OBJECTIVES: For patients with de novo acute myeloid leukemia (AML), adding fractionated dose gemtuzumab ozogamicin (GO) to standard chemotherapy (SC) has resulted in improved outcomes. Such combination therapies may be perceived to increase the hospitalization burden (i.e., increasing either hospital admissions or length-of-hospital-stay [LOS]). Therefore, this analysis seeks to evaluate whether adding GO to SC is associated with an increased hospitalization burden.

METHODS: This post hoc analysis included participants aged 50-70 years with treatment-naïve AML from the ALFA-0701 trial (NCT00927498), who received fractionated dose GO + SC (n=131) or SC alone (n=137). All patients were hospitalized for treatment administration. We compared number of admissions (planned or unplanned) and LOS with GO + SC vs SC, in the as-treated population and by treatment phase (induction vs consolidation). Data shown are for the safety reporting period (up to 28 days after last dose of study treatment).

RESULTS: Throughout the safety reporting period, the mean number of hospital admissions was identical for GO + SC vs SC (2.9), with no significant difference in mean LOS (10.9 vs 10.0 weeks, p=0.16). Similarly, the mean number of intensive care unit admissions was 1.1 vs 1.0 for GO + SC vs SC, with mean LOS 1.25 vs 1.54 weeks, p=0.71.

For patients receiving induction chemotherapy (including second induction/salvage), no significant difference was seen in LOS between GO + SC vs SC (mean 6.1 vs 5.6 weeks, p=0.64). For patients receiving consolidation chemotherapy (n=97 in each treatment arm), no significant difference was seen in mean LOS (6.5 vs 6.1 weeks for GO + SC vs SC, p=0.42).

CONCLUSIONS: This analysis shows that, in the ALFA-0701 trial, adding GO to SC for frontline AML did not significantly alter the associated hospitalization burden. Adding GO to SC is therefore not expected to increase healthcare resource utilization or related costs.