Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study
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 diff...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-05-01
|
| Series: | Blood Advances |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2473952925001697 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850133514786177024 |
|---|---|
| author | Bei Hu Patrick M. Reagan Laurie H. Sehn Jeff P. Sharman Mark Hertzberg Huilai Zhang Austin Kim Charles Herbaux Lysiane Molina Dai Maruyama Frank Stenner Saibah Chohan Rucha Kothari Connie Lee Batlevi Jamie Hirata Deniz Sahin Calvin Lee Matthew Sugidono Hervé Tilly |
| author_facet | Bei Hu Patrick M. Reagan Laurie H. Sehn Jeff P. Sharman Mark Hertzberg Huilai Zhang Austin Kim Charles Herbaux Lysiane Molina Dai Maruyama Frank Stenner Saibah Chohan Rucha Kothari Connie Lee Batlevi Jamie Hirata Deniz Sahin Calvin Lee Matthew Sugidono Hervé Tilly |
| author_sort | Bei Hu |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-7d981cfce8c047c6a8ce9fd837dadb3e |
| institution | OA Journals |
| issn | 2473-9529 |
| language | English |
| publishDate | 2025-05-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Blood Advances |
| spelling | doaj-art-7d981cfce8c047c6a8ce9fd837dadb3e2025-08-20T02:31:56ZengElsevierBlood Advances2473-95292025-05-019102489249910.1182/bloodadvances.2024014707Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX studyBei Hu0Patrick M. Reagan1Laurie H. Sehn2Jeff P. Sharman3Mark Hertzberg4Huilai Zhang5Austin Kim6Charles Herbaux7Lysiane Molina8Dai Maruyama9Frank Stenner10Saibah Chohan11Rucha Kothari12Connie Lee Batlevi13Jamie Hirata14Deniz Sahin15Calvin Lee16Matthew Sugidono17Hervé Tilly18Department of Hematologic Oncology, Atrium Health Levine Cancer Institute, Wake Forest School of Medicine, Charlotte, NC; Correspondence: Bei Hu, Malignant Hematology, Atrium Health Levine Cancer Institute, Building 2, 1021 Morehead Medical Dr, Charlotte, NC 28204;Department of Medicine, Hematology/Oncology, Wilmot Cancer Institute, University of Rochester, Rochester, NYDivision of Medical Oncology, BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, BC, CanadaDivision of Hematology, Willamette Valley Cancer Institute and Research Center, Florence, ORDepartment of Hematology, Prince of Wales Hospital, Sydney, NSW, AustraliaDepartment of Lymphoma, Tianjin Medical University Cancer Hospital, Tianjin, ChinaDivision of Hematologic Malignancies, Dana-Farber Cancer Institute, Boston, MADepartment of Clinical Hematology, Centre Hospitalier Universitaire Montpellier, Montpellier, FranceDepartment of Hematology, Hématologie Clinique, Centre Hospitalier Universitaire de Grenoble, La Tronche, FranceDepartment of Hematology/Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo, JapanDepartment of Oncology, University Hospital of Basel, Basel, SwitzerlandHoffmann-La Roche Ltd, Mississauga, ON, CanadaGenentech, Inc., South San Francisco, CAGenentech, Inc., South San Francisco, CAGenentech, Inc., South San Francisco, CAF. Hoffmann-La Roche Ltd, Basel, SwitzerlandGenentech, Inc., South San Francisco, CAGenentech, Inc., South San Francisco, CADepartment of Hematology, Centre Henri-Becquerel and University of Rouen, Rouen, FranceAbstract: 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.http://www.sciencedirect.com/science/article/pii/S2473952925001697 |
| spellingShingle | Bei Hu Patrick M. Reagan Laurie H. Sehn Jeff P. Sharman Mark Hertzberg Huilai Zhang Austin Kim Charles Herbaux Lysiane Molina Dai Maruyama Frank Stenner Saibah Chohan Rucha Kothari Connie Lee Batlevi Jamie Hirata Deniz Sahin Calvin Lee Matthew Sugidono Hervé Tilly Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study Blood Advances |
| title | Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study |
| title_full | Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study |
| title_fullStr | Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study |
| title_full_unstemmed | Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study |
| title_short | Subgroup analysis of older patients ≥60 years with diffuse large B-cell lymphoma in the phase 3 POLARIX study |
| title_sort | subgroup analysis of older patients ≥60 years with diffuse large b cell lymphoma in the phase 3 polarix study |
| url | http://www.sciencedirect.com/science/article/pii/S2473952925001697 |
| work_keys_str_mv | AT beihu subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT patrickmreagan subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT lauriehsehn subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT jeffpsharman subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT markhertzberg subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT huilaizhang subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT austinkim subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT charlesherbaux subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT lysianemolina subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT daimaruyama subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT frankstenner subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT saibahchohan subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT ruchakothari subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT connieleebatlevi subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT jamiehirata subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT denizsahin subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT calvinlee subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT matthewsugidono subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy AT hervetilly subgroupanalysisofolderpatients60yearswithdiffuselargebcelllymphomainthephase3polarixstudy |