Resumen de Gemtuzumab ozogamicin for the treatment of untreated acute myeloid leukemia
Gloria Calzado Gómez, Rocío Gavira Moreno, Emilio Jesús Alegre del Rey, S. Fénix Caballero
Gemtuzumab ozogamicin (GO) is a recombinant, humanized anti-CD33 monoclonal covalently attached to the cytotoxic antitumor antibiotic calicheamicin. It has been approved in combination therapy with daunorubicin and cytarabine for treatment of patients aged 15 years and above with previously untreated, de novo CD33-positive acute myeloid leukemia (AML) except acute promyelocyte leukemia (APL). The efficacy and safety of GO were evaluated in a randomized, open-label and multicenter phase III study (ALFA-0701 study). Patients, (No. = 280) with previously untreated AML, were randomized (1:1) to standard chemotherapy (control group) with or without five doses of intravenous GO (3 mg/m2 on days 1,4, and 7 during induction and day 1 of each of the two consolidation chemotherapy courses). The primary endpoint was event-free survival (EFS), secondary end points included overall survival (OS) and safety. The addition of GO significantly increased median EFS (HR: 0.562:95% confidence interval (CI): 0.415-0.762; p = 0.0002). Subgroup analyses of EFS, indicated a more encouraging treatment effect in patients with favorable/intermediate cytogenetic risk (HR: 0.591; 95% CI, 0.407-0.857; p = 0.0047; vs adverse HR: 1.08). Improvement in SLP did not translate into a significant difference in overall survival (OS). All-causality grade 3 or 4 adverse events included infections and infestations (78% of GO group and 77% control group), hemorrhage (21% and 8%, respectively), skin toxicity (11% and 17%), mucosal toxicity (16% and 6,6%), pain (15% and 3,6%), nausea or vomiting or diarrhea (17% and 10%), pulmonary toxicity (13% and 14%). The main toxicity associated with GO was prolonged thrombocytopenia and veno occlusive disease. The incremental efficacy cost (IEC) in Spain was 3,686.4 to- 4,608 €/month without event gained. The addition of GO to standard chemotherapy improve the EFS in untreated AML patients, without causing excessive toxicity. The effect is more pronounced in patients with favorable/intermediate cytogenetic risk. Its high IEC could restrict the use of GO to the previous subgroup of patients. © 2020 Rasgo Editorial S.A.. All rights reserved.
