Elderly CLL: meta-analysis evaluates ibrutinib safety vs other regimens

  • Zhou Y & al.
  • Medicine (Baltimore)
  • 1 Aug 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In elderly patients with chronic lymphocytic leukemia (CLL), ibrutinib was not associated with a significantly higher risk for hematologic adverse events (AEs) comprising anemia, thrombocytopenia, neutropenia, or febrile neutropenia vs other treatments.
  • Ibrutinib was tied to a higher risk for abdominal manifestations, including vomiting, abdominal pain, constipation, and diarrhea.

Why this matters

  • CLL is mainly diagnosed in elderly male patients.

Study design

  • Meta-analysis to investigate ibrutinib-associated AEs in elderly patients with CLL.
  • A search of medical publications databases yielded 5 applicable studies including 2456 patients with CLL: 1113 received ibrutinib and 1343 were considered nonibrutinib control patients. 
  • Mean age: 68.8 years in ibrutinib-treated patients; 68.0 years in control patients.
  • Funding: None.

Key results

  • Ibrutinib-treated patients demonstrated no significant increase in risk for:
    • Anemia: risk ratio (RR), 0.90; 95% CI, 0.67-1.21; P=.49.
    • Thrombocytopenia: RR, 0.61; 95% CI, 0.32-1.14; P=.12.
    • Neutropenia: RR, 0.50; 95% CI, 0.25-1.00; P=.05.
    • Febrile neutropenia: RR, 0.89; 95% CI, 0.32-2.49; P=.83.
  • Risk for respiratory tract infection was comparable in ibrutinib-treated patients and control patients: RR, 1.01; 95% CI, 0.78-1.30; P=.96.
  • Ibrutinib-treated patients had significantly elevated risk for:
    • Abdominal manifestations: RR, 1.62; 95% CI, 1.32-2.00; P=.00001.
    • Diarrhea: RR, 2.14; 95% CI, 1.44-3.17; P=.0002.

Limitations

  • Control group received a range of different therapies.
  • Bleeding events not captured.