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Levis, Mark J.; Hamadani, Mehdi; Logan, Brent; Jones, Richard J.; Singh, Anurag K.; Litzow, Mark; Wingard, John R.; Papadopoulos, Esperanza B.; Perl, Alexander E.; Soiffer, Robert J.; Ustun, Celalettin; Ueda Oshima, Masumi; Uy, Geoffrey L.; Waller, Edmund K.; Vasu, Sumithra; Solh, Melhem; Mishra, Asmita; Muffly, Lori; Kim, Hee-Je; Mikesch, Jan-Henrik; Najima, Yuho; Onozawa, Masahiro; Thomson, Kirsty; Nagler, Arnon; [...]

Gilteritinib as Post-Transplant Maintenance for Acute Myeloid Leukemia With Internal Tandem Duplication Mutation of FLT3

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  • Medientyp: E-Artikel
  • Titel: Gilteritinib as Post-Transplant Maintenance for Acute Myeloid Leukemia With Internal Tandem Duplication Mutation of FLT3
  • Beteiligte: Levis, Mark J.; Hamadani, Mehdi; Logan, Brent; Jones, Richard J.; Singh, Anurag K.; Litzow, Mark; Wingard, John R.; Papadopoulos, Esperanza B.; Perl, Alexander E.; Soiffer, Robert J.; Ustun, Celalettin; Ueda Oshima, Masumi; Uy, Geoffrey L.; Waller, Edmund K.; Vasu, Sumithra; Solh, Melhem; Mishra, Asmita; Muffly, Lori; Kim, Hee-Je; Mikesch, Jan-Henrik; Najima, Yuho; Onozawa, Masahiro; Thomson, Kirsty; Nagler, Arnon; [...]
  • Erschienen: American Society of Clinical Oncology (ASCO), 2024
  • Erschienen in: Journal of Clinical Oncology (2024)
  • Sprache: Englisch
  • DOI: 10.1200/jco.23.02474
  • ISSN: 0732-183X; 1527-7755
  • Entstehung:
  • Anmerkungen:
  • Beschreibung: <jats:sec><jats:title>PURPOSE</jats:title><jats:p> Allogeneic hematopoietic cell transplantation (HCT) improves outcomes for patients with acute myeloid leukemia (AML) harboring an internal tandem duplication mutation of FLT3 ( FLT3-ITD) AML. These patients are routinely treated with a FLT3 inhibitor after HCT, but there is limited evidence to support this. Accordingly, we conducted a randomized trial of post-HCT maintenance with the FLT3 inhibitor gilteritinib (ClinicalTrials.gov identifier: NCT02997202 ) to determine if all such patients benefit or if detection of measurable residual disease (MRD) could identify those who might benefit. </jats:p></jats:sec><jats:sec><jats:title>METHODS</jats:title><jats:p> Adults with FLT3-ITD AML in first remission underwent HCT and were randomly assigned to placebo or 120 mg once daily gilteritinib for 24 months after HCT. The primary end point was relapse-free survival (RFS). Secondary end points included overall survival (OS) and the effect of MRD pre- and post-HCT on RFS and OS. </jats:p></jats:sec><jats:sec><jats:title>RESULTS</jats:title><jats:p> Three hundred fifty-six participants were randomly assigned post-HCT to receive gilteritinib or placebo. Although RFS was higher in the gilteritinib arm, the difference was not statistically significant (hazard ratio [HR], 0.679 [95% CI, 0.459 to 1.005]; two-sided P = .0518). However, 50.5% of participants had MRD detectable pre- or post-HCT, and, in a prespecified subgroup analysis, gilteritinib was beneficial in this population (HR, 0.515 [95% CI, 0.316 to 0.838]; P = .0065). Those without detectable MRD showed no benefit (HR, 1.213 [95% CI, 0.616 to 2.387]; P = .575). </jats:p></jats:sec><jats:sec><jats:title>CONCLUSION</jats:title><jats:p> Although the overall improvement in RFS was not statistically significant, RFS was higher for participants with detectable FLT3-ITD MRD pre- or post-HCT who received gilteritinib treatment. To our knowledge, these data are among the first to support the effectiveness of MRD-based post-HCT therapy. </jats:p></jats:sec>