AML-243: Gemtuzumab Ozogamicin plus Standard Chemotherapy Carries a Comparable Burden of Hospitalization Compared with Standard Chemotherapy Alone in Acute Myeloid Leukemia

Context For patients with de novo acute myeloid leukemia (AML), adding fractionated dosing of 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]). Objective To evaluate whether adding GO to SC is associated with an increased hospitalization burden. Design In this phase 3 open-label trial, patients were enrolled between January 2008 and November 2010, and randomized 1:1 to GO+SC or SC alone. Data shown are for the safety reporting period (up to 28 days after last dose of study treatment). Setting Multicenter study conducted in France. Patients Patients were aged 50-70 years, had treatment-naive AML, and received fractionated-dose GO+SC (n=131) or SC alone (n=137) in the ALFA-0701 trial ( NCT00927498 ). Interventions Induction: 3+7 daunorubicin+cytarabine with/without GO 3 mg/m2 on days 1,4, 7. Consolidation: 2 courses with/without GO 3 mg/m2 on day 1. Main outcome measures Primary outcomes were previously published. In this post hoc analysis, we compared number of hospital admissions (planned or unplanned) and LOS with GO+SC vs SC, in the as-treated population and by treatment phase (induction vs consolidation). Results 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. Sponsor Pfizer.