The DOI matches its Crossref record; 18 of the 18 references it cites were found in a registry or an index.
Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non–Germinal Center B-Cell Diffuse Large B-Cell Lymphoma
Open accessAbstract
PURPOSE: Ibrutinib has shown activity in non–germinal center B-cell diffuse large B-cell lymphoma (DLBCL). This double-blind phase III study evaluated ibrutinib and rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in untreated non–germinal center B-cell DLBCL. PATIENTS AND METHODS: Patients were randomly assigned at a one-to-one ratio to ibrutinib (560 mg per day orally) plus R-CHOP or placebo plus R-CHOP. The primary end point was event-free survival (EFS) in the intent-to-treat (ITT) population and the activated B-cell (ABC) DLBCL subgroup. Secondary end points included progression-free survival (PFS), overall survival (OS), and safety. RESULTS: A total of 838 patients were randomly assigned to ibrutinib plus R-CHOP (n = 419) or placebo plus R-CHOP (n = 419). Median age was 62.0 years; 75.9% of evaluable patients had ABC subtype disease, and baseline characteristics were balanced. Ibrutinib plus R-CHOP did not improve EFS in the ITT (hazard ratio [HR], 0.934) or ABC (HR, 0.949) population. A preplanned analysis showed a significant interaction between treatment and age. In patients age younger than 60 years, ibrutinib plus R-CHOP improved EFS (HR, 0.579), PFS (HR, 0.556), and OS (HR, 0.330) and slightly increased serious adverse events (35.7% v 28.6%), but the proportion of patients receiving at least six cycles of R-CHOP was similar between treatment arms (92.9% v 93.0%). In patients age 60 years or older, ibrutinib plus R-CHOP worsened EFS, PFS, and OS, increased serious adverse events (63.4% v 38.2%), and decreased the proportion of patients receiving at least six cycles of R-CHOP (73.7% v 88.8%). CONCLUSION: The study did not meet its primary end point in the ITT or ABC population. However, in patients age younger than 60 years, ibrutinib plus R-CHOP improved EFS, PFS, and OS with manageable safety. In patients age 60 years or older, ibrutinib plus R-CHOP was associated with increased toxicity, leading to compromised R-CHOP administration and worse outcomes. Further investigation is warranted.
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Cites
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Self-citationRevised Response Criteria for Malignant Lymphoma
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“ibrutinib, which is indicated in younger patients, from its adverse effect when combined with R-CHOP in older patients; this may be attributable to multiple factors, including impaired immune responses leading to increased infections.(25) Additionally, DLBCL subtype analysis, determined by immunohistochemistry at cent…”
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Cited by
Nakhoda, S., Vistarop, A., & Wang, Y. L. (2023) · British Journal of Haematology · doi:10.1111/bjh.18418 · Cited by 104
BTK inhibitors: past, present, and future
Cool, A., Nong, T., Montoya, S., & Taylor, J. (2024) · Trends in Pharmacological Sciences · doi:10.1016/j.tips.2024.06.006 · Cited by 63
Adaptive T-cell immunity controls senescence-prone MyD88- or CARD11-mutant B-cell lymphomas
Reimann, M., Schrezenmeier, J., Richter-Pechanska, P., Dolnik, A., Hick, T. P., Schleich, K., Cai, X., Fan, D. N. Y., Lohneis, P., Maßwig, S., et al. (2021) · Blood · doi:10.1182/blood.2020005244 · Cited by 59
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Metadata
- Authors
- Younes, A., Sehn, L. H., Johnson, P., Zinzani, P. L., Hong, X., Zhu, J., Patti, C., Belada, D., Samoilova, O., Suh, C., Leppä, S., Rai, S., Turgut, M., Jurczak, W., Cheung, M. C., Gurion, R., Yeh, S.-P., Lopez-Hernandez, A., Dührsen, U., Thieblemont, C., Chiattone, C. S., Balasubramanian, S., Carey, J., Liu, G., Shreeve, S. M., Sun, S., Zhuang, S. H., Vermeulen, J., Staudt, L. M., Wilson, W., & on behalf of the PHOENIX investigators
- Venue
- Journal of Clinical Oncology
- Published
- 2019-05-20
- Volume
- 37
- Issue
- 15
- Pages
- 1285-1295
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2923453543
- Cited by
- 608
- References
- 18
- FWCI
- 46.79
- Type
- journal article
- Language
- en
- Open access
- green
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- CoChat. (2026). Citation check: Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non–Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. https://app.cochat.ai/papers/10.1200/jco.18.02403
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- Younes, A., Sehn, L. H., Johnson, P., Zinzani, P. L., Hong, X., Zhu, J., Patti, C., Belada, D., Samoilova, O., Suh, C., Leppä, S., Rai, S., Turgut, M., Jurczak, W., Cheung, M. C., Gurion, R., Yeh, S.-P., Lopez-Hernandez, A., Dührsen, U., . . . on behalf of the PHOENIX investigators. (2019). Randomized Phase III Trial of Ibrutinib and Rituximab Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Non–Germinal Center B-Cell Diffuse Large B-Cell Lymphoma. Journal of Clinical Oncology. https://doi.org/10.1200/jco.18.02403
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.