Publication Date:
2018-11-29
Description:
Introduction: Gemtuzumab ozogamicin (GO; MylotargTM) was approved by the US Food and Drug Administration in 2017 and the European Medicines Agency in 2018 in combination with standard of care (SOC) chemotherapy (daunorubicin/cytarabine) for the treatment of de novo acute myeloid leukemia (AML). Although initial remission rates for de novo AML are high, overall survival (OS) is low; however, a proportion of patients experience long-term remission (〉5 years) and can be considered cured. Statistically cured populations can be estimated by fitting mixture cure models (MCMs) to survival data, a method that takes into account background survival rates. The objective of this research was to assess and compare the statistical cure rates with GO plus SOC vs SOC alone among adult patients with de novo AML. Methods: MCMs (Weibull, lognormal, and gamma) were fitted to patient-level data from the phase 3 ALFA-0701 trial on event-free survival (EFS) and OS of patients with remission (GO plus SOC: n=100; SOC alone: n=96), and OS of all patients (with remission and refractory; GO plus SOC: n=135; SOC alone: n=136). As refractory patients do not experience remission, this methodology would not provide clinically meaningful results since they are unlikely to experience a cure. Analyses for the subgroup excluding patients with adverse cytogenetics were also explored. For the GO plus SOC arm, P values
Print ISSN:
0006-4971
Electronic ISSN:
1528-0020
Topics:
Biology
,
Medicine