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Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial

In this post hoc subgroup analysis of 200 patients enrolled in China from the phase III PHOENIX trial (N = 838, NCT01855750), addition of ibrutinib to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R‐CHOP) did not improve event‐free survival (EFS) versus placebo+R‐CHOP in...

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Autores principales: Zhu, Jun, Hong, Xiaonan, Song, Yu Qin, Hodkinson, Brendan, Balasubramanian, Sriram, Wang, Songbai, Zhang, Qingyuan, Shi, Yuankai, Huang, Huiqiang, Zhang, Huilai, Zhu, Yan, Shreeve, Stephen Martin, Sun, Steven, Wang, Ze, Wang, Xiaocan, Fan, Yue, Wilson, Wyndham, Vermeulen, Jessica
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9713042/
https://www.ncbi.nlm.nih.gov/pubmed/36467814
http://dx.doi.org/10.1002/jha2.517
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author Zhu, Jun
Hong, Xiaonan
Song, Yu Qin
Hodkinson, Brendan
Balasubramanian, Sriram
Wang, Songbai
Zhang, Qingyuan
Shi, Yuankai
Huang, Huiqiang
Zhang, Huilai
Zhu, Yan
Shreeve, Stephen Martin
Sun, Steven
Wang, Ze
Wang, Xiaocan
Fan, Yue
Wilson, Wyndham
Vermeulen, Jessica
author_facet Zhu, Jun
Hong, Xiaonan
Song, Yu Qin
Hodkinson, Brendan
Balasubramanian, Sriram
Wang, Songbai
Zhang, Qingyuan
Shi, Yuankai
Huang, Huiqiang
Zhang, Huilai
Zhu, Yan
Shreeve, Stephen Martin
Sun, Steven
Wang, Ze
Wang, Xiaocan
Fan, Yue
Wilson, Wyndham
Vermeulen, Jessica
author_sort Zhu, Jun
collection PubMed
description In this post hoc subgroup analysis of 200 patients enrolled in China from the phase III PHOENIX trial (N = 838, NCT01855750), addition of ibrutinib to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R‐CHOP) did not improve event‐free survival (EFS) versus placebo+R‐CHOP in the intent‐to‐treat (ITT; n = 200, hazard ratio [HR] = 0.83, 95% confidence interval [CI]: 0·509–1.349; p = 0.4495) or activated B‐cell‐like (ABC; n = 141 [based on available gene‐expression profiling data], HR = 0.86, 95% CI: 0.467–1.570; p = 0.6160) subpopulations. However, ibrutinib+R‐CHOP improved EFS (HR = 0·50, 95% CI: 0.251–1.003) and progression‐free survival (PFS; HR = 0.48, 95% CI: 0.228–1.009) versus placebo+R‐CHOP in patients aged <60 but not ≥60 years. Grade ≥3 serious treatment‐emergent adverse events occurred more with ibrutinib+R‐CHOP (45·6% vs. 31·3%). The percentage of patients receiving ≥6 cycles of R‐CHOP was similar across treatment arms in those <60 years. A numerical trend was seen towards improved EFS and PFS with ibrutinib+R‐CHOP versus placebo+R‐CHOP in patients with MYC‐high/BCL2‐high co‐expression. In this slightly younger Chinese subgroup, ibrutinib+R‐CHOP did not improve EFS in the ITT and ABC subpopulations but improved outcomes with manageable safety in patients <60 years, consistent with overall PHOENIX study outcomes.
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spelling pubmed-97130422022-12-02 Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial Zhu, Jun Hong, Xiaonan Song, Yu Qin Hodkinson, Brendan Balasubramanian, Sriram Wang, Songbai Zhang, Qingyuan Shi, Yuankai Huang, Huiqiang Zhang, Huilai Zhu, Yan Shreeve, Stephen Martin Sun, Steven Wang, Ze Wang, Xiaocan Fan, Yue Wilson, Wyndham Vermeulen, Jessica EJHaem Haematologic Malignancy ‐ Lymphoid In this post hoc subgroup analysis of 200 patients enrolled in China from the phase III PHOENIX trial (N = 838, NCT01855750), addition of ibrutinib to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R‐CHOP) did not improve event‐free survival (EFS) versus placebo+R‐CHOP in the intent‐to‐treat (ITT; n = 200, hazard ratio [HR] = 0.83, 95% confidence interval [CI]: 0·509–1.349; p = 0.4495) or activated B‐cell‐like (ABC; n = 141 [based on available gene‐expression profiling data], HR = 0.86, 95% CI: 0.467–1.570; p = 0.6160) subpopulations. However, ibrutinib+R‐CHOP improved EFS (HR = 0·50, 95% CI: 0.251–1.003) and progression‐free survival (PFS; HR = 0.48, 95% CI: 0.228–1.009) versus placebo+R‐CHOP in patients aged <60 but not ≥60 years. Grade ≥3 serious treatment‐emergent adverse events occurred more with ibrutinib+R‐CHOP (45·6% vs. 31·3%). The percentage of patients receiving ≥6 cycles of R‐CHOP was similar across treatment arms in those <60 years. A numerical trend was seen towards improved EFS and PFS with ibrutinib+R‐CHOP versus placebo+R‐CHOP in patients with MYC‐high/BCL2‐high co‐expression. In this slightly younger Chinese subgroup, ibrutinib+R‐CHOP did not improve EFS in the ITT and ABC subpopulations but improved outcomes with manageable safety in patients <60 years, consistent with overall PHOENIX study outcomes. John Wiley and Sons Inc. 2022-08-30 /pmc/articles/PMC9713042/ /pubmed/36467814 http://dx.doi.org/10.1002/jha2.517 Text en © 2022 The Authors. eJHaem published by British Society for Haematology and John Wiley & Sons Ltd. https://creativecommons.org/licenses/by/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ (https://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Haematologic Malignancy ‐ Lymphoid
Zhu, Jun
Hong, Xiaonan
Song, Yu Qin
Hodkinson, Brendan
Balasubramanian, Sriram
Wang, Songbai
Zhang, Qingyuan
Shi, Yuankai
Huang, Huiqiang
Zhang, Huilai
Zhu, Yan
Shreeve, Stephen Martin
Sun, Steven
Wang, Ze
Wang, Xiaocan
Fan, Yue
Wilson, Wyndham
Vermeulen, Jessica
Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial
title Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial
title_full Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial
title_fullStr Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial
title_full_unstemmed Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial
title_short Ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre B‐cell‐like diffuse large B‐cell lymphoma: A Chinese subgroup analysis of the phase III PHOENIX trial
title_sort ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone in patients with previously untreated non‐germinal centre b‐cell‐like diffuse large b‐cell lymphoma: a chinese subgroup analysis of the phase iii phoenix trial
topic Haematologic Malignancy ‐ Lymphoid
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9713042/
https://www.ncbi.nlm.nih.gov/pubmed/36467814
http://dx.doi.org/10.1002/jha2.517
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