60 years.
- Complete response rates were numerically higher with Pola-R-CHP than R-CHOP across all age groups, reaching 80.7% vs 76.1% in patients ≥ 60 years.
- Safety analysis revealed similar rates of grade 3-4 adverse events between arms (62.7% vs 61.5%), though febrile neutropenia was more frequent with Pola-R-CHP (16.3% vs 7.6%).
IN PRACTICE:
“The benefit-risk profile favored Pola-R-CHP vs R-CHOP in elderly patients with previously untreated DLBCL. Results were consistent with those of the overall POLARIX population and suggest that elderly populations can benefit from treatment with Pola-R-CHP with manageable toxicities,” the authors of the study wrote.
SOURCE:
This study was led by Bei Hu, MD, Atrium Health Levine Cancer Institute in Charlotte, North Carolina. It was published online in March in Blood Advances.
LIMITATIONS:
According to the authors, potential limitations of the study included the arbitrary age classifications used in the analysis and the lack of quantified clinical factors such as frailty and comorbidities. The analysis was not powered to demonstrate statistical significance in terms of efficacy; thus, no formal hypothesis testing was performed.
DISCLOSURES:
The POLARIX study was sponsored by F. Hoffmann-La Roche Ltd. and Genentech, Inc. Bei Hu, MD, disclosed relationships with ADC Therapeutics, BeiGene, F. Hoffmann-La Roche Ltd./Genentech, Inc., Janssen, and Juno/Bristol Myers Squibb. Additional disclosures are noted in the original article.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.
