Gemtuzumab ozogamicin in first-line treatment of CBF-AML: insights from a retrospective multi-center analysis.
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.
Authors
Ronnacker Ronnacker, Muller Muller, Mikesch Mikesch, Zukunft Zukunft, Weinbergerová Weinbergerová, Šrámek Šrámek, Valka Valka, Novak Novak, Zak Zak, Szotkowski Szotkowski, Koristek Koristek, Krekeler Krekeler, Unglaub Unglaub, Sauer Sauer, Ruhnke Ruhnke, Kraus Kraus, Schaffrath Schaffrath, Müller Müller, Kaes Kaes, Niemann Niemann, Fransecky Fransecky, Hess Hess, Crysandt Crysandt, Jost Jost, Millo Millo, Gaertner Gaertner, Repp Repp, Jentzsch Jentzsch, Hoppe Hoppe, Klein Klein, Modemann Modemann, Michalowski Michalowski, Fischbach Fischbach, Blau Blau, Ruhs Ruhs, Ritter Ritter, Lohmeyer Lohmeyer, Steffen Steffen, Hauser Hauser, Kaufmann Kaufmann, Krause Krause, Knabe Knabe, Spiekermann Spiekermann, Serve Serve, Platzbecker Platzbecker, Baldus Baldus, Müller-Tidow Müller-Tidow, Lenz Lenz, Reinhardt Reinhardt, Mayer Mayer, Bornhäuser Bornhäuser, Röllig Röllig, Schliemann Schliemann, Hanoun Hanoun
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