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<p>The addition of gemtuzumab ozogamicin (GO) to intensive chemotherapy (IC) has become a mainstay in treating patients with core binding factor acute myeloid leukemia (CBF-AML). However, evidence for the efficacy of GO in this particular subgroup is primarily based on meta-analytic data from different trials conducted more than a decade ago. In this registry-based study, we evaluated the impact of adding GO to IC in 265 CBF-AML patients from the SAL, AMLCG, and CELL cooperative study groups. Patients receiving GO had a 2-year overall survival of 90% compared with 80% in those without GO (hazard ratio [HR] 0.45, 95% confidence interval [CI] 0.21–0.95, <i>P</i> = 0.036) and a 2-year event-free survival of 51% versus 36% (HR 0.69, 95% CI 0.48–0.99, <i>P</i> = 0.046). While complete remission rates in GO vs. non-GO patients were comparable (89% vs. 90%, <i>P</i> = 0.81), more GO patients achieved measurable residual disease-negative remission (77% vs. 49%, <i>P</i> &lt; 0.001), resulting in numerically reduced cumulative incidence of relapse (HR 0.67, 95% CI 0.43–1.02, <i>P</i> = 0.06). Despite delayed platelet recovery, high-grade toxicities were not increased in GO-treated patients. These findings support the integration of GO into treatment protocols for IC-eligible patients with CBF-AML.</p>

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Gemtuzumab ozogamicin in first-line treatment of CBF-AML: insights from a retrospective multi-center analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月21日

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  • Julian Ronnacker,
  • Philippe J. Muller,
  • Jan-Henrik Mikesch,
  • Sven Zukunft,
  • Barbora Weinbergerová,
  • Jiří Šrámek,
  • Jan Valka,
  • Jan Novak,
  • Pavel Zak,
  • Tomas Szotkowski,
  • Zdenek Koristek,
  • Carolin Krekeler,
  • Julia M. Unglaub,
  • Tim Sauer,
  • Leo Ruhnke,
  • Sabrina Kraus,
  • Judith Schaffrath,
  • Lutz P. Müller,
  • Sabrina Kaes,
  • Dirk Niemann,
  • Lars Fransecky,
  • Patrick P. Hess,
  • Martina Crysandt,
  • Edgar Jost,
  • Joana Millo,
  • Johannes Gaertner,
  • Roland Repp,
  • Madlen Jentzsch,
  • Lea Hoppe,
  • Stefan Klein,
  • Franziska Modemann,
  • Nina Michalowski,
  • Klaudia Fischbach,
  • Wolfgang Blau,
  • Marion Ruhs,
  • Markus Ritter,
  • Julian Lohmeyer,
  • Björn Steffen,
  • Sarah Hauser,
  • Martin Kaufmann,
  • Stefan W. Krause,
  • Ricarda Knabe,
  • Karsten Spiekermann,
  • Hubert Serve,
  • Uwe Platzbecker,
  • Claudia D. Baldus,
  • Carsten Müller-Tidow,
  • Georg Lenz,
  • Hans Christian Reinhardt,
  • Jirí Mayer,
  • Martin Bornhäuser,
  • Christoph Röllig,
  • Christoph Schliemann,
  • Maher Hanoun

摘要

The addition of gemtuzumab ozogamicin (GO) to intensive chemotherapy (IC) has become a mainstay in treating patients with core binding factor acute myeloid leukemia (CBF-AML). However, evidence for the efficacy of GO in this particular subgroup is primarily based on meta-analytic data from different trials conducted more than a decade ago. In this registry-based study, we evaluated the impact of adding GO to IC in 265 CBF-AML patients from the SAL, AMLCG, and CELL cooperative study groups. Patients receiving GO had a 2-year overall survival of 90% compared with 80% in those without GO (hazard ratio [HR] 0.45, 95% confidence interval [CI] 0.21–0.95, P = 0.036) and a 2-year event-free survival of 51% versus 36% (HR 0.69, 95% CI 0.48–0.99, P = 0.046). While complete remission rates in GO vs. non-GO patients were comparable (89% vs. 90%, P = 0.81), more GO patients achieved measurable residual disease-negative remission (77% vs. 49%, P < 0.001), resulting in numerically reduced cumulative incidence of relapse (HR 0.67, 95% CI 0.43–1.02, P = 0.06). Despite delayed platelet recovery, high-grade toxicities were not increased in GO-treated patients. These findings support the integration of GO into treatment protocols for IC-eligible patients with CBF-AML.