Intensified cytarabine dose during consolidation in adult AML patients under 65 years is not associated with survival benefit: real-world data from the German SAL-AML registry

• Published in: Journal of cancer research and clinical oncology 2023-07, Vol.149 (8), p.4611-4621
• Main Authors: Hanoun, Maher, Ruhnke, Leo, Kramer, Michael, Hanoun, Christine, Schäfer-Eckart, Kerstin, Steffen, Björn, Sauer, Tim, Krause, Stefan W., Schliemann, Christoph, Mikesch, Jan-Henrik, Kaufmann, Martin, Hänel, Mathias, Jost, Edgar, Brümmendorf, Tim H., Fransecky, Lars, Kraus, Sabrina, Einsele, Hermann, Niemann, Dirk, Neubauer, Andreas, Kullmer, Johannes, Seggewiss-Bernhard, Ruth, Görner, Martin, Held, Gerhard, Kaiser, Ulrich, Scholl, Sebastian, Hochhaus, Andreas, Reinhardt, H. Christian, Platzbecker, Uwe, Baldus, Claudia D., Müller-Tidow, Carsten, Bornhäuser, Martin, Serve, Hubert, Röllig, Christoph
• Format: Article
• Language: English
• Subjects: Acute myeloid leukemia; Age; Allografts; Cancer Research; Cytarabine; Cytogenetics; Dosage; Hematology; Hematopoietic stem cells; Internal Medicine; Leukemia; Malignancy; Medicine; Medicine & Public Health; NCT; NCT03188874; Oncology; Patients; Remission; Remission (Medicine); Stem cell transplantation
• ISSN: 0171-5216; 1432-1335
• DOI: 10.1007/s00432-022-04356-9

Purpose Higher doses of cytarabine appear to improve long-term outcome in acute myeloid leukemia (AML), in particular for younger patients. To this end, the optimal dosage of single-agent cytarabine in consolidation therapy remains elusive. Here, we assessed the impact of different dosages of cytarabine consolidation after 7 + 3 induction on outcome in a large real-world data set from the German Study Alliance Leukemia-Acute Myeloid Leukemia (SAL-AML) registry. Methods Patients between 18 and 64 years of age, registered between April 2005 and September 2020, who attained complete remission after intensive induction and received at least one consolidation cycle with intermediate (IDAC) or high-dose cytarabine (HiDAC) were selected. To account for differences in patient and disease characteristics between both groups, the average treatment effect was estimated by propensity score weighting. Results Six-hundred-forty-two patients received HiDAC consolidation with median dosage of 17.6 (IQR (interquartile range), 16.5–18.0) g/m 2 for a median number of 3 cycles (IQR, 2–3), whereas 178 patients received IDAC consolidation with 5.9 (IQR, 5.7–8.6) g/m 2 for a median of 2 cycles (IQR, 1–3). Both groups differed significantly in some important characteristics (age, sex, cytogenetic risk group, ECOG performance status, disease status, HCT-CI, number of induction cycles). After propensity score weighting for differences in patient and disease characteristics, relapse-free survival after 2 years was comparable between HiDAC-treated (55.3%) and IDAC-treated (55.6%) patients (HR = 0.935, p  = 0.69). Moreover, no significant differences in overall survival were observed after 2 years (84.7 vs. 80.6%, HR = 1.101, p  = 0.65). Notably, more patients treated with IDAC received allogeneic hematopoietic cell transplantation in first remission (37.6 vs. 19.8%, p