IBRORS-MCL study: a Spanish retrospective and observational study of relapsed/refractory mantle-cell lymphoma treated with ibrutinib in routine clinical practice

Int J Hematol. 2022 Sep;116(3):381-392. doi: 10.1007/s12185-022-03367-z. Epub 2022 May 13.

Abstract

This retrospective study evaluated 66 patients diagnosed with relapsed and/or refractory mantle cell lymphoma (R/R MCL) treated with ibrutinib in Spain in routine clinical practice. At diagnosis, patients had a median age of 64.5 years, 63.6% presented with intermediate/high sMIPI (simplified prognostic index for advanced-stage mantle cell lymphoma), 24.5% had the blastoid variant, and 55.6% had a Ki67 > 30%. Patients had received a median of 2 prior lines of therapy (range 1-2; min-max 1-7). Overall response rate was 63.5%, with 38.1% of patients achieving complete response (CR). With a median duration of ibrutinib exposure of 10.7 months (range 5.2-19.6; min-max 0.3-36), the median progression-free survival (PFS) and overall survival (OS) were 20 months [95% confidence interval (CI) 8.8-31.1] and 32 months (95% CI 22.6-41.3), respectively, and were not reached in patients achieving CR. No grade ≥ 3 cardiovascular toxicity or bleeding was reported. This study supports that treatment with ibrutinib leads to high response rates and favorable survival outcomes in patients with R/R MCL.

Keywords: Clinical practice; Ibrutinib; Mantle-cell lymphoma; Real-world evidence; Relapsed/refractory.

Publication types

  • Observational Study

MeSH terms

  • Adenine / analogs & derivatives
  • Adult
  • Humans
  • Lymphoma, Mantle-Cell*
  • Middle Aged
  • Neoplasm Recurrence, Local / drug therapy
  • Piperidines
  • Pyrazoles / adverse effects
  • Pyrimidines
  • Retrospective Studies

Substances

  • Piperidines
  • Pyrazoles
  • Pyrimidines
  • ibrutinib
  • Adenine