Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma
Language English Country United States Media print-electronic
Document type Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
Grant support
P30 CA008748
NCI NIH HHS - United States
PubMed
34904799
PubMed Central
PMC11702892
DOI
10.1056/nejmoa2115304
Knihovny.cz E-resources
- MeSH
- Cyclophosphamide adverse effects therapeutic use MeSH
- Lymphoma, Large B-Cell, Diffuse drug therapy mortality MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Doxorubicin adverse effects therapeutic use MeSH
- Double-Blind Method MeSH
- Immunoconjugates administration & dosage adverse effects MeSH
- Middle Aged MeSH
- Humans MeSH
- Antibodies, Monoclonal administration & dosage adverse effects MeSH
- Prednisone adverse effects therapeutic use MeSH
- Antineoplastic Combined Chemotherapy Protocols adverse effects therapeutic use MeSH
- Rituximab adverse effects therapeutic use MeSH
- Aged MeSH
- Vincristine adverse effects therapeutic use MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Male MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Names of Substances
- Cyclophosphamide MeSH
- Doxorubicin MeSH
- Immunoconjugates MeSH
- Antibodies, Monoclonal MeSH
- polatuzumab vedotin MeSH Browser
- Prednisone MeSH
- R-CHOP protocol MeSH Browser
- Rituximab MeSH
- Vincristine MeSH
BACKGROUND: Diffuse large B-cell lymphoma (DLBCL) is typically treated with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP). However, only 60% of patients are cured with R-CHOP. Polatuzumab vedotin is an antibody-drug conjugate targeting CD79b, which is ubiquitously expressed on the surface of malignant B cells. METHODS: We conducted a double-blind, placebo-controlled, international phase 3 trial to evaluate a modified regimen of R-CHOP (pola-R-CHP), in which vincristine was replaced with polatuzumab vedotin, as compared with standard R-CHOP, in patients with previously untreated intermediate-risk or high-risk DLBCL. Patients 18 to 80 years of age were randomly assigned in a 1:1 ratio to receive six cycles of either pola-R-CHP or R-CHOP, plus two cycles of rituximab alone. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival and safety. RESULTS: Overall, 879 patients underwent randomization: 440 were assigned to the pola-R-CHP group and 439 to the R-CHOP group. After a median follow-up of 28.2 months, the percentage of patients surviving without progression was significantly higher in the pola-R-CHP group than in the R-CHOP group (76.7% [95% confidence interval (CI), 72.7 to 80.8] vs. 70.2% [95% CI, 65.8 to 74.6] at 2 years; stratified hazard ratio for progression, relapse, or death, 0.73 by Cox regression; 95% CI, 0.57 to 0.95; P = 0.02). Overall survival at 2 years did not differ significantly between the groups (88.7% [95% CI, 85.7 to 91.6] in the pola-R-CHP group and 88.6% [95% CI, 85.6 to 91.6] in the R-CHOP group; hazard ratio for death, 0.94; 95% CI, 0.65 to 1.37; P = 0.75). The safety profile was similar in the two groups. CONCLUSIONS: Among patients with previously untreated intermediate-risk or high-risk DLBCL, the risk of disease progression, relapse, or death was lower among those who received pola-R-CHP than among those who received R-CHOP. (Funded by F. Hoffmann-La Roche/Genentech; POLARIX ClinicalTrials.gov number, NCT03274492.).
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Diffuse Large B-Cell Lymphoma (DLBCL): Early Patient Management and Emerging Treatment Options
Targeted Drug Delivery and Theranostic Strategies in Malignant Lymphomas
ClinicalTrials.gov
NCT03274492