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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. | LitMetric

AI Article Synopsis

  • A subgroup analysis of 200 patients from the phase III PHOENIX trial found that ibrutinib added to the R-CHOP regimen did not enhance event-free survival (EFS) when compared to a placebo in the overall population and specific subgroups.
  • In patients under 60 years old, ibrutinib combined with R-CHOP showed improved EFS and progression-free survival (PFS), while patients 60 and older did not benefit similarly.
  • The combination treatment led to a higher occurrence of serious adverse events (45.6% vs. 31.3%) but maintained a similar treatment cycle completion rate among younger patients.

Article Abstract

In this post hoc subgroup analysis of 200 patients enrolled in China from the phase III PHOENIX trial (= 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;  = 200, hazard ratio [HR] = 0.83, 95% confidence interval [CI]: 0·509-1.349; = 0.4495) or activated B-cell-like (ABC;  = 141 [based on available gene-expression profiling data], HR = 0.86, 95% CI: 0.467-1.570; = 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 -high/-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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Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9713042PMC
http://dx.doi.org/10.1002/jha2.517DOI Listing

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