| Autor: |
Wang ES; Roswell Park Comprehensive Cancer Center, Buffalo, NY, USA., Aplenc R; The Children's Hospital of Philadelphia, Philadelphia, PA, USA., Chirnomas D; Pfizer Inc, New York, NY, USA., Dugan M; Franciscan Alliance, Indianapolis, IN, USA., Fazal S; Allegheny Health Network, Pittsburgh, PA, USA., Iyer S; Houston Medical Center, Houston, TX, USA., Lin TL; University of Kansas Medical Center, Kansas City, KS, USA., Nand S; Loyola University Medical Center, Maywood, IL, USA., Pierce KJ; Pfizer Inc, Groton, CT, USA., Shami PJ; Huntsman Cancer Institute, University of Utah, Salt Lake City, UT, USA., Vermette JJ; Pfizer Inc, Cambridge, MA, USA., Abboud CN; Washington University Medical School, St. Louis, MO, USA. |
| Abstrakt: |
Gemtuzumab ozogamicin (GO) remained available to US clinicians through an open-label expanded-access protocol (NCT02312037) until GO was reapproved. Patients were aged ≥3 months with relapsed/refractory (R/R) acute myeloid leukemia (AML), high-risk myelodysplastic syndrome, or acute promyelocytic leukemia (APL), and had exhausted other treatment options. Three hundred and thirty one patients received GO as monotherapy for R/R AML ( n = 139), combination therapy for R/R AML ( n = 183), or treatment for R/R APL ( n = 9). Corresponding treatment discontinuations occurred in 68, 39, and 33% of patients. All-causality grade 5 AEs occurred in 52, 22, and 22% of patients in the monotherapy, combination, and APL groups, respectively. Corresponding grades 3 and 4 treatment-related AEs were reported in 60, 55 and 78% of patients. Hepatotoxicity occurred in five patients: veno-occlusive disease ( n = 4) and drug-induced liver injury ( n = 1). GO was generally well tolerated in patients with R/R AML or APL. Most frequent treatment-related grade ≥3 AEs were hematologic AEs. Clinicaltrials.gov identifier: NCT02312037. |
