Pediatric CML: are adult data driving TKI discontinuation?

  • de Bruijn CMA & al.
  • Br J Haematol
  • 6 Mar 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • More than two-thirds of the studied pediatric patients with chronic myeloid leukemia (CML) experienced molecular relapse after imatinib discontinuation.
  • These findings contrast with those of the adult STIM and EURO-SKI studies.

Why this matters

  • Study data in adults with CML may have biased decisions for TKI discontinuation in pediatric patients.

Study design

  • STOP IMAPED study to investigate effects of imatinib discontinuation in 14 pediatric patients with CML who sustained deep molecular remission (DMR) for ≥2 years.
  • All patients had achieved DMR at a median of 16 (range, 6-91) months.
  • Median age at discontinuation, 14 (range, 9-23) years.
  • Data for years 2015, 2016 were sourced from the International Paediatric CML (I-CML-ped) study.
  • Funding: None disclosed.  

Key results

  • Median follow-up, 105 (range, 51-183) months.
  • 10/14 patients experienced molecular relapse at a median of 3 (range, 1-6) months after imatinib discontinuation; 7 resumed imatinib, 3 initiated dasatinib.
  • All 10 patients regained DMR at a median of 8.5 (range, 1-34) months.
  • At the time of analysis, all patients were alive, there were no cases of progression to advanced phase.
  • 28.6% probability of maintaining DMR at 6 months after discontinuation.
  • Univariate analysis identified no significant predictors of sustained DMR.

Limitations

  • Retrospective data; limited sample size.

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