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Volume 22 - Issue 2, April-June 2020
SPECIAL ARTICLES
GEMTUZUMAB OZOGAMICIN FOR THE TREATMENT OF UNTREATED ACUTE MYELOID LEUKEMIA
CALZADO GÓMEZ GLORIA, GAVIRA MORENO ROCÍO, ALEGRE DEL REY EMILIO JESÚS, FÉNIX CABALLERO SILVIA


Gemtuzumab ozogamicin (GO) is a recombinant, humanized anti-CD33 mon-
oclonal 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 promyelocytic 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 previ- ously 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 fa- vorable/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 dif- ference 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 re- strict the use of GO to the previous subgroup of patients.

ACUTE MYELOID LEUKEMIA — CYTOGENETICS — EVENT FREE SURVIVAL — GEMTUZUMAB OZOGAMICIN — OVERALL SURVIVAL — UNTREATED



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